paliperidone (Rx)

Brand and Other Names:Invega, Invega Sustenna, more...Invega Trinza, Invega Hafyera
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet, extended release

  • 1.5mg
  • 3mg
  • 6mg
  • 9mg

IM injectable suspension prefilled syringe (once monthly, Invega Sustenna)

  • 39mg
  • 78mg
  • 117mg
  • 156mg
  • 234mg

IM injectable suspension prefilled syringe (q3month, Invega Trinza)

  • 273mg
  • 410mg
  • 546mg
  • 819mg

IM injectable suspension prefilled syringe (q6month, Invega Hafyera)

  • 1,092mg/3.5mL
  • 1,560mg/5mL

Schizophrenia

PO

  • 6 mg PO qAM; may be titrated upward or downward in increments of 3 mg/day at intervals ≥5 days; not to exceed 12 mg/day

IM, extended-released 1-month (Invega Sustenna)

  • 234 mg in deltoid on treatment day 1, then 156 mg 1 week later (day 8)
  • Recommended maintenance dose is 117 mg IM once monthly, although some patients may require lower or higher dosages (monthly dose range 39-234 mg)

IM, extended-released 3-months (Invega Trinza)

  • Patients must be adequately treated with Invega Sustenna (1-month paliperidone) for at least 4 months before initiating Invega Trinza
  • Dose initiation dependent on once-monthly Invega Sustenna dose
    • Initiate Invega Trinza when the next 1-month paliperidone dose is scheduled with an Invega Trinza dose based on the previous 1-month injection dose (see below)
  • Conversion from monthly injection to 3-month injection
    • Invega Sustenna 78 mg/month: Initiate Invega Trinza at 273 mg IM q3mo
    • Invega Sustenna 117 mg/month: Initiate Invega Trinza at 410 mg IM q3mo
    • Invega Sustenna 156 mg/month: Initiate Invega Trinza at 546 mg IM q3mo
    • Invega Sustenna 234 mg/month: Initiate Invega Trinza at 819 mg IM q3mo
  • Conversion from 3-month IM injection to extended-release tablets
    • 273 mg IM (last 3 months to 24wk): 3 mg ER tab
    • 410 mg IM (last 3 months to 24wk): 3 mg ER tab; 6 mg if >24wk
    • 546 mg IM (last 3 months to 18 wk): 3 mg ER tab; 6 mg if 18-24 wk; 9 mg if >24 wk
    • 819 mg IM (last 3 months to 18 wk): 6 mg ER tab; 9 mg if 18-24 wk; 12 mg if >24 wk

IM, extended-released 6-months (Invega Hafyera)

  • Patients must be adequately treated with Invega Sustenna (1-month paliperidone) for at least 4 months OR with Invega Trinza (3-month paliperidone) for at least one 3-month cycle before initiating Invega Hafyera
  • Conversion from monthly injection to 6-month injection
    • Initiate Invega Hafyera when next Invega Sustenna dose is scheduled
    • Invega Sustenna 156 mg/month: Initiate Invega Hafyera at 1,092 mg IM q6mo
    • Invega Sustenna 234 mg/month: Initiate Invega Hafyera at 1,560 mg IM q6mo
    • There are no equivalent doses of Invega Hafyera for Invega Sustenna 39-mg, 78-mg, or 117-mg doses, which were not studied
  • Conversion from 3-month injection to 6-month injection
    • Initial Invega Hafyera dose is based on the previous Invega Trinza
    • Initiate Invega Hafyera when next Invega Trinza dose is scheduled
    • May administer Invega Hafyera dose up to 2 weeks before or after the next scheduled Invega Trinza
    • Invega Trinza 546 mg q3mo: Initiate Invega Hafyera at 1,092 mg IM q6mo
    • Invega Trinza 819 mg q3mo: Initiate Invega Hafyera at 1,560 mg IM q6mo
    • There are no equivalent doses of Invega Hafyera for Invega Trinza 273-mg or 410-mg doses, which were not studied
  • Dosing interval and dosage adjustments
    • Following initial dose, administer Invega Hafyera IM q6mo
    • May adjust dosage every 6 months between 1,092 mg and 1,560 mg based on individual response and tolerability, if necessary
    • Owing to the potential longer duration to Invega Hafyera, patient’s response to an adjusted dose may not be apparent for several months

Schizoaffective Disorder

Indicated for schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers or antidepressants

6 mg PO qDay in am (range 3-12 mg); titration may not be necessary; if exceeding 6 mg/day, increases of 3 mg/day recommended at intervals of 4 days of more; not to exceed 12 mg/day

IM (initial): 234 mg in deltoid on treatment day 1, then 156 mg 1 week later (day 8)

IM (maintenance): Administer once each month IM in deltoid or gluteal muscle; adjust dose based on tolerability and/or efficacy using available strengths; maintenance dose ranges between 78-234 mg once monthly

Dosing Modifications

Renal impairment (PO)

  • CrCl 50-79 mL/min: 3 mg/day initially; not to exceed 6 mg/day
  • CrCl 10-49 mL/min: 1.5 mg/day initially; not to exceed 3 mg/day
  • CrCl <10 mL/min: Not recommended

Renal impairment (IM)

  • Invega Hafyera: Not recommended for all severities of renal impairment
  • Invega Sustenna
    • Mild (CrCl 50-79 mL/min): 156 mg IM in deltoid on treatment day 1, then 117 mg 1 week later; maintenance: 78 mg IM monthly
    • Moderate to severe (CrCl <50 mL/min): Not recommended
  • Invega Trinza
    • Mild (CrCl 50-79 mL/min): Adjust dosage and stabilize the patient using the 1-month paliperidone palmitate extended-release injectable suspension (Invega Sustenna), then transition to Invega Trinza
    • Moderate to severe (CrCl <50 mL/min): Not recommended

Hepatic impairment

  • IM: Not studied
  • PO
    • Mild-to-moderate: No dosage adjustment necessary
    • Severe: Not studied

Dosing Considerations

Patients with Parkinson disease or dementia with Lewy bodies can experience increased sensitivity to paliperidone

Manifestations can include confusion, obtundation, postural instability with frequent falls, extrapyramidal symptoms, and clinical features consistent with neuroleptic malignant syndrome

Dosage Forms & Strengths

tablet, extended-release

  • 1.5mg
  • 3mg
  • 6mg
  • 9mg

Schizophrenia

<12 years: Safety and efficacy not established

≥12 years (<51 kg): 3 mg/day PO initially; may be increased if necessary in increments of 3 mg/day at intervals ≥5 days; not to exceed 6 mg/day

≥12 years (≥51 kg): 3 mg/day PO initially; may be increased if necessary in increments of 3 mg/day at intervals ≥5 days; not to exceed 12 mg/day

Schizoaffective Disorder

<18 years: Safety and efficacy not established

After oral administration in elderly subjects, the peak plasma concentration and AUC increased 1.2-fold compared to young subjects; may be attributable to age-related decreases in creatinine clearance

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Interactions

Interaction Checker

and paliperidone

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            Contraindicated (2)

            • goserelin

              goserelin increases toxicity of paliperidone by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • leuprolide

              leuprolide increases toxicity of paliperidone by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            Serious - Use Alternative (72)

            • afatinib

              paliperidone increases levels of afatinib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Reduce afatinib daily dose by 10 mg if not tolerated when coadministered with P-gp inhibitors.

            • alfuzosin

              alfuzosin and paliperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • amiodarone

              amiodarone and paliperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • apomorphine

              paliperidone decreases effects of apomorphine by pharmacodynamic antagonism. Avoid or Use Alternate Drug.

              apomorphine and paliperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • aripiprazole

              aripiprazole and paliperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • arsenic trioxide

              arsenic trioxide and paliperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • artemether

              artemether and paliperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • atomoxetine

              atomoxetine and paliperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • benzhydrocodone/acetaminophen

              benzhydrocodone/acetaminophen, paliperidone. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

            • bromocriptine

              paliperidone decreases effects of bromocriptine by pharmacodynamic antagonism. Avoid or Use Alternate Drug.

            • cabergoline

              paliperidone decreases effects of cabergoline by pharmacodynamic antagonism. Contraindicated.

            • calcium/magnesium/potassium/sodium oxybates

              paliperidone, calcium/magnesium/potassium/sodium oxybates. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

            • ceritinib

              ceritinib and paliperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • clozapine

              clozapine and paliperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • degarelix

              degarelix and paliperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • desflurane

              desflurane and paliperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • disopyramide

              disopyramide and paliperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • dopamine

              paliperidone decreases effects of dopamine by pharmacodynamic antagonism. Contraindicated.

            • edoxaban

              paliperidone will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended

            • encorafenib

              encorafenib and paliperidone both increase QTc interval. Avoid or Use Alternate Drug. Encorafenib is associated with dose-dependent QTc interval prolongation. Avoid with drugs known to prolong QT interval.

            • entrectinib

              paliperidone and entrectinib both increase QTc interval. Avoid or Use Alternate Drug.

            • erdafitinib

              erdafitinib will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If coadministration unavoidable, separate administration by at least 6 hr before or after administration of P-gp substrates with narrow therapeutic index.

            • eribulin

              eribulin and paliperidone both increase QTc interval. Avoid or Use Alternate Drug. Potential for enhanced QTc-prolonging effects; if concurrent use is necessary then ECG monitoring is recommended.

            • escitalopram

              escitalopram increases toxicity of paliperidone by QTc interval. Avoid or Use Alternate Drug.

            • fexinidazole

              fexinidazole and paliperidone both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels and/or prolong QT interval.

            • glasdegib

              paliperidone and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • histrelin

              histrelin increases toxicity of paliperidone by QTc interval. Avoid or Use Alternate Drug. Increases risk of torsades de pointes.

            • hydrocodone

              hydrocodone, paliperidone. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

            • hydroxychloroquine sulfate

              hydroxychloroquine sulfate and paliperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • ibutilide

              ibutilide and paliperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • indapamide

              indapamide and paliperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • inotuzumab

              inotuzumab and paliperidone both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

            • ivosidenib

              ivosidenib and paliperidone both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of QTc prolonging drugs with ivosidenib or replace with alternate therapies. If coadministration of a QTc prolonging drug is unavoidable, monitor for increased risk of QTc interval prolongation.

            • lasmiditan

              lasmiditan increases levels of paliperidone by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

            • lefamulin

              lefamulin and paliperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • levodopa

              paliperidone decreases effects of levodopa by pharmacodynamic antagonism. Avoid or Use Alternate Drug.

            • levodopa inhaled

              paliperidone decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Atypical (2nd generation) antipsychotics inhibit dopamine D2 receptors in varying degrees (clozapine and quetiapine are lower risk). .

            • lisuride

              paliperidone decreases effects of lisuride by pharmacodynamic antagonism. Contraindicated.

            • macimorelin

              macimorelin and paliperidone both increase QTc interval. Avoid or Use Alternate Drug. Macimorelin causes an increase of ~11 msec in the corrected QT interval. Avoid coadministration with drugs that prolong QT interval, which could increase risk for developing torsade de pointes-type ventricular tachycardia. Allow sufficient washout time of drugs that are known to prolong the QT interval before administering macimorelin.

            • mefloquine

              mefloquine increases toxicity of paliperidone by QTc interval. Avoid or Use Alternate Drug. Mefloquine may enhance the QTc prolonging effect of high risk QTc prolonging agents.

            • methyldopa

              paliperidone decreases effects of methyldopa by pharmacodynamic antagonism. Contraindicated.

            • metoclopramide intranasal

              paliperidone, metoclopramide intranasal. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.

              paliperidone increases toxicity of metoclopramide intranasal by pharmacodynamic synergism. Avoid or Use Alternate Drug. Potential for additive effects, including increased frequency and severity of tardive dyskinesia, other extrapyramidal symptoms, and neuroleptic malignant syndrome.

            • mobocertinib

              mobocertinib and paliperidone both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce mobocertinib dose and monitor QTc interval more frequently.

            • ondansetron

              paliperidone and ondansetron both increase QTc interval. Avoid or Use Alternate Drug. Avoid with congenital long QT syndrome; ECG monitoring recommended with concomitant medications that prolong QT interval, electrolyte abnormalities, CHF, or bradyarrhythmias.

            • oxaliplatin

              oxaliplatin will increase the level or effect of paliperidone by Other (see comment). Avoid or Use Alternate Drug. Monitor for ECG changes if therapy is initiated in patients with drugs known to prolong QT interval.

            • panobinostat

              paliperidone and panobinostat both increase QTc interval. Avoid or Use Alternate Drug. Panobinostat is known to significantly prolong QT interval. Panobinostat prescribing information states use with drugs known to prolong QTc is not recommended.

            • pentamidine

              paliperidone and pentamidine both increase QTc interval. Avoid or Use Alternate Drug.

            • pimavanserin

              paliperidone and pimavanserin both increase QTc interval. Avoid or Use Alternate Drug. Coadministration may increase the risk of QT prolongation and cardiac arrhythmia.

            • pimozide

              paliperidone and pimozide both increase QTc interval. Avoid or Use Alternate Drug.

            • pitolisant

              paliperidone and pitolisant both increase QTc interval. Avoid or Use Alternate Drug.

            • pomalidomide

              paliperidone increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

            • pramipexole

              paliperidone decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

            • procainamide

              paliperidone and procainamide both increase QTc interval. Avoid or Use Alternate Drug.

            • quinidine

              quinidine will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              quinidine and paliperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • ribociclib

              ribociclib and paliperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • riociguat

              paliperidone will increase the level or effect of riociguat by decreasing metabolism. Avoid or Use Alternate Drug. Coadministration of riociguat (substrate of CYP isoenzymes 1A1, 2C8, 3A, 2J2) with strong CYP inhibitors may require a decreased initial dose of 0.5 mg PO TID; monitor for signs of hypotension and reduce dose if needed

            • romidepsin

              paliperidone and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.

            • ropinirole

              paliperidone decreases effects of ropinirole by pharmacodynamic antagonism. Contraindicated.

            • safinamide

              paliperidone decreases effects of safinamide by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Dopamine antagonists may decrease safinamide effects and exacerbate Parkinson disease symptoms.

            • saquinavir

              saquinavir, paliperidone. Either increases toxicity of the other by QTc interval. Avoid or Use Alternate Drug. Increased risk of QT prolongation and cardiac arrhythmias.

            • selinexor

              selinexor, paliperidone. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.

            • sodium oxybate

              paliperidone, sodium oxybate. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

            • sotalol

              paliperidone and sotalol both increase QTc interval. Avoid or Use Alternate Drug.

            • sotorasib

              sotorasib will decrease the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.

            • sufentanil SL

              sufentanil SL, paliperidone. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration may result in hypotension, profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

            • tepotinib

              tepotinib will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.

            • triptorelin

              triptorelin increases toxicity of paliperidone by QTc interval. Avoid or Use Alternate Drug. Increases risk of torsades de pointes.

            • umeclidinium bromide/vilanterol inhaled

              paliperidone increases toxicity of umeclidinium bromide/vilanterol inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.

            • vandetanib

              paliperidone, vandetanib. Either increases toxicity of the other by QTc interval. Avoid or Use Alternate Drug. Avoid coadministration with drugs known to prolong QT interval; if a drug known to prolong QT interval must be used, more frequent ECG monitoring is recommended.

            • vemurafenib

              vemurafenib and paliperidone both increase QTc interval. Avoid or Use Alternate Drug. Concomitant use of vemurafenib with drugs that prolong QT interval is not recommended.

            • venetoclax

              paliperidone will increase the level or effect of venetoclax by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If a P-gp inhibitor must be used, reduce the venetoclax dose by at least 50%. Monitor more closely for signs of venetoclax toxicities.

            • vilanterol/fluticasone furoate inhaled

              paliperidone increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.

            Monitor Closely (372)

            • abobotulinumtoxinA

              abobotulinumtoxinA increases effects of paliperidone by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.

            • acarbose

              paliperidone, acarbose. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • aclidinium

              aclidinium decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of aclidinium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • albiglutide

              paliperidone, albiglutide. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • albuterol

              paliperidone increases and albuterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              albuterol and paliperidone both increase QTc interval. Use Caution/Monitor.

            • alfentanil

              alfentanil and paliperidone both increase sedation. Use Caution/Monitor.

            • alfuzosin

              paliperidone and alfuzosin both increase QTc interval. Use Caution/Monitor.

            • almotriptan

              almotriptan, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • alprazolam

              alprazolam and paliperidone both increase sedation. Use Caution/Monitor.

            • amifostine

              amifostine, paliperidone. Either increases effects of the other by anti-hypertensive channel blocking. Use Caution/Monitor. Due to its alpha adrenergic antagonism, atypical antipsychotic agents has the potential to enhance the effect of certain antihypertensive agents. Monitor blood pressure and adjust dose accordingly.

            • amiodarone

              amiodarone will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • amitriptyline

              amitriptyline and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              paliperidone and amitriptyline both increase sedation. Use Caution/Monitor.

            • amobarbital

              amobarbital and paliperidone both increase sedation. Use Caution/Monitor.

            • amoxapine

              paliperidone and amoxapine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely.

              amoxapine and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              paliperidone and amoxapine both increase sedation. Use Caution/Monitor.

            • anticholinergic/sedative combos

              anticholinergic/sedative combos decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              anticholinergic/sedative combos decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of anticholinergic/sedative combos by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • apomorphine

              paliperidone and apomorphine both increase sedation. Use Caution/Monitor.

            • arformoterol

              paliperidone increases and arformoterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              arformoterol and paliperidone both increase QTc interval. Use Caution/Monitor.

            • aripiprazole

              aripiprazole and paliperidone both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              aripiprazole and paliperidone both increase sedation. Use Caution/Monitor.

            • armodafinil

              paliperidone increases and armodafinil decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • artemether/lumefantrine

              artemether/lumefantrine and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

            • atorvastatin

              atorvastatin will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • atracurium

              atracurium decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              atracurium decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of atracurium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • atropine

              atropine decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              atropine decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of atropine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • atropine IV/IM

              paliperidone increases effects of atropine IV/IM by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              atropine IV/IM decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              atropine IV/IM decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

            • azelastine

              azelastine and paliperidone both increase sedation. Use Caution/Monitor.

            • baclofen

              baclofen and paliperidone both increase sedation. Use Caution/Monitor.

            • bedaquiline

              paliperidone and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely

            • belladonna alkaloids

              belladonna alkaloids decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              belladonna alkaloids decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • belladonna and opium

              belladonna and opium and paliperidone both increase sedation. Use Caution/Monitor.

              belladonna and opium decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              belladonna and opium decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of belladonna and opium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • benazepril

              paliperidone increases toxicity of benazepril by pharmacodynamic synergism. Use Caution/Monitor. Increases risk of hypotension.

              benazepril increases toxicity of paliperidone by pharmacodynamic synergism. Use Caution/Monitor. Increases risk of hypotension.

            • benperidol

              benperidol and paliperidone both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              benperidol and paliperidone both increase sedation. Use Caution/Monitor.

            • benzphetamine

              paliperidone increases and benzphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • berotralstat

              berotralstat will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.

            • betrixaban

              paliperidone increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.

            • bosutinib

              bosutinib increases levels of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • brexanolone

              brexanolone, paliperidone. Either increases toxicity of the other by sedation. Use Caution/Monitor.

            • brompheniramine

              brompheniramine and paliperidone both increase sedation. Use Caution/Monitor.

            • buprenorphine

              buprenorphine and paliperidone both increase sedation. Use Caution/Monitor.

            • buprenorphine buccal

              buprenorphine buccal and paliperidone both increase sedation. Use Caution/Monitor.

            • buprenorphine, long-acting injection

              paliperidone increases toxicity of buprenorphine, long-acting injection by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of buprenorphine and benzodiazepines or other CNS depressants increases risk of adverse reactions including overdose, respiratory depression, and death. Cessation of benzodiazepines or other CNS depressants is preferred in most cases. In some cases, monitoring at a higher level of care for tapering CNS depressants may be appropriate. In others, gradually tapering a patient off of a prescribed benzodiazepine or other CNS depressant or decreasing to the lowest effective dose may be appropriate.

            • butabarbital

              butabarbital and paliperidone both increase sedation. Use Caution/Monitor.

            • butalbital

              butalbital and paliperidone both increase sedation. Use Caution/Monitor.

            • butorphanol

              butorphanol and paliperidone both increase sedation. Use Caution/Monitor.

            • caffeine

              paliperidone increases and caffeine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • captopril

              paliperidone, captopril. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs lower blood pressure. Monitor blood pressure.

            • carbamazepine

              carbamazepine will decrease the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Paliperidone dose may need to be increased when coadministered with strong inducers of both CYP3A4 and P-gp

            • carbinoxamine

              carbinoxamine and paliperidone both increase sedation. Use Caution/Monitor.

            • carisoprodol

              carisoprodol and paliperidone both increase sedation. Use Caution/Monitor.

            • cenobamate

              cenobamate, paliperidone. Either increases effects of the other by sedation. Use Caution/Monitor.

            • ceritinib

              paliperidone increases levels of ceritinib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • chloral hydrate

              chloral hydrate and paliperidone both increase sedation. Use Caution/Monitor.

            • chlordiazepoxide

              chlordiazepoxide and paliperidone both increase sedation. Use Caution/Monitor.

            • chloroquine

              chloroquine increases toxicity of paliperidone by QTc interval. Use Caution/Monitor.

            • chlorpheniramine

              chlorpheniramine and paliperidone both increase sedation. Use Caution/Monitor.

            • chlorpromazine

              chlorpromazine and paliperidone both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              chlorpromazine and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              chlorpromazine and paliperidone both increase sedation. Use Caution/Monitor.

            • chlorpropamide

              paliperidone, chlorpropamide. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • chlorzoxazone

              chlorzoxazone and paliperidone both increase sedation. Use Caution/Monitor.

            • cinnarizine

              cinnarizine and paliperidone both increase sedation. Use Caution/Monitor.

            • ciprofloxacin

              ciprofloxacin and paliperidone both increase QTc interval. Use Caution/Monitor. Ciprofloxacin elicits minimal effects on QT interval. Caution if used in combination with other drugs known to affect QT interval or in patients with other risk factors.

            • cisatracurium

              cisatracurium decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              cisatracurium decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of cisatracurium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • citalopram

              paliperidone and citalopram both increase QTc interval. Use Caution/Monitor. ECG monitoring is recommended, along with drugs that may prolong the QT interval.

            • clarithromycin

              clarithromycin will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              clarithromycin and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

            • clemastine

              clemastine and paliperidone both increase sedation. Use Caution/Monitor.

            • clobazam

              paliperidone, clobazam. Other (see comment). Use Caution/Monitor. Comment: Concomitant administration can increase the potential for CNS effects (e.g., increased sedation or respiratory depression).

            • clomipramine

              clomipramine and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              paliperidone and clomipramine both increase sedation. Use Caution/Monitor.

            • clonazepam

              clonazepam and paliperidone both increase sedation. Use Caution/Monitor.

            • clonidine

              clonidine, paliperidone. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Additive hypotensive effects; potential delirium.

            • clorazepate

              clorazepate and paliperidone both increase sedation. Use Caution/Monitor.

            • clotrimazole

              clotrimazole will decrease the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • clozapine

              clozapine and paliperidone both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              clozapine and paliperidone both increase sedation. Use Caution/Monitor.

            • codeine

              codeine and paliperidone both increase sedation. Use Caution/Monitor.

            • crizotinib

              crizotinib and paliperidone both increase QTc interval. Use Caution/Monitor. ECG monitoring is recommended, along with drugs that may prolong the QT interval.

            • cyclizine

              cyclizine and paliperidone both increase sedation. Use Caution/Monitor.

              cyclizine decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              cyclizine decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of cyclizine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • cyclobenzaprine

              cyclobenzaprine and paliperidone both increase sedation. Use Caution/Monitor.

              cyclobenzaprine decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              cyclobenzaprine decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of cyclobenzaprine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • cyproheptadine

              cyproheptadine and paliperidone both increase sedation. Use Caution/Monitor.

            • dabigatran

              paliperidone will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • dantrolene

              dantrolene and paliperidone both increase sedation. Use Caution/Monitor.

            • darifenacin

              darifenacin decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              darifenacin decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of darifenacin by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • dasatinib

              dasatinib and paliperidone both increase QTc interval. Use Caution/Monitor.

            • desflurane

              desflurane and paliperidone both increase sedation. Use Caution/Monitor.

            • desipramine

              desipramine and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              paliperidone and desipramine both increase sedation. Use Caution/Monitor.

            • deutetrabenazine

              paliperidone and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              paliperidone and deutetrabenazine both increase sedation. Use Caution/Monitor.

              paliperidone and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • dexchlorpheniramine

              dexchlorpheniramine and paliperidone both increase sedation. Use Caution/Monitor.

            • dexfenfluramine

              paliperidone increases and dexfenfluramine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • dexmedetomidine

              dexmedetomidine and paliperidone both increase sedation. Use Caution/Monitor.

            • dexmethylphenidate

              paliperidone increases and dexmethylphenidate decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • dextroamphetamine

              paliperidone increases and dextroamphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • dextromethorphan

              dextromethorphan, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • dextromoramide

              dextromoramide and paliperidone both increase sedation. Use Caution/Monitor.

            • diamorphine

              diamorphine and paliperidone both increase sedation. Use Caution/Monitor.

            • diazepam

              diazepam and paliperidone both increase sedation. Use Caution/Monitor.

            • dicyclomine

              dicyclomine decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              dicyclomine decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of dicyclomine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • diethylpropion

              paliperidone increases and diethylpropion decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • difenoxin hcl

              difenoxin hcl and paliperidone both increase sedation. Use Caution/Monitor.

            • dihydroergotamine

              dihydroergotamine, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • dimenhydrinate

              dimenhydrinate and paliperidone both increase sedation. Use Caution/Monitor.

            • diphenhydramine

              diphenhydramine and paliperidone both increase sedation. Use Caution/Monitor.

              diphenhydramine decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              diphenhydramine decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of diphenhydramine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • diphenoxylate hcl

              diphenoxylate hcl and paliperidone both increase sedation. Use Caution/Monitor.

            • dipipanone

              dipipanone and paliperidone both increase sedation. Use Caution/Monitor.

            • dobutamine

              paliperidone increases and dobutamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • dofetilide

              dofetilide and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

            • dolasetron

              dolasetron and paliperidone both increase QTc interval. Use Caution/Monitor.

            • dopamine

              paliperidone increases and dopamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • dopexamine

              paliperidone increases and dopexamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • dosulepin

              paliperidone and dosulepin both increase sedation. Use Caution/Monitor.

            • doxepin

              doxepin and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              paliperidone and doxepin both increase sedation. Use Caution/Monitor.

            • doxylamine

              doxylamine and paliperidone both increase sedation. Use Caution/Monitor.

            • dronedarone

              dronedarone will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              dronedarone and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

            • droperidol

              droperidol and paliperidone both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              droperidol and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              droperidol and paliperidone both increase sedation. Use Caution/Monitor.

            • elagolix

              elagolix will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • eletriptan

              eletriptan, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • eliglustat

              eliglustat increases levels of paliperidone by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Monitor therapeutic drug concentrations, as indicated, or consider reducing the dosage of the P-gp substrate and titrate to clinical effect.

            • ephedrine

              paliperidone increases and ephedrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • epinephrine

              epinephrine and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              paliperidone increases and epinephrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • epinephrine racemic

              epinephrine racemic and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              paliperidone increases and epinephrine racemic decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • ergoloid mesylates

              ergoloid mesylates, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • ergotamine

              ergotamine, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • erythromycin base

              erythromycin base will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              erythromycin base and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              erythromycin ethylsuccinate and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

            • erythromycin lactobionate

              erythromycin lactobionate will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              erythromycin lactobionate and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

            • erythromycin stearate

              erythromycin stearate will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              erythromycin stearate and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

            • esketamine intranasal

              esketamine intranasal, paliperidone. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

            • estazolam

              estazolam and paliperidone both increase sedation. Use Caution/Monitor.

            • ethanol

              paliperidone and ethanol both increase sedation. Use Caution/Monitor.

            • exenatide injectable solution

              paliperidone, exenatide injectable solution. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • exenatide injectable suspension

              paliperidone, exenatide injectable suspension. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • ezogabine

              ezogabine, paliperidone. Either increases toxicity of the other by QTc interval. Use Caution/Monitor. Slight and transient QT-prolongation observed with ezogabine, particularly when dose titrated to 1200 mg/day. QT interval should be monitored when ezogabine is prescribed with agents known to increase QT interval.

            • felodipine

              felodipine will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • fenfluramine

              paliperidone increases and fenfluramine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              paliperidone decreases effects of fenfluramine by pharmacodynamic antagonism. Use Caution/Monitor. Potent serotonin receptor antagonists may decrease fenfluramine efficacy. If coadministered, monitor appropriately.

            • fentanyl

              fentanyl, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • fesoterodine

              fesoterodine decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              fesoterodine decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of fesoterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • flavoxate

              flavoxate decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              flavoxate decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of flavoxate by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • flecainide

              flecainide and paliperidone both increase QTc interval. Use Caution/Monitor.

            • flibanserin

              flibanserin, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • fluconazole

              fluconazole and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

            • fluoxetine

              fluoxetine and paliperidone both increase QTc interval. Use Caution/Monitor.

            • fluphenazine

              fluphenazine and paliperidone both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              fluphenazine and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              fluphenazine and paliperidone both increase sedation. Use Caution/Monitor.

            • flurazepam

              flurazepam and paliperidone both increase sedation. Use Caution/Monitor.

            • fluvoxamine

              fluvoxamine and paliperidone both increase QTc interval. Use Caution/Monitor.

            • formoterol

              formoterol and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              paliperidone increases and formoterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • foscarnet

              foscarnet and paliperidone both increase QTc interval. Use Caution/Monitor.

            • fosphenytoin

              fosphenytoin will decrease the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • fostemsavir

              paliperidone and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.

            • frovatriptan

              frovatriptan, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • gemtuzumab

              paliperidone and gemtuzumab both increase QTc interval. Use Caution/Monitor.

            • glecaprevir/pibrentasvir

              paliperidone will increase the level or effect of glecaprevir/pibrentasvir by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              glecaprevir/pibrentasvir will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • glimepiride

              paliperidone, glimepiride. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • glipizide

              paliperidone, glipizide. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • glyburide

              paliperidone, glyburide. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • glycopyrrolate

              paliperidone increases effects of glycopyrrolate by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • glycopyrrolate inhaled

              glycopyrrolate inhaled decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              glycopyrrolate inhaled decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of glycopyrrolate inhaled by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • guanfacine

              guanfacine, paliperidone. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Additive hypotensive effects; potential delirium.

            • haloperidol

              haloperidol and paliperidone both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              haloperidol and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              haloperidol and paliperidone both increase sedation. Use Caution/Monitor.

            • henbane

              henbane decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              henbane decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of henbane by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • homatropine

              homatropine decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              homatropine decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of homatropine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • hydromorphone

              hydromorphone and paliperidone both increase sedation. Use Caution/Monitor.

            • hydroxyzine

              hydroxyzine and paliperidone both increase sedation. Use Caution/Monitor.

            • hyoscyamine

              hyoscyamine decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              hyoscyamine decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of hyoscyamine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • hyoscyamine spray

              paliperidone increases effects of hyoscyamine spray by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              hyoscyamine spray decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              hyoscyamine spray decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

            • iloperidone

              iloperidone and paliperidone both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              iloperidone and paliperidone both increase QTc interval. Use Caution/Monitor.

              iloperidone and paliperidone both increase sedation. Use Caution/Monitor.

            • imipramine

              imipramine and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              paliperidone and imipramine both increase sedation. Use Caution/Monitor.

            • indacaterol, inhaled

              indacaterol, inhaled, paliperidone. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • indinavir

              indinavir will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • insulin aspart

              paliperidone, insulin aspart. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • insulin degludec

              paliperidone decreases effects of insulin degludec by Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; dose of antidiabetic agents may need adjustment and increased frequency of glucose monitoring may be required.

            • insulin degludec/insulin aspart

              paliperidone decreases effects of insulin degludec/insulin aspart by Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; dose of antidiabetic agents may need adjustment and increased frequency of glucose monitoring may be required.

            • insulin detemir

              paliperidone, insulin detemir. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • insulin glargine

              paliperidone, insulin glargine. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • insulin glulisine

              paliperidone, insulin glulisine. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • insulin inhaled

              paliperidone decreases effects of insulin inhaled by Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; dose of antidiabetic agents may need adjustment and increased frequency of glucose monitoring may be required.

            • insulin lispro

              paliperidone, insulin lispro. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • insulin NPH

              paliperidone, insulin NPH. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • insulin regular human

              paliperidone, insulin regular human. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • ipratropium

              ipratropium decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              ipratropium decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of ipratropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • isoproterenol

              paliperidone increases and isoproterenol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • istradefylline

              istradefylline will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Consider dose reduction of sensitive P-gp substrates.

            • itraconazole

              itraconazole and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              itraconazole will increase the level or effect of paliperidone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • ketoconazole

              ketoconazole will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              ketoconazole and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

            • ketotifen, ophthalmic

              paliperidone and ketotifen, ophthalmic both increase sedation. Use Caution/Monitor.

            • lapatinib

              lapatinib will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              lapatinib and paliperidone both increase QTc interval. Use Caution/Monitor.

            • lasmiditan

              lasmiditan, paliperidone. Either increases effects of the other by sedation. Use Caution/Monitor. Coadministration of lasmiditan and other CNS depressant drugs, including alcohol have not been evaluated in clinical studies. Lasmiditan may cause sedation, as well as other cognitive and/or neuropsychiatric adverse reactions.

            • lemborexant

              lemborexant, paliperidone. Either increases effects of the other by sedation. Modify Therapy/Monitor Closely. Dosage adjustment may be necessary if lemborexant is coadministered with other CNS depressants because of potentially additive effects.

            • lenvatinib

              paliperidone and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.

            • levalbuterol

              paliperidone increases and levalbuterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • levofloxacin

              levofloxacin and paliperidone both increase QTc interval. Use Caution/Monitor.

            • levomilnacipran

              levomilnacipran, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • levorphanol

              levorphanol and paliperidone both increase sedation. Use Caution/Monitor.

            • linezolid

              linezolid, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • liraglutide

              paliperidone, liraglutide. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • lisdexamfetamine

              paliperidone increases and lisdexamfetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • lithium

              lithium, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • lofepramine

              lofepramine and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              paliperidone and lofepramine both increase sedation. Use Caution/Monitor.

            • lofexidine

              paliperidone and lofexidine both increase sedation. Use Caution/Monitor.

              paliperidone and lofexidine both increase QTc interval. Use Caution/Monitor. ECG monitoring is recommended.

            • lomitapide

              lomitapide increases levels of paliperidone by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing dose when used concomitantly with lomitapide.

            • lonafarnib

              lonafarnib will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Lonafarnib is a weak P-gp inhibitor. Monitor for adverse reactions if coadministered with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Reduce P-gp substrate dose if needed.

            • loprazolam

              loprazolam and paliperidone both increase sedation. Use Caution/Monitor.

            • loratadine

              loratadine will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • lorazepam

              lorazepam and paliperidone both increase sedation. Use Caution/Monitor.

            • lorcaserin

              lorcaserin, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • lormetazepam

              lormetazepam and paliperidone both increase sedation. Use Caution/Monitor.

            • lovastatin

              lovastatin will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • loxapine

              loxapine and paliperidone both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              loxapine and paliperidone both increase sedation. Use Caution/Monitor.

            • loxapine inhaled

              loxapine inhaled and paliperidone both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              loxapine inhaled and paliperidone both increase sedation. Use Caution/Monitor.

            • lumefantrine

              lumefantrine and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

            • lurasidone

              lurasidone, paliperidone. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Potential for increased CNS depressant effects when used concurrently; monitor for increased adverse effects and toxicity.

            • maprotiline

              maprotiline and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              paliperidone and maprotiline both increase sedation. Use Caution/Monitor.

            • maraviroc

              maraviroc, paliperidone. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of orthostatic hypotension.

            • marijuana

              paliperidone and marijuana both increase sedation. Use Caution/Monitor.

            • meclizine

              meclizine decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              meclizine decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of meclizine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • melatonin

              paliperidone and melatonin both increase sedation. Use Caution/Monitor.

            • meperidine

              meperidine and paliperidone both increase sedation. Use Caution/Monitor.

              meperidine, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • meprobamate

              paliperidone and meprobamate both increase sedation. Use Caution/Monitor.

            • metaproterenol

              paliperidone increases and metaproterenol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • metaxalone

              metaxalone and paliperidone both increase sedation. Use Caution/Monitor.

            • metformin

              paliperidone, metformin. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • methadone

              methadone and paliperidone both increase QTc interval. Use Caution/Monitor.

              methadone and paliperidone both increase sedation. Use Caution/Monitor.

              methadone, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • methamphetamine

              paliperidone increases and methamphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • methocarbamol

              methocarbamol and paliperidone both increase sedation. Use Caution/Monitor.

            • methscopolamine

              methscopolamine decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              methscopolamine decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of methscopolamine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • methylenedioxymethamphetamine

              paliperidone increases and methylenedioxymethamphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • methylergonovine

              methylergonovine, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • methylphenidate

              paliperidone increases toxicity of methylphenidate by pharmacodynamic antagonism. Use Caution/Monitor. Closely monitor for signs of altered clinical response to either methylphenidate or an antipsychotic when using these drugs in combination.

            • metoclopramide

              paliperidone and metoclopramide both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

            • midazolam

              midazolam and paliperidone both increase sedation. Use Caution/Monitor.

            • midazolam intranasal

              midazolam intranasal, paliperidone. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.

            • midodrine

              paliperidone increases and midodrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • mifepristone

              mifepristone, paliperidone. QTc interval. Modify Therapy/Monitor Closely. Use alternatives if available.

            • miglitol

              paliperidone, miglitol. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • milnacipran

              milnacipran, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • mirtazapine

              paliperidone and mirtazapine both increase sedation. Use Caution/Monitor.

            • modafinil

              paliperidone increases and modafinil decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • morphine

              morphine and paliperidone both increase sedation. Use Caution/Monitor.

            • motherwort

              paliperidone and motherwort both increase sedation. Use Caution/Monitor.

            • moxifloxacin

              moxifloxacin and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

            • moxonidine

              paliperidone and moxonidine both increase sedation. Use Caution/Monitor.

            • nabilone

              paliperidone and nabilone both increase sedation. Use Caution/Monitor.

            • nalbuphine

              nalbuphine and paliperidone both increase sedation. Use Caution/Monitor.

            • naldemedine

              paliperidone increases levels of naldemedine by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor naldemedine for potential adverse effects if coadministered with P-gp inhibitors.

            • naratriptan

              naratriptan, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • nateglinide

              paliperidone, nateglinide. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • nicardipine

              nicardipine will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • nifedipine

              nifedipine will decrease the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • nilotinib

              nilotinib will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              nilotinib and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

            • nintedanib

              paliperidone increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy.

            • norepinephrine

              paliperidone increases and norepinephrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • nortriptyline

              nortriptyline and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              paliperidone and nortriptyline both increase sedation. Use Caution/Monitor.

            • octreotide

              octreotide and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

            • octreotide (Antidote)

              octreotide (Antidote) and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

            • ofloxacin

              ofloxacin and paliperidone both increase QTc interval. Use Caution/Monitor.

            • olanzapine

              olanzapine and paliperidone both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              olanzapine and paliperidone both increase sedation. Use Caution/Monitor.

            • oliceridine

              oliceridine, paliperidone. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

            • olodaterol inhaled

              paliperidone and olodaterol inhaled both increase QTc interval. Use Caution/Monitor. Drugs that prolong the QTc interval and may potentiate the effects of beta2 agonists on the cardiovascular system; increased risk of ventricular arrhythmias

            • onabotulinumtoxinA

              onabotulinumtoxinA decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              onabotulinumtoxinA decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • opium tincture

              opium tincture and paliperidone both increase sedation. Use Caution/Monitor.

            • orphenadrine

              orphenadrine and paliperidone both increase sedation. Use Caution/Monitor.

            • osilodrostat

              osilodrostat and paliperidone both increase QTc interval. Use Caution/Monitor.

            • osimertinib

              osimertinib and paliperidone both increase QTc interval. Use Caution/Monitor. Conduct periodic monitoring with ECGs and electrolytes in patients taking drugs known to prolong the QTc interval.

            • oxazepam

              oxazepam and paliperidone both increase sedation. Use Caution/Monitor.

            • oxybutynin

              oxybutynin decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              oxybutynin decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of oxybutynin by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • oxybutynin topical

              oxybutynin topical decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              oxybutynin topical decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of oxybutynin topical by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • oxybutynin transdermal

              oxybutynin transdermal decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              oxybutynin transdermal decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of oxybutynin transdermal by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • oxycodone

              oxycodone and paliperidone both increase sedation. Use Caution/Monitor.

            • oxymorphone

              oxymorphone and paliperidone both increase sedation. Use Caution/Monitor.

            • ozanimod

              ozanimod and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely. The potential additive effects on heart rate, treatment with ozanimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties.

            • pancuronium

              pancuronium decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              pancuronium decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of pancuronium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • papaveretum

              papaveretum and paliperidone both increase sedation. Use Caution/Monitor.

            • papaverine

              paliperidone and papaverine both increase sedation. Use Caution/Monitor.

            • paroxetine

              paliperidone and paroxetine both increase QTc interval. Use Caution/Monitor.

              paroxetine, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • pasireotide

              paliperidone and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • pentazocine

              pentazocine and paliperidone both increase sedation. Use Caution/Monitor.

            • pentobarbital

              pentobarbital and paliperidone both increase sedation. Use Caution/Monitor.

            • perphenazine

              paliperidone and perphenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              perphenazine and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              paliperidone and perphenazine both increase sedation. Use Caution/Monitor.

            • phendimetrazine

              paliperidone increases and phendimetrazine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • phenelzine

              phenelzine, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • phenobarbital

              phenobarbital will decrease the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              phenobarbital and paliperidone both increase sedation. Use Caution/Monitor.

            • phentermine

              paliperidone increases and phentermine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • phenylephrine

              paliperidone increases and phenylephrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • phenylephrine PO

              paliperidone increases and phenylephrine PO decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor. .

            • phenytoin

              phenytoin will decrease the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • pholcodine

              paliperidone and pholcodine both increase sedation. Use Caution/Monitor.

            • pimozide

              paliperidone and pimozide both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              paliperidone and pimozide both increase sedation. Use Caution/Monitor.

            • pioglitazone

              paliperidone, pioglitazone. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • pirbuterol

              paliperidone increases and pirbuterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • posaconazole

              paliperidone and posaconazole both increase QTc interval. Use Caution/Monitor.

            • pralidoxime

              pralidoxime decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              pralidoxime decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of pralidoxime by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • pramlintide

              paliperidone, pramlintide. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • primidone

              primidone and paliperidone both increase sedation. Use Caution/Monitor.

            • procarbazine

              procarbazine, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • prochlorperazine

              paliperidone and prochlorperazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              prochlorperazine and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              paliperidone and prochlorperazine both increase sedation. Use Caution/Monitor.

            • promazine

              promazine and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

            • promethazine

              paliperidone and promethazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              promethazine and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              promethazine and paliperidone both increase sedation. Use Caution/Monitor.

              promethazine, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • propantheline

              propantheline decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              propantheline decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of propantheline by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • propofol

              propofol and paliperidone both increase sedation. Use Caution/Monitor.

            • propylhexedrine

              paliperidone increases and propylhexedrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • protriptyline

              protriptyline and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              paliperidone and protriptyline both increase sedation. Use Caution/Monitor.

            • quazepam

              quazepam and paliperidone both increase sedation. Use Caution/Monitor.

            • quercetin

              quercetin will decrease the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • quetiapine

              paliperidone and quetiapine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              paliperidone and quetiapine both increase sedation. Use Caution/Monitor.

              quetiapine, paliperidone. Either increases toxicity of the other by QTc interval. Use Caution/Monitor. Avoid use with drugs that prolong QT and in patients with risk factors for prolonged QT interval. Postmarketing cases show QT prolongation with overdose in patients with concomitant illness or with drugs known to cause electrolyte imbalance or prolong QT.

            • quinine

              paliperidone and quinine both increase QTc interval. Use Caution/Monitor.

            • ramelteon

              paliperidone and ramelteon both increase sedation. Use Caution/Monitor.

            • ranolazine

              ranolazine will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              paliperidone and ranolazine both increase QTc interval. Use Caution/Monitor.

            • rapacuronium

              rapacuronium decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              rapacuronium decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of rapacuronium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • remimazolam

              remimazolam, paliperidone. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely. Coadministration may result in profound sedation, respiratory depression, coma, and/or death. Continuously monitor vital signs during sedation and recovery period if coadministered. Carefully titrate remimazolam dose if administered with opioid analgesics and/or sedative/hypnotics.

            • repaglinide

              paliperidone, repaglinide. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • rifampin

              rifampin will decrease the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Paliperidone dose may need to be increased when coadministered with strong inducers of both CYP3A4 and P-gp

            • rifaximin

              paliperidone increases levels of rifaximin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • rilpivirine

              rilpivirine increases toxicity of paliperidone by QTc interval. Use Caution/Monitor. Rilpivirine should be used with caution when co-administered with a drug with a known risk of Torsade de Pointes.

            • risperidone

              paliperidone and risperidone both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              paliperidone and risperidone both increase QTc interval. Use Caution/Monitor.

              paliperidone and risperidone both increase sedation. Use Caution/Monitor.

              paliperidone, risperidone. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Paliperidone is the major active metabolite of risperidone, consideration should be given to the additive paliperidone exposure if any of these medications are coadministered.

            • ritonavir

              ritonavir will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • rocuronium

              rocuronium decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              rocuronium decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of rocuronium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • rosiglitazone

              paliperidone, rosiglitazone. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • salmeterol

              paliperidone increases and salmeterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • sarecycline

              sarecycline will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors.

            • saxagliptin

              paliperidone, saxagliptin. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • scopolamine

              scopolamine decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              scopolamine decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of scopolamine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • scullcap

              paliperidone and scullcap both increase sedation. Use Caution/Monitor.

            • secobarbital

              secobarbital and paliperidone both increase sedation. Use Caution/Monitor.

            • selegiline

              selegiline, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • selpercatinib

              selpercatinib increases toxicity of paliperidone by QTc interval. Use Caution/Monitor.

            • shepherd's purse

              paliperidone and shepherd's purse both increase sedation. Use Caution/Monitor.

            • simvastatin

              simvastatin will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • sirolimus

              sirolimus will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • sitagliptin

              paliperidone, sitagliptin. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • sodium sulfate/?magnesium sulfate/potassium chloride

              sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of paliperidone by QTc interval. Use Caution/Monitor. Consider predose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. .

              sodium sulfate/?magnesium sulfate/potassium chloride increases effects of paliperidone by unknown mechanism. Use Caution/Monitor. Closely monitor for evidence of enhanced CNS depression when using higher dose of magnesium sulfate together with a CNS depressant.

            • sodium sulfate/potassium sulfate/magnesium sulfate

              sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of paliperidone by QTc interval. Use Caution/Monitor. Consider predose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. .

              sodium sulfate/potassium sulfate/magnesium sulfate increases effects of paliperidone by unknown mechanism. Use Caution/Monitor. Closely monitor for evidence of enhanced CNS depression when using higher dose of magnesium sulfate together with a CNS depressant.

            • solifenacin

              solifenacin decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              solifenacin decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of solifenacin by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • sorafenib

              sorafenib and paliperidone both increase QTc interval. Use Caution/Monitor.

            • St John's Wort

              St John's Wort will decrease the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Paliperidone dose may need to be increased when coadministered with strong inducers of both CYP3A4 and P-gp

            • stiripentol

              stiripentol will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing the dose of P-glycoprotein (P-gp) substrates, if adverse reactions are experienced when administered concomitantly with stiripentol.

              stiripentol, paliperidone. Either increases effects of the other by sedation. Use Caution/Monitor. Concomitant use stiripentol with other CNS depressants, including alcohol, may increase the risk of sedation and somnolence.

            • sufentanil

              sufentanil and paliperidone both increase sedation. Use Caution/Monitor.

            • sulfamethoxazole

              sulfamethoxazole and paliperidone both increase QTc interval. Use Caution/Monitor.

            • sumatriptan

              sumatriptan, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • sumatriptan intranasal

              sumatriptan intranasal, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • tacrolimus

              tacrolimus will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • tapentadol

              tapentadol and paliperidone both increase sedation. Use Caution/Monitor.

            • telavancin

              paliperidone and telavancin both increase QTc interval. Use Caution/Monitor.

            • temazepam

              temazepam and paliperidone both increase sedation. Use Caution/Monitor.

            • terbutaline

              paliperidone increases and terbutaline decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • tetrabenazine

              paliperidone and tetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely.

            • thioridazine

              paliperidone and thioridazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              thioridazine and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              paliperidone and thioridazine both increase sedation. Use Caution/Monitor.

            • thiothixene

              paliperidone and thiothixene both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              paliperidone and thiothixene both increase sedation. Use Caution/Monitor.

            • tiotropium

              tiotropium decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tiotropium decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of tiotropium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • tolazamide

              paliperidone, tolazamide. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • tolbutamide

              paliperidone, tolbutamide. Other (see comment). Use Caution/Monitor. Comment: Atypical antipsychotics have been associated with hyperglycemia that may alter blood glucose control; monitor glucose levels closely.

            • tolterodine

              tolterodine decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              tolterodine decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of tolterodine by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • tolvaptan

              tolvaptan will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • topiramate

              paliperidone and topiramate both increase sedation. Modify Therapy/Monitor Closely.

            • tramadol

              tramadol and paliperidone both increase sedation. Use Caution/Monitor.

            • tranylcypromine

              tranylcypromine, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • trazodone

              trazodone will decrease the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              trazodone and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              paliperidone and trazodone both increase sedation. Use Caution/Monitor.

            • triazolam

              triazolam and paliperidone both increase sedation. Use Caution/Monitor.

            • triclabendazole

              triclabendazole and paliperidone both increase QTc interval. Use Caution/Monitor.

            • triclofos

              triclofos and paliperidone both increase sedation. Use Caution/Monitor.

            • trifluoperazine

              paliperidone and trifluoperazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              trifluoperazine and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              paliperidone and trifluoperazine both increase sedation. Use Caution/Monitor.

            • trimethoprim

              paliperidone and trimethoprim both increase QTc interval. Use Caution/Monitor.

            • trimipramine

              trimipramine and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

              paliperidone and trimipramine both increase sedation. Use Caution/Monitor.

            • triprolidine

              triprolidine and paliperidone both increase sedation. Use Caution/Monitor.

            • tropisetron

              paliperidone and tropisetron both increase QTc interval. Use Caution/Monitor.

            • trospium chloride

              trospium chloride decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              trospium chloride decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of trospium chloride by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • tucatinib

              tucatinib will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.

            • vecuronium

              vecuronium decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

              vecuronium decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

              paliperidone increases effects of vecuronium by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

            • venlafaxine

              paliperidone and venlafaxine both increase QTc interval. Use Caution/Monitor.

              venlafaxine, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • verapamil

              verapamil will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • vilazodone

              vilazodone, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • voclosporin

              voclosporin, paliperidone. Either increases effects of the other by QTc interval. Use Caution/Monitor.

            • voriconazole

              paliperidone and voriconazole both increase QTc interval. Use Caution/Monitor.

            • xylometazoline

              paliperidone increases and xylometazoline decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • yohimbine

              paliperidone increases and yohimbine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • ziconotide

              paliperidone and ziconotide both increase sedation. Use Caution/Monitor.

            • ziprasidone

              paliperidone and ziprasidone both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              paliperidone and ziprasidone both increase QTc interval. Modify Therapy/Monitor Closely.

              paliperidone and ziprasidone both increase sedation. Use Caution/Monitor.

            • zolmitriptan

              zolmitriptan, paliperidone. unspecified interaction mechanism. Use Caution/Monitor. Serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotics may enhance serotonergic effect of serotonin modulators, which may result in serotonin syndrome. Monitor for evidence of serotonin toxicity (eg, mental status changes, autonomic instability, and neuromuscular hyperactivity) or neuroleptic malignant syndrome (eg, hyperthermia, muscle rigidity, autonomic dysfunction).

            • zotepine

              paliperidone and zotepine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Use Caution/Monitor.

              paliperidone and zotepine both increase sedation. Use Caution/Monitor.

            Minor (8)

            • azithromycin

              azithromycin and paliperidone both increase QTc interval. Minor/Significance Unknown.

            • brimonidine

              brimonidine increases effects of paliperidone by pharmacodynamic synergism. Minor/Significance Unknown. Increased CNS depression.

            • chasteberry

              chasteberry decreases effects of paliperidone by pharmacodynamic antagonism. Minor/Significance Unknown. (Theoretical interaction).

            • ethanol

              ethanol, paliperidone. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Additive CNS depression.

            • eucalyptus

              paliperidone and eucalyptus both increase sedation. Minor/Significance Unknown.

            • nefazodone

              nefazodone will increase the level or effect of paliperidone by P-glycoprotein (MDR1) efflux transporter. Minor/Significance Unknown.

            • pazopanib

              paliperidone and pazopanib both increase QTc interval. Minor/Significance Unknown.

            • sage

              paliperidone and sage both increase sedation. Minor/Significance Unknown.

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            Adverse Effects

            >10%

            Invega Hafyera

            • Upper respiratory tract infection (12%)
            • Injection site reactions (11%)

            Invega Sustenna

            • Injection site reaction (12%)

            Oral (adults)

            • Extrapyramidal symptoms (7-20%)
            • Akathisia (4-17%)
            • Tachycardia (12-14%)
            • Headache (11-14%)
            • Somnolence (6-11%)

            Oral (children and adolescents)

            • Somnolence (9-26%)
            • Extrapyramidal symptoms (4-23%)
            • Akathisia (4-17%)
            • Vomiting (6-11%)

            1-10%

            Invega Hafyera

            • Weight increased (9%)
            • Headache (7%)
            • Extrapyramidal symptoms (7%)
            • Parkinsonism (5%)
            • Akathisia (4%)
            • Hyperkinesia (4%)
            • Urinary tract infection (3%)
            • Back pain (3%)
            • Musculoskeletal pain (3%)
            • Psychosis (3%)
            • Anxiety (3%)
            • Insomnia (3%)
            • Diarrhea (2%)
            • Dyskinesia (2%)
            • Dystonia (1%)

            Invega Sustenna

            • Weight increased (10%)
            • Headache (7%)
            • Parkinsonism (4-6%)
            • Hyperkinesia (5%)
            • Upper respiratory tract infection (5%)
            • Akathisia (3-5%)
            • Tremor (2%)
            • Dystonia (1%)

            Invega Trinza

            • Upper respiratory tract infection (10%)
            • Headache (9%)
            • Weight increased (9%)
            • Parkinsonism (4-6%)
            • Hyperkinesia (5%)
            • Akathisia (3-5%)
            • Injection site reaction (3%)
            • Urinary tract infection (3%)
            • Dyskinesia (1-3%)
            • Tremor (1%)
            • Dystonia (1%)

            Oral (adults)

            • Salivary hypersecretion (<4%)
            • Upper abdominal pain (1-3%)
            • Dry mouth (1-3%)
            • Bundle branch block (<3%)
            • Sinus arrhythmia (<3%)
            • Atrioventricular (AV) block (1-2%)
            • Fatigue (1-2%)
            • Asthenia (<2%)

            Oral (children and adolescents)

            • Tachycardia (6-9%)
            • Anxiety (4-9%)
            • Increased weight (2-7%)
            • Salivary hypersecretion (2-6%)
            • Dizziness (2-6%)
            • Amenorrhea (6%)
            • Galactorrhea (4%)
            • Nasopharyngitis (4%)
            • Gynecomastia (3%)
            • Blurred vision (3%)
            • Dry mouth (3%)
            • Swollen tongue (3%)
            • Lethargy (3%)
            • Tongue paralysis (3%)
            • Asthenia (2-3%)
            • Fatigue (2-3%)
            • Epistaxis (2%)

            <1%

            Invega Hafyera

            • Tremor

            Invega Sustenna

            • Dyskinesia
            • Urinary tract infection

            Frequency Not Defined

            Invega Hafyera

            • Blood and lymphatic system disorders: Anemia
            • Cardiac disorders: Bradycardia, tachycardia
            • Ear and labyrinth disorders: Vertigo
            • Gastrointestinal disorders: Constipation, nausea, vomiting
            • General disorders and administration site conditions: Fatigue
            • Hepatobiliary disorders: Transaminases increased
            • Infections and infestations: Cystitis, respiratory tract infection, tonsillitis
            • Metabolism and nutritional disorders: Decreased appetite, increased appetite, weight decreased
            • Psychiatric disorders: Depression
            • Reproductive system and breast disorders: Breast pain, menstrual disorder
            • Skin and SC tissue disorders: Rash
            • Vascular disorders: Hypertension

            Invega Sustenna and Trinza

            • Cardiac disorders: AV block first degree, bundle branch block, palpitations, postural orthostatic tachycardia syndrome
            • Eye disorders: Eye movement disorder, eye rolling, oculogyric crisis, vision blurred
            • Gastrointestinal disorders: Abdominal discomfort/abdominal pain upper, diarrhea, dry mouth, toothache
            • General disorders and administration site conditions: Asthenia, chest discomfort
            • Immune system disorders: Hypersensitivity
            • Investigations: Electrocardiogram (ECG) abnormal
            • Metabolism and nutrition disorders: Hyperinsulinemia
            • Musculoskeletal and connective tissue disorders: Myalgia, pain in extremity, joint stiffness, muscle spasms, muscle twitching, nuchal rigidity
            • Nervous system disorders: Bradykinesia, cerebrovascular accident, convulsion, dizziness, dizziness postural, dysarthria, hypertonia, lethargy, oromandibular dystonia, psychomotor hyperactivity, syncope
            • Psychiatric disorders: Agitation, nightmare
            • Reproductive system and breast disorders: Breast discharge, erectile dysfunction, gynecomastia, sexual dysfunction
            • Respiratory, thoracic, and mediastinal disorders: Cough
            • Skin and SC tissue disorders: Drug eruption, eczema, pruritus, pruritus generalized, urticaria
            • Vascular disorders: Hypotension, orthostatic hypotension

            Tablets

            • Cardiac disorders: Bradycardia, palpitations
            • Eye disorders: Eye movement disorder
            • Gastrointestinal disorders: Flatulence
            • General disorders: Edema
            • Immune system disorders: Anaphylactic reaction
            • Infections and infestations: Urinary tract infection
            • Investigations: ALT/AST increased
            • Musculoskeletal and connective tissue disorders: Arthralgia, pain in extremity
            • Nervous system disorders: Opisthotonos
            • Psychiatric disorders: Agitation, insomnia, nightmare
            • Reproductive system and breast disorders: Breast discomfort, menstruation irregular, retrograde ejaculation
            • Respiratory, thoracic, and mediastinal disorders: Nasal congestion
            • Skin and SC tissue disorders: pruritus, rash Vascular disorders: Hypertension

            Postmarketing Reports

            Angioedema, catatonia, ileus, somnambulism, swollen tongue, thrombotic thrombocytopenic purpura, urinary incontinence, and urinary retention

            Invega Sustenna

            • Anaphylactic reactions
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            Warnings

            Black Box Warnings

            Increased mortality in elderly patients with dementia-related psychosis

            • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death
            • Not approved for use in patients with dementia-related psychosis

            Contraindications

            Documented hypersensitivity to paliperidone or risperidone

            Cautions

            Increased incidence of cerebrovascular adverse reactions (eg, stroke, transient ischemic attack, including fatalities) reported

            Neuroleptic malignant syndrome (NMS) reported in association with antipsychotic drugs; if NMS is suspected, discontinue treatment and provide symptomatic treatment and monitoring

            May induce orthostatic hypotension; use with caution in patients with known cardiovascular or cerebrovascular disease and patients predisposed to hypotension

            Motor instability, somnolence, and orthostatic hypotension reported, which may lead to falls and, consequently, fractures or other fall-related injuries; assess risk of falls when initiating treatment and recurrently for patients receiving repeated doses, particularly the elderly, with diseases, conditions, or medications that could exacerbate these effects

            Hyperprolactinemia reported; may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotrophin secretion and gonadal steroidogenesis in female and male patients; galactorrhea, amenorrhea, gynecomastia, and impotence reported; long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density in both female and male subjects

            May cause CNS depression (somnolence, sedation, dizziness), which may impair abilities to perform tasks requiring mental alertness, including operating heavy machinery

            Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold

            Antipsychotic use has been associated with esophageal dysmotility and aspiration; use with caution in patients at risk of aspiration pneumonia

            Rare cases of priapism reported

            Use caution when prescribing to patients who will be experiencing conditions which may contribute to elevation in core body temperature (eg, exercising strenuously, extreme heat exposure, concomitant medication with anticholinergic activity, dehydration)

            Avoid use in severe preexisting GI stenosis

            Rare cases of intraoperative floppy iris syndrome reported with risperidone in patients undergoing cataract surgery; paliperidone is active metabolite of risperidone; use caution; benefits or risks of interrupting paliperidone or risperidone use prior to cataract surgery not established

            Patients with Parkinson disease may be more sensitive to CNS and extrapyramidal effects

            May mask toxicity of other drugs or conditions (eg, intestinal obstruction) due to antiemetic effects

            May increase risk of death in elderly patients with dementia-related psychosis

            Use caution in patients with history of suicidal ideation or any form of psychotic illness; may increase risk of suicide attempt

            Certain circumstances may increase risk of the occurrence of Torsades de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including bradycardia; hypokalemia or hypomagnesemia; concomitant use of other drugs that prolong the QTc interval; and presence of congenital prolongation of the QT interval

            Patient should see healthcare provider or go to the nearest emergency room right away if erection lasts more than 4 hr

            Tardive dyskinesia

            • Tardive dyskinesia may develop
            • Risk of developing tardive dyskinesia and likelihood that it will become irreversible appears to increase with duration of treatment and cumulative dose; syndrome may develop after relatively brief treatment periods or after discontinuing treatment
            • May remit, partially or completely, if treatment withdrawn; antipsychotic treatment may suppress (or partially suppress) signs and symptoms of syndrome and thereby possibly mask underlying process
            • Reserve chronic antipsychotic treatment for patients who suffer from a chronic illness known to respond to antipsychotic drugs, and for whom alternative are not available or appropriate
            • In patients who require chronic treatment, use lowest dose and the shortest duration of treatment producing a satisfactory clinical response; periodically reassess need for continued treatment

            Metabolic changes

            • Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular or cerebrovascular risk (eg, hyperglycemia, dyslipidemia, hyperprolactinemia, body weight gain)
            • Hyperglycemia and diabetes mellitus (DM), in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, have also been reported
            • Regularly monitor patients diagnosed with DM who started an atypical antipsychotic for worsening of glucose control
            • Patients with risk factors for DM (eg, obesity, family history of diabetes) who are starting treatment should undergo fasting blood glucose testing upon initiation and periodically during treatment
            • Monitor any patient treated with atypical antipsychotics for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness

            Leukopenia, neutropenia, and agranulocytosis

            • Leukopenia/neutropenia and agranulocytosis reported
            • Possible risk factors for leukopenia/neutropenia include preexisting low white blood cell (WBC) count and history of drug-induced leukopenia/neutropenia
            • Monitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly if such symptoms or signs occur
            • If history of clinically significant low WBC count or drug-induced leukopenia/neutropenia, monitor complete blood cell count (CBC) frequently during first few months of therapy; discontinue if WBC decline <1000/ mm3 and continue monitoring WBC until recovery

            Drug interaction overview

            • Substrate of P-gp and CYP3A4
            • Centrally-acting drugs and alcohol
              • Use with caution
              • Centrally-acting drugs and alcohol may modulate the CNS effects of paliperidone
            • Drugs that cause orthostatic hypotension
              • Monitor orthostatic vital signs in patients who are vulnerable to hypertension
              • Drugs that induce orthostatic hypotension may enhance the orthostatic hypotensive effects of paliperidone
            • Strong CYP3A4 and P-gp inducers (Invega Hafyera only)
              • Avoid coadministration of CYP3A4 and/or P-gp inducers
              • If a strong inducer is necessary, consider using paliperidone extended-release tablets
            • Levodopa and other dopamine agonists
              • Monitor and manage appropriately
              • Paliperidone may antagonize the effect of levodopa and other dopamine agonists
            • Drugs that prolong QT interval
              • Avoid coadministration with other drugs that are known to prolong QTc including Class 1A (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmic medications, antipsychotic medications (eg, chlorpromazine, thioridazine), fluoroquinolones (eg, moxifloxacin), or any other class of medications known to prolong the QTc interval
              • Paliperidone may enhance the QT-prolonging effects of such drugs
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            Pregnancy & Lactation

            Pregnancy

            Neonates exposed to antipsychotic drugs during third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery

            Available data of pregnant females exposed to paliperidone have not established a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes

            Drug detected in plasma in adults up to 18 months after a single 3-month paliperidone injection; clinical significance administered before pregnancy or anytime during pregnancy is unknown

            Pregnancy exposure registry

            Clinical considerations

            • There are risks to the mother associated with untreated schizophrenia and with exposure to antipsychotics during pregnancy
            • Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs; monitor for extrapyramidal and/or withdrawal symptoms and manage appropriately

            Infertility

            • Based on pharmacologic action of paliperidone (D2 receptor antagonism), treatment may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potential

            Lactation

            Limited data from published literature report presence of paliperidone in human breast milk

            There is no information on effects on breastfed infant, or on milk production

            Sedation, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements) reported in breastfed infants exposed to risperidone (parent compound of paliperidone)

            Monitor infants exposed to treatment through breast milk for excess sedation, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements)

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Paliperidone palmitate is hydrolyzed to paliperidone, a major active metabolite of risperidone

            Mechanism of action of paliperidone is unclear

            However, its efficacy in the treatment of schizophrenia could be mediated through a combination of central dopamine D2 and serotonin 5HT2A receptor antagonism

            Absorption

            Bioavailability: 28%

            Peak plasma time

            • PO: 24 hr
            • Invega Sustenna: 13 days
            • Invega Trinza: 30-33 days
            • Invega Hafyera: 29-32 days; release profile and dosing regimen results in sustained concentrations over 6 months

            Distribution

            Protein bound: 74% (racemic paliperidone)

            Vd

            • PO: 487 L
            • Invega Sustenna: 391 L
            • Invega Trinza and Hafyera: 1,960 L

            Metabolism

            Metabolized by CYP2D6 and CYP3A4

            Elimination

            Excretion

            • PO: Urine (80%), feces (11%)

            Half-life

            • PO: 23 hr
            • Invega Sustenna: 25-49 days
            • Invega Trinza: 118-139 days
            • Invega Hafyera: 148 days (1,092-mg dose); 159 days (1,560-mg dose)
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            Administration

            Oral administration

            May be taken with or without food

            Swallow tablet whole with liquids; do not chew, crush or divide

            The tablet shell, along with insoluble core components, is eliminated from the body; patients should not be concerned if they occasionally notice in their stool, something that looks like a tablet

            Avoid alcohol during treatment

            IM Preparation

            Invega Sustenna or Trinza: Shake prefilled syringe vigorously for at least 15 seconds within 5 minutes before administration to ensure a homogeneous suspension

            Invega Hafyera: Shake syringe with the syringe tip cap pointing up VERY FAST for at least 15 seconds, rest briefly, then shake again for 15 seconds; do not divide dose into multiple injections

            IM administration

            Administer only by a healthcare professional

            Visually inspect syringe for foreign matter and discoloration prior to administration, whenever product and container permit

            Do not mix with any other product or diluent

            Avoid inadvertent injection into a blood vessel

            Administer dose in a single injection; do not administer the dose in divided injections

            Inject slowly, deep into the upper-outer quadrant of the gluteal muscle

            Future injections should be alternated between the two gluteal muscles

            Needle length and gauge

            • Deltoid injection: If patient ≥90 kg, use 1.5-in. 22-gauge needle; if patient <90 kg, use 1-in. 23-gauge needle
            • Gluteal injection: Use 1.5-in. 22-gauge needle regardless of patient weight
            • Invega Hafyera
              • Do not use needles from Invega Sustenna or Trinza or other commercially-available needles to reduce the risk of blockage

            Once monthly IM injection

            • Before initiating once monthly IM therapy, establish PO tolerability with paliperidone or risperidone
            • First 2 doses are injected into deltoid; maintenance doses may be injected into either deltoid or gluteal muscle

            Every 3-months IM administration

            • Before initiating q3mo IM therapy, establish tolerability with once-monthly paliperidone for at least 4 months
            • Initiate Invega Trinza when the next 1-month paliperidone dose is scheduled with an Invega Trinza dose based on the previous 1-month injection dose

            Every 6-months IM administration

            • Before initiating q6mo IM therapy, establish tolerability with once-monthly paliperidone for at least 4 months
            • May administer Invega Hafyera dose up to 1 week before or after the next scheduled Invega Sustenna
            • Ensure the 2 injection cycles preceding the switch should be the same dosage strength before starting Invega Hafyera
            • Incomplete administration
              • Proper shaking can reduce likelihood for an incomplete injection
              • Storing carton in a horizontal orientation improves the ability to resuspend this highly concentrated product
              • In the event of an incompletely administered dose, do not reinject the dose remaining in the syringe and do not administer another Invega Hafyera
              • Closely monitor and treat with oral paliperidone supplementation as clinically appropriate until the next scheduled Invega Hafyera
              • See prescribing information of the oral paliperidone product for the recommended dosage of these products

            Missed Doses

            Invega Sustenna

            • Second dose
              • To avoid a missed dose, may give second dose 4 days before or after the one-week time point
              • <4 wk since first injection: Administer second initiation dose of 156 mg IM in deltoid muscle as soon as possible, then administer a third injection of 117 mg IM (deltoid or gluteal) 5 weeks afterwards; thereafter resume regular monthly dosing
              • 4-7 wk since first injection: Resume dose with 2 injections of 156 mg IM in deltoid muscle 1 week apart; thereafter, resume regular monthly dosing
              • >7 wk since first injection: Restart with recommended initiation
            • Third and subsequent doses
              • To avoid a missed dose, may give injection 7 days before or after the monthly time point
              • 4-6 wk since last injection: Resume regular monthly dosing as soon as possible at previous stabilized dose; followed in monthly injections
              • >6 wk to 6 months since last injection: Resume same dose as previously stabilized, unless stabilized on 234 mg/month, then the first 2 injections should each be 156 mg given 1 wk apart; thereafter, resume previously stabilized dose 1 month later
              • >6 months since last injection: Administer 234 mg IM in deltoid on Day 1, then 156 mg IM in deltoid on Day 8; thereafter, resume administration 1 month after Day 8 at the previously stabilized dose (deltoid or gluteal)

            Invega Trinza

            • If necessary, patients may be given the injection up to 2 weeks before or after the 3-month time point
            • Missed dose >9 months since last injection: Must reinitiate with the 1-month paliperidone as previously described
            • Missed dose 3.5-4 months since last injection: Administer the patient’s regular dose as soon as possible, then continue with the 3-month injection following this dose
            • Missed dose 4-9 months since last injection: Do not administer the next dose, instead use reinitiation schedule
            • Reinitiation schedule based on last dose of Invega Trinza
              • Administer Invega Sustenna, 2 doses given 1 week apart into deltoid muscle (ie, Day 1 and Day 8), then administer Invega Trinza 1 month after Day 8 (in deltoid or gluteal muscle)
              • Last dose 273 mg: Invega Sustenna 78 mg IM on Days 1 and 8, then Invega Trinza 273 mg IM 1 month after Day 8
              • Last dose 410 mg: Invega Sustenna 117 mg IM on Days 1 and 8, then Invega Trinza 410 mg IM 1 month after Day 8
              • Last dose 546 mg: Invega Sustenna 156 mg IM on Days 1 and 8, then Invega Trinza 546 mg IM 1 month after Day 8
              • Last dose 819 mg: Invega Sustenna 156 mg IM on Days 1 and 8, then Invega Trinza 819 mg IM 1 month after Day 8

            Invega Hafyera

            • To avoid a missed dose, may give injection up to 2 weeks before or 3 weeks after scheduled 6-mo dose
            • Missed dose >6 mo and 3 weeks to <8 mo since last injection
              • Do not administer next Invega Hafyera dose
              • Last dose 1,092 mg: Administer Invega Sustenna 156 mg IM into deltoid muscle on Day 1; 1 month after Day 1, administer Invega Hafyera 1,092 mg IM into gluteal muscle
              • Last dose 1,560 mg: Administer Invega Sustenna 234 mg IM into deltoid muscle on Day 1; 1 month after Day 1, administer Invega Hafyera 1,560 mg IM into gluteal muscle
            • Missed dose >8 mo to ≤11 mo since last injection
              • Do not administer next Invega Hafyera dose
              • Last dose 1,092 mg: Invega Sustenna 156 mg IM on Days 1 and 8, then Invega Hafyera 1,092 mg IM 1 month after Day 8
              • Last dose 1,560 mg: Invega Sustenna
              • 156 mg IM on Days 1 and 8, then Invega Hafyera 1,560 mg IM 1 month after Day 8
            • Missed dose >11 mo since last injection
              • Reinitiate treatment with Invega Sustenna as described in its prescribing information
              • Resume Invega Hafyera after patient has been adequately treated with Invega Sustenna for at least 4 months

            Storage

            Tablets

            • Store up to 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)
            • Protect from moisture
            • Keep out of reach of children

            IM

            • Store at room temperature 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF) are permitted
            • Do not mix with any other product or diluent
            • Ship and store in a horizontal position; see arrows on product carton for proper orientation
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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            paliperidone oral
            -
            9 mg tablet
            paliperidone oral
            -
            6 mg tablet
            paliperidone oral
            -
            3 mg tablet
            paliperidone oral
            -
            1.5 mg tablet
            paliperidone oral
            -
            1.5 mg tablet
            paliperidone oral
            -
            3 mg tablet
            paliperidone oral
            -
            3 mg tablet
            paliperidone oral
            -
            9 mg tablet
            paliperidone oral
            -
            1.5 mg tablet
            paliperidone oral
            -
            6 mg tablet
            paliperidone oral
            -
            9 mg tablet
            paliperidone oral
            -
            1.5 mg tablet
            paliperidone oral
            -
            9 mg tablet
            paliperidone oral
            -
            6 mg tablet
            paliperidone oral
            -
            3 mg tablet
            paliperidone oral
            -
            1.5 mg tablet
            Invega oral
            -
            9 mg tablet
            Invega oral
            -
            6 mg tablet
            Invega oral
            -
            3 mg tablet
            Invega oral
            -
            1.5 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            paliperidone oral

            PALIPERIDONE EXTENDED-RELEASE - ORAL

            (PAL-ee-PER-i-done)

            COMMON BRAND NAME(S): Invega

            WARNING: There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.If you are using paliperidone in combination with other medication to treat depression, also carefully read the drug information for the other medication.

            USES: This medication is used to treat certain mental/mood disorders (such as schizophrenia, schizoaffective disorder). This medication can decrease hallucinations and help you to think more clearly and positively about yourself, feel less agitated, and take a more active part in everyday life.Paliperidone belongs to a class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.

            HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the tablets whole with liquid. Do not crush or chew the tablets. Doing so can release all of the drug at once, increasing the risk of side effects.The dosage is based on your age, medical condition, and response to treatment.Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Keep taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor.Tell your doctor if your condition persists or worsens.

            SIDE EFFECTS: Drowsiness, dizziness, lightheadedness, drooling, stomach/abdominal pain, weight gain, or tiredness may occur. If any of these side effects persist or worsen, tell your doctor promptly.Dizziness and lightheadedness can increase the risk of falling. Get up slowly when rising from a sitting or lying position.An empty tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: difficulty swallowing, muscle spasms, shaking (tremor), mental/mood changes (such as restlessness), interrupted breathing during sleep.This drug may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.This drug may also cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor. (See also Notes section.)Paliperidone may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any unusual/uncontrolled movements (especially of the face, lips, mouth, tongue, arms, or legs).This medication may increase a certain natural substance (prolactin) made by your body. For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor right away.Get medical help right away if you have any very serious side effects, including: severe dizziness, fainting, seizures.This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, signs of kidney problems (such as change in the amount of urine).Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking paliperidone, tell your doctor or pharmacist if you are allergic to it; or to risperidone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, seizures, low white blood cell count, Parkinson's disease, dementia, esophagus/stomach/intestinal movement or blockage disorders (such as difficulty swallowing, peritonitis, cystic fibrosis, Meckel's diverticulum), certain eye problems (cataracts, glaucoma), personal or family history of diabetes, high cholesterol/triglyceride levels, heart disease, breathing trouble during sleep (sleep apnea).Paliperidone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using paliperidone, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using paliperidone safely.This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery (including cataract/glaucoma eye surgery), tell your doctor or dentist if you are taking or have ever taken this medication, and about all the other products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, lightheadedness, and QT prolongation (see above). Drowsiness, dizziness, and lightheadedness can increase the risk of falling.During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away.Since untreated mental/mood problems (such as schizophrenia, schizoaffective disorders, depression) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.This medication passes into breast milk and may have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops symptoms such as muscle stiffness or shakiness, unusual sleepiness, or difficulty feeding. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: metoclopramide.Many drugs besides paliperidone may affect the heart rhythm (QT prolongation), including amiodarone, chlorpromazine, moxifloxacin, quinidine, sotalol, procainamide, thioridazine, among others.Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness/dizziness, fast/irregular heartbeat, unusual/uncontrolled movements.

            NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as blood sugar, weight, blood pressure, blood cholesterol/triglyceride levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

            MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.