loxapine inhaled (Rx)

Brand and Other Names:Adasuve

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for oral inhalation

  • 10mg/single-use inhaler

Schizophrenia & Bipolar I Agitation

Indicated for acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults

10 mg inhaled PO once within a 24-hr period

Must be administered only by a healthcare professional

Dosing Considerations

Because of the risk of bronchospasm, is only available through a restricted program under a risk evaluation and mitigation strategy (REMS) and must be administered only in an enrolled healthcare facility

Prior to administering, screen all patients for a history of asthma, COPD, or other pulmonary disease, and examine patients (including chest auscultation) for respiratory signs (eg, wheezing)

Administration

Step 1. Open pouch and remove inhaler from package (indicator light on inhaler is off)

Step 2. Firmly pull the plastic tab from the rear of the inhaler; check that the green light turns on to indicate that the inhaler is ready for use

Use the inhaler within 15 minutes after removing the tab to prevent automatic deactivation of the inhaler; the green light will turn off, indicating that the inhaler is not usable

Discard the inhaler after one use

Step 3. Explain procedure to patient; inform the patient that the inhaler may produce a flash of light and a clicking sound, and it may become warm during use

Step 4. Instruct the patient to hold the inhalator away from the mouth and breathe out fully to empty the lungs

Step 5. Instruct the patient to put the mouthpiece of the inhaler between the lips, close the lips, and inhale through the mouthpiece with a steady deep breath; check that the green light turns off indicating that the dose has been delivered

Step 6. Instruct the patient to remove the mouthpiece from the mouth and hold the breath for as long as possible, up to 10 seconds

NOTE: If the green light remains on after the patient inhales, the dose has NOT been delivered; instruct the patient to repeat Steps 4-6 up to 2 additional times; if the green light still does not turn off, discard the inhaler and use a new one

Safety and efficacy not established

Next:

Interactions

Interaction Checker

and loxapine inhaled

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      Serious - Use Alternative

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            Contraindicated (1)

            • amisulpride

              amisulpride, loxapine inhaled. Either increases toxicity of the other by Other (see comment). Contraindicated. Comment: Increases risk of neuroleptic malignant syndrome.

            Serious - Use Alternative (24)

            • apomorphine

              loxapine inhaled decreases effects of apomorphine by pharmacodynamic antagonism. Contraindicated.

            • benzhydrocodone/acetaminophen

              benzhydrocodone/acetaminophen, loxapine inhaled. 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

              loxapine inhaled decreases effects of bromocriptine by pharmacodynamic antagonism. Contraindicated.

            • cabergoline

              loxapine inhaled decreases effects of cabergoline by pharmacodynamic antagonism. Contraindicated.

            • calcium/magnesium/potassium/sodium oxybates

              loxapine inhaled, 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.

            • dopamine

              loxapine inhaled decreases effects of dopamine by pharmacodynamic antagonism. Contraindicated.

            • fentanyl

              fentanyl, loxapine inhaled. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration with other CNS depressants, such as skeletal muscle relaxants, may cause respiratory depression, hypotension, profound sedation, coma, and/or death. Consider dose reduction of either or both agents to avoid serious adverse effects. Monitor for hypotension, respiratory depression, and profound sedation.

            • fentanyl intranasal

              fentanyl intranasal, loxapine inhaled. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration with other CNS depressants, such as skeletal muscle relaxants, may cause respiratory depression, hypotension, profound sedation, coma, and/or death. Consider dose reduction of either or both agents to avoid serious adverse effects. Monitor for hypotension, respiratory depression, and profound sedation.

            • fentanyl transdermal

              fentanyl transdermal, loxapine inhaled. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration with other CNS depressants, such as skeletal muscle relaxants, may cause respiratory depression, hypotension, profound sedation, coma, and/or death. Consider dose reduction of either or both agents to avoid serious adverse effects. Monitor for hypotension, respiratory depression, and profound sedation.

            • fentanyl transmucosal

              fentanyl transmucosal, loxapine inhaled. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration with other CNS depressants, such as skeletal muscle relaxants, may cause respiratory depression, hypotension, profound sedation, coma, and/or death. Consider dose reduction of either or both agents to avoid serious adverse effects. Monitor for hypotension, respiratory depression, and profound sedation.

            • hydrocodone

              hydrocodone, loxapine inhaled. 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.

            • levodopa

              loxapine inhaled decreases effects of levodopa by pharmacodynamic antagonism. Contraindicated.

            • lisuride

              loxapine inhaled decreases effects of lisuride by pharmacodynamic antagonism. Contraindicated.

            • methyldopa

              loxapine inhaled decreases effects of methyldopa by pharmacodynamic antagonism. Contraindicated.

            • metoclopramide intranasal

              loxapine inhaled, 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.

              loxapine inhaled 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.

            • mometasone inhaled

              mometasone inhaled increases toxicity of loxapine inhaled by Other (see comment). Avoid or Use Alternate Drug. Comment: Agents used to treat airway disease may enhance the toxic effect of inhaled loxapine.

            • olopatadine intranasal

              loxapine inhaled and olopatadine intranasal both increase sedation. Avoid or Use Alternate Drug. Coadministration increases risk of CNS depression, which can lead to additive impairment of psychomotor performance and cause daytime impairment.

            • pramipexole

              loxapine inhaled decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.

            • ropinirole

              loxapine inhaled decreases effects of ropinirole by pharmacodynamic antagonism. Contraindicated.

            • rotigotine

              loxapine inhaled decreases effects of rotigotine by pharmacodynamic antagonism. Contraindicated.

            • safinamide

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

            • selinexor

              selinexor, loxapine inhaled. 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

              loxapine inhaled, 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.

            • sufentanil SL

              sufentanil SL, loxapine inhaled. 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.

            Monitor Closely (254)

            • abobotulinumtoxinA

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

            • aclidinium

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

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

            • albuterol

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

            • alfentanil

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

            • almotriptan

              almotriptan, loxapine inhaled. 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 loxapine inhaled both increase sedation. Use Caution/Monitor.

            • amitriptyline

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

            • amobarbital

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

            • amoxapine

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

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

            • anticholinergic/sedative combos

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

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

            • apomorphine

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

            • arformoterol

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

            • aripiprazole

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

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

            • armodafinil

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

            • atracurium

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

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

            • atropine

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

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

            • atropine IV/IM

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

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

            • azelastine

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

            • baclofen

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

            • belladonna alkaloids

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

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

            • belladonna and opium

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

              belladonna and opium and loxapine inhaled both increase sedation. Use Caution/Monitor.

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

            • benperidol

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

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

            • benzphetamine

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

            • benztropine

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

              benztropine decreases levels of loxapine inhaled by pharmacodynamic antagonism. Use Caution/Monitor.

            • brexanolone

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

            • brompheniramine

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

            • buprenorphine

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

            • buprenorphine buccal

              buprenorphine buccal and loxapine inhaled both increase sedation. Use Caution/Monitor.

            • buprenorphine, long-acting injection

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

            • butalbital

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

            • butorphanol

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

            • caffeine

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

            • carbinoxamine

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

            • carisoprodol

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

            • chloral hydrate

              chloral hydrate and loxapine inhaled both increase sedation. Use Caution/Monitor.

            • chlordiazepoxide

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

            • chlorpheniramine

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

            • chlorpromazine

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

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

            • chlorzoxazone

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

            • cinnarizine

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

            • cisatracurium

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

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

            • clemastine

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

            • clomipramine

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

            • clonazepam

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

            • clonidine

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

            • clorazepate

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

            • clozapine

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

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

            • codeine

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

            • cyclizine

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

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

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

            • cyclobenzaprine

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

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

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

            • cyproheptadine

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

            • dantrolene

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

            • daridorexant

              loxapine inhaled and daridorexant both increase sedation. Modify Therapy/Monitor Closely. Coadministration increases risk of CNS depression, which can lead to additive impairment of psychomotor performance and cause daytime impairment.

            • darifenacin

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

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

            • desflurane

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

            • desipramine

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

            • deutetrabenazine

              loxapine inhaled 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.

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

            • dexchlorpheniramine

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

            • dexfenfluramine

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

            • dexmedetomidine

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

            • dexmethylphenidate

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

            • dextroamphetamine

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

            • dextromethorphan

              dextromethorphan, loxapine inhaled. 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 loxapine inhaled both increase sedation. Use Caution/Monitor.

            • diamorphine

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

            • diazepam

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

            • dicyclomine

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

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

            • diethylpropion

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

            • difelikefalin

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

            • difenoxin hcl

              difenoxin hcl and loxapine inhaled both increase sedation. Use Caution/Monitor.

            • dihydroergotamine

              dihydroergotamine, loxapine inhaled. 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 loxapine inhaled both increase sedation. Use Caution/Monitor.

            • diphenhydramine

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

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

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

            • diphenoxylate hcl

              diphenoxylate hcl and loxapine inhaled both increase sedation. Use Caution/Monitor.

            • dipipanone

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

            • dobutamine

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

            • donepezil transdermal

              donepezil transdermal, loxapine inhaled. Either decreases effects of the other by pharmacodynamic antagonism. Use Caution/Monitor.

            • dopamine

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

            • dopexamine

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

            • dosulepin

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

            • doxepin

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

            • doxylamine

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

            • droperidol

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

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

            • eletriptan

              eletriptan, loxapine inhaled. 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).

            • ephedrine

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

            • epinephrine

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

            • epinephrine racemic

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

            • ergoloid mesylates

              ergoloid mesylates, loxapine inhaled. 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, loxapine inhaled. 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).

            • estazolam

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

            • ethanol

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

            • etomidate

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

            • fenfluramine

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

            • fentanyl

              fentanyl, loxapine inhaled. 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

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

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

            • flavoxate

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

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

            • flibanserin

              flibanserin, loxapine inhaled. affecting hepatic/intestinal enzyme CYP3A4 metabolism. 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).

            • fluphenazine

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

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

            • flurazepam

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

            • formoterol

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

            • frovatriptan

              frovatriptan, loxapine inhaled. 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).

            • ganaxolone

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

            • glycopyrrolate

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

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

            • glycopyrrolate inhaled

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

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

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

            • glycopyrronium tosylate topical

              glycopyrronium tosylate topical, loxapine inhaled. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.

            • guanfacine

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

            • haloperidol

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

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

            • henbane

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

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

            • homatropine

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

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

            • hydromorphone

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

            • hydroxyzine

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

            • hyoscyamine

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

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

            • hyoscyamine spray

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

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

            • iloperidone

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

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

            • imipramine

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

            • incobotulinumtoxinA

              loxapine inhaled, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.

            • ipratropium

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

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

            • isoproterenol

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

            • ketamine

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

            • ketotifen, ophthalmic

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

            • lemborexant

              lemborexant, loxapine inhaled. 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.

            • levalbuterol

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

            • levomilnacipran

              levomilnacipran, loxapine inhaled. 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 loxapine inhaled both increase sedation. Use Caution/Monitor.

            • linezolid

              linezolid, loxapine inhaled. 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).

            • lisdexamfetamine

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

            • lithium

              lithium, loxapine inhaled. 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

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

            • lofexidine

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

            • loprazolam

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

            • lorazepam

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

              lorazepam, loxapine inhaled. Mechanism: unknown. Use Caution/Monitor. Risk of resp. depression, hypotension.

            • lorcaserin

              lorcaserin, loxapine inhaled. 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 loxapine inhaled both increase sedation. Use Caution/Monitor.

            • lurasidone

              lurasidone, loxapine inhaled. 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

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

            • maraviroc

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

            • marijuana

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

            • meclizine

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

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

            • melatonin

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

            • meperidine

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

              meperidine, loxapine inhaled. 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

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

            • metaproterenol

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

            • metaxalone

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

            • methadone

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

              methadone, loxapine inhaled. 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

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

            • methocarbamol

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

            • methscopolamine

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

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

            • methylenedioxymethamphetamine

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

            • methylergonovine

              methylergonovine, loxapine inhaled. 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

              loxapine inhaled 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

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

            • midazolam

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

            • midazolam intranasal

              midazolam intranasal, loxapine inhaled. 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

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

            • milnacipran

              milnacipran, loxapine inhaled. 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

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

            • modafinil

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

            • morphine

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

            • motherwort

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

            • moxonidine

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

            • nabilone

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

            • nalbuphine

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

            • naratriptan

              naratriptan, loxapine inhaled. 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).

            • norepinephrine

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

            • nortriptyline

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

            • olanzapine

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

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

            • oliceridine

              oliceridine, loxapine inhaled. 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.

            • onabotulinumtoxinA

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

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

            • opium tincture

              opium tincture and loxapine inhaled both increase sedation. Use Caution/Monitor.

            • orphenadrine

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

            • oxazepam

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

            • oxybutynin

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

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

            • oxybutynin topical

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

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

            • oxybutynin transdermal

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

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

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

            • oxycodone

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

            • oxymorphone

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

            • paliperidone

              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.

            • pancuronium

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

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

            • papaveretum

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

            • papaverine

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

            • paroxetine

              paroxetine, loxapine inhaled. 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).

            • pentazocine

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

            • pentobarbital

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

            • perphenazine

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

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

            • phendimetrazine

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

            • phenelzine

              phenelzine, loxapine inhaled. 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 and loxapine inhaled both increase sedation. Use Caution/Monitor.

            • phentermine

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

            • phenylephrine

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

            • phenylephrine PO

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

            • pholcodine

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

            • pimozide

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

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

            • pirbuterol

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

            • pralidoxime

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

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

            • primidone

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

            • procarbazine

              procarbazine, loxapine inhaled. 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

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

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

            • promethazine

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

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

              promethazine, loxapine inhaled. 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

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

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

            • propofol

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

            • propylhexedrine

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

            • protriptyline

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

            • quazepam

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

            • quetiapine

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

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

            • ramelteon

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

            • rapacuronium

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

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

            • remimazolam

              remimazolam, loxapine inhaled. 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.

            • rimabotulinumtoxinB

              loxapine inhaled, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.

            • risperidone

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

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

            • rizatriptan

              rizatriptan, loxapine inhaled. 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).

            • rocuronium

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

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

            • rotigotine

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

            • salmeterol

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

            • scopolamine

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

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

            • scullcap

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

            • secobarbital

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

            • selegiline

              selegiline, loxapine inhaled. 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).

            • sevoflurane

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

            • shepherd's purse

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

            • sodium sulfate/?magnesium sulfate/potassium chloride

              sodium sulfate/?magnesium sulfate/potassium chloride increases effects of loxapine inhaled 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 effects of loxapine inhaled 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

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

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

            • sufentanil

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

            • sumatriptan

              sumatriptan, loxapine inhaled. 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, loxapine inhaled. 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).

            • tapentadol

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

            • temazepam

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

            • terbutaline

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

            • tetrabenazine

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

            • thioridazine

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

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

            • thiothixene

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

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

            • tiotropium

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

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

            • tolterodine

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

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

            • topiramate

              loxapine inhaled and topiramate both increase sedation. Modify Therapy/Monitor Closely.

            • tramadol

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

            • tranylcypromine

              tranylcypromine, loxapine inhaled. 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

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

            • triazolam

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

            • triclofos

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

            • trifluoperazine

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

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

            • trihexyphenidyl

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

              trihexyphenidyl decreases levels of loxapine inhaled by pharmacodynamic antagonism. Use Caution/Monitor.

            • trimipramine

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

            • triprolidine

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

            • trospium chloride

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

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

            • vecuronium

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

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

            • venlafaxine

              venlafaxine, loxapine inhaled. 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).

            • vilazodone

              vilazodone, loxapine inhaled. 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).

            • xylometazoline

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

            • yohimbine

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

            • ziconotide

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

            • ziprasidone

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

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

            • zolmitriptan

              zolmitriptan, loxapine inhaled. 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

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

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

            Minor (6)

            • brimonidine

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

            • chasteberry

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

            • ethanol

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

            • eucalyptus

              loxapine inhaled and eucalyptus both increase sedation. Minor/Significance Unknown.

            • sage

              loxapine inhaled and sage both increase sedation. Minor/Significance Unknown.

            • smoking

              smoking decreases levels of loxapine inhaled by affecting hepatic enzyme CYP1A2 metabolism. Minor/Significance Unknown.

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            Adverse Effects

            >10%

            Respiratory adverse effects in patients with COPD (19%)

            Dysgeusia (14%)

            Sedation (12%)

            1-10%

            Throat irritation (3%)

            <1%

            Bronchospasm (0.8%)

            Akathisia (0.4%)

            Neck dystonia and oculogyration (0.4%)

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            Warnings

            Black Box Warnings

            Bronchospasm

            • Can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest
            • Administer only in an enrolled healthcare facility that has immediate access on-site to supplies and personnel and ready access to emergency response services; facilities must have a short-acting bronchodilator, including a nebulizer and inhalation solution, for immediate treatment of bronchospasm
            • Prior to administering, screen patients regarding a current diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and examine (including chest auscultation) patients for respiratory signs
            • Monitor for signs and symptoms of bronchospasm following treatment

            Dementia-related psychosis

            • Patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death as shown in short-term controlled trials
            • The deaths appeared to be either cardiovascular (eg, heart failure, stroke, sudden death) or infectious (eg, pneumonia) in nature
            • This drug is not approved for the treatment of patients with dementia-related psychosis

            Contraindications

            Current diagnosis or history of asthma, COPD, or other lung disease associated with bronchospasm

            Acute respiratory symptoms or signs (eg, wheezing)

            Current use of medications to treat airways disease, such as asthma or COPD

            History of bronchospasm following treatment

            Known hypersensitivity (including serious skin reactions) to loxapine or amoxapine

            Cautions

            Can cause bronchospasm (see Black Box Warnings)

            Monitor for signs and symptoms of bronchospasm following administration; perform a physical exam, including chest auscultation at least q15min for at least 1 hr after the dose

            Increased mortality in elderly patients with demential-related psychosis (see Black Box Warnings)

            Antipsychotic drugs can cause neuroleptic malignant syndrome; symptoms include hyperpyrexia, muscle rigidity, altered mental status, and autonomic instability; associated findings include increased CPK, rhabdomyolysis, increased urine and serum myoglobin, and renal failure

            May cause hypotension, orthostatic hypotension, and syncope

            Lowers seizure threshold; use caution in patients with history of seizures

            May cause cognitive and motor impairment

            May cause sedation and somnolence; use caution when driving or operating machinery and when coadministered with other drugs known to cause CNS depression

            May cause anticholinergic adverse reactions, including exacerbation of glaucoma and urinary retention; caution when coadministered with other drugs that elicit anticholinergic effects

            Increased incidence of stroke and transient ischemic attack in elderly patients with dementia-related psychosis treated with antipsychotic drugs

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            Pregnancy & Lactation

            Pregnancy

            There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics during pregnancy; healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866- 961-2388 or online at http://womensmentalhealth.org/ clinical-and-researchprograms/pregnancyregistry/

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

            The available data from published case reports and pharmacovigilance cases with loxapine in pregnant women are insufficient to determine a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes

            There are risks to mother associated with untreated schizophrenia or bipolar I disorder and with exposure to antipsychotics, including loxapine during pregnancy

            Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder reported in neonates exposed to antipsychotic drugs, including loxapine, during third trimester of pregnancy; these symptoms have varied in severity

            Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately; some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization

            Animal data

            • In animal reproduction studies, increased embryofetal toxicity and death in rat fetuses and offspring were observed when pregnant rats were orally administered loxapine, during period of organogenesis, at doses approximately less or equal to maximum recommended human dose (MRHD) based on mg/m2 body surface area

            Lactation

            There is no available information on presence of loxapine in human milk, effects on breastfed infant, or on milk production

            The drug is present in milk of lactating dogs; when a drug is present in animal milk, it is likely that the drug will be present in human milk

            The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed child from therapy or from underlying maternal condition

            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

            Typical antipsychotic (dibenzoxazepine subclass of tricyclic antipsychotic agents); mechanism of action is unknown, but is theorized to antagonize central dopamine D2 and serotonin 5-HT2a receptors

            Absorption

            Peak Plasma Time: 2 minutes

            Peak Plasma Concentration: 257 ng/mL

            AUC: 66 ng•h/mL (0-2 hr); 188 ng•h/mL (infinity)

            Distribution

            Protein Bound: 96.6%

            Metabolism

            Metabolized extensively in the liver by hydroxylation; forms 8-OH-loxapine by CYP1A2 and forms 7-OH-loxapine by CYP3A4 and CYP2D6

            Metabolized by N-oxidation to form loxapine N-oxide by flavanoid monoamine oxidases

            Demethylated to form amoxapine Because there are multiple metabolic pathways, the risk of metabolic interactions caused by an effect on an individual isoform is minimal

            Because there are multiple metabolic pathways, the risk of metabolic interactions caused by an effect on an individual isoform is minimal

            Elimination

            Half-life: 7.16 hr (range 6-8 hr)

            Excretion: feces (unconjugated metabolites); urine (conjugated metabolites)

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            Images

            No images available for this drug.
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            Patient Handout

            A Patient Handout is not currently available for this monograph.
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            Formulary

            FormularyPatient Discounts

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            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
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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.