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paroxetine (Rx)Brand and Other Names:Paxil, Brisdelle, more...Paxil CR, Pexeva

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 10mg
  • 20mg
  • 30mg
  • 40mg

capsule

  • 7.5mg

tablet, extended-release

  • 12.5mg
  • 25mg
  • 37.5mg

oral suspension

  • 10mg/5mL
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Depression

Conventional: 20 mg PO qDay initially; may increase by 10 mg/day qWeek not to exceed 50 mg/day

Paxil CR: 25 mg PO qDay initially; may increase by 12.5 mg/day qWeek not to exceed 62.5 mg/day

Obsessive-Compulsive Disorder

20 mg PO qDay initially; may increase by 10 mg qWeek, not to exceed 60 mg/day

Panic Disorder

10 mg PO qDay initially; may increase by 10 mg qWeek (target dose 40 mg/day), not to exceed 60 mg/day, OR

Paxil CR: 12.5 mg PO qDay initial, increase by 12.5 mg qWeek not to exceed 75 mg/day

Social Phobia

20 mg PO qDay OR

Paxil CR: 12.5 mg PO qDay initially; may increase by 12.5 mg qWeek, not to exceed 37.5 mg/day

Generalized Anxiety Disorder

20 mg PO qDay initially, may increase by 10 mg qWeek, up to 50 mg/day doses have been used but no increase in benefit seen at doses >20 mg/day

Posttraumatic Stress Disorder

20 mg PO qDay initially; may increase by 10 mg qWeek, up to 50 mg/day doses have been used but no increase in benefit seen at doses >20 mg/day

Premenstrual Dysphoric Disorder

Paxil CR: 12.5 mg PO qDay initially; may increase at 1 week intervals not to exceed 25 mg/day

Menopausal Vasomotor Symptoms

Brisdelle: Indicated to treat moderate-to-severe vasomotor symptoms associated with menopause

Brisdelle: 7.5 mg PO qHS

Paxil CR (Off-label): 12.5-25 mg PO qDay

Dosing Modifications

Severe renal impairment (CrCl <30 mL/min)

  • Conventional: 10 mg PO qDay initially; may titrate; not to exceed 40 mg/day
  • Paxil CR: 12.5 mg PO qDay initially; may titrate; not to exceed 50 mg/day

Stuttering (Off-label)

20 mg PO qDay

Vasovagal Syncope (Off-label)

20 mg/day PO

Diabetic Neuropathy (Off-label)

10 mg/day PO initially; may increase to 20-60 mg/day

Safety and efficacy not established

Caution should be used in the elderly because paroxetine is the most sedating and anticholinergic of the selective serotonin reuptake inhibitors

The elderly are prone to SSRI/SNRI-induced hyponatremia; monitor closely

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Interactions

Interaction Checker

paroxetine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10% (Based on 40 mg Dose)

            Nausea (15-24%)

            Insomnia (11-24%)

            Dry mouth (9-18%)

            Headache (17%)

            Asthenia (10-15%)

            Constipation (10-15%)

            Diarrhea (9-12%)

            Dizziness (6-14%)

            Ejaculation disorder (10-15%)

            Tremor (4-11%)

            1-10% (Based on 40 mg Dose)

            Anxiety (5-10%)

            Blurred vision (5-10%)

            Decreased appetite (5-10%)

            Impotence (2-9%)

            Nervousness (2-5%)

            Paresthesia (2-5%)

            Hypomania (0.3 to 2.2%)

            Frequency Not Defined (Based on 40 mg Dose)

            Hypertension

            Tachycardia

            Emotional lability

            Pruritus

            Weight gain

            Arthralgia

            Tinnitus

            Vertigo

            Angle clossure glaucoma

            Serious

            • Depression exacerbation
            • Mania (rare)
            • Serotonin syndrome
            • Suicidal thoughts (rare)
            • Suicide (rare)
            • Seizure (rare)
            • Toxic epidermal necrolysis
            • Hyponatremia (rare)
            • Bleeding, abnormal (rare)
            • Acute hepatitis (rare)
            • Stevens-Johnson Syndrome
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            Warnings

            Black Box Warnings

            In short-term studies, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults (<24 years) taking antidepressants for major depressive disorders and other psychiatric illnesses

            This increase was not seen in patients aged >24 years; a slight decrease in suicidal thinking was seen in adults >65 years

            In children and young adults, risks must be weighed against the benefits of taking antidepressants

            Patients should be monitored closely for changes in behavior, clinical worsening, and suicidal tendencies; this should be done during the initial 1-2 months of therapy and dosage adjustments

            The patient’s family should communicate any abrupt changes in behavior to the healthcare provider

            Worsening behavior and suicidal tendencies that are not part of the presenting symptoms may require discontinuation of therapy

            This drug is not approved for use in pediatric patients

            Contraindications

            Hypersensitivity

            Concomitant pimozide

            Coadministration with serotonergic drugs

            • Concomitant use or within 14 days of MAOIs increases risk of serotonin syndrome
            • Reactions to concomitant administration with MAOIs include tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, hyperthermia with features resembling neuroleptic malignant syndrome, seizures, rigidity, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma
            • Starting paroxetine in a patient who is being treated with linezolid or IV methylene blue is contraindicated because of an increased risk of serotonin syndrome
            • If linezolid or IV methylene blue must be administered, discontinue SSRI immediately and monitor for CNS toxicity; may resume 24 hr after last linezolid or methylene blue dose, or after 2 weeks of monitoring (5 weeks for fluoxetine), whichever comes first

            Cautions

            Clinical worsening and suicidal ideation may occur despite medication in adolescents and young adults (18-24 years)

            Use caution in patients with bipolar disorder, seizure disorder, history of suicidal thought/behavior

            Risk of mydriasis; may trigger angle closure attack in patients with angle closure glaucoma with anatomically narrow angles without a patent iridectomy

            Conflicting evidence regarding use of SSRIs during pregnancy and increased risk of persistent pulmonary hypertension of the newborn (see Pregnancy)

            Risk of complications such as feeding difficulties, irritability, and respiratory problems reported in neonates exposed to SNRIs/SSRIs late in third trimester

            Risk of cardiovascular defects in infants whose mothers took drug during early pregnancy

            Withdraw gradually

            Use lower starting dose in renal impairment (CrCl <30 mL/min) or severe hepatic impairment

            Increases risk of hyponatremia and impairment of cognitive and motor functions in the elderly

            May cause or exacerbate sexual dysfunction

            Inability to remain still due to feelings of agitation or restlessness reported; may occur within first few weeks of therapy

            May impair platelet aggregation especially when used in combination with aspirin or NSAIDs; increases risk of bleeding in patients taking anticoagulants/antiplatelets concomitantly

            Epidemiologic studies on bone fracture risk following exposure to some antidepressants, including SSRIs, have reported an association between antidepressant treatment and fractures; there are multiple possible causes for this observation and it is unknown to what extent fracture risk is directly attributable to SSRI treatment

            Bone fractures reported to be associated with antidepresant use

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            Pregnancy & Lactation

            Pregnancy

            Pregnancy category: D

            Teratogenic effects: Epidemiologic studies have shown that infants exposed to paroxetine in the first trimester of pregnancy have an increased risk of congenital malformations, particularly cardiovascular malformations

            Use late in the third trimester associated with complications in newborns and may require prolonged hospitalization, respiratory support, and tube feeding

            A study of nearly 28,000 women taking SSRIs confirmed 5 previously reported birth defercts associated with paroxetine, including heart defects, anencephaly, and abdominal wall defects (BMJ 2015; 351:h3190)

            Persistent pulmonary hypertension of the newborn

            • Potential risk of persistent pulmonary hypertension of the newborn (PPHN) when used during pregnancy
            • Initial public health advisory in 2006 was based on a single published study; since then, there have been conflicting findings from new studies, making it unclear whether use of SSRIs during pregnancy can cause PPHN
            • FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN
            • FDA recommendation: FDA advises health care professionals not to alter their current clinical practice of treating depression during pregnancy and to report any adverse events to the FDA MedWatch program
            • A meta-analysis of 7 observational studies, found exposure to SSRIs in late pregnancy (ie, >20 weeks' gestation) more than doubled the risk of PPHN that could not be explained by other etiologies (eg, congenital malformations, meconium aspiration) (BMJ 2014;348:f6932)

            Lactation

            Excreted in breast milk; use caution (AAP states effect on nursing infants is unknown but may be of concern)

            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

            SSRI; little or no affinity for alpha-adrenergic histamine or cholinergic receptor

            Absorption

            Peak plasma time: 5.2-8.1 hr (immediate-release); 6-10 hr (controlled-release)

            Peak plasma concentration: 61.7 ng/mL

            Distribution

            Protein bound: 93-95%

            Vd: 8.7 L/kg

            Metabolism

            Metabolism: Hepatic P450 enzyme CYP2D6

            Enzymes inhibited: CYP2D6

            Metabolites: Inactive

            Elimination

            Half-life: 21 hr

            Dialyzable: No

            Excretion: Urine (64%); feces (36%)

            Pharmacogenomics

            Several SSRIs (eg, fluoxetine, fluvoxamine, paroxetine, sertraline) are metabolized by CYP2D6

            CYP2D6 is involved in the metabolism of approximately 20% of drugs in clinical use, and it displays large individual-to-individual variability in activity due to genetic polymorphisms

            More than 80 CYP2D6 variant alleles have been identified; however, 4 of the most prevalent alleles, CYP2D6*3, *4, *5, and *6, account for 93-97% of CYP2D6 poor metabolizers (PMs)

            CYP2D6*4, the most common variant (~25% frequency in whites), causes a splicing defect; CYP2D6*3 (2.7% frequency) causes a frameshift mutation; and CYP3D6*5 (2.6%) is an entire deletion of the CYP2D6 gene; individuals homozygous for these alleles have no CYP2D6 activity

            The impact of CYP2D6 activity is further complicated in some SSRIs (eg, fluoxetine, fluvoxamine, paroxetine, sertraline) that in addition to being substrates for CYP2D6, are also known to moderately inhibit CYP2D6 activity

            Genetic testing laboratories

            • Genotyping tests for CYP2D6 variants are commercially available through the following companies
            • Applied Biosystems (http://www.appliedbiosystems.com/)
            • GenPath Diagnostics (http://www.genpathdiagnostics.com/)
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            Images

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            Formulary

            FormularyPatient Discounts

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            • 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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