PAROXAT 20/MG FC TAB 30/FC TAB

Indications

Approved Uses

For paroxetine (IR, oral): Major depressive disorder (MDD), obsessive-compulsive disorder (OCD), panic disorder, social anxiety disorder (social phobia), generalized anxiety disorder (GAD), post-traumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD). (Menopausal vasomotor symptoms are NOT an approved indication for paroxetine 20 mg IR; that indication applies to low-dose paroxetine 7.5 mg.)

Off-Label Uses

Common off-label uses: premature ejaculation; menopausal vasomotor symptoms (off-label for standard doses, noting only 7.5 mg is approved for VMS); certain chronic pain conditions/neuropathic pain (limited evidence); body dysmorphic disorder (often treated similarly to OCD).

Dosage & Administration

Dosing by Condition

Adults (paroxetine IR): MDD 20 mg daily; may increase by 10 mg weekly; max 50 mg/day. OCD 20 mg daily; target 40-60 mg/day; max 60 mg/day. Panic disorder 10 mg daily then increase; target ~40 mg/day; max 60 mg/day. Social anxiety disorder 20 mg daily; usual 20-50 mg/day; max 60 mg/day. GAD 20 mg daily; usual 20-50 mg/day (commonly max 50 mg/day). PTSD 20 mg daily; usual 20-50 mg/day (commonly max 50 mg/day). PMDD 20 mg daily either continuously or during luteal phase only.

Initial Dose

20mg once daily for Major Depressive Disorder, Social Anxiety Disorder, or Generalized Anxiety Disorder; 10mg once daily for Panic Disorder.

Maintenance Dose

20-50mg/day for Major Depressive Disorder; 40-60mg/day for OCD; 10-60mg/day for Panic Disorder; 20-50mg/day for Social Anxiety Disorder and GAD.

Maximum Dose

50mg/day for Major Depressive Disorder; 60mg/day for OCD, Panic Disorder, and Social Anxiety Disorder.

Children's Dosage

Not approved for use in children and adolescents under 18 years of age for major depressive disorder. Off-label use for OCD and social anxiety disorder has been studied.

Dose Adjustment Notes

Titrate by 10 mg increments no more frequently than weekly; in elderly or severe hepatic impairment or severe renal impairment (CrCl <30 mL/min), start 10 mg/day and use lower target doses with cautious titration (generally do not exceed 40 mg/day).

How to Take

Swallow tablet whole with water. Take once daily in the morning, with or after food to reduce nausea. Do not crush or chew the tablet.

Side Effects

Common Side Effects

Nausea, somnolence/drowsiness, insomnia, sexual dysfunction, sweating, dry mouth, dizziness, headache, tremor, constipation/diarrhea, decreased appetite, asthenia/fatigue, weight gain (with longer-term use).

Side Effect Frequency

Very common (≥10%): nausea, somnolence, insomnia, sexual dysfunction (e.g., decreased libido, delayed ejaculation/anorgasmia), sweating, dry mouth, dizziness, headache. Common (1-10%): constipation/diarrhea, tremor, asthenia/fatigue, decreased appetite, abnormal dreams, agitation/anxiety, blurred vision, yawning, weight change. Important uncommon/rare but clinically significant: hyponatremia/SIADH, abnormal bleeding (esp. with NSAIDs/anticoagulants), serotonin syndrome, mania/hypomania, seizures, angle-closure glaucoma/acute mydriasis, severe skin reactions.

Safety & Warnings

Contraindications

Contraindicated with MAOIs (including within 14 days of stopping an MAOI; and allow 14 days after stopping paroxetine before starting an MAOI), and with thioridazine or pimozide; contraindicated in patients with hypersensitivity to paroxetine/excipients; avoid/contraindicated with linezolid or IV methylene blue unless no alternatives and with close monitoring.

Warnings & Precautions

Monitor for clinical worsening/suicidality (especially early therapy and in <25); avoid serotonergic combinations that raise serotonin syndrome risk; taper to prevent discontinuation syndrome; screen for bipolar disorder/mania risk; use caution with seizure disorders; increased bleeding risk with NSAIDs/anticoagulants; monitor for hyponatremia (elderly/diuretics); consider angle-closure glaucoma risk; potent CYP2D6 inhibition (interaction management); pregnancy: potential fetal/neonatal risks with exposure, especially late pregnancy.

Age Restriction

Not approved for pediatric use (<18 years) for any indication; avoid routine use in <18 unless specialist-directed.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major interactions: MAOIs/linezolid/IV methylene blue (serotonin syndrome-avoid/contraindicated), thioridazine and pimozide (QT/proarrhythmia-contraindicated), other serotonergic agents (e.g., triptans, tramadol, fentanyl, lithium, other SSRIs/SNRIs/TCAs-serotonin syndrome), anticoagulants/antiplatelets/NSAIDs (bleeding risk), strong CYP2D6 inhibition by paroxetine (↑ levels of CYP2D6 substrates; reduces tamoxifen activation), and alcohol/CNS depressants (additive impairment).

Interaction Severity

MAJOR/contraindicated: MAOIs (including linezolid and IV methylene blue) due to serotonin syndrome risk; thioridazine and pimozide due to QT/arrhythmia risk. MODERATE/clinically significant: other serotonergic drugs (triptans, tramadol, lithium, St John’s wort) → serotonin syndrome; anticoagulants/antiplatelets/NSAIDs → bleeding risk; strong CYP2D6 substrates (e.g., TCAs, some antipsychotics) → increased levels; tamoxifen → reduced activation/efficacy (avoid).

Food Interaction

May be taken with or without food; taking with food can improve GI tolerability (e.g., nausea).

Special Populations

Pregnancy

Category D

Children

Not approved for use in children and adolescents under 18 years of age for major depressive disorder. Off-label use for OCD and social anxiety disorder has been studied.

Elderly

Start at 10mg once daily. The usual effective dose is 20mg/day, but may be increased up to a maximum of 40mg/day.

Kidney Impairment

Severe renal impairment (CrCl <30 mL/min): start 10 mg once daily and titrate slowly; do not exceed 40 mg/day; mild-moderate impairment generally no adjustment but use caution.

Liver Impairment

Hepatic impairment: start 10 mg once daily and titrate slowly; do not exceed 40 mg/day (use lower/slow titration in severe impairment).

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered the same day; if it is close to the next dose, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Do not stop abruptly; taper gradually (commonly over at least several weeks, individualized) to reduce discontinuation symptoms (e.g., dizziness, sensory disturbances, anxiety/irritability, flu-like symptoms).

Overdose

Overdose may cause nausea/vomiting, tremor, agitation/somnolence, tachycardia, seizures, and serotonin syndrome; management is urgent medical evaluation with supportive care (airway/ventilation, vitals), consider activated charcoal if early and appropriate, treat seizures/serotonin syndrome as indicated, and monitor ECG; no specific antidote.

Patient Counseling

Take PAROXAT (paroxetine) exactly as prescribed, once daily at the same time each day; it can be taken with or without food (taking with food may reduce nausea). Benefits may take 2-4 weeks (sometimes longer) to be noticeable-continue even if you do not feel better right away. Do not stop suddenly; taper only under prescriber guidance to reduce discontinuation symptoms (e.g., dizziness, “electric shock” sensations, irritability, flu-like symptoms). Avoid alcohol and use caution with driving/operating machinery until you know how it affects you (may cause drowsiness or impair concentration). Seek urgent help for suicidal thoughts, worsening depression/anxiety, severe agitation, or unusual behavior changes-especially early in treatment or after dose changes. Avoid combining with other serotonergic drugs (e.g., MAOIs, linezolid, triptans, tramadol, St John’s wort) unless supervised due to serotonin syndrome risk; inform all healthcare providers/pharmacists because paroxetine has important drug interactions (notably via CYP2D6 inhibition and increased bleeding risk with NSAIDs/anticoagulants). Discuss pregnancy planning/breastfeeding with your clinician (paroxetine is generally avoided in pregnancy when possible, especially 1st trimester).

Monitoring Requirements

Monitor for suicidality/clinical worsening especially early and after dose changes; monitor for serotonin syndrome when combined with serotonergic agents; monitor for hyponatremia/SIADH risk (especially elderly/diuretics) and for abnormal bleeding if on NSAIDs/anticoagulants; monitor weight/sexual dysfunction and discontinuation symptoms.

Pharmacology

Mechanism of Action

Selective serotonin reuptake inhibitor (SSRI): inhibits SERT to increase synaptic serotonin in the CNS; paroxetine also has relatively higher anticholinergic activity among SSRIs.

Duration of Effect

Clinical antidepressant/anxiolytic effect persists with continued daily dosing; symptomatic benefit is maintained over weeks to months once therapeutic response is achieved (not a single-dose effect).

Half-Life

Approximately 21 hours (typical range about 15-24 hours; may be longer in some patients due to nonlinear/saturable metabolism).

Bioavailability

Approximately 50% (reduced by first-pass metabolism; systemic exposure can increase with repeated dosing due to saturable metabolism/CYP2D6 inhibition).

Metabolism

Extensive hepatic metabolism, primarily via CYP2D6; paroxetine is also a strong CYP2D6 inhibitor and exhibits nonlinear (saturable) pharmacokinetics; metabolites are largely inactive and eliminated in urine/feces.

Protein Binding

High protein binding ~95% (commonly cited range 93-95%).

Product Information

Available Dosage Forms

This SFDA product: film-coated tablet (oral). (Paroxetine as a molecule is also available in some markets as immediate-release tablets, controlled/extended-release tablets, and oral suspension; a capsule form is specific to paroxetine 7.5 mg for VMS and is not applicable to this 20 mg tablet product.)

Composition per Dose

Each film-coated tablet: Paroxetine 20 mg (as paroxetine hydrochloride)

Generic Availability

Yes

OTC Alternatives

No OTC alternative equivalent to paroxetine for its approved indications; OTC options (e.g., sleep aids or herbal products) are not appropriate substitutes for prescription SSRI therapy.

Psych Class

Antidepressant-SSRI

Controlled Substance

No

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