PAXIL Film‑coated tablet / Oral suspension (2020)

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Apotex Corp

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BOXED WARNING SECTION

Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term ...

1. Description

PAXIL (paroxetine hydrochloride) is an orally administered psychotropic drug. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as ()trans4R(4'-fluorophenyl) ...

2. Clinical Pharmacology

Pharmacodynamics The efficacy of paroxetine in the treatment of major depressive disorder, social anxiety disorder, obsessive compulsive disorder (OCD), panic disorder (PD), generalized anxiety disorder ...

3. Indications and Usage

Major Depressive Disorder PAXIL is indicated for the treatment of major depressive disorder. The efficacy of PAXIL in the treatment of a major depressive episode was established in 6‑week controlled trials ...

4. Contraindications

The use of MAOIs intended to treat psychiatric disorders with PAXIL or within 14 days of stopping treatment with PAXIL is contraindicated because of an increased risk of serotonin syndrome. The use of ...

5. Warnings

Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior ...

6.1. General

Activation of Mania/Hypomania During premarketing testing, hypomania or mania occurred in approximately 1.0% of unipolar patients treated with PAXIL compared to 1.1% of active‑control and 0.3% of placebo‑treated ...

6.2. Information for Patients

Information for Patients PAXIL should not be chewed or crushed, and should be swallowed whole. Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of PAXIL and triptans, ...

6.3. Laboratory Tests

There are no specific laboratory tests recommended.

6.4. Drug Interactions

Tryptophan As with other serotonin reuptake inhibitors, an interaction between paroxetine and tryptophan may occur when they are coadministered. Adverse experiences, consisting primarily of headache, nausea, ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Two‑year carcinogenicity studies were conducted in rodents given paroxetine in the diet at 1, 5, and 25 mg/kg/day (mice) and 1, 5, and 20 mg/kg/day (rats). These doses are up to 2.4 (mouse) ...

6.7. Pregnancy

Pregnancy Category D. See WARNINGS: Usage in Pregnancy: Teratogenic Effects and Nonteratogenic Effects.

6.8. Labor and Delivery

The effect of paroxetine on labor and delivery in humans is unknown.

6.9. Nursing Mothers

Like many other drugs, paroxetine is secreted in human milk, and caution should be exercised when PAXIL is administered to a nursing woman.

6.10. Pediatric Use

Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS: Clinical Worsening and Suicide Risk). Three placebo-controlled trials in 752 pediatric patients ...

6.11. Geriatric Use

SSRIs and SNRIs, including PAXIL, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event (see PRECAUTIONS: Hyponatremia). ...

7. Adverse Reactions

Associated With Discontinuation of Treatment Twenty percent (1,199/6,145) of patients treated with PAXIL in worldwide clinical trials in major depressive disorder and 16.1% (84/522), 11.8% (64/542), 9.4% ...

8. Drug Abuse and Dependence

Controlled Substance Class PAXIL is not a controlled substance. Physical and Psychologic Dependence PAXIL has not been systematically studied in animals or humans for its potential for abuse, tolerance ...

9. Overdosage

Human Experience Since the introduction of PAXIL in the United States, 342 spontaneous cases of deliberate or accidental overdosage during paroxetine treatment have been reported worldwide (circa 1999). ...

10. Dosage and Administration

Major Depressive Disorder Usual Initial Dosage PAXIL should be administered as a single daily dose with or without food, usually in the morning. The recommended initial dose is 20 mg/day. Patients were ...

11. How Supplied

Tablets Film‑coated, modified‑oval as follows: 10-mg yellow, scored tablets engraved on the front with PAXIL and on the back with 10. NDC 60505-3663-3 Bottles of 30 20-mg pink, scored tablets engraved ...

12. Storage and Handling

Store tablets between 15° and 30°C (59° and 86°F). Store suspension at or below 25°C (77°F).