Paroxetine 10 mg Immediate Release Tablets — Generic For Paxil — Zydus

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS.

PAROXETINE tablets, for oral use

Initial U.S. Approval: 1992

PAROXETINE- paroxetine tablet, film coated

Zydus Pharmaceuticals USA Inc.

These highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS.

PAROXETINE tablets, for oral use

Initial U.S. Approval: 1992

Warning: Suicidal Thoughts And Behaviors

See full prescribing information for complete boxed warning.

Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. Paroxetine is not approved for use in pediatric patients. (5.1, 8.4)

Recent Major Changes

Warnings and Precautions (5.4)

11/2024

Indications And Usage

Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of (1):

Major Depressive Disorder (MDD)

Obsessive Compulsive Disorder (OCD)

Panic Disorder (PD)

Social Anxiety Disorder (SAD)

Generalized Anxiety Disorder (GAD)

Posttraumatic Stress Disorder (PTSD)

Dosage And Administration

Recommended starting and maximum daily dosage for MDD, OCD, PD, and PTSD: (2.2)

Indication

Starting Daily Dose

Maximum Daily Dose

Mdd

20 mg

50 mg

Ocd

20 mg

60 mg

Pd

10 mg

60 mg

Ptsd

20 mg

50 mg

Recommended starting dosage for SAD and GAD is 20 mg daily. (2.3)

Elderly patients, patients with severe renal impairment or severe hepatic impairment: Starting dosage is 10 mg daily. Maximum dosage is 40 mg daily. (2.4)

When discontinuing paroxetine tablets, reduce dosage gradually. (2.6, 5.7)

Dosage Forms And Strengths

Tablets: 10 mg, scored; 20 mg, scored; 30 mg; and 40 mg tablets. (3)

Contraindications

Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within 14 days of discontinuing a MAOI. (4, 5.3, 7)

Concomitant use of pimozide or thioridazine. (4, 5.3,7)

Known hypersensitivity to paroxetine or to any of the inactive ingredients in paroxetine tablets. (4)

Warnings And Precautions

• (5.4) 11/2024 INDICATIONS AND USAGE Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of (1):
• Major Depressive Disorder (MDD)
• Obsessive Compulsive Disorder (OCD)
• Panic Disorder (PD)
• Social Anxiety Disorder (SAD)
• Generalized Anxiety Disorder (GAD)
• Posttraumatic Stress Disorder (PTSD) DOSAGE AND ADMINISTRATION
• Recommended starting and maximum daily dosage for MDD, OCD, PD, and PTSD: (2.2) Indication Starting Daily Dose Maximum Daily Dose MDD 20 mg 50 mg OCD 20 mg 60 mg PD 10 mg 60 mg PTSD 20 mg 50 mg

• (5.4) 11/2024 INDICATIONS AND USAGE Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of (1):
• Major Depressive Disorder (MDD)
• Obsessive Compulsive Disorder (OCD)
• Panic Disorder (PD)
• Social Anxiety Disorder (SAD)
• Generalized Anxiety Disorder (GAD)
• Posttraumatic Stress Disorder (PTSD) DOSAGE AND ADMINISTRATION
• Recommended starting and maximum daily dosage for MDD, OCD, PD, and PTSD: (2.2) Indication Starting Daily Dose Maximum Daily Dose MDD 20 mg 50 mg OCD 20 mg 60 mg PD 10 mg 60 mg PTSD 20 mg 50 mg

Serotonin Syndrome:Increased risk when co-administered with other serotonergic agents, but also when taken alone. If occurs, discontinue paroxetine and serotonergic agents and initiate supportive measures. (5.2)

Embryofetal Toxicity:May cause fetal harm. Meta-analyses of epidemiological studies have shown increased risk (less than 2-fold) of cardiovascular malformations with exposure during the first trimester. (5.4, 8.1)

Increased Risk of Bleeding:Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, other antiplatelet drugs, warfarin, and other anticoagulant drugs may increase risk. (5.5)

Activation of Mania/Hypomania:Screen patients for bipolar disorder. (5.6)

Seizures:Use with caution in patients with seizure disorders. (5.8)

Angle-Closure Glaucoma:Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. (5.9)

Sexual Dysfunction: paroxetine may cause symptoms of sexual dysfunction. (5.13)

Adverse Reactions

Most common adverse reactions (≥ 5% and at least twice placebo) are abnormal ejaculation, asthenia, constipation, decreased appetite, diarrhea, dizziness, dry mouth, female genital disorder, impotence, infection, insomnia, libido decreased, male genital disorder, nausea, nervousness, somnolence, sweating, tremor, yawn. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Drugs Highly Bound to Plasma Protein: Monitor for adverse reactions and reduce dosage of paroxetine or other protein-bound drugs (e.g., warfarin) as warranted. (7)

Drugs Metabolized by CYP2D6: Reduce dosage of drugs metabolized by CYP2D6 as warranted. (7)

Concomitant use with tamoxifen: Consider use of an alternative antidepressant with little or no CYP2D6 inhibition. (5.11, 7)

Use In Specific Populations

Pregnancy:SSRI use, particularly later in pregnancy, may increase the risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, irritability) in the neonate. (8.1)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 1/2025