Paroxetine Hydrochloride

PAROXETINE HYDROCHLORIDE- paroxetine hydrochloride hemihydrate tablet, film coated, extended release
Lannett Company, Inc.

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)]. Paroxetine is not approved for use in pediatric patients [see Use in Specific Populations (8.4)].

1 INDICATIONS AND USAGE

Paroxetine is indicated in adults for the treatment of:

  • Major depressive disorder (MDD)

  • Panic disorder (PD)

  • Social anxiety disorder (SAD)

  • Premenstrual dysphoric disorder (PMDD)

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Administer Paroxetine as a single daily dose in the morning, with or without food. Swallow tablets whole and do not chew or crush.

2.2 Dosage in Patients with Major Depressive Disorder, Panic Disorder, and Social Anxiety Disorder

The recommended initial dosage and maximum dosage of Paroxetine in patients with MDD, PD, and SAD are presented in Table 1.

In patients with an inadequate response, dosage may be increased in increments of 12.5 mg per day at intervals of at least 1 week, depending on tolerability.

Table 1: Recommended Daily Dosage of Paroxetine in Patients with MDD, PD, and SAD

Indication

Starting Dose

Maximum Dose

MDD

25 mg

62.5 mg

PD

12.5 mg

75 mg

SAD

12.5 mg

37.5 mg

2.3 Dosage in Patients with Premenstrual Dysphoric Disorder

The recommended starting dosage in women with PMDD is 12.5 mg per day. Paroxetine may be administered either continuously (every day throughout the menstrual cycle) or intermittently (only during the luteal phase of the menstrual cycle, i.e., starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing is repeated with each new cycle.

In patients with an inadequate response, the dosage may be increased to the maximum recommended dosage of 25 mg per day, depending on tolerability. Institute dosage adjustments at intervals of at least 1 week.

2.4 Screen for Bipolar Disorder Prior to Starting Paroxetine

Prior to initiating treatment with Paroxetine or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.6)].

2.5 Dosage Modifications for Elderly Patients, Patients with Severe Renal Impairment and Patients with Severe Hepatic Impairment

The recommended initial dose of Paroxetine is 12.5 mg per day for elderly patients, patients with severe renal impairment, and patients with severe hepatic impairment. Reduce initial dose and increase up-titration intervals if necessary. Dosage should not exceed 50 mg per day for MDD or PD and should not exceed 37.5 mg per day for SAD [see Use in Specific Populations (8.5, 8.6)].

2.6 Switching Patients to or from a Monoamine Oxidase Inhibitor Antidepressant

At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of Paroxetine. In addition, at least 14 days must elapse after stopping Paroxetine before starting an MAOI antidepressant [see Contraindications (4), Warnings and Precautions (5.2)].

2.7 Discontinuation of Treatment with Paroxetine

Adverse reactions may occur upon discontinuation of Paroxetine [see Warnings and Precautions ( 5.6)]. Gradually reduce the dosage rather than stopping Paroxetine abruptly whenever possible.

3 DOSAGE FORMS AND STRENGTHS

Paroxetine Extended-Release Tablets, USP are supplied as film-coated, extended-release, round convex tablets, as follows:

  • 12.5 mg white tablets (debossed with “KU” on one side and “470” on the other)
  • 25 mg pink tablets (debossed with “KU” on one side and “471” on the other)

  • 37.5 mg blue tablets (debossed with “KU” on one side and “472” on the other)

4 CONTRAINDICATIONS

Paroxetine is contraindicated in patients:

  • Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7)].

  • Taking thioridazine because of risk of QT prolongation [see Warnings and Precautions ( 5.3), Drug Interactions ( 7)].

  • Taking pimozide because of risk of QT prolongation [see Warnings and Precautions (5.3), Drug Interactions (7)].

  • With known hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) to paroxetine or to any of the inactive ingredients in Paroxetine [see Adverse Reactions (6.1, 6.2)].

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