PAROXETINE

PAROXETINE- paroxetine hydrochloride hemihydrate tablet, film coated
Chartwell RX, LLC.

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)
  • Obsessive compulsive disorder (OCD)
  • Panic disorder (PD)
  • Social anxiety disorder (SAD)
  • Generalized anxiety disorder (GAD)
  • Posttraumatic stress disorder (PTSD)

2 DOSAGE AND ADMINISTRATION

2.1 Administration Information

Administer paroxetine as a single daily dose in the morning, with or without food.

2.2 Recommended Dosage for MDD, OCD, PD, and PTSD

The recommended starting dosages and maximum dosages of paroxetine in patients with MDD, OCD, PD, and PTSD are presented in Table 1.

In patients with an inadequate response, increase dosage in increments of 10 mg per day at intervals of at least 1 week, depending on tolerability.

Table 1: Recommended Daily Dosage of paroxetine in Patients with MDD, OCD, PD, and PTSD

Indication

Starting Dose

Maximum Dose

MDD

20 mg

50 mg

OCD

20 mg

60 mg

PD

10 mg

60 mg

PTSD

20 mg

50 mg

2.3 Recommended Dosage for SAD and GAD

SAD

The starting and recommended dosage in patients with SAD is 20 mg daily. In clinical trials the effectiveness of paroxetine was demonstrated in patients dosed in a range of 20 mg to 60 mg daily. While the safety of paroxetine has been evaluated in patients with SAD at doses up to 60 mg daily, available information does not suggest any additional benefit for doses above 20 mg daily [see Clinical Studies ( 14.4)] .

GAD

The starting and recommended dosage in patients with GAD is 20 mg daily. In clinical trials the effectiveness of paroxetine in GAD was demonstrated in patients dosed in a range of 20 mg to 50 mg daily. There is not sufficient evidence to suggest a greater benefit to doses higher than 20 mg daily [see Clinical Studies ( 14.5)] .

In patients with an inadequate response, increase dosage in increments of 10 mg per day at intervals of at least 1 week, depending on tolerability.

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 Recommended Dosage for Elderly Patients, Patients with Severe Renal Impairment, and Patients with Severe Hepatic Impairment

The recommended initial dosage is 10 mg per day for elderly patients, patients with severe renal impairment, and patients with severe hepatic impairment. Dosage should not exceed 40 mg/day.

2.6 Switching Patients to or From a Monoamine Oxidase Inhibitor (MAOI)

At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI 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 ( 5.7)] . Gradually reduce the dosage rather than stopping paroxetine abruptly whenever possible.

3 DOSAGE FORMS AND STRENGTHS

Paroxetine Tablets, USP are available as:

  • The 10 mg tablets are yellow, film-coated, capsule-shaped tablets, with a partial score bar on one side and debossed with “Y121” on the other side.
  • The 20 mg tablets are pink, film-coated, capsule-shaped tablets with a partial score bar on one side and debossed with “Y122” on the other side.
  • The 30 mg tablets are blue, film-coated, capsule-shaped tablets, debossed with “Y123” on one side.
  • The 40 mg tablets are green, film-coated, capsule-shaped tablets, debossed with “Y124” on one side.

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) and 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 any of the inactive ingredients in paroxetine tablets [see Adverse Reactions ( 6.1), ( 6.2)] .

5 WARNINGS AND PRECAUTIONS

5.1 Suicidal Thoughts and Behaviors in Adolescents and Young Adults

In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 2.

Table 2: Risk Differences of the Number of Patients with Suicidal Thoughts and Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients

Age Range

Drug-Placebo Difference in Number of Patients with Suicidal Thoughts and Behaviors per 1,000 Patients Treated

Increases Compared to Placebo

<18 years old

14 additional cases

18-24 years old

5 additional cases

Decreases Compared to Placebo

25-64 years old

1 fewer case

≥65 years old

6 fewer cases

Paroxetine is not approved for use in pediatric patients.

It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors.

Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing paroxetine, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

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