PEXEVA

PEXEVA- paroxetine mesylate tablet, film coated
Sebela Pharmaceuticals 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 anti-depressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)]. PEXEVA is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4)] .

1 INDICATIONS AND USAGE

PEXEVA is indicated in adults for the treatment of:

  • Major depressive disorder (MDD)
  • Obsessive-compulsive disorder (OCD)
  • Panic disorder (PD)
  • Generalized anxiety disorder (GAD)

2 DOSAGE AND ADMINISTRATION

2.1 Administration Information

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

2.2 Recommended Dosage

The recommended initial dosage and maximum dosage of PEXEVA in patients with MDD, OCD, PD, and GAD 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 PEXEVA in Patients with MDD, OCD, PD, and GAD
Indication Starting Dose Maximum Dose
MDD 20 mg 50 mg
OCD 20 mg 60 mg
PD 10 mg 60 mg
GAD 20 mg 50 mg

2.3 Screen for Bipolar Disorder Prior to Starting PEXEVA

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

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

The recommended initial dose is 10 mg/day for elderly patients, patients with severe renal impairment and patients with severe hepatic impairment. Dosage should not exceed 40 mg/day [see Use in Specific Populations ( 8.5, 8.6)]

2.5 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 PEXEVA. In addition, at least 14 days must elapse after stopping PEXEVA before starting an MAOI antidepressant [see Contraindications ( 4), Warnings and Precautions ( 5.2)] .

2.6 Discontinuation of Treatment with PEXEVA

Adverse reactions may occur upon discontinuation of PEXEVA [see Warnings and Precaution ( 5.7)] . Gradually reduce the dosage rather than stopping PEXEVA abruptly whenever possible.

3 DOSAGE FORMS AND STRENGTHS

PEXEVA is available as oval, film-coated tablets which contains paroxetine mesylate equivalent to paroxetine as follows:

10 mg tablets: white, oval, film-coated tablets, with the inscription “POT 10” on one side.

20 mg tablets: dark orange, oval, film-coated tablets, with the inscription “POT 20” on one side. The tablets are scored on both sides.

30 mg tablets: yellow, oval, film-coated tablets, with the inscription “POT 30” on one side.

40 mg tablets: rose, oval, film-coated tablets, with the inscription “POT 40” on one side.

4 CONTRAINDICATIONS

PEXEVA 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 Interaction ( 7)] .
  • Taking thioridazine because of risk of QT prolongation [see Warnings and Precautions ( 5.3), Drug Interaction ( 7)] .
  • Taking pimozide because of risk of QT prolongation [see Warnings and Precautions ( 5.3), Drug Interaction ( 7)] .
  • With known hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) to paroxetine or to any of the inactive ingredients in PEXEVA [see Adverse Reactions ( 6.2, 6.3)]

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 include 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 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 1.

TABLE 2: Risk Differences of the Number of Patients of Suicidal Thoughts and Behaviors in the Pooled Placebo-Controlled Trails of Antidepressants in Pediatric and Adult Patients
Age Range Drug-Placebo Difference in Number of Patients of Suicidal Thoughts and Behaviors per 1,000 Patients Treated
Increases Compared to Placebo
<18 years old 14 additional patients
18-24 years old 5 additional patients
Decreases Compared to Placebo
25-64 years old 1 fewer patient
≥65 years old 6 fewer 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 4 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 of 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 PEXEVA, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts and behaviors.

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