COMPOSITION: Each capsule contains: Active ingredient: Sertraline hydrochloride 55.954 mg (equivalent to 50 mg Sertraline base) Excipients: Microcrystalline cellulose PH102, Dibasic calcium phosphate (dehydrate), Sodium starch glycolate, Polysorbate 80 (Tween 80), Hydroxy propyl methyl cellulose(4000), Magnesium stearate. Capsule shell: Gelatin, Titanium Dioxide, Brilliant Blue, Erythrosine, Carmoisine, Quinoline. Capsule body: Gelatin, Titanium Dioxide, Brilliant Blue, Carmoisine, Sunset yellow. PHARMACEUTICAL FORM: Hard gelatin capsule of opaque black cap and opaque scarlet red body filled with granular powder. 1 INDICATIONS DEPRESTAT (sertraline hydrochloride capsules) is indicated for: Adults • Depression DEPRESTAT is indicated for the symptomatic relief of depressive illness. However, the antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. • Panic Disorder DEPRESTAT is indicated for the symptomatic relief of panic disorder, with or without agoraphobia. The health professional who elects to use DEPRESTAT for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. • Obsessive-Compulsive Disorder DEPRESTAT is indicated for the symptomatic relief of obsessive-compulsive disorder (OCD). The obsessions or compulsions must be experienced as intrusive, markedly distressing, time- consuming, or significantly interfering with the person’s social or occupational functioning. The health professional who elects to use DEPRESTAT for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. 1.1 Pediatrics Pediatrics (< 18 years of age): There is no authorized indication for pediatric use 1.2 Geriatrics Geriatrics (> 65 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness (see 7.1.4 Geriatrics). 2 CONTRAINDICATIONS • DEPRESTAT is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see COMPOSITION. • Monoamine Oxidase Inhibitors Cases of serious, sometimes fatal, reactions have been reported in patients receiving sertraline hydrochloride in combination with a monoamine oxidase inhibitor (MAOI), including the selective MAOI, selegiline and the reversible MAOI (reversible inhibitor of monoamine oxidase -RIMA), moclobemide and linezolid, an antibiotic which is a reversible non-selective MAOI and methylthioninium chloride (methylene blue), which is a MAOI. Some cases presented with features resembling the serotonin syndrome. Similar cases have been reported with other antidepressants during combined treatment with an MAOI and in patients who have recently discontinued an antidepressant and have been started on an MAOI. Symptoms of a drug interaction between an SSRI and an MAOI include: hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes that include confusion, irritability, and extreme agitation progressing to delirium and coma. Therefore, DEPRESTAT should not be used in combination with an MAOI, or within 14 days of discontinuing treatment with an MAOI. Similarly, at least 14 days should elapse after discontinuing DEPRESTAT treatment before starting an MAOI. • Pimozide The concomitant use of DEPRESTAT and pimozide is contraindicated as sertraline hydrochloride has been shown to increase plasma pimozide levels. Elevation of pimozide blood concentration may result in QT interval prolongation and severe arrhythmias including Torsade de Pointes. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Increased risk of self-harm, harm to others, suicidal thinking and behavior with antidepressants use. Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of agitation-type and/or suicidal thoughts and behaviors (see 7 WARNINGS AND PRECAUTIONS, Psychiatric, Potential Association with Behavioral and Emotional Changes, Including Self-Harm). 4 DOSAGE AND ADMINISTRATION 4.1 Dosing Considerations Switching Patients to or from a Monoamine Oxidase Inhibitor At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with DEPRESTAT. In addition, at least 14 days should be allowed after stopping DEPRESTAT before starting an MAOI (see 2 CONTRAINDICATIONS). 4.2 Recommended Dose and Dosage Adjustment Depression and Obsessive-Compulsive Disorder As no clear dose-response relationship has been demonstrated over a range of 50-200 mg/day, a dose of 50 mg/day is recommended as the initial dose
