Zoloft^®

Abbreviated Prescribing Information¹

Formulation/presentation: Zoloft^® (Sertraline HCL) film-coated tablets are available in packs of 50 mg × 30’s. Indications: Treatment of symptoms of depression, including depression accompanied by symptoms of anxiety, in patients with or without a history of mania. Obsessive-compulsive disorder (OCD). Panic disorder, with or without agoraphobia. Post-traumatic stress disorder (PTSD). Social phobia (social anxiety disorder). Dosage: Depression, OCD: 50 mg/day. Panic disorder, PTSD, and social phobia: Initially 25 mg/day. After 1 week, increase dose to 50 mg/day. All dose changes should be made at intervals of ≥1 week, max: 200 mg/day. Contraindications: Monoamine oxidase inhibitors (MAOIs), pimozide, hypersensitivity to sertraline. Special warnings and precautions: Monitor patients for the emergence of signs and symptoms of serotonin syndrome (SS) or neuroleptic malignant syndrome (NMS) or suicide/suicidal thoughts or clinical worsening or glycemic control in diabetic patients. Sertraline 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 sertraline treatment before starting an MAOI. Use with caution and avoid if possible co-administration of sertraline with other drugs which enhance the effects of serotonergic neurotransmission. Caution in patients with risk factors for QTc prolongation or angle-closure glaucoma or history of glaucoma. Limited controlled experience regarding the optimal timing of switching antidepressants. Activation of mania/hypomania. In any patient who develops seizures. Monitor patients for caution in patients taking SSRIs, particularly in concomitant use with drugs known to affect platelet function. Hyponatremia. Bone fractures. Lower or less frequent dose should be used in patients with hepatic impairment. Dosing does not have to be adjusted based on the degree of renal impairment. False positive test results may be expected for several days following discontinuation. Physicians must monitor pediatric patients on long-term treatment for abnormalities in growth and development. Side effects/adverse effects: Nausea, diarrhea/loose stools, anorexia, dizziness, somnolence, tremor, insomnia, dyspepsia, male sexual dysfunction (ejaculatory delay), dry mouth, increased sweating.

API-ZOLOFT-0324

Reference: 1. Malaysia Zoloft^® Approved Prescribing Information dated 25 March 2024.