SETRAL 50MG 30TAB

Indications

Approved Uses

Major depressive disorder (MDD), obsessive-compulsive disorder (OCD), panic disorder, post-traumatic stress disorder (PTSD), social anxiety disorder (social phobia), premenstrual dysphoric disorder (PMDD)

Dosage & Administration

Dosing by Condition

Adults-MDD: start 50 mg once daily; usual range 50-200 mg/day (max 200 mg/day). OCD: start 50 mg once daily; range 50-200 mg/day (max 200 mg/day). Panic disorder/PTSD/Social anxiety disorder: start 25 mg once daily for 1 week then 50 mg once daily; range 50-200 mg/day (max 200 mg/day). PMDD: 50 mg once daily either continuously or luteal-phase only; may increase as needed; max 150 mg/day (continuous) or 100 mg/day (luteal-phase). Pediatrics (OCD): 6-12 years start 25 mg/day; 13-17 years start 50 mg/day; max 200 mg/day.

How to Take

Take sertraline orally once daily at the same time each day; may be taken with or without food; swallow the film‑coated tablet with water (do not crush/chew unless specifically advised). Morning or evening dosing is acceptable based on tolerability (e.g., insomnia vs somnolence).

Side Effects

Common Side Effects

Nausea, diarrhea, dry mouth, headache, dizziness, insomnia or somnolence, increased sweating, tremor, fatigue, and sexual dysfunction (e.g., delayed ejaculation/ejaculatory dysfunction, decreased libido).

Side Effect Frequency

Very common (≥10%): nausea, diarrhea/loose stools, insomnia, headache, dizziness, somnolence, dry mouth, ejaculatory disorder/delayed ejaculation. Common (1-10%): decreased appetite, fatigue, tremor, increased sweating, agitation/anxiety, decreased libido, erectile dysfunction, dyspepsia, vomiting, constipation. Uncommon/rare (<1%): hyponatremia (SIADH), abnormal bleeding, seizures, mania/hypomania, hallucinations, serotonin syndrome; QT prolongation is rare and not a typical sertraline signal at usual doses.

Drug Interactions

Drug Interactions

Major interactions: MAOIs/linezolid/IV methylene blue (contraindicated-serotonin syndrome); pimozide (contraindicated-QT prolongation); other serotonergic agents (e.g., triptans, tramadol, other SSRIs/SNRIs, lithium, St John’s wort) ↑ serotonin syndrome risk; NSAIDs/aspirin/anticoagulants incl. warfarin ↑ bleeding risk (monitor/INR if warfarin); CYP interactions (e.g., cimetidine may ↑ sertraline; sertraline may ↑ levels of some TCAs via CYP2D6-monitor).

Special Populations

Breastfeeding

Caution

Kidney Impairment

No renal dose adjustment needed.

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly; taper gradually over several weeks (individualize-often at least 2-4 weeks, longer if high dose/long duration) to reduce discontinuation symptoms.

Overdose

Overdose may cause somnolence, nausea/vomiting, tachycardia, tremor, agitation, dizziness; severe cases can include seizures, serotonin syndrome, arrhythmias/QT prolongation, coma-management is immediate emergency evaluation with supportive care, consider activated charcoal if early, and cardiac/mental status monitoring (no specific antidote).

Pharmacology

Mechanism of Action

Selective serotonin reuptake inhibitor (SSRI): inhibits presynaptic serotonin (5‑HT) reuptake, increasing serotonergic neurotransmission in the CNS; minimal affinity for most other receptor systems at therapeutic doses.

Onset of Action

Initial symptom improvement may be seen within 1-2 weeks; full therapeutic effect typically requires 4-6 weeks (sometimes longer for anxiety/OCD).

Excretion

Eliminated primarily as metabolites via both feces and urine (each roughly ~40-45%); little unchanged drug in urine.

Product Information

Available Dosage Forms

For this product: film‑coated tablet (oral). Sertraline in general is also available in capsules (some markets) and an oral concentrate/solution (some markets), but those are not applicable to SETRAL 50 mg F.C. tablets.

Composition per Dose

Each film-coated tablet: 50mg sertraline (as sertraline hydrochloride)

Generic Availability

Yes

Psych Class

Antidepressant-SSRI

Controlled Substance

No

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