LUSTRAL 50/MG TAB 30/TAB

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)

Off-Label Uses

Common off-label uses include generalized anxiety disorder (GAD) and premature ejaculation; other off-label uses with some evidence include binge eating disorder and body dysmorphic disorder.

Dosage & Administration

Dosing by Condition

Adults-MDD: start 50 mg once daily; 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/day either continuously or intermittently (luteal phase); may increase by 50 mg per cycle as needed; max 150 mg/day (continuous) or 100 mg/day (intermittent). Pediatrics (OCD): 6-12 years start 25 mg/day; 13-17 years start 50 mg/day; max 200 mg/day.

Initial Dose

50mg once daily (25mg once daily for panic disorder, PTSD, and social anxiety disorder for the first week)

Maintenance Dose

50-200mg once daily.

Maximum Dose

200mg per day.

Children's Dosage

OCD (6-12 years): Initial 25mg/day, may increase to 50mg/day after 1 week, max 200mg/day. OCD (13-17 years): Initial 50mg/day, max 200mg/day. Not approved for MDD in patients under 18 years.

Dose Adjustment Notes

Titrate in increments at intervals of at least 1 week; hepatic impairment: use lower dose or less frequent dosing; renal impairment: no dosage adjustment generally required; elderly: no mandatory adjustment but consider lower starting dose/closer monitoring due to hyponatremia/bleeding risk.

How to Take

Oral: take once daily at the same time each day; may be taken with or without food; swallow tablet with water (do not crush/chew unless a scored tablet is specifically intended for splitting). Morning or evening dosing is acceptable based on tolerability.

Side Effects

Common Side Effects

Nausea, diarrhea, insomnia, somnolence, dizziness, headache, dry mouth, fatigue, ejaculation failure, decreased libido, increased sweating, loss of appetite, tremor.

Side Effect Frequency

Very common (>10%): nausea, diarrhea/loose stools, insomnia, headache, dizziness, dry mouth, increased sweating, ejaculatory dysfunction/ejaculation failure. Common (1-10%): somnolence, tremor, fatigue, decreased appetite, dyspepsia, agitation/anxiety, decreased libido. Less common/rare but clinically important: hyponatremia/SIADH, abnormal bleeding, serotonin syndrome, mania/hypomania activation, seizures, and angle-closure glaucoma risk in predisposed patients; QT prolongation is not a typical sertraline signal compared with some other SSRIs.

Safety & Warnings

Contraindications

Contraindicated with: (1) MAOIs (including linezolid or IV methylene blue) or within 14 days of stopping an MAOI; (2) pimozide; (3) hypersensitivity to sertraline. Disulfiram contraindication applies only to the oral solution (not applicable to this tablet product).

Warnings & Precautions

Monitor for suicidality/clinical worsening (especially early and in young patients), serotonin syndrome with serotonergic co-meds, bleeding risk with NSAIDs/anticoagulants/antiplatelets, mania/hypomania in bipolar disorder, hyponatremia (elderly/diuretics), seizure risk, angle-closure glaucoma risk, hepatic impairment precautions, and taper to discontinue.

Age Restriction

Pediatric: approved for OCD in children ≥6 years; not approved for pediatric major depressive disorder (MDD). Adults: approved for indicated adult disorders.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Key interactions: MAOIs/linezolid/IV methylene blue (contraindicated-serotonin syndrome), pimozide (contraindicated-QT/proarrhythmia risk), other serotonergic drugs (e.g., triptans, tramadol, other antidepressants-serotonin syndrome risk), anticoagulants/antiplatelets/NSAIDs (increased bleeding risk; monitor), and other QT-prolonging drugs (additive risk).

Interaction Severity

MAJOR/Contraindicated: MAOIs (including linezolid and IV methylene blue) due to serotonin syndrome risk; pimozide due to QT prolongation risk. MODERATE/Clinically significant: other serotonergic agents (triptans, tramadol, lithium, other SSRIs/SNRIs, St John’s wort) → serotonin syndrome; NSAIDs/aspirin/anticoagulants (including warfarin) → bleeding risk (monitor INR if warfarin); strong CYP inhibitors (e.g., cimetidine) may increase sertraline exposure. MINOR: antacids (no clinically meaningful interaction).

Food Interaction

May be taken with or without food

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Category C

Breastfeeding

Caution

Children

OCD (6-12 years): Initial 25mg/day, may increase to 50mg/day after 1 week, max 200mg/day. OCD (13-17 years): Initial 50mg/day, max 200mg/day. Not approved for MDD in patients under 18 years.

Elderly

Start at 25-50mg/day and titrate slowly. Monitor for hyponatremia, falls, and drug interactions. Standard adult maximum dose applies but use clinical judgment.

Kidney Impairment

No renal dose adjustment is generally required.

Liver Impairment

Mild hepatic impairment: use a lower dose or less frequent dosing; Moderate-to-severe hepatic impairment: not recommended/avoid (or use only with extreme caution if no alternatives).

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered the same day; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule; do not double doses.

Stopping the Medicine

Do not stop abruptly; taper gradually using an individualized schedule (often over several weeks) to reduce discontinuation symptoms (e.g., dizziness, irritability/anxiety, sensory disturbances, nausea).

Overdose

Overdose may cause nausea/vomiting, somnolence, tremor, tachycardia, agitation, dizziness; severe cases can include seizures, serotonin syndrome, arrhythmias/QT prolongation, and coma-management is urgent medical evaluation with supportive care (airway, vitals, ECG), consider activated charcoal if appropriate; no specific antidote.

Patient Counseling

Take once daily consistently (with or without food); expect several weeks for full benefit; do not stop abruptly-taper with prescriber guidance; report worsening mood/suicidal thoughts, agitation, or serotonin syndrome symptoms; avoid or limit alcohol and use caution with driving until effects are known; check before using NSAIDs/aspirin/other serotonergic medicines due to bleeding/serotonin syndrome risks.

Monitoring Requirements

Monitor for clinical worsening/suicidality especially early and after dose changes; monitor for serotonin syndrome when combined with serotonergic drugs; monitor sodium (hyponatremia/SIADH risk) in elderly or at-risk patients; monitor bleeding/bruising and INR if on warfarin; assess response and tolerability periodically.

Pharmacology

Mechanism of Action

Selective serotonin reuptake inhibitor (SSRI): inhibits presynaptic neuronal reuptake of serotonin (5‑HT) in the CNS, increasing serotonergic neurotransmission; minimal effects on norepinephrine/dopamine reuptake and minimal receptor binding at therapeutic doses.

Onset of Action

Initial symptom improvement may occur in 1-2 weeks; full therapeutic effect typically takes 4-6 weeks (sometimes longer).

Duration of Effect

Supports once-daily dosing (~24-hour dosing interval); steady state is reached in about 1 week.

Half-Life

Sertraline terminal half-life ~26 hours; desmethylsertraline (active metabolite) ~62-104 hours.

Bioavailability

Approximately 44% (increased when taken with food)

Metabolism

Extensive hepatic metabolism with significant first-pass effect; primarily N-demethylation to desmethylsertraline (weakly active) via multiple CYP enzymes-mainly CYP2B6, CYP2C19, CYP2C9, CYP2D6, and CYP3A4-followed by further oxidative metabolism and conjugation (e.g., glucuronidation).

Excretion

Eliminated primarily as metabolites: ~40-45% in urine and ~40-45% in feces; <0.2% excreted unchanged in urine.

Product Information

Available Dosage Forms

Tablet; oral concentrate solution (in some markets).

Composition per Dose

Each tablet: 50mg sertraline (as sertraline hydrochloride)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antidepressant-SSRI

Controlled Substance

No

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