SETRAL 100MG 10 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

Generalized anxiety disorder, Premature ejaculation, Body dysmorphic disorder, Binge eating disorder, Bulimia nervosa, Hot flashes associated with menopause

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/day; range 50-200 mg/day (max 200 mg/day). PMDD: 50 mg/day either continuously or luteal-phase only; continuous max 150 mg/day; luteal-phase max 100 mg/day. Pediatrics-OCD: ages 6-12 start 25 mg/day; ages 13-17 start 50 mg/day; titrate up to 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

50-200 mg once daily.

Maximum Dose

200 mg once daily.

Children's Dosage

OCD in children 6-12 years: Initial 25mg/day, max 200mg/day. OCD in adolescents 13-17 years: Initial 50mg/day, max 200mg/day. Not approved for MDD in patients under 18 years

Dose Adjustment Notes

Titrate no more frequently than every 1 week; use lower or less frequent dosing in hepatic impairment; no dosage adjustment is generally required in renal impairment; consider lower starting doses in older adults based on tolerability/hyponatremia risk.

How to Take

Oral: take once daily at the same time each day (morning or evening), with or without food; swallow the film‑coated tablet with water.

Side Effects

Common Side Effects

Common: nausea, diarrhea, dry mouth, dyspepsia, headache, dizziness, insomnia or somnolence, sweating, tremor, fatigue, and sexual dysfunction (decreased libido, delayed ejaculation/ejaculatory dysfunction).

Side Effect Frequency

Very common (≥10%): nausea, diarrhea, insomnia, dizziness, headache, ejaculation disorder/sexual dysfunction; Common (1-10%): dry mouth, somnolence, fatigue, tremor, increased sweating, decreased appetite/anorexia, agitation/anxiety; Uncommon/rare: hyponatremia (SIADH), abnormal bleeding, mania/hypomania, seizures, serotonin syndrome, QT prolongation (rare).

Safety & Warnings

Contraindications

Contraindicated with MAOIs (including linezolid and IV methylene blue) or within 14 days of stopping an MAOI; contraindicated with pimozide; contraindicated in patients with hypersensitivity to sertraline/excipients.

Warnings & Precautions

Key precautions: monitor for suicidality/clinical worsening (especially early and in younger patients), screen for bipolar disorder/mania risk, watch for serotonin syndrome with serotonergic drugs, increased bleeding risk with NSAIDs/anticoagulants, hyponatremia risk (elderly/diuretics), seizure risk, hepatic impairment considerations, and taper to discontinue.

Age Restriction

Pediatric use: approved for Obsessive-Compulsive Disorder (OCD) in children ≥6 years; not approved for Major Depressive Disorder (MDD) in patients <18 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major interactions: MAOIs/linezolid/IV methylene blue (contraindicated-serotonin syndrome), pimozide (contraindicated-QT risk), other serotonergic agents (e.g., triptans, tramadol, lithium, other SSRIs/SNRIs, St John’s wort-serotonin syndrome risk), and agents increasing bleeding risk (NSAIDs/aspirin/anticoagulants incl. warfarin-monitor for bleeding/INR).

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 drugs (e.g., tramadol, triptans, lithium) → serotonin syndrome risk; anticoagulants/antiplatelets/NSAIDs (including warfarin) → bleeding risk (monitor INR/bleeding); strong CYP inhibitors (e.g., cimetidine) may increase sertraline levels. Alcohol: advise avoidance/caution (additive CNS effects).

Food Interaction

Can be taken with or without food; taking with food may improve GI tolerability and can modestly increase absorption; avoid grapefruit juice (may increase sertraline exposure).

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Not assigned a pregnancy category (risk summary provided

Children

OCD in children 6-12 years: Initial 25mg/day, max 200mg/day. OCD in adolescents 13-17 years: Initial 50mg/day, max 200mg/day. Not approved for MDD in patients under 18 years

Elderly

Start at lower doses (e.g., 25-50mg/day), titrate slowly, monitor for hyponatremia and drug interactions due to polypharmacy

Kidney Impairment

No renal dose adjustment is generally required.

Liver Impairment

Hepatic impairment: reduce starting and therapeutic dose by ~50% in mild impairment; use is generally not recommended in moderate to severe hepatic impairment.

Storage & Patient Advice

Missed Dose

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

Stopping the Medicine

Do not stop abruptly; taper gradually (commonly over several weeks, individualized to dose/duration and patient tolerance) to reduce discontinuation symptoms.

Overdose

Overdose may cause somnolence, nausea/vomiting, tachycardia, tremor, agitation, dizziness; severe cases can include seizures and serotonin syndrome; management is urgent medical evaluation with supportive care (airway/ventilation, cardiac monitoring, consider activated charcoal if early), no specific antidote.

Patient Counseling

Take once daily at the same time with or without food; expect several weeks for full benefit; do not stop abruptly-taper with prescriber guidance; report suicidal thoughts/behavior changes, serotonin syndrome symptoms, or unusual bleeding; avoid or limit alcohol; use caution with driving until effects are known; check before starting NSAIDs/aspirin or other serotonergic medicines.

Monitoring Requirements

Monitor for clinical worsening/suicidality especially at initiation and dose changes; monitor for serotonin syndrome when combined with serotonergic agents; consider serum sodium (hyponatremia/SIADH risk) in older adults or at-risk patients; monitor bleeding/INR if used with warfarin or other anticoagulants/antiplatelets/NSAIDs.

Pharmacology

Mechanism of Action

Selective serotonin reuptake inhibitor (SSRI): inhibits presynaptic serotonin (5‑HT) reuptake, increasing serotonergic neurotransmission in the CNS.

Onset of Action

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

Duration of Effect

Approximately 24 hours per dose (supports once-daily dosing); therapeutic benefit is maintained only with continued daily administration-symptoms may return over days to weeks after discontinuation.

Half-Life

Sertraline: Approximately 26 hours. Desmethylsertraline (active metabolite): 62-104 hours.

Bioavailability

Approximately 44% (food can increase exposure modestly).

Metabolism

Extensive hepatic metabolism mainly via N-demethylation to N-desmethylsertraline (less active); metabolism involves multiple CYP enzymes with CYP2B6, CYP2C19, CYP2C9, CYP2D6 and CYP3A4 contributing (no single predominant pathway).

Excretion

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

Product Information

Available Dosage Forms

For SETRAL (this SFDA product): film‑coated tablet (oral).

Composition per Dose

Each film-coated tablet: 100mg sertraline (as sertraline hydrochloride)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antidepressant-SSRI

Controlled Substance

No

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