RIASERTAL 100/MG FC TAB 30/FC 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)

Dosage & Administration

Dosing by Condition

MDD: Initial 50 mg/day, maintenance 50-200 mg/day, max 200 mg/day. OCD: Initial 50 mg/day, maintenance 50-200 mg/day, max 200 mg/day. Panic disorder: Initial 25 mg/day for 1 week then 50 mg/day, maintenance 50-200 mg/day, max 200 mg/day. PTSD: Initial 25 mg/day for 1 week then 50 mg/day, maintenance 50-200 mg/day, max 200 mg/day. Social anxiety disorder: Initial 25 mg/day for 1 week then 50 mg/day, maintenance 50-200 mg/day, max 200 mg/day. PMDD: 50 mg/day continuously or limited to luteal phase, max 150 mg/day continuous or 100 mg/day luteal phase

How to Take

Swallow the film-coated tablet whole with water; take once daily at the same time each day, with or without food (morning or evening). Do not crush or chew unless specifically directed.

Side Effects

Common Side Effects

Nausea, diarrhea, headache, insomnia, dizziness, dry mouth, fatigue, somnolence, sweating, tremor, dyspepsia, and sexual dysfunction (e.g., ejaculation disorder, decreased libido).

Side Effect Frequency

Very common (≥10%): nausea, diarrhea, insomnia, headache, dizziness, dry mouth, somnolence, and male ejaculatory dysfunction/delayed ejaculation. Common (1-10%): tremor, increased sweating, fatigue, decreased appetite, agitation/anxiety, decreased libido, dyspepsia. Rare/serious (frequency varies/rare): hyponatremia/SIADH, serotonin syndrome, seizures, mania/hypomania, hepatic injury, QT prolongation (generally low risk), and angle-closure glaucoma in predisposed patients.

Safety & Warnings

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Key interactions: MAOIs (contraindicated-serotonin syndrome), pimozide (contraindicated-QT/proarrhythmia risk), linezolid/IV methylene blue (avoid/contraindicated-serotonin syndrome), other serotonergic agents (e.g., triptans, tramadol, fentanyl, lithium, other SSRIs/SNRIs, St John’s wort-serotonin syndrome), anticoagulants/antiplatelets/NSAIDs (increased bleeding), and CYP2D6 substrates with narrow therapeutic index (sertraline can increase levels).

Alcohol Interaction

Avoid

Special Populations

Breastfeeding

Caution

Kidney Impairment

No renal dose adjustment is generally required.

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 at least 2-4 weeks, individualized to dose/duration and symptoms).

Overdose

Overdose may cause nausea/vomiting, tremor, agitation, dizziness, somnolence, tachycardia, seizures, and serotonin syndrome; management is immediate emergency evaluation with supportive care (airway/ventilation, cardiac monitoring), consider activated charcoal if appropriate; no specific antidote.

Pharmacology

Mechanism of Action

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

Onset of Action

Pharmacologic onset within hours after a dose; clinical symptom improvement typically begins in 1-2 weeks, with full effect often in 4-6 weeks.

Excretion

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

Product Information

Available Dosage Forms

Film-coated tablet (this product). Sertraline may also be available in other markets as an oral concentrate/solution, but capsules are not a standard sertraline dosage form.

Composition per Dose

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

Generic Availability

Yes

Psych Class

Antidepressant-SSRI

Controlled Substance

No

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