SETAPRO 10/MG FC TAB 30/FC TAB

Indications

Approved Uses

Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD).

Off-Label Uses

Panic disorder, social anxiety disorder, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD), binge eating disorder

Dosage & Administration

Dosing by Condition

MDD (adults): 10 mg once daily; may increase to 20 mg once daily after at least 1 week based on response/tolerability (max 20 mg/day). GAD (adults): 10 mg once daily; may increase to 20 mg once daily after at least 1 week (max 20 mg/day).

Initial Dose

10 mg once daily.

Maintenance Dose

10-20 mg once daily.

Maximum Dose

20 mg once daily.

Children's Dosage

Major Depressive Disorder (12-17 years): 10 mg once daily, may be increased to 20 mg once daily after at least 3 weeks. Generalized Anxiety Disorder (≥7 years): 10 mg once daily, may be increased to 20 mg once daily after at least 2 weeks. Not approved for children under 12 for MDD or under 7 for GAD.

Dose Adjustment Notes

Elderly (≥65 years) and hepatic impairment: start 5 mg once daily and the recommended maximum is 10 mg/day; renal impairment: no adjustment in mild-moderate impairment, use caution in severe renal impairment (e.g., CrCl <30 mL/min).

How to Take

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

Side Effects

Common Side Effects

Nausea, insomnia, somnolence, dizziness, dry mouth, sweating, diarrhea, constipation, fatigue, headache, ejaculation disorder, decreased libido, anorgasmia

Side Effect Frequency

Very common: nausea, headache. Common: insomnia or somnolence, dizziness, dry mouth, increased sweating, diarrhea or constipation, fatigue, decreased appetite, sexual dysfunction (e.g., ejaculation disorder, decreased libido/anorgasmia). Uncommon/rare but clinically important: hyponatremia/SIADH, QT prolongation/arrhythmia risk, serotonin syndrome, abnormal bleeding, mania/hypomania, seizures.

Safety & Warnings

Contraindications

Contraindicated with MAOIs (concomitant or within 14 days of stopping an MAOI; and allow at least 14 days after stopping escitalopram before starting an MAOI), concomitant pimozide, and hypersensitivity to escitalopram/citalopram; avoid use with linezolid or IV methylene blue unless no alternatives and with close monitoring.

Warnings & Precautions

Monitor for suicidality/clinical worsening (especially early and in patients <25), serotonin syndrome (especially with serotonergic drugs), QT prolongation risk (cardiac disease, electrolyte abnormalities, QT-prolonging drugs), hyponatremia/SIADH (elderly/diuretics), bleeding risk with NSAIDs/anticoagulants, mania/hypomania activation (screen for bipolar disorder), seizure risk, and discontinuation syndrome with abrupt stopping.

Age Restriction

Not approved for children <12 years; in adolescents 12-17 years, escitalopram is approved for MDD in some jurisdictions (and for GAD in ≥7 years in the US), but local labeling should be followed.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Key interactions: MAOIs (contraindicated-serotonin syndrome), pimozide (contraindicated-QT prolongation), linezolid/IV methylene blue (avoid/contraindicated-serotonin syndrome), other serotonergic agents (e.g., triptans, tramadol, fentanyl, lithium, St John’s wort-serotonin syndrome), NSAIDs/antiplatelets/anticoagulants (bleeding risk), CYP2C19 inhibitors (e.g., omeprazole, cimetidine-↑ escitalopram exposure), and other QT-prolonging drugs (additive QT risk).

Interaction Severity

MAJOR/Contraindicated: MAOIs (including linezolid and IV methylene blue) due to serotonin syndrome risk; pimozide due to QT prolongation. MODERATE: other serotonergic agents (e.g., triptans, tramadol, lithium, fentanyl, St John’s wort) → serotonin syndrome risk; QT‑prolonging drugs → additive QT risk; NSAIDs/anticoagulants/antiplatelets → bleeding risk; strong CYP2C19 inhibitors (e.g., omeprazole, cimetidine) → increased escitalopram exposure/QT risk. MINOR: alcohol (additive CNS effects).

Food Interaction

No restriction.

Alcohol Interaction

Avoid

Special Populations

Breastfeeding

Caution

Children

Major Depressive Disorder (12-17 years): 10 mg once daily, may be increased to 20 mg once daily after at least 3 weeks. Generalized Anxiety Disorder (≥7 years): 10 mg once daily, may be increased to 20 mg once daily after at least 2 weeks. Not approved for children under 12 for MDD or under 7 for GAD.

Elderly

Recommended dose is 10 mg once daily; maximum dose 10 mg/day due to increased risk of QT prolongation and hyponatremia

Kidney Impairment

Mild-to-moderate renal impairment: no dose adjustment; severe impairment (CrCl <20 mL/min): use with caution (limited data).

Liver Impairment

Hepatic impairment: recommended dose 10 mg once daily and generally do not exceed 10 mg/day (use caution in severe impairment).

Storage & Patient Advice

Storage Conditions

Store below 30°C. Keep in original packaging. Keep out of reach of children.

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 (commonly over at least 2-4 weeks, individualized to dose/duration and patient tolerance) to reduce discontinuation symptoms.

Overdose

Overdose may cause nausea/vomiting, dizziness, tremor, agitation/somnolence, tachycardia, seizures, serotonin syndrome, and QT prolongation/arrhythmias; management is supportive with ECG/cardiac monitoring, consider activated charcoal early when appropriate, and seek emergency care-no specific antidote.

Patient Counseling

Take once daily at the same time with or without food; expect benefit to build over several weeks; do not stop abruptly-taper with prescriber; report suicidal thoughts/behavior changes, serotonin syndrome symptoms, or unusual bleeding; avoid/limit alcohol and use caution driving until effects are known; inform clinicians about all medicines/herbals (especially serotonergic drugs, NSAIDs/anticoagulants, and QT‑prolonging agents); discuss use in pregnancy/breastfeeding with prescriber.

Monitoring Requirements

Monitor for clinical worsening/suicidality (especially early and after dose changes); monitor for serotonin syndrome; consider baseline/follow-up ECG in patients with QT-risk factors or on QT‑prolonging drugs; monitor sodium (hyponatremia/SIADH risk) in elderly or at-risk patients; assess bleeding risk if combined with NSAIDs/anticoagulants and monitor response/tolerability.

Pharmacology

Mechanism of Action

Selective serotonin reuptake inhibitor (SSRI): inhibits the serotonin transporter (SERT), increasing synaptic serotonin in the CNS.

Onset of Action

Some improvement may occur within 1-2 weeks; full antidepressant/anxiolytic effect typically takes 4-6 weeks (sometimes longer).

Duration of Effect

Therapeutic effect is maintained over ~24 hours with once-daily dosing at steady state; clinical benefit persists with continued daily administration.

Half-Life

27-32 hours.

Bioavailability

Approximately 80%.

Metabolism

Hepatic metabolism primarily via CYP2C19 and CYP3A4, with contribution from CYP2D6; metabolites (e.g., desmethyl- and didesmethyl- forms) are less active.

Excretion

Eliminated mainly via hepatic metabolism with renal excretion of metabolites; a small fraction is excreted unchanged in urine (approximately 8%).

Protein Binding

Approximately 56%.

Product Information

Available Dosage Forms

Film-coated tablet (this product).

Composition per Dose

Each film-coated tablet: 10 mg escitalopram (as oxalate)

Generic Availability

Yes

OTC Alternatives

No OTC alternative.

Psych Class

Antidepressant-SSRI

Controlled Substance

No

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