ENTAPRO 10/MG FC TAB 30/FC TAB

Indications

Approved Uses

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

Off-Label Uses

Examples of off‑label uses include PTSD, PMDD, vasomotor symptoms (hot flashes), and premature ejaculation; OCD/panic/social anxiety may be approved in some jurisdictions but should be treated as off‑label unless specifically authorized locally.

Dosage & Administration

Dosing by Condition

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

MDD (≥12 years): Initial 10 mg once daily; may increase to 20 mg after ≥3 weeks. GAD (≥7 years): Initial 10 mg once daily; may increase to 20 mg after ≥2 weeks. Safety and efficacy not established for other uses

Dose Adjustment Notes

Elderly and hepatic impairment: 10 mg once daily recommended (generally avoid exceeding 10 mg/day). Renal impairment: no adjustment in mild-moderate; use caution in severe impairment (CrCl <20 mL/min). Dose increases (if needed) are typically to 20 mg/day after at least 1 week based on response/tolerability.

How to Take

Swallow the film‑coated tablet whole with water, once daily; may be taken with or without food; take at the same time each day.

Side Effects

Common Side Effects

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

Side Effect Frequency

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

Safety & Warnings

Contraindications

Contraindicated with MAOIs (concomitant use or within 14 days of stopping an MAOI; and allow 14 days after stopping escitalopram before starting an MAOI) and with pimozide; contraindicated in patients with hypersensitivity to escitalopram/citalopram.

Warnings & Precautions

Key warnings/precautions: suicidality risk in children/adolescents/young adults-monitor closely; serotonin syndrome risk with serotonergic drugs/MAOIs; QT prolongation risk (caution with cardiac disease, electrolyte abnormalities, or QT-prolonging drugs); abnormal bleeding risk with NSAIDs/anticoagulants/antiplatelets; hyponatremia/SIADH (higher risk in elderly/diuretics); activation of mania/hypomania (screen for bipolar disorder); seizure risk; and discontinuation syndrome-taper when stopping.

Age Restriction

Not approved for pediatric use <12 years for MDD; approved for MDD in adolescents 12-17 years and for GAD in patients 7 years and older

Drug Interactions

Drug Interactions

Major interactions include: 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), QT-prolonging drugs (additive QT risk), and CYP2C19 inhibitors (e.g., omeprazole, cimetidine) which can increase escitalopram exposure.

Interaction Severity

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

Food Interaction

No restriction.

Special Populations

Pregnancy

Category C

Children

MDD (≥12 years): Initial 10 mg once daily; may increase to 20 mg after ≥3 weeks. GAD (≥7 years): Initial 10 mg once daily; may increase to 20 mg after ≥2 weeks. Safety and efficacy not established for other uses

Elderly

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

Kidney Impairment

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

Liver Impairment

Hepatic impairment: recommended dose is 10 mg once daily (and generally avoid exceeding 10 mg/day); use caution in severe hepatic impairment.

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly; taper gradually (commonly over at least 2-4 weeks, individualized) to reduce discontinuation symptoms (e.g., dizziness, irritability, anxiety, sensory disturbances).

Overdose

Overdose may cause nausea/vomiting, dizziness, tremor, agitation/somnolence, tachycardia, seizures, serotonin syndrome, and QT prolongation/arrhythmias; management is supportive with urgent emergency evaluation, consideration of activated charcoal if early, and ECG/cardiac monitoring-no specific antidote.

Patient Counseling

Take once daily as prescribed (with or without food) at a consistent time; benefit may take several weeks-do not stop abruptly; report suicidal thoughts/behavior changes, serotonin syndrome symptoms, unusual bleeding, or severe agitation; avoid/limit alcohol and use caution with driving until effects are known; inform clinicians about all medicines/supplements (especially MAOIs, serotonergic agents, NSAIDs/anticoagulants, and QT‑prolonging drugs); discuss use in pregnancy/breastfeeding.

Monitoring Requirements

Monitor clinically for worsening depression/suicidality (especially early and after dose changes), serotonin syndrome, and mania/hypomania; consider serum sodium in at‑risk patients (e.g., elderly/diuretics) and ECG/QT risk assessment in patients with cardiac risk factors or on QT‑prolonging drugs.

Pharmacology

Mechanism of Action

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

Onset of Action

Pharmacologic effect begins within hours; clinical symptom improvement typically starts in 1-2 weeks with full effect in 4-6 weeks.

Duration of Effect

Approximately 24 hours per dose (supports once-daily dosing); therapeutic antidepressant/anxiolytic benefit is maintained with continuous daily use and diminishes over days after discontinuation.

Half-Life

27-33 hours.

Bioavailability

Approximately 80% (about 80%).

Metabolism

Hepatic metabolism primarily via CYP2C19, with contributions from CYP3A4 and CYP2D6, forming demethylated and didemethylated metabolites (less active).

Excretion

After hepatic metabolism, escitalopram and its metabolites are eliminated via both urine and feces; only a small fraction is excreted unchanged in urine (about 8%).

Protein Binding

Approximately 56% protein bound.

Product Information

Available Dosage Forms

Film‑coated tablet (this product: 10 mg); escitalopram may also be available in some markets as an oral solution/drops, but that is not this registered product.

Composition per Dose

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

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antidepressant-SSRI

Controlled Substance

No

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.