ENTAPRO 20/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 (jurisdiction-dependent): PTSD, PMDD, vasomotor symptoms of menopause, premature ejaculation.

Dosage & Administration

Dosing by Condition

MDD (adults): 10 mg once daily initially; may increase to 20 mg once daily after ≥1 week; max 20 mg/day. GAD (adults): 10 mg once daily initially; may increase to 20 mg once daily after ≥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

Adolescents 12-17 years (MDD only, some guidelines): 10mg once daily, max 20mg/day. Not approved for children under 12 years

Dose Adjustment Notes

If needed, dose may be increased after at least 1 week; elderly and hepatic impairment: use lower doses and generally do not exceed 10 mg/day; severe renal impairment: use with caution; when discontinuing, taper gradually to reduce withdrawal symptoms; consider lower doses with strong CYP2C19 inhibition/poor metabolizer status.

How to Take

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

Side Effects

Common Side Effects

Nausea, insomnia, somnolence, dizziness, dry mouth, sweating, diarrhea, constipation, fatigue, headache, sexual dysfunction (decreased libido, ejaculation disorder, anorgasmia), tremor, increased sweating

Side Effect Frequency

Very common (≥10%): nausea, headache. Common (1-10%): insomnia, somnolence, dizziness, diarrhea, constipation, dry mouth, increased sweating, fatigue, decreased appetite, sexual dysfunction (e.g., decreased libido, ejaculation disorder/anorgasmia).

Safety & Warnings

Contraindications

Contraindicated with: (1) concomitant use of MAOIs or within 14 days of stopping an MAOI (and vice versa), (2) concomitant pimozide, (3) known hypersensitivity to escitalopram/citalopram. Also avoid/contraindicated with linezolid or IV methylene blue unless no alternatives and with close monitoring due to serotonin syndrome risk.

Warnings & Precautions

Warnings/precautions: suicidality monitoring (boxed warning), serotonin syndrome risk (esp. with serotonergic drugs/MAOIs), QT prolongation risk (avoid/add caution with QT-prolonging drugs, cardiac disease, electrolyte abnormalities), bleeding risk with NSAIDs/anticoagulants/antiplatelets, hyponatremia/SIADH (higher risk in elderly/diuretics), mania/hypomania activation (screen for bipolar), seizure risk, angle-closure glaucoma risk, and discontinuation syndrome with abrupt stopping.

Age Restriction

Pediatric: approved for Major Depressive Disorder (MDD) in adolescents 12-17 years; not approved for MDD in children <12 years. Generalized Anxiety Disorder (GAD): approved in adults only (not pediatric).

Drug Interactions

Drug Interactions

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

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, St John’s wort) → serotonin syndrome risk; QT‑prolonging drugs → additive QT risk; NSAIDs/antiplatelets/anticoagulants → increased bleeding risk; strong CYP2C19 inhibitors (e.g., omeprazole) → increased escitalopram exposure/QT risk.

Food Interaction

No clinically significant food interaction; may be taken with or without food.

Special Populations

Pregnancy

Category C

Children

Adolescents 12-17 years (MDD only, some guidelines): 10mg once daily, max 20mg/day. Not approved for children under 12 years

Elderly

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

Kidney Impairment

Mild-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 10 mg once daily (and generally do not exceed 10 mg/day), especially in moderate to severe impairment.

Storage & Patient Advice

Stopping the Medicine

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

Overdose

Overdose may cause nausea/vomiting, dizziness, tremor, agitation, somnolence, seizures, serotonin syndrome, tachycardia, and QT prolongation/torsades; management is supportive with urgent emergency evaluation, ECG/cardiac monitoring, activated charcoal if appropriate, and benzodiazepines for agitation/seizures (no specific antidote).

Patient Counseling

Take once daily at the same time, with or without food; benefit may take several weeks; do not stop abruptly-taper with prescriber; report worsening depression/suicidal thoughts, agitation, or unusual behavior; avoid/limit alcohol and use caution with driving until effects known; check with a clinician before combining with other serotonergic drugs or NSAIDs/anticoagulants; seek urgent care for serotonin syndrome symptoms; discuss sexual dysfunction if bothersome.

Monitoring Requirements

Monitor for clinical worsening/suicidality especially early and after dose changes; consider serum sodium in at‑risk patients (e.g., elderly/diuretics) for hyponatremia; consider ECG/QT risk assessment in patients with cardiac disease, electrolyte abnormalities, or concomitant QT‑prolonging drugs; monitor for serotonin syndrome when combined with serotonergic agents.

Pharmacology

Mechanism of Action

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

Bioavailability

Approximately 80%.

Metabolism

Hepatic metabolism primarily via CYP2C19, with contributions from CYP3A4 and CYP2D6; major metabolites include S-desmethylcitalopram (S-DCT) and S-didesmethylcitalopram (S-DDCT).

Excretion

Eliminated mainly via hepatic metabolism with subsequent renal excretion of metabolites; ~8% is excreted in urine as unchanged escitalopram, with the remainder largely as metabolites (minor fecal excretion).

Protein Binding

Approximately 56% protein bound.

Product Information

Available Dosage Forms

Film‑coated tablet (this product); escitalopram may also be available in some markets as an oral solution/drops.

Composition per Dose

Each film-coated tablet: 20mg 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.