CIPRALEX 10MG TAB

Indications

Approved Uses

Major depressive disorder; generalized anxiety disorder

Off-Label Uses

Off‑label (evidence varies): PTSD, PMDD, vasomotor symptoms of menopause (hot flashes), premature ejaculation, and some eating disorders (e.g., binge eating) in selected patients.

Dosage & Administration

Dosing by Condition

MDD: 10 mg once daily; may increase to 20 mg/day after at least 1 week if needed. GAD: 10 mg once daily; may increase to 20 mg/day after at least 1 week. Panic disorder: 5 mg once daily for 1 week, then 10 mg once daily; may increase to 20 mg/day. Social anxiety disorder: 10 mg once daily; may adjust within 5-20 mg/day. OCD: 10 mg once daily; may increase to 20 mg/day.

Initial Dose

10 mg orally once daily

Maintenance Dose

10-20 mg once daily.

Maximum Dose

10 mg once daily for elderly and hepatic impairment; 20 mg once daily otherwise

Children's Dosage

Major Depressive Disorder (≥12 years): 10mg once daily, max 20mg/day. Not approved for children under 12 years

Dose Adjustment Notes

Elderly (≥65 years) and hepatic impairment: start 5 mg once daily and the recommended maximum is 10 mg/day; mild-moderate renal impairment: no adjustment; severe renal impairment (CrCl <30 mL/min): use with caution; dose increases are generally assessed after at least 1 week based on response/tolerability.

How to Take

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

Side Effects

Common Side Effects

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

Side Effect Frequency

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

Safety & Warnings

Contraindications

Contraindicated with: (1) concomitant MAOIs or within 14 days of stopping an MAOI (and allow 14 days after stopping escitalopram before starting an MAOI); (2) concomitant pimozide; (3) hypersensitivity to escitalopram/citalopram. Avoid/Do not use with linezolid or IV methylene blue unless no alternatives and with close monitoring due to serotonin syndrome risk.

Warnings & Precautions

Warnings/precautions: suicidality monitoring (especially early and with dose changes), serotonin syndrome risk with serotonergic agents, QT prolongation risk (caution/avoid with congenital long QT, significant bradycardia, electrolyte abnormalities, or QT-prolonging drugs), bleeding risk with NSAIDs/antithrombotics, hyponatremia/SIADH (elderly/diuretics), mania/hypomania (screen for bipolar disorder), seizure risk, angle-closure glaucoma risk, and discontinuation symptoms with abrupt stopping.

Age Restriction

Pediatric use: Not approved for Major Depressive Disorder (MDD) in patients <12 years; approved for MDD in adolescents 12-17 years. For anxiety indications (e.g., GAD), pediatric approval is not established/varies by jurisdiction; do not assume approval in <18 years without local label confirmation.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

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

Interaction Severity

MAJOR/contraindicated: MAOIs (including linezolid and IV methylene blue) due to serotonin syndrome risk; pimozide due to QT prolongation. MODERATE/clinically significant: other serotonergic drugs (e.g., tramadol, triptans, fentanyl, 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, cimetidine) → increased escitalopram exposure (may require dose limitation). MINOR: alcohol may increase CNS impairment (advise avoidance).

Food Interaction

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

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Children

Major Depressive Disorder (≥12 years): 10mg once daily, max 20mg/day. Not approved for children under 12 years

Elderly

Recommended dose is 10mg once daily; do not exceed 10mg/day in patients over 65 years due to increased risk of QT prolongation, hyponatremia, and accumulation

Kidney Impairment

Mild-moderate renal impairment: no dose adjustment. Severe renal impairment: use with caution (commonly referenced at CrCl <30 mL/min); no specific adjustment but monitor closely.

Liver Impairment

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

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered the same day; if it is close to 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, longer if high dose/long duration or if symptoms emerge) to reduce discontinuation symptoms (e.g., dizziness, irritability/anxiety, sensory disturbances, insomnia, headache, nausea).

Overdose

Overdose may cause nausea/vomiting, dizziness, somnolence, tremor/agitation, seizures, serotonin syndrome, tachycardia, and QT prolongation/arrhythmias; management is supportive with airway/ventilation as needed, activated charcoal if appropriate, ECG/cardiac monitoring, and symptom-directed care-seek emergency care immediately.

Patient Counseling

Take once daily consistently (with/without food); onset may take 1-4 weeks; continue as prescribed and do not stop abruptly (taper with clinician); report worsening mood/suicidal thoughts, agitation, or serotonin syndrome symptoms; avoid alcohol and use caution with driving until effects known; discuss bleeding risk with NSAIDs/anticoagulants and avoid St John’s wort/other serotonergic drugs unless advised; seek advice if pregnant/planning pregnancy or breastfeeding.

Monitoring Requirements

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

Pharmacology

Mechanism of Action

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

Onset of Action

Within 24 hours for pharmacologic effect; clinical antidepressant/anxiolytic response typically begins in 1-2 weeks with full effect in 4-6 weeks

Duration of Effect

Approximately 24 hours (supports once-daily dosing); clinical therapeutic benefit is maintained with continued daily use

Half-Life

27-32 hours in normal adults; approximately doubled in hepatic impairment

Bioavailability

~80%.

Metabolism

Hepatic metabolism primarily via CYP2C19, with contributions from CYP3A4 and CYP2D6, forming S-desmethylcitalopram (S-DCT) and S-didesmethylcitalopram (S-DDCT), which are less pharmacologically active than escitalopram.

Excretion

Primarily hepatic metabolism (CYP2C19, CYP2D6, CYP3A4) with renal excretion mainly as metabolites; about ~8% is excreted in urine as unchanged escitalopram.

Product Information

Available Dosage Forms

Film‑coated tablet (this product: 10 mg); escitalopram is also available in some markets as oral drops/solution, but that is a different product presentation than this SFDA-registered tablet.

Composition per Dose

Each film-coated tablet: 10mg escitalopram (as oxalate 12.77mg)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antidepressant-SSRI

Controlled Substance

No

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