ZELAX 10/MG FC CAP 30/FC TAB

Indications

Approved Uses

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

Off-Label Uses

Examples of common off‑label uses: panic disorder, social anxiety disorder, obsessive‑compulsive disorder, PTSD, premenstrual dysphoric disorder (PMDD), and menopausal vasomotor symptoms.

Dosage & Administration

Initial Dose

10mg once daily (5mg once daily for panic disorder during first week)

Maintenance Dose

10-20 mg once daily.

Maximum Dose

10 mg once daily

Children's Dosage

Safety and efficacy not established in pediatric patients

Dose Adjustment Notes

Hepatic impairment: start 5 mg once daily and do not exceed 10 mg/day; elderly: generally start 5 mg once daily and do not exceed 10 mg/day; renal impairment: no adjustment in mild-moderate, use caution in severe impairment (e.g., CrCl <20 mL/min).

Safety & Warnings

Contraindications

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

Warnings & Precautions

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

Age Restriction

Pediatric: not approved. Approved in adults only

Drug Interactions

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., triptans, tramadol, lithium, St John’s wort), NSAIDs/anticoagulants (bleeding risk), QT‑prolonging drugs (additive QT risk), strong CYP2C19 inhibitors (e.g., omeprazole/esomeprazole, fluconazole) increasing escitalopram exposure. MINOR: cimetidine (increases levels); alcohol may worsen CNS effects.

Food Interaction

No restriction.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Caution

Children

Safety and efficacy not established in pediatric patients

Elderly

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

Liver Impairment

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

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly; taper gradually (individualize-commonly over at least several weeks) to reduce discontinuation symptoms.

Patient Counseling

Take once daily at the same time with or without food; do not stop abruptly-taper with prescriber; expect gradual benefit (weeks); avoid combining with MAOIs/other serotonergic agents without medical advice; report suicidal thoughts, severe agitation, fever/rigidity (serotonin syndrome), abnormal bleeding, or palpitations/syncope; use caution with alcohol and driving if sedated; store below 30°C.

Monitoring Requirements

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

Pharmacology

Mechanism of Action

Selective serotonin reuptake inhibitor (SSRI) that inhibits the serotonin transporter (SERT), increasing synaptic serotonin with minimal activity at other receptors.

Duration of Effect

Approximately 24 hours per dose (supports once-daily dosing); antidepressant/anxiolytic symptom control is maintained only with continued daily dosing and wanes over days after discontinuation.

Half-Life

27-32 hours.

Bioavailability

~80%.

Metabolism

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

Protein Binding

~56%.

Product Information

Available Dosage Forms

Film‑coated tablet (oral).

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

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