DEPRALEX 10/MG FC TAB 28/FC TAB

Indications

Approved Uses

Approved indications depend on the local SFDA label; in general established labeling supports Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD), while panic disorder/social anxiety/OCD are not universally approved for escitalopram in all jurisdictions.

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. GAD (adults): 10 mg once daily; may increase to 20 mg once daily after at least 1 week if needed. (Other conditions such as panic disorder/SAD/OCD are label-dependent and should only be included if specifically approved on the local SFDA product label.)

Initial Dose

10 mg once daily for major depressive disorder and generalized anxiety disorder. No 5 mg once daily dosing for panic disorder is mentioned in FDA-approved labeling

Maintenance Dose

10-20 mg once daily.

Maximum Dose

20 mg once daily.

Children's Dosage

Approved for Major Depressive Disorder in adolescents aged 12-17 years (10-20mg daily) and Generalized Anxiety Disorder in children aged 7 years and older (10-20mg daily).

Dose Adjustment Notes

Elderly: recommended 10 mg/day (use caution with higher doses due to QT risk). Hepatic impairment: 10 mg/day recommended (especially in hepatic impairment). Renal impairment: no adjustment in mild-moderate; severe renal impairment-use with caution. Dose increases, if needed, are typically after at least 1 week based on response/tolerability.

How to Take

Oral: take escitalopram 10 mg once daily, at the same time each day, with or without food; swallow the film‑coated tablet with water.

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

Safety & Warnings

Contraindications

Contraindicated with MAOIs (concomitant use or within 14 days of stopping an MAOI; and allow at least 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 monitoring (boxed warning), serotonin syndrome risk (esp. with serotonergic/MAOI-like agents), QT prolongation risk (caution with cardiac disease, electrolyte abnormalities, and QT-prolonging drugs), hyponatremia/SIADH (esp. elderly/diuretics), increased bleeding risk with NSAIDs/anticoagulants/antiplatelets, activation of mania/hypomania (screen for bipolar), seizure risk, discontinuation syndrome (taper), and angle-closure glaucoma risk in narrow-angle glaucoma.

Age Restriction

Not approved for MDD in patients <12 years; approved for MDD in adolescents 12-17 years and for GAD in children ≥7 years (and adults).

Drug Interactions

Drug Interactions

Major interactions: MAOIs/linezolid/IV methylene blue (avoid/contraindicated-serotonin syndrome), pimozide (contraindicated-QT), other serotonergic drugs (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); alcohol may worsen CNS effects though not a strict pharmacokinetic interaction.

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; NSAIDs/anticoagulants/antiplatelets → bleeding risk; other QT‑prolonging drugs → additive QT risk; strong CYP2C19 inhibitors (e.g., omeprazole) may increase escitalopram exposure. MINOR: alcohol may increase CNS impairment.

Food Interaction

No restriction.

Special Populations

Children

Approved for Major Depressive Disorder in adolescents aged 12-17 years (10-20mg daily) and Generalized Anxiety Disorder in children aged 7 years and older (10-20mg daily).

Elderly

Recommended dose is 10 mg once daily for elderly patients. Maximum dose is 10 mg once daily due to increased risk of QT prolongation and hyponatremia. However, the prescribing information does not explicitly state that 10 mg is both the recommended AND maximum dose with no flexibility; it states 10 mg/day is recommended for most elderly patients

Kidney Impairment

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

Liver Impairment

Hepatic impairment: recommended dose 10 mg once daily (often start 5 mg daily and titrate cautiously); avoid exceeding 10 mg/day.

Storage & Patient Advice

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, seizures, serotonin syndrome, tachycardia, and QT prolongation/arrhythmias; management is urgent medical evaluation with supportive care and ECG/cardiac monitoring (no specific antidote).

Patient Counseling

Take once daily at the same time with or without food; benefit may take several weeks-continue as prescribed; do not stop abruptly (taper with clinician); watch for worsening mood/suicidal thoughts early in therapy; avoid/limit alcohol and use caution with driving until effects known; report serotonin syndrome symptoms; inform providers about all medicines (especially MAOIs/serotonergic drugs, NSAIDs/anticoagulants, QT‑prolonging drugs).

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 (hyponatremia/SIADH risk, especially elderly); consider ECG/QT risk assessment in patients with risk factors or on QT‑prolonging drugs; periodically reassess efficacy and tolerability.

Product Information

Available Dosage Forms

For DEPRALEX specifically: film‑coated tablet (oral). Escitalopram as an INN may also exist as an oral solution in some markets, but that is not this registered product.

Composition per Dose

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

Generic Availability

Yes

Psych Class

Antidepressant-SSRI

Controlled Substance

No

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