ESCITAM 10 MG TABLET

Indications

Approved Uses

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

Dosage & Administration

Dosing by Condition

MDD (adults): 10 mg once daily; may increase to 20 mg once daily after at least 1 week; max 20 mg/day. GAD (adults): 10 mg once daily; may increase to 20 mg once daily after at least 1 week; max 20 mg/day. Elderly or hepatic impairment: 10 mg once daily maximum (often start 5 mg once daily if clinically appropriate).

Initial Dose

10 mg once daily.

Maintenance Dose

10-20 mg once daily.

Maximum Dose

20 mg per day (10 mg/day in elderly)

Children's Dosage

Not approved for children under 7 years. For MDD: approved in adolescents 12 years and older at 10 mg once daily (max 20 mg/day). For GAD: approved in pediatric patients 7 years and older

Dose Adjustment Notes

May increase dose based on response/tolerability after at least 1 week; elderly and hepatic impairment: maximum 10 mg/day; mild-moderate renal impairment: no adjustment, severe renal impairment: use with caution; when discontinuing, taper gradually to reduce withdrawal symptoms.

How to Take

Swallow the film-coated tablet whole with water, once daily, with or without food; take at the same time each day (morning or evening).

Side Effects

Common Side Effects

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

Side Effect Frequency

Very common (≥10%): nausea, headache. Common (1-10%): insomnia, somnolence, dizziness, diarrhea, constipation, increased sweating, fatigue, sexual dysfunction (e.g., decreased libido, anorgasmia, ejaculation disorder), decreased appetite. Uncommon/rare: hyponatremia (SIADH), QT prolongation/arrhythmia risk, seizures, mania/hypomania activation, abnormal bleeding, serotonin syndrome.

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) hypersensitivity to escitalopram/citalopram. Linezolid or IV methylene blue should generally be avoided (or only used with strict monitoring due to serotonin syndrome risk) rather than listed as absolute contraindications in all labels.

Warnings & Precautions

Warnings/precautions: monitor for suicidality/clinical worsening (especially early and in young adults), serotonin syndrome risk with serotonergic drugs, QT prolongation risk (avoid/add caution with QT-risk factors and interacting drugs), hyponatremia/SIADH (higher risk in elderly/diuretics), mania/hypomania activation (screen for bipolar), increased bleeding risk with NSAIDs/anticoagulants, seizure risk, angle-closure glaucoma risk, and taper to avoid discontinuation syndrome.

Age Restriction

Pediatric use: approved for Major Depressive Disorder (MDD) in adolescents ≥12 years; not approved for MDD in <12 years. For Generalized Anxiety Disorder (GAD), approval is for adults (≥18 years) in many major labels; pediatric GAD use is not established/approved.

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 in many settings-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), strong CYP2C19 inhibitors (e.g., omeprazole/cimetidine-may increase levels), and alcohol (may worsen CNS effects).

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, fentanyl, St John’s wort) and QT-prolonging agents (additive QT risk); NSAIDs/antiplatelets/anticoagulants (increased bleeding risk); strong CYP2C19 inhibitors (e.g., omeprazole) may increase escitalopram exposure.

Food Interaction

No restriction.

Special Populations

Children

Not approved for children under 7 years. For MDD: approved in adolescents 12 years and older at 10 mg once daily (max 20 mg/day). For GAD: approved in pediatric patients 7 years and older

Elderly

Start at 5 mg once daily; maintenance dose 10 mg once daily; maximum 10 mg/day. Monitor for hyponatremia and QT prolongation.

Kidney Impairment

Mild-moderate renal impairment: no dose adjustment generally required; severe renal impairment (e.g., CrCl <20 mL/min): use with caution due to limited data.

Liver Impairment

Hepatic impairment: start 10 mg once daily and do not exceed 10 mg/day (especially in hepatic impairment/elderly); use caution in severe impairment due to reduced clearance.

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly; taper gradually (commonly over several weeks, individualized) to reduce discontinuation symptoms (e.g., dizziness, sensory disturbances, anxiety/irritability, nausea).

Overdose

Overdose may cause nausea/vomiting, dizziness, tremor, agitation/somnolence, tachycardia, seizures, serotonin syndrome, 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; do not stop abruptly-taper with prescriber guidance; watch for suicidal thoughts/behavioral changes early in therapy or after dose changes; avoid/limit alcohol and use caution with driving until effects are known; report symptoms of serotonin syndrome, unusual bleeding/bruising, or hyponatremia (e.g., confusion, weakness).

Monitoring Requirements

Monitor for clinical worsening/suicidality (especially early and after dose changes), serotonin syndrome, and mania/hypomania; consider serum sodium (hyponatremia/SIADH risk) in elderly or symptomatic patients; consider ECG/QT risk assessment in patients with cardiac disease, electrolyte abnormalities, or concomitant QT-prolonging drugs.

Pharmacology

Mechanism of Action

Selective serotonin reuptake inhibitor (SSRI): inhibits the serotonin transporter (SERT), increasing synaptic serotonin; escitalopram is the S-enantiomer of citalopram.

Onset of Action

Some improvement may occur within 1-2 weeks; full therapeutic effect typically takes 4-6 weeks.

Duration of Effect

Approximately 24 hours per dose (supports once-daily dosing); symptom control is maintained with continued daily dosing, with clinical benefits persisting over weeks to months during ongoing therapy.

Half-Life

27-33 hours.

Bioavailability

Approximately 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

Extensively metabolized hepatically; eliminated via urine and feces mainly as metabolites, with a small fraction excreted unchanged in urine (about 8%).

Protein Binding

Approximately 56%.

Product Information

Available Dosage Forms

Film-coated tablet (this product).

Composition per Dose

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

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antidepressant-SSRI

Controlled Substance

No

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