CITOXAL 20/MG FC TAB 30/FC TAB

Indications

Approved Uses

Major depressive disorder (MDD) and generalized anxiety disorder (GAD).

Off-Label Uses

Obsessive-compulsive disorder (OCD), Panic disorder, Social anxiety disorder, Post-traumatic stress disorder (PTSD), Premenstrual dysphoric disorder (PMDD), Vasomotor symptoms associated with menopause.

Dosage & Administration

Dosing by Condition

MDD (adults): start 10 mg PO once daily; may increase to 20 mg once daily after at least 1 week if needed; max 20 mg/day. GAD (adults): start 10 mg PO once daily; may increase to 20 mg once daily after at least 1 week if needed; 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

Not approved for pediatric use

Dose Adjustment Notes

Dose increases should occur only after assessing response/tolerability (commonly after ≥1 week); hepatic impairment and older adults generally require lower doses (often max 10 mg/day); mild-moderate renal impairment usually needs no adjustment, but severe renal impairment warrants caution; taper gradually when discontinuing.

How to Take

Oral: take once daily, with or without food, at the same time each day; swallow the film‑coated tablet whole with water (do not crush/chew unless specifically advised).

Side Effects

Common Side Effects

Nausea, insomnia, ejaculation disorder, diarrhea, dry mouth, somnolence, dizziness, sweating, constipation, fatigue, decreased libido, anorgasmia, headache

Side Effect Frequency

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

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; avoid/contraindicated with linezolid or IV methylene blue unless no alternatives and with close monitoring.

Warnings & Precautions

Key precautions: monitor for suicidality (especially early and in <25), serotonin syndrome with serotonergic co-meds, QT prolongation risk (cardiac disease, electrolyte abnormalities, high doses/interactions), bleeding risk with NSAIDs/anticoagulants, mania/hypomania activation (screen for bipolar disorder), hyponatremia/SIADH (elderly/diuretics), seizure risk, angle-closure glaucoma risk, and taper to avoid discontinuation syndrome.

Age Restriction

Not approved for use in children and adolescents <18 years for depression; may be used from ≥12 years for OCD (where locally approved).

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major interactions: MAOIs/linezolid/IV methylene blue (serotonin syndrome-avoid/contraindicated), pimozide (QT-contraindicated), other serotonergic agents (serotonin syndrome), QT-prolonging drugs (additive QT risk), NSAIDs/antiplatelets/anticoagulants (bleeding risk), strong CYP2C19 inhibitors e.g., omeprazole/cimetidine (↑ escitalopram exposure; consider dose limits), and alcohol/CNS depressants (additive impairment).

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 agents (e.g., tramadol, triptans, lithium, fentanyl) ↑ serotonin syndrome risk; NSAIDs/antiplatelets/anticoagulants ↑ bleeding risk; other QT‑prolonging drugs ↑ arrhythmia risk; strong CYP2C19 inhibitors (e.g., omeprazole, cimetidine) ↑ escitalopram exposure (may require dose limitation).

Food Interaction

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

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Children

Not approved for pediatric use

Elderly

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

Kidney Impairment

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

Liver Impairment

Hepatic impairment: recommended 10 mg once daily; generally do not exceed 10 mg/day (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 scheduled 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, individualized) to reduce discontinuation symptoms.

Overdose

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

Patient Counseling

Take once daily at the same time; with or without food. Benefits may take several weeks; continue as prescribed. Do not stop abruptly-taper with clinician guidance. Seek urgent help for suicidal thoughts, severe agitation, or serotonin syndrome symptoms. Avoid/limit alcohol and use caution with driving until effects are known. Report unusual bleeding/bruising, palpitations/syncope (QT risk), and symptoms of low sodium (confusion, headache, weakness). Tell providers about all medicines (especially MAOIs/linezolid/methylene blue, tramadol/triptans, NSAIDs/anticoagulants).

Monitoring Requirements

Monitor for clinical worsening/suicidality (especially early and after dose changes); monitor for serotonin syndrome when combined with serotonergic drugs; consider ECG/QT risk assessment in patients with risk factors or on QT‑prolonging drugs; monitor for hyponatremia/SIADH risk (especially elderly/diuretics); monitor for mania/hypomania in bipolar risk.

Pharmacology

Mechanism of Action

Selective serotonin reuptake inhibitor (SSRI): inhibits the serotonin transporter (SERT), reducing presynaptic reuptake and increasing serotonergic neurotransmission in the CNS.

Onset of Action

Initial symptom improvement may occur within 1-2 weeks; full therapeutic effect typically requires 4-6 weeks of continuous daily dosing.

Duration of Effect

Single-dose pharmacodynamic/PK coverage supports once-daily dosing for ~24 hours; however, the therapeutic antidepressant/anxiolytic effect is sustained only with continuous daily dosing and persists for days to weeks after discontinuation (with gradual waning).

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 hepatically metabolized (mainly CYP2C19, also CYP3A4/CYP2D6); elimination occurs via urine and feces primarily as metabolites, with a small fraction excreted unchanged in urine.

Product Information

Available Dosage Forms

Film‑coated tablet (this product).

Composition per Dose

Each film-coated tablet: 20 mg escitalopram (as oxalate)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antidepressant-SSRI

Controlled Substance

No

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