CIPRAM 20/MG FC TAB 28/FC TAB

Indications

Approved Uses

Major depressive disorder (depressive episodes).

Dosage & Administration

Dosing by Condition

Major depressive disorder: start 20 mg once daily; may increase to 40 mg/day if needed after at least 1 week; max 40 mg/day (but max 20 mg/day in >60 years/hepatic impairment/CYP2C19 poor metabolizers

Initial Dose

20mg once daily (10mg once daily for panic disorder)

Maintenance Dose

20-40mg once daily.

Maximum Dose

40mg per day (20mg per day in elderly patients and those with hepatic impairment)

Children's Dosage

Not approved for use in children under 18 years.

Dose Adjustment Notes

Use the lowest effective dose; max 20 mg/day in patients >60 years, hepatic impairment, or CYP2C19 poor metabolizers and when used with strong CYP2C19 inhibitors (e.g., omeprazole/cimetidine); reassess response after several weeks; taper gradually when discontinuing.

How to Take

Oral: take once daily at the same time each day; may be taken with or without food; swallow the film‑coated tablet with water.

Safety & Warnings

Contraindications

Contraindicated with: (1) concomitant MAOIs or within 14 days of stopping an MAOI (and vice versa), (2) concomitant pimozide, (3) known hypersensitivity to citalopram; additionally, avoid/use is contraindicated in patients with congenital long QT syndrome per product safety warnings; do not start with linezolid or IV methylene blue unless no alternatives and with close monitoring.

Warnings & Precautions

Warnings/precautions: suicidality risk in children/adolescents/young adults (≤24) with close monitoring; QT prolongation risk (avoid congenital long QT and minimize other QT-risk factors/drugs; dose limits apply); serotonin syndrome risk with serotonergic/MAOI-like agents; bleeding risk with NSAIDs/anticoagulants; hyponatremia/SIADH (higher risk in elderly/diuretics); activation of mania/hypomania; seizure risk; hepatic impairment requires dose cap; taper to avoid discontinuation symptoms.

Age Restriction

Not approved under 18 years.

Drug Interactions

Drug Interactions

Key interactions: MAOIs/linezolid/IV methylene blue (serotonin syndrome-avoid/contraindicated), pimozide (QT prolongation-contraindicated), other QT-prolonging drugs and electrolyte-lowering agents (additive QT/TdP risk), other serotonergic drugs incl. triptans, tramadol, lithium, other SSRIs/SNRIs, St John’s wort (serotonin syndrome risk), NSAIDs/aspirin/anticoagulants incl. warfarin (bleeding risk), CYP2C19 inhibitors (e.g., omeprazole, cimetidine) increasing citalopram exposure and QT risk; enzyme inducers (e.g., carbamazepine) may reduce levels.

Interaction Severity

MAJOR/contraindicated: MAOIs (including linezolid and IV methylene blue) due to serotonin syndrome; pimozide due to QT prolongation. MODERATE/clinically significant: other QT‑prolonging drugs; other serotonergic agents (e.g., triptans, tramadol, lithium) increasing serotonin syndrome risk; NSAIDs/antiplatelets/warfarin increasing bleeding risk; CYP2C19 inhibitors (e.g., omeprazole, cimetidine) increasing citalopram exposure/QT risk. MINOR: alcohol (additive CNS effects) and enzyme inducers (may reduce levels).

Food Interaction

No restriction

Special Populations

Pregnancy

Category C

Children

Not approved for use in children under 18 years.

Elderly

Maximum dose 20mg once daily; start at 10-20mg once daily and titrate cautiously; monitor for QT prolongation and hyponatremia

Kidney Impairment

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

Liver Impairment

Hepatic impairment: maximum recommended dose 20 mg/day (use caution, especially in severe impairment).

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly; taper gradually (commonly over at least 1-2 weeks, longer if high dose/long duration) to reduce SSRI discontinuation symptoms.

Overdose

Overdose may cause nausea/vomiting, dizziness, tremor, somnolence, tachycardia, seizures, serotonin syndrome, and QT prolongation/arrhythmias (including torsades); management is urgent emergency evaluation with supportive care and ECG/cardiac monitoring (consider activated charcoal if early and appropriate).

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); avoid or limit alcohol and use caution with driving until effects known; seek urgent care for suicidal thoughts, severe agitation/confusion/fever (serotonin syndrome), or palpitations/fainting (possible arrhythmia); inform providers about all medicines (especially MAOIs/linezolid/methylene blue, QT‑prolonging drugs, NSAIDs/anticoagulants, and omeprazole/cimetidine).

Monitoring Requirements

Monitor clinical response and suicidality (especially early and after dose changes); assess for serotonin syndrome when combined with serotonergic drugs; consider ECG and electrolytes (K+, Mg2+) in patients with cardiac disease, bradycardia, congenital long QT, or on QT‑prolonging drugs; monitor for hyponatremia/SIADH (especially elderly/diuretics); consider liver function in hepatic impairment and bleeding risk if on anticoagulants/NSAIDs.

Pharmacology

Mechanism of Action

Selective serotonin reuptake inhibitor (SSRI): inhibits presynaptic serotonin (5‑HT) reuptake, increasing serotonergic neurotransmission in the CNS.

Duration of Effect

Pharmacologic effect per dose lasts approximately 24 hours (supports once-daily dosing); clinical antidepressant benefit is maintained only with continued daily dosing and does not persist for weeks after stopping.

Half-Life

Approximately 35 hours (range ~33-37 hours)

Metabolism

Hepatic metabolism primarily via CYP2C19, with contributions from CYP3A4 and CYP2D6; major metabolites include demethylcitalopram (DCT) and didemethylcitalopram (DDCT)

Product Information

Available Dosage Forms

Film-coated tablet (this product

Composition per Dose

Each film-coated tablet: 20mg citalopram as hydrobromide salt.

Generic Availability

Yes

OTC Alternatives

No OTC alternative equivalent to citalopram for treating major depressive disorder.

Psych Class

Antidepressant-SSRI

Controlled Substance

No

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