CIPRALEX 20/MG FC TAB 28/FC TAB

Indications

Approved Uses

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

Off-Label Uses

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

Dosage & Administration

Dosing by Condition

MDD (adults): 10 mg once daily, may increase to 20 mg once daily after at least 1 week; GAD (adults): 10 mg once daily, may increase to 20 mg once daily after at least 1 week; Elderly: 5 mg once daily initially, maximum 10 mg once daily.

Initial Dose

10 mg once daily.

Maintenance Dose

10-20 mg once daily.

Maximum Dose

20mg once daily (10mg once daily in elderly)

Children's Dosage

Not approved for pediatric use; no specific dosages established

Dose Adjustment Notes

Dose increases should be based on response/tolerability and generally not before at least 1 week; elderly: recommended max 10 mg/day; hepatic impairment: 10 mg/day; severe renal impairment (CrCl <20 mL/min): use with caution; when discontinuing, taper

Side Effects

Common Side Effects

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

Side Effect Frequency

Escitalopram (CIPRALEX 20 mg film‑coated tablets, oral): Very common (≥10%): nausea, headache, insomnia, somnolence. Common (1-10%): decreased appetite, anxiety, restlessness/akathisia, abnormal dreams, decreased libido, anorgasmia, ejaculation disorder/delayed ejaculation, dizziness, tremor, paresthesia, yawning, diarrhea, constipation, vomiting, dry mouth, increased sweating, fatigue, pyrexia, weight increase/weight decrease. Uncommon (0.1-1%): bruxism, agitation, panic attacks, confusion, taste disturbance, visual disturbance, tinnitus, tachycardia, urticaria/rash/pruritus, alopecia, abnormal uterine bleeding/menorrhagia, edema, epistaxis. Rare/Not known (serious): hyponatremia/SIADH, serotonin syndrome, QT prolongation/torsades risk, abnormal bleeding (incl. GI), mania/hypomania, seizures, angle‑closure glaucoma, severe allergic reactions.

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 (especially in children/adolescents/young adults), serotonin syndrome risk (esp. with serotonergic drugs/MAOI-like agents), QT prolongation risk (avoid/add caution with QT-prolonging drugs and in electrolyte abnormalities/bradycardia/congenital long QT), screening for bipolar disorder/mania risk, hyponatremia/SIADH (elderly/diuretics), increased bleeding risk with NSAIDs/antiplatelets/anticoagulants, seizure risk, discontinuation syndrome with abrupt stop, and angle-closure glaucoma risk in anatomically narrow angles.

Age Restriction

Safety and effectiveness in pediatric patients <12 years have not been established; approved for adolescents ≥12 years and adults for MDD

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major interactions: MAOIs (including linezolid and IV methylene blue) contraindicated/avoid due to serotonin syndrome; pimozide contraindicated (QT prolongation); other serotonergic agents (e.g., triptans, tramadol, fentanyl, lithium, St John’s wort) increase serotonin syndrome risk; NSAIDs/antiplatelets/anticoagulants increase bleeding risk; CYP2C19 inhibitors (e.g., omeprazole, cimetidine) can increase escitalopram exposure; other QT-prolonging drugs increase arrhythmia risk.

Interaction Severity

MAJOR/contraindicated: MAOIs (incl. within 14 days), pimozide; avoid/contraindicated: linezolid or IV methylene blue unless no alternatives (serotonin syndrome risk). MODERATE: other serotonergic drugs (e.g., triptans, tramadol, lithium, St John’s wort), QT‑prolonging drugs, NSAIDs/antiplatelets/anticoagulants (bleeding risk), strong CYP2C19 inhibitors (e.g., omeprazole/cimetidine) may increase levels. MINOR/precaution: alcohol (additive CNS effects).

Food Interaction

No restriction.

Special Populations

Pregnancy

Consult Doctor

Children

Not approved for pediatric use; no specific dosages established

Elderly

Start at 5-10mg once daily; maximum dose 10mg once daily; increased risk of hyponatremia and falls; monitor closely

Kidney Impairment

Mild-to-moderate renal impairment: no dose adjustment; severe renal impairment: use with caution (commonly referenced threshold CrCl <30 mL/min).

Liver Impairment

Hepatic impairment: recommended 10 mg once daily (use caution with severe impairment; generally do not exceed 10 mg/day).

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly; taper gradually over several weeks (individualize-often at least 2-4 weeks, longer if needed) to reduce discontinuation symptoms (e.g., dizziness, irritability/anxiety, sensory disturbances, sleep disturbance, headache).

Overdose

Overdose may cause CNS effects (somnolence, agitation, tremor, seizures, coma), GI symptoms (nausea/vomiting), cardiovascular effects (tachycardia, QT prolongation/arrhythmias), and serotonin syndrome; management is immediate emergency evaluation with supportive care and ECG/cardiac monitoring (no specific antidote; consider activated charcoal when 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; watch for suicidal thoughts/behavioral changes early in therapy; avoid combining with other serotonergic drugs unless advised and seek urgent care for serotonin syndrome symptoms; caution with driving if drowsy/dizzy; limit/avoid alcohol; report abnormal bleeding/bruising (esp. with NSAIDs/anticoagulants) and discuss pregnancy/breastfeeding with the prescriber.

Monitoring Requirements

Monitor for clinical worsening/suicidality especially early and after dose changes; monitor for serotonin syndrome; consider ECG/QT risk assessment in patients with risk factors or on QT‑prolonging drugs; consider serum sodium (hyponatremia/SIADH) in elderly or symptomatic patients; periodically assess response and adverse effects.

Pharmacology

Mechanism of Action

Selective serotonin reuptake inhibitor (SSRI) that inhibits the serotonin transporter (SERT), increasing serotonergic neurotransmission in the CNS.

Onset of Action

Initial symptom improvement often in 1-2 weeks; meaningful response typically 2-4 weeks; full effect may take 4-6 (up to 8) weeks with continued daily dosing.

Duration of Effect

Antidepressant/anxiolytic clinical benefit is maintained with continuous daily dosing; effects persist over days to weeks while therapy continues. After stopping, pharmacologic exposure declines over several days (escitalopram half-life ~27-32 hours), and clinical symptoms may gradually return; tapering is recommended to reduce discontinuation symptoms.

Half-Life

27-33 hours.

Bioavailability

Approximately 80%.

Metabolism

Hepatic metabolism mainly via CYP2C19, with contributions from CYP3A4 and CYP2D6, forming demethylated metabolites (less active).

Product Information

Available Dosage Forms

Film‑coated tablet (this product); escitalopram is also available in some markets as oral drops/oral solution.

OTC Alternatives

No OTC alternative

Psych Class

Antidepressant-SSRI

Controlled Substance

No

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