📋 Indications & Clinical Dosage
*Major depression:*
Adult: 25 mg daily at bedtime, increased to 50 mg daily if necessary after 2 weeks.
⛔ Contraindications
Dementia, elderly over 75 years, hepatic impairment if baseline serum transaminases exceed 3 times the upper limit of reference range
⚠️ Precautions & Warnings
Moderate to severe renal impairment, moderate hepatic impairment, history of alcohol abuse or alcoholism, bipolar disorder, diabetes, hypomania, mania, nonalcoholic fatty liver disease, obesity Monitor BP and heart rate in hypertensive patients. Test liver function before treatment and then regularly thereafter especially when clinically indicated. Dose adjustment may be necessary if smoking started or stopped during treatment.
🔄 Drug Interactions
Fluvoxamine, ciprofloxacin, other CYP1A2 inhibitors, alcohol, smoking, hepatotoxic drugs
⚠️ Adverse Reactions / Side Effects
Agitation, anxiety, abdominal pain, back pain, constipation, diarrhoea, dizziness, drowsiness, fatigue, headache, increased serum transaminases, nausea, sleep disturbances, sweating, vomiting, blurred vision, eczema, paraesthesia, restless legs syndrome, tinnitus. Rare: Hepatic failure, hepatic injury, hepatitis, rash, weight changes, pruritus, suicidal behavior.
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Contraindicated
Lactation / Breastfeeding:
Contraindicated
📚 Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.