📋 Indications & Clinical Dosage
*Adjunctive therapy of partial-onset seizures with or without secondary generalization:*
Adult and Children above 16 yrs: Initially 25-50 mg twice daily, adjusted according to response; maintenance 25-100 mg twice daily.
⛔ Contraindications
Last stage of renal disease, patients undergoing dialysis
⚠️ Precautions & Warnings
Caution in hepatic impairment, avoid abrupt withdrawal; reduce daily dose in steps of 50 mg at weekly intervals, then reduce to 20 mg daily in the last week of treatment
🔄 Drug Interactions
CYP2C19 strong inhibitors, Rifampicin, Carbamazepine, phenobarbital, phenytoin, oral contraceptives, lonafarnib, intranasal metoclopramide, selinexor.
⚠️ Adverse Reactions / Side Effects
Anxiety, constipation, loss of appetite, depression, dizziness, insomnia, irritability, malaise, nausea, somnolence, vertigo, vomiting, aggression, agitation. Rare: Neutropenia, psychotic disorder, suicidal ideation
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Use only if potential benefit outweighs risk
Lactation / Breastfeeding:
Caution advised, avoid
📚 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.