📋 Indications & Clinical Dosage
*All forms of epilepsy:*
Children 1-11 months: Initially 250 mcg once daily for 4 nights, increased over 2-4 weeks, usual dose 0.5-1 mg daily at night, may be given in 3 divided doses if necessary; 1-4 years: Initially 250 mcg once daily for 4 nights, increased over 2-4 weeks, usual dose 1-3 mg daily at night, may be given in 3 divided doses if necessary; 5-11 years: Initially 500 mcg once daily for 4 nights, increased over 2-4 weeks, usual dose 3-6 mg daily at night, may be given in 3 divided doses if necessary; 12-17 years: Initially 1 mg once daily for 4 nights, increased over 2-4 weeks, usual dose 4-8 mg daily at night, may be given in 3-4 divided doses if necessary.
*All forms of epilepsy, Myoclonus:*
Adult: Initially 1 mg once daily for 4 nights, increased over 2-4 weeks, usual dose 4-8 mg daily at night, adjusted according to response, may be given in 3-4 divided doses if necessary.
Elderly: Initially 500 mcg once daily for 4 nights, increased over 2-4 weeks, usual dose 4-8 mg daily at night, adjusted according to response, may be given in 3-4 divided doses if necessary.
⛔ Contraindications
Acute pulmonary insufficiency, coma, current alcohol or drug abuse, respiratory depression, sleep apnoea, myasthenia gravis, severe hepatic impairment.
⚠️ Precautions & Warnings
Pulmonary insufficiency, acute porphyrias, airways obstruction, brain damage, cerebellar ataxia, depression, spinal ataxia, suicidal ideation, mild to moderate hepatic impairment, renal impairment, el-derly. Withdraw gradually.
🔄 Drug Interactions
Alcohol, CNS depressants, other anticonvulsants, CYP3A4 inhibitors or inducers.
⚠️ Adverse Reactions / Side Effects
Aggression, anxiety, amnesia, bronchial and salivary hyper-secretion in infants and small children, coordination disturbances, confusion, dizziness, drowsiness, fatigue, muscle hypotonia, nystagmus, poor concentration, restlessness, withdrawal symptoms (in children). Rare: blood disorders, dysarthria, GI symptoms, headache, paradoxical effects, pruritus, respiratory depression, reversible hair loss, sexual dysfunction, skin pigmentation changes, suicidal ideation, urinary incontinence, urticaria, visual disturbances on long-term treatment
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Avoid unless the potential benefit outweighs the 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.