📋 Indications & Clinical Dosage
*Schizophrenia:*
Adult: 10-15 mg once daily; usual dose 15 mg once daily (max. per dose 30 mg once daily).
Children15-18 yrs: Initially 2 mg once daily for 2 days, increased to 5 mg once daily for 2 days, thereafter increased to 10 mg once daily, further increased if necessary in steps of 5 mg to max 30 mg daily.
*Treatment and recurrence prevention of mania:*
Adult: 15 mg once daily, increased if necessary, at interval of 2 weeks, up to30 mg once daily.
Children 13-18 yr: Initially 2 mg once daily for 2 days, increased to 5 mg once daily for 2 days, thereafter increased to usual dose of 10 mg once daily, further increased if necessary in steps of 5 mg to max 30 mg daily, max duration of treatment 12 weeks.
*Bipolar Disorder, Acute Manic or Mixed Episodes:*
Adult: Initially30 mg daily. Titrate: May decrease to 15 mg every day based on tolerability.
⛔ Contraindications
CNS depression, phaeochromocytoma, comatose state
⚠️ Precautions & Warnings
Severe hepatic impairment. Cerebrovascular disease, elderly (reduce initial dose), dementia, tardive dyskinesia; reduce dose or discontinue. Signs ofneuroleptic malignant syndrome, discontinue, history of seizures, diabetes, monitor patients for signs of hyperglycaemia.
🔄 Drug Interactions
Potent inhibitors of CYP3A4 or 2D. Potent inducers of CYP3A4, Alpha blockers, alcohol, CNS drugs
⚠️ Adverse Reactions / Side Effects
Anxiety, hypersalivation, malaise, depression, dry mouth, anorexia, alopecia, bradycardia, hepatitis, hyponatraemia, infection, laryngospasm, myalgia, oedema, oropharyngeal spasm, pancreatitis, pathological gambling, respiratory disorders, rhabdomyolysis, suicidal ideation, sweating, urinary disorders
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Use only if potential benefit outweighs risk
Lactation / Breastfeeding:
Contraindicated, 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.