📋 Indications & Clinical Dosage
*Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia), mixed dyslipidaemia (type IIb), or homozygous familial hypercholesterolaemia, alone or with risk factors for myopathy orrhabdomyolysis, or with risk of cardiovascular events:*
Adult: Initially 5-10 mg once daily, then increased if necessary up to 20 mg once daily, dose to be increased at intervals of at least 4 weeks.
Children10-18 yrs: initially 5 mg daily, increased if necessary at intervals of at least 4 wk to usual, max 20 mg once daily.
*Prevention of cardiovascular events in patients at high risk of a first cardiovascular event:*
Adult: 20 mg once daily.
Adult 70 years and over: Initially 5 mg once daily; then increased if necessary up to 20 mg once daily.
⛔ Contraindications
Severe renal impairment. Active liver disease including elevated serum transaminases, myopathy, risk of renal failure secondary to rhabdomyolysis, hypothyroidism, history of hereditary muscle disorders, history of muscle toxicity with a statin or fibrate, alcohol abuse.
⚠️ Precautions & Warnings
Severe hepatic impairment, history of liver disease. Monitor liver function before and 3 months after starting treatment, Advise patients to report unexplained muscle weakness or pain; monitor creatine kinase levels, renal impairment, elderly (more than 70 years).
🔄 Drug Interactions
Gemfibrozil, fibrates, nicotinic acid, cyclosporin, azole antifungals, protease inhibitors, macrolides, warfarin, antacids, oral contraceptives.
⚠️ Adverse Reactions / Side Effects
Proteinuria, Gynaecomastia, haematuria, oedema, Stevens-Johnson syndrome, headache, dizziness, GI upset, myalgia, anaesthesia.
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Contraindicated in pregnancy.
Lactation / Breastfeeding:
Not recommended.
📚 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.