📋 Indications & Clinical Dosage
*Primary hypercholesterolaemia, Combined hyperlipidaemia, Heterozygous familial hypercholesterolaemia, Homozygous familial hypercholestrolaemia adjucnt to diet and other appropriate measures:*
Adult: Usual dose 10 mg once daily; increased if necessary 40 mg once daily, dose to be increased at intervals of at least 4 weeks; max 80 mg per day.
Children 10-18 yrs: initially 10 mg once daily, increased if necessary at intervals of at least 4 week to usual max 20 mg once daily; max 80 mg once daily in homozygous familial hypercholesterolaemia.
*Primary prevention of cardiovascular events in patients at high risk of a first cardiovascular event:*
Adult: 20 mg once daily, dose can be increased if necessary.
*Secondary prevention of cardiovascular events:*
Adult: 80 mg once daily.
⛔ Contraindications
Active liver disease, persistent raised liver enzymes. Ensure adequate contraception.
⚠️ Precautions & Warnings
Haemorrhagic stroke, history of alcohol abuse or liver disease. Perform liver function tests before and during therapy.Reduced dose required (max. 10mg daily) with concomitant ciclosporin, or tipranavir combined withritonavir. Maximum dose of 40 mg once daily when combined with anion-exchange resin for heterozygous familial hypercholesterolaemia
🔄 Drug Interactions
Cyclosporin, fibrates, azole antifungals, niacin, drugs metabolised by cytochrome P450 3A4, digoxin, erythromycin, oral contraceptives, antacids, warfarin.
⚠️ Adverse Reactions / Side Effects
Back pain, epistaxis, hyperglycaemia, nasopharyngitis, pharyngeolaryngeal pain, anorexia, blurred vision, chest pain, hypoglycaemia, malaise, neck pain, peripheral oedema, pyrexia, tinnitus, weight gain, and elevated ALT and CPK levels.
🤰 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.