📋 Indications & Clinical Dosage
*Types Ila, Ilb, Ill, IV, V hyperlipidaemia, including familial hypercholesterolaemia:*
Adults: Initially 200 mg once daily with food or 67 mg 3 times daily.
Children 4-15 yrs: one 67 mg cap/20 kg body-weight, max 4 cap of 67 mg or max 3 cap of 67 mg with concomitant statin daily; 15-18 yr: initially 3 cap of 67 mg daily, increased if necessary to 4 cap of 67 mg daily, max 3 cap of 67 mg daily with concomitant statin.
*Severe hyperlipidaemia:*
Adult: 267 mg once daily with food.
⛔ Contraindications
Severe renal or hepatic dysfunction, gall bladder disease, photoallergy or phototoxic reactions with fibrates or ketoprofen.
⚠️ Precautions & Warnings
Monitor liver enzymes, renal or hepatic impairment, pancreatitis. Correct hyperthyroidism before initiating treatment
🔄 Drug Interactions
Anticoagulants, cyclosporin, statins, fibrates.
⚠️ Adverse Reactions / Side Effects
Hepatitis, rhahdomyolysis, GI upset, skin rashes, headache, fatigue, vertigo, myalgia, gallstones. Rare: Sexual asthenia, muscle toxicity (discontinue), hepatitis, alopecia, photosensitivity, interstitial pneumopathies.
🤰 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.