Adjunct to diet & other lipid lowering treatments in the treatment of homozygous familial hypercholesterolaemia. Prevention of major CV events in patients who are estimated to have a high risk for a 1st CV event, as an adjunct to correction of other risk factors.
Dosage/Direction for Use
Treatment of hypercholesterolaemia 5 or 10 mg once daily. Max: 40 mg. Prevention of CV events 20 mg daily. Childn & adolescents 10-17 yr Initially 5 mg daily. Dose range: 5-20 mg once daily. Elderly >70 yr 5 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients w/ active liver disease including unexplained, persistent elevations of serum transaminases & any serum transaminases elevation >3x the upper limit of normal. Severe renal impairment; myopathy. Patients receiving ciclosporin; w/ predisposing factors for myopathy/rhabdomyolysis eg, moderate renal impairment, hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity w/ another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, Asian patients. Pregnancy & lactation.
Special Precautions
Proteinuria. Skeletal muscle effects; inexplicable muscle pain, weakness or cramps associated w/ malaise or fever. Patients who consume excessive quantities of alcohol &/or have a history of liver disease. Interstitial lung disease; risk of hyperglycaemia; increase HbA1c & fasting serum glucose levels. May affect ability to drive or operate machinery.
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