Adjunct to diet when response to diet & exercise is inadequate in patients w/ primary hypercholesterolemia or mixed dyslipidemia (type IIb). Reduces elevated LDL-C, total cholesterol, trigylcerides, Apo B & increases HDL-C.
Dosage/Direction for Use
Statin-naive patient or patient who switched from another HMG-CoA reductase inhibitor Initially 5 or 10 mg once daily, adjust dose after 4 wk, if necessary. Patient w/ severe hypercholesterolaemia at high CV risk (particularly those w/ familial hypercholesterolaemia) who do not achieve treatment goal on 20 mg & whom routine follow-up will be performed Max dose: 40 mg. Patient w/ predisposing factors to myopathy & Asian patient Initially 5 mg. Severe renal impairment (CrCl <30 mL/min/1.73 m2) not on hemodialysis Initially 5 mg once daily. Max: 10 mg once daily. Hepatic impairment (Child-Pugh score 8 & 9) Max: 20 mg once daily. Elderly >70 yr Initially 5 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Myopathy. Concomitant use w/ ciclosporin. Active liver disease including unexplained, persistent elevations of serum transaminases & any serum transaminase elevation >3x ULN. Pregnancy & lactation.
Special Precautions
Discontinue use or reduce dose if serum transaminases level is >3 x ULN; in markedly elevated creatinine kinase (>5x ULN) or if muscular symptoms are severe & cause daily discomfort. Patients who consume excessive quantities of alcohol &/or have history of liver disease. Perform LFTs prior to initiation of therapy & 3 mth later. Childn.
Sign Out
