Indications

Mixed dyslipidaemia; Heterozygous familial; Nonfamilial hypercholesterolaemia.

Contraindication

Active liver disease or unexplained persistent elevations of serum transaminases. Concomitant use w/ ciclosporin, gemfibrozil, telaprevir, tipranavir. Pregnancy and lactation.

Special Precautions

History of liver disease; patients who consume substantial quantities of alcohol; patients w/ risk factors for myopathy or rhabdomyolysis. Hypothyroidism should be properly managed prior to statin therapy initiation. Renal impairment. Childn <10 yr. Premenarcheal females. Monitoring Parameters Monitor creatine kinase (CK) periodically and LFT. Discontinue if there is significant or persistent increase in CK levels, serum aminotransferase levels or evidence of myopathy.

Side Effects

Headache, flatulence, constipation, dyspepsia, nausea, diarrhoea, vomiting, anorexia. Pain in extremity, musculoskeletal and pharyngolaryngeal; myopathy, muscle spasms, myalgia, arthralgia, nasopharyngitis, insomnia, UTI. Increased serum aminotransferase, glycosylated haemoglobin and fasting serum glucose levels.

Drug Interactions

May increase risk of myopathy and rhabdomyolysis w/ CYP3A4 potent inhibitor (e.g. HIV or HCV protease inhibitors, itraconazole, clarithromycin), fenofibrate, colchicines, fixed combination of lopinavir/ritonavir. May decrease plasma concentration w/ CYP3A4 inducer (e.g. rifampicin, efavirenz). May significantly increase AUC and peak plasma concentration of digoxin. Increased AUC for norethindrone and ethinyl estradiol.

Route of Administration

Oral

Dosage

As directed by the physician