Adults w/ primary hypercholesterolaemia (heterozygous familial & non-familial) or mixed dyslipidaemia, as an adjunct to diet in combination w/ a statin or statin w/ other lipid-lowering therapies in patients unable to reach LDL-C goals w/ the max tolerated dose of a statin; or alone or in combination w/ other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Adults w/ established or at high risk for ASCVD to reduce CV risk by lowering LDL-C levels, as an adjunct to correction of other risk factors in patients on a max tolerated dose of a statin w/ or w/o ezetimibe; or alone or in combination w/ ezetimibe in patients who are statin-intolerant, or for whom a statin is contraindicated.
180 mg once daily. Concomitant simvastatin therapy: Limit simvastatin dose to 20 mg daily (or 40 mg daily for patients w/ severe hypercholesterolaemia & high risk for CV complications, who have not achieved their treatment goals on lower doses & when the benefits are expected to outweigh the potential risks).
Potential risk of myopathy w/ concomitant use of statins. Risk of hyperuricaemia & precipitate gout in patients w/ medical history of gout or predisposed to gout. Perform LFTs at initiation of therapy. Discontinue if increased transaminases >3 x ULN persist. Contains lactose; not to be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. Limited experience in patients w/ severe renal impairment (eGFR <30 mL/min/1.73 m2). Not studied in patients w/ ESRD on dialysis &/or severe hepatic impairment (Child-Pugh C). Consider periodic LFTs in patients w/ severe hepatic impairment. May cause foetal harm to pregnant women. Discontinue prior to conception. Effective contraception in women of child-bearing potential before initiating & during treatment. Safety & efficacy in childn <18 yr have not been established.
Sign Out
