Primary hypercholesterolemia (type IIa including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIb) in adult, adolescent & childn ≥6 yr as an adjunct to diet when response to diet & other non-pharmacological treatments (eg, exercise, wt reduction) is inadequate. Homozygous familial hypercholesterolemia as an adjunct to diet & other lipid lowering treatments (eg, LDL apheresis) or if such treatments are not appropriate. 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.
Individualized dosage. Hypercholesterolemia Initially 5 or 10 mg once daily. Severe hypercholesterolemia at high CV risk Final titration to a max of 40 mg. Prevention of CV events 20 mg daily. Childn & adolescent 6-17 yr (Tanner stage <II-V) Initially 5 mg daily. Childn 10-17 yr 5-20 mg once daily, 6-9 yr 5-10 mg once daily. Elderly >70 yr, moderate renal impairment CrCl <60 mL/min, Asian & patient w/ predisposing factors to myopathy Start dose at 5 mg.
View Robestar overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease including unexplained, persistent elevations of serum transaminases & any serum transaminase elevation >3 x ULN. Severe renal impairment (CrCl <30 mL/min). Myopathy. Patients receiving concomitant ciclosporin. Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation.
Proteinuria. Skeletal muscle effects eg, myalgia, myopathy & rarely, rhabdomyolysis. Clinical monitoring of creatine kinase levels monitoring is recommended. Discontinue therapy if creatine kinase levels are markedly elevated (>5 x ULN). Not to be co-administered w/ systemic formulations of fusidic acid or w/in 7 days of stopping fusidic acid treatment. Not to be used in patients w/ acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis. Patients who consume excessive quantities of alcohol &/or have history of liver disease. Carry out liver function tests prior to & 3 mth following the initiation of treatment. Discontinue or reduce dose if the level of serum transaminases is >3 x ULN. Patients w/ secondary hypercholesterolemia caused by hypothyroidism or nephrotic syndrome. Concomitant use w/ PIs. Interstitial lung disease. DM. Use appropriate contraceptive measures. May affect ability to drive & use machines. Childn <6 yr. Asians.
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