LIPEX

What it is

Lipex contains simvastatin . It is available in film-coated tablet strengths of 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg .

Approved indications

— Adjunct to diet for treatment of hypercholesterolaemia . — Reduction of the risk of cardiovascular death, major cardiovascular events including stroke, and hospitalisation due to angina pectoris in patients at high risk of coronary heart disease (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing coronary heart disease . — Adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10–17 years of age, with heterozygous familial hypercholesterolaemia .

Dosing overview

The dosage range for simvastatin is 10 to 80 mg per day, given as a single dose in the evening . For adults at high risk of coronary heart disease or with existing coronary heart disease, the usual starting dose is 40 mg per day . For hypercholesterolaemia and combined hyperlipidaemia in patients not in high-risk categories, the recommended starting dose is 10 to 20 mg per day given in the evening . For paediatric patients aged 10–17 years with heterozygous familial hypercholesterolaemia, the recommended usual starting dose is 10 mg once daily in the evening, with a dosing range of 10–40 mg per day and a maximum recommended dose of 40 mg per day . In patients taking fibrates other than gemfibrozil or fenofibrate, the dose of Lipex should not exceed 10 mg per day . In patients taking amiodarone, verapamil, diltiazem, or products containing elbasvir or grazoprevir concomitantly with simvastatin, the dose should not exceed 20 mg per day . In patients taking amlodipine concomitantly with simvastatin, the dose should not exceed 40 mg per day . In patients taking niacin (nicotinic acid) of 1 g per day or more, the dose should not exceed 40 mg per day .

Key safety warnings

Simvastatin occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase above 10 times the upper limit of normal, and sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, with rare fatalities . Predisposing factors for myopathy include advanced age (65 years or older), female gender, uncontrolled hypothyroidism, and renal impairment . An increased risk of myopathy in Chinese subjects has been identified; caution should be used when prescribing simvastatin to Asian patients and the lowest dose necessary should be employed . Patients starting therapy with simvastatin or whose dose is being increased should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness, and simvastatin therapy should be discontinued immediately if myopathy is diagnosed or suspected . Periodic creatine kinase determinations may be considered in patients starting therapy or whose dose is being increased, and periodic creatine kinase determinations are recommended for patients titrating to the 80 mg dose .

Contraindications

Hypersensitivity to any component . Active liver disease or unexplained persistent elevations of serum transaminases . Pregnancy and lactation, and women of childbearing potential unless on an effective contraceptive and highly unlikely to conceive . Myopathy secondary to other lipid lowering agents . Concomitant administration of potent CYP3A4 inhibitors such as itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone and drugs containing cobicistat . Concomitant administration of gemfibrozil, ciclosporin or danazol . Concomitant use with fusidic acid .

PBS listing

The 40 mg tablet strength is listed on the PBS with unrestricted and restricted items at an ex-manufacturer price of A$11.27 .

Regulatory history

Lipex 10 mg and 20 mg tablet strengths were first registered on the ARTG on 12 September 1991 . The 40 mg tablet strength was first registered on 2 April 1997 . The 80 mg tablet strength was first registered on 16 February 1999 .