LIPOSTAT

What it is

Lipostat contains pravastatin sodium . It is available in tablet strengths of 10 mg, 20 mg, 40 mg and 80 mg . Pravastatin is an HMG-CoA reductase inhibitor that reduces cholesterol biosynthesis by competitively inhibiting the enzyme catalysing the early rate-limiting step in cholesterol biosynthesis .

Approved indications

— As an adjunct to diet for the treatment of hypercholesterolaemia. — Patients with previous myocardial infarction including those who have normal (4.0 to 5.5 mmol/L) serum cholesterol levels. — Patients with unstable angina pectoris. — As an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older.

Dosing overview

In primary hypercholesterolaemic patients with significant renal or hepatic dysfunction, and in the elderly, a starting dose of 10 mg daily at bedtime is recommended. In patients taking ciclosporin, therapy should be initiated with 10 mg/day and titration to higher doses should be performed with caution.

Key safety warnings

Myalgia, myopathy and rhabdomyolysis have been reported with the use of HMG-CoA reductase inhibitors, and certain predisposing factors may increase the risk of muscle toxicity and therefore justify careful evaluation of benefit-risk and special clinical monitoring. Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if associated with malaise or fever. Statin therapy should be temporarily interrupted when creatine kinase levels are greater than 5 times the upper limit of normal or when there are severe clinical symptoms, and should be discontinued if markedly elevated creatine phosphokinase levels occur or myopathy is suspected or diagnosed. Pravastatin must not be co-administered with systemic formulations of fusidic acid or within 7 days of stopping fusidic acid treatment, as there have been reports of rhabdomyolysis including some fatalities in patients receiving this combination. There is sufficient evidence to support an association between statin use and new-onset type 2 diabetes mellitus, although the risk appears to be mainly in patients already at increased risk, including those with raised fasting glucose, history of hypertension, raised triglycerides and raised body mass, and such patients should be monitored both clinically and biochemically according to national guidelines. HMG-CoA reductase inhibitors have been associated with biochemical abnormalities of liver function, and marked persistent increases in serum transaminases exceeding 3 times the upper limit of normal were seen in 1.3% of patients treated with pravastatin. Liver function tests should be performed before treatment begins and periodically thereafter in all patients.

Contraindications

Hypersensitivity to any component of this medication. Active liver disease or unexplained persistent elevations of serum transaminase elevation exceeding 3 times the upper limit of normal in liver function tests. HMG-CoA reductase inhibitors are contraindicated during pregnancy. Concomitant use of fusidic acid.

Regulatory history

Lipostat was first registered on the Australian Register of Therapeutic Goods on 5 August 2005, with four strengths listed: 10 mg, 20 mg, 40 mg and 80 mg tablets in blister packs .