APX-PRAVASTATIN

What it is

APX-PRAVASTATIN is pravastatin sodium 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 inhibiting the enzyme catalysing the early rate-limiting step in cholesterol production.

Approved indications

— As an adjunct to diet for the treatment of hypercholesterolaemia. — Patients with previous myocardial infarction including those who have normal 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

The recommended starting dose for adults is 10 to 20 mg once daily at bedtime. 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. The recommended dosage range is 10 to 80 mg administered once a day at bedtime. For the prevention of coronary heart disease in patients with hypercholesterolaemia, the dose is 40 mg per day as a single dose. The recommended dose is 20 mg once daily in children 8 to 13 years of age. The recommended dose is 40 mg once daily in adolescents 14 to 18 years of age.

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. Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, and CK levels should be measured; statin therapy should be temporarily interrupted when CK 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 CPK levels occur or myopathy is suspected. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving pravastatin and fusidic acid in combination, and pravastatin must not be co-administered with fusidic acid. There have been rare reports of immune-mediated necrotizing myopathy during or after treatment with some statins, characterised by persistent proximal muscle weakness and elevated serum creatinine kinase which persists despite discontinuation of statin treatment. HMG-CoA reductase inhibitors have been associated with biochemical abnormalities of liver function, and marked persistent increases in serum transaminases were seen in 1.3% of patients treated with pravastatin. There have been rare post-marketing reports of fatal and non-fatal hepatic failure in patients taking statins, including pravastatin. There is sufficient evidence to support an association between statin use and new-onset type 2 diabetes mellitus; however, the risk appears to be mainly in patients already at increased risk of developing diabetes.

Contraindications

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

PBS listing

No source document provides information about PBS listing status, item numbers, restriction type or ex-manufacturer price for APX-PRAVASTATIN.

Regulatory history

APX-PRAVASTATIN registered on the ARTG with four entries on 23 June 2020: 10 mg, 20 mg, 40 mg and 80 mg tablet formulations under licence category RE.