PRAVASTATIN-WGR

What it is

PRAVASTATIN-WGR is a medicine containing 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 competitively inhibiting the enzyme that catalyses 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.

Key safety warnings

Myalgia, myopathy and rhabdomyolysis have been reported with HMG-CoA reductase inhibitors. Rhabdomyolysis with renal dysfunction secondary to myoglobinuria has rarely been reported with pravastatin, occurring very rarely in about 1 case per 100,000 patient-years. 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 kinase levels occur or myopathy is suspected or diagnosed. 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. As for other HMG-CoA reductase inhibitors, combination of pravastatin with fibrates is not recommended and should be generally avoided. HMG-CoA reductase inhibitors have been associated with biochemical abnormalities of liver function, with marked persistent increases in serum transaminases (greater than 3 times the upper limit of normal) seen in 1.3% of patients treated with pravastatin. Liver function tests should be performed before treatment begins and periodically thereafter in all patients. 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, with risk factors including raised fasting glucose, history of hypertension, raised triglycerides and raised body mass.

Contraindications

Hypersensitivity to any component of the medication. Active liver disease or unexplained persistent elevations of serum transaminase exceeding 3 times the upper limit of normal in liver function tests. HMG-CoA reductase inhibitors are contraindicated during pregnancy. Pravastatin should not be administered to women of childbearing age unless using effective contraception and are highly unlikely to conceive and have been informed of the potential hazards. Concomitant use of fusidic acid.

PBS listing

Information on PBS listing, item count and ex-manufacturer price is not available in the provided source documents.

Regulatory history

PRAVASTATIN-WGR was first listed on the ARTG on 23 June 2020 with four registered strengths: 10 mg, 20 mg, 40 mg and 80 mg tablet formulations.