PRAVACHOL

What it is

PRAVACHOL is pravastatin sodium, available in tablet form in strengths of 10 mg, 20 mg, 40 mg and 80 mg. The tablets are yellow capsule shaped biconvex tablets.

Approved indications

— As an adjunct to diet for the treatment of hypercholesterolaemia. — For use in patients with previous myocardial infarction, including those who have normal serum cholesterol levels (4.0–5.5 mmol/L). — For use in 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 patients with significant renal or hepatic dysfunction, and in the elderly, a starting dose of 10 mg daily at bedtime is recommended.

Key safety warnings

**Muscle toxicity.** Myalgia, myopathy and rhabdomyolysis have been reported with the use of HMG-CoA reductase inhibitors. Very rarely (in about 1 case over 100,000 patient-years), rhabdomyolysis occurs, with or without secondary renal insufficiency. 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 CK levels are > 5 x ULN or when there are severe clinical symptoms. **Interaction with fusidic acid.** PRAVACHOL must not be co-administered with fusidic acid. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving pravastatin and fusidic acid in combination. **Liver function.** There have been rare post-marketing reports of fatal and non-fatal hepatic failure in patients taking statins, including PRAVACHOL. Liver function tests should be performed before treatment begins and periodically thereafter in all patients. **Pregnancy and women of childbearing potential.** Since HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, they may cause foetal harm when administered to a pregnant woman. Therefore, HMG-CoA reductase inhibitors are contraindicated during pregnancy.

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 (ULN) in liver function tests. HMG-CoA reductase inhibitors are contraindicated during pregnancy.

PBS listing

PRAVACHOL is listed on the PBS in strengths of 10 mg, 20 mg, 40 mg and 80 mg. The 20 mg tablet is available with both restricted and unrestricted listings at an ex-manufacturer price of A$7.40. The 40 mg tablet has unrestricted and restricted listings at A$8.17. The 10 mg tablet has restricted and unrestricted listings at A$7.12. The 80 mg tablet has restricted and unrestricted listings at A$10.22.

Regulatory history

PRAVACHOL 40 mg was first registered on the ARTG on 11 December 1996. The 10 mg and 20 mg strengths were listed on 6 March 2000. The 80 mg strength was registered on 16 March 2005.