PRAVASTATIN SANDOZ

What it is

Pravastatin Sandoz is a tablet formulation of pravastatin sodium available in strengths of 10 mg, 20 mg, 40 mg and 80 mg. Pravastatin is an HMG-CoA reductase inhibitor that reduces cholesterol biosynthesis by acting as a competitive inhibitor of 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 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 concomitantly with pravastatin, 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. Certain predisposing factors may increase the risk of muscle toxicity and justify careful evaluation of benefit/risk and special clinical monitoring. Uncomplicated myalgia has been reported in pravastatin-treated patients, and myopathy was reported to be possibly due to pravastatin in less than 0.1% of patients in clinical trials. Myopathy should be considered in any patients with diffuse myalgia, muscle tenderness or weakness, muscle cramps and/or marked elevation of creatine phosphokinase. Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if associated with malaise or fever. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving pravastatin and fusidic acid in combination. Pravastatin must not be co-administered with fusidic acid. HMG-CoA reductase inhibitors have been associated with biochemical abnormalities of liver function. Marked persistent increases in serum transaminases exceeding 3 times the upper limit of normal were seen in 1.3% of patients treated with pravastatin for an average period of 18 months. In clinical trials, these elevations were usually not associated with clinical signs and symptoms of liver disease and usually declined to pre-treatment levels upon discontinuation of therapy. 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. Risk factors include raised fasting glucose, history of hypertension, raised triglycerides and raised body mass. Patients at risk should be monitored both clinically and biochemically according to national guidelines.

Contraindications

Hypersensitivity to any component of this 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. Concomitant use of fusidic acid.

Regulatory history

Pravastatin Sandoz was first registered on the ARTG on 22 May 2012 in strengths of 10 mg, 20 mg, 40 mg and 80 mg tablet formulations supplied in blister packs.