CHOLSTAT

What it is

CHOLSTAT contains pravastatin sodium , a medicine used to lower cholesterol levels. Pravastatin is a HMG-CoA reductase inhibitor that reduces cholesterol biosynthesis by competitively inhibiting the enzyme HMG-CoA reductase, which catalyses the early rate-limiting step in cholesterol biosynthesis, the conversion of HMG-CoA to mevalonate .

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

For adults, the recommended starting dose is 10 to 20 mg once daily at bedtime, or 10 mg daily at bedtime for those with significant renal or hepatic dysfunction and the elderly . 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, and the same dose is recommended for secondary prevention of myocardial infarction in patients with average serum cholesterol .

For paediatric patients, the recommended dose is 20 mg once daily in children aged 8 to 13 years , and 40 mg once daily in adolescents aged 14 to 18 years .

Key safety warnings

Myalgia, myopathy and rhabdomyolysis have been reported with the use of HMG-CoA reductase inhibitors, with myopathy defined as muscle aching or muscle weakness in conjunction with increases in creatine phosphokinase values to greater than ten times the upper limit of normal reported in less than 0.1% of patients in clinical trials . Very rarely, rhabdomyolysis occurs at about 1 case over 100,000 patient-years and is an acute potentially fatal condition of skeletal muscle characterised by massive muscle destruction associated with major increase in creatine kinase leading to myoglobinuria . 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, and pravastatin must not be co-administered with fusidic acid . HMG-CoA reductase inhibitors have been associated with biochemical abnormalities of liver function, with marked persistent increases exceeding 3 times the upper limit of normal in serum transaminases 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, and if serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment, therapy should be promptly interrupted . There have been rare reports of an immune-mediated necrotizing myopathy during or after treatment with some statins, clinically characterised by persistent proximal muscle weakness and elevated serum creatinine kinase which persists despite discontinuation of statin treatment .

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 .

PBS listing

CHOLSTAT is registered on the ARTG in three strengths: 10 mg, 20 mg and 40 mg pravastatin sodium tablets . PBS listing information for this medicine is not available in the provided sources.

Regulatory history

CHOLSTAT was first listed on the ARTG on 2 December 2003 across three strengths (10 mg, 20 mg and 40 mg) under licence category RE, sponsored by Alphapharm .