Pravastatin

Hypolipidaemic/Anti-atheroma · HMG-CoA reductase inhibitor

Indications

To reduce risk of total mortality, CHD death, recurrent MI, need for revascularization procedures, number of days in hospital and risk of strokes in patients with previous MI or unstable angina and total serum cholesterol level > 4.8mmol/litre or LDL-cholesterol >3.2mmol/litre. Adjunct to diet to slow progression of coronary atherosclerosis and reduce incidence of cardiac events in patients with hypercholesterolaemia and coronary artery disease. Adjunct to diet to reduce risk of MI, need for revascularization procedures and cardiovascular deaths in patients with hypercholesterolaemia without evident coronary heart disease. Primary hypercholesterolaemia unresponsive to diet.

Dosage

Adults: Usually,10-40 mg once daily at bedtime. Children: Under 8 yr, not recommended. Hyperlipidaemia including familial hypercholesterolaemia: 8-14 yr, 10 mg once daily at night, adjusted at intervals of at least 4 wk to max 20 mg once daily at night; 14-18 yr, 10 mg once daily at night, adjusted at intervals of at least 4 wk to max 40 mg once daily at night. To prevent cardiovascular events in patients with hypercholesterolaemia/previous MI or unstable angina: Adults: 40 mg daily at night. Reduction of hyperlipidaemia in patients receiving immunosuppressive therapy following solid-organ transplantation: Adults: Initially 20 mg daily at night, increased up to 40 mg daily if required. Expert medical supervision necessary in case of max dose.

Adverse Effects

Rash, myalgia, arthralgia, headache, non-cardiac chest pain, GI upset, fatigue. Reports of depression, sleep disturbances, memory loss, sexual dysfunction and immune-mediated necrotising myopathy.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Contraindicated in pregnancy. Lactation: Contraindicated or not recommended. Contraindications: Active liver disease. Adequate contraception must be used. Precautions: History of alcohol abuse or liver disease. Perform liver function tests before and during therapy, withdraw if ALT or AST >3xULN. Advise patients to report unexplained muscle weakness or pain; measure creatine kinase levels, withdraw if >5 × ULN. Renal impairment, hypothyroidism, history of muscle toxicity or muscle disorders, elderly. Interstitial lung disease; advise patients to report symptoms incl dyspnoea, non-productive cough, fatigue, wt loss, fever. Risk of new onset of diabetes; risk factors include hypertension, raised triglycerides, BMI and fasting blood glucose at baseline.

Interactions

Cyclosporin, gemfibrozil, fibrates, nicotinic acid, macrolides. Take 1 hour before or 4 hour after cholestyramine or colestipol.

Advice to Patient

Take with or without meals. Take medication at same time each day. Contact prescriber if there is chest pain, memory loss, depression, personality changes, numbness, weakness, tingling, muscle pain, cramps, vision changes or skin rash. Avoid excessive intake of alcohol. Have periodic blood tests as advised by prescriber to check drug's effectiveness.

Pharmacokinetics

Onset of action: Several days. Peak effect: 4 wks. LDL-reduction: 40 mg/day: 34%. Absorption: Rapidly absorbed; average absorption 34%. Metabolism: Hepatic; extensive first-pass metabolism. Bioavailability: 17%. Half-life elimination: Children and adolescents (4.9-15.6 yrs): 1.6 hrs. Adults: 77 hrs (including all metabolites). Pravastatin: Approx. 2-3 hrs. Time to peak, serum: 1.-1.5 hrs. Excretion: Faeces (70%). Urine (approx. 20%).

Brands with this active ingredient

Compiled by Healify Pharmacy from published drug references. How we compile it →

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