Prior to initiating Pravastatin Sodium Tablets, secondary causes of hypercholesterolaemia should be excluded and patients should be placed on a standard lipid-lowering diet which should be continued during treatment.
Pravastatin Sodium Tablets are administered orally once daily preferably in the evening with or without food.
Hypercholesterolaemia: The recommended dose range is 10-40 mg once daily. The therapeutic response is seen within a week and the full effect of a given dose occurs within four weeks, therefore periodic lipid determinations should be performed and the dosage adjusted accordingly. The maximum daily dose is 40 mg.
Cardiovascular prevention: In all preventive morbidity and mortality trials, the only studied starting and maintenance dose was 40 mg daily.
Dosage after transplantation: Following organ transplantation a starting dose of 20 mg per day is recommended in patients receiving immunosuppressive therapy (see Interactions). Depending on the response of the lipid parameters, the dose may be adjusted up to 40 mg under close medical supervision (see Interactions).
Children: The documentation on efficacy and safety in patients less than 18 years old is limited; therefore, the use of Pravastatin Sodium Tablets is not recommended in these patients.
Elderly patients: There is no dose adjustment necessary in these patients unless there are predisposing risk factors (see Precautions).
Renal or hepatic impairment: A starting dose of 10 mg a day is recommended in patients with moderate or severe renal impairment or significant hepatic impairment. The dosage should be adjusted according to the response of lipid parameters and under medical supervision.
Concomitant therapy: The lipid lowering effects of Pravastatin Sodium Tablets on total cholesterol and LDL-cholesterol are enhanced when combined with a bile acid-binding resin (e.g. cholestyramine, colestipol). Pravastatin Sodium Tablets should be given either one hour before or at least four hours after the resin (see Interactions).
For patients taking cyclosporin with or without other immunosuppressive medicinal products, treatment should begin with 20 mg of pravastatin once daily and titration to 40 mg should be performed with caution (see Interactions).