Indications, posology and method of administration
THERAPEUTIC INDICATIONS
- Hypercholesterolaemia:
Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
- Primary prevention:
Reduction of cardiovascular mortality and morbidity in patients with moderate or severe hypercholesterolaemia and at high risk of a first cardiovascular event, as an adjunct to diet. - Secondary prevention:
Reduction of cardiovascular mortality and morbidity in patients with a history of myocardial infarction or unstable angina pectoris and with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors.
- Post transplantation:
Reduction of post transplantation hyperlipidaemia in patients receiving immunosuppressive therapy following solid organ transplantation.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Prior to initiating pravastatin sodium, secondary causes of hypercholesterolaemia should be excluded and patients should be placed on a standard lipid-lowering diet which should be continued during treatment.
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: 40 mg daily.
Dosage after transplantation: Following organ transplantation a starting dose of 20 mg per day is recommended in patients receiving immunosuppressive therapy. Depending on the response of the lipid parameters, the dose may be adjusted up to 40 mg under close medical supervision.
Children and adolescents(8 – 18 years of age): The recommended dose range is 10 – 20 mg once daily between 8 and 13 years of age and 10 – 40 mg daily between 14 and 18 years of age.
Elderly patients: There is no dose adjustment necessary in these patients unless there are predisposing risk factors.
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 on total cholesterol and LDL-cholesterol are enhanced when combined with a bile acid-binding resin (e.g. colestyramine, colestipol). Pravastatin sodium should be given either one hour before or at least four hours after the resin.
For patients taking ciclosporin 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.
Method of administration:
Pravastatin sodium is administered orally once daily preferably in the evening with or without food.
CONTRAINDICATIONS
- Hypersensitivity to the active substance or to any of the excipients.
- Active liver disease including unexplained persistent elevations of serum transaminase elevation exceeding 3 x the upper limit of normal.
- Pregnancy and lactation.
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