The product should be used, in addition to diet restricted in saturated fat and cholesterol, to decrease the risk for atherosclerotic vascular disease due to hypercholesterolemia.
PRAVALIP is used in the following cases:
A- Primary prevention of coronary events:
In hypercholesterolemic patients without clinically evident coronary heart disease, PRAVALIP is indicated to:
1- Reduce the risk of myocardial infarction.
2- Reduce the risk of undergoing myocardial revascularization procedures.
3- Reduce the risk of cardiovascular mortality with no increase in death for non-cardiovascular causes.
B- Primary prevention of coronary events:
In hypercholesterolemic patients with clinically evident coronary artery disease, the product is indicated to:
1- Slow the progression of coronary atherosclerosis.
2- Reduce the risk of stroke and transient ischemic attack.
PRAVALIP is used as an adjunct to diet for the reduction of elevated total and LDL cholesterol levels in patients with primary hypercholesterolemia (Type IIa and IIb).
1- Hypersensitivity to any component of this medication.
2- Pregnancy and lactation:
- Pregnancy category x: As safety in pregnant women has not been established, treatment should be immediately discontinued as soon as pregnancy is recognized.
- Lactation: A small amount of Pravastatin is excreted in human breast milk. Because of the potential for serious adverse reactions in suckling infants, women taking Pravastatin should not nurse.
3- Active liver diseases and unexplained persistent elevations in liver function tests.
The product is well tolerated, it may rarely cause mild and transient side effects such as:
Abdominal pain, constipation, diarrhea, nausea, headache, skin rashes and myopathy.
DOSAGE AND ADMINSTRATION:
In addition to the diet restricted in saturated fat and cholesterol, the recommended doses are the following:
1- Starting dose is 10-20 mg once daily at bedtime.
2- In primary hypercholesterolemic patients with a history of significant renal or hepatic dysfunction, a starting dose of 10 mg daily at bedtime is recommended.
3- In patients taking immunosuppressive drugs such as cyclosporine therapy should begin with
10 mg once a day at bedtime and the maximum dosage is 20 mg/day.
4- In the elderly: 10-20 mg once daily at bedtime is recommended to achieve a maximum reduction in LDL-cholesterol.
Note: The maximum effect of the product is achieved within 4 weeks from initiating therapy. The recommended dosage range is generally 10-40 mg once a day at bedtime regardless to meals.
Boxes containing 20 tablets.