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PRAVACHOL

Generic Name:
Pravastatin

COMMON BRAND NAME(S):
Pravachol

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Uses: (1) Treats abnormally high total blood cholesterol levels (in people with types IIa and IIb hypercholesterolemia) due to increased low-density lipoprotein (LDL) cholesterol (used with a cholesterol-lowering diet after an adequate trial of non-drug methods has failed); (2) helps prevent a first heart attack or stroke and reduces death from cardiovascular disease in people with increased blood cholesterol levels at risk of a first heart attack. Also serves to help prevent a repeat heart attack; (3) slows progression and in some cases makes small reversals in coronary artery disease (atherosclerosis); (4) used to decrease triglycerides in mixed lipidemias; (5) reduces risk of strokes or transient ischemic attacks (TIAs)-the CARE trial of 4,159 patients found that strokes were lowered by 32%; (6) approved to increase HDL-C in patients with heterozygous familial and nonfamilial primary hypercholesterolemia and mixed dyslipidemia; (7) lowers apolipoprotein B.

Other (unlabeled) generally accepted uses: (1) Reduces temporary blood flow (to the heart) problems (myocardial ischemia) when combined with other therapies; (2) may have a role in decreasing development of type 2 diabetes in men (WOSCOPS); (3) may have a role in reducing development of osteoporosis (emerging data).

How This Drug Works: This drug blocks the liver enzyme that starts production of cholesterol. Its principal action is the reduction of low-density lipoproteins (LDL), the fraction of total blood cholesterol that is thought to increase the risk of coronary heart disease. This drug also increases the level of high-density lipoproteins (HDL), the cholesterol fraction that is thought to reduce the risk of heart disease. There is an increasing evidence base that tells us that this drug has strong beneficial effects on blood flow, the blood vessel walls and what is in the blood itself. Specific compounds or effects of platelet derived growth factor (PDGF), undesirable blood clotting via thrombin-antithrombin III, thrombomodulin and other chemicals may be beneficially lowered or effects mitigated by statins. Pravastatin lowered the likelihood of blood to clot (thrombogenicity) caused by both platelets and endothelial cells. This medicine also leads to improvement in opening (vasodilation) of the brachial artery that required the lining or endothelium.

Available Dosage Forms and Strengths

Tablets - 10 mg, 20 mg, 40 mg, 80 mg

Recommended Dose Ranges (Actual dose and schedule must be determined for each patient individually.)

Infants and Children: Under 2 years of age-do not use this drug. 2 to 18 years of age-dose not established.

18 TO 60 Years of Age: Hypercholesterolemia: Patients are put on a standard cholesterol lowering diet (see www.americanheart.org). Patients remain on this diet once the medicine is started, and dosing is begun with 40 mg once a day at bedtime. Because the peak benefit is seen in 4 weeks, lipid tests should be obtained periodically, and dosing adjusted depending on reaching goals and on treatment guidelines (such as NCEP ATP 3). If goals are not reached after 4 weeks, add on therapy' of a different medicine (such as ezetimibe) or the 80 mg dose is appropriate.

Over 60 Years of Age: Starting dose for those with kidney or liver compromise is 10 mg daily. A geriatric use subsection has been added to the Precautions of FDA-sanctioned labeling. The results of the CARE and LIPID studies had 6,593 people who used 40 mg for up to 6 years. In those studies, 36.1 % were 65 or older. Adverse events and responses were similar to those seen in younger people. A measure called area under the curve (AUC) was 25-50% higher than in younger patients, but peak level and half life were similar. Dosing changes are not thought to be needed.

Conditions Requiring Dosing Adjustments

Liver Function: Used with caution by patients with liver disease. Starting dose is decreased to 10 mg per day. Pravastatin should not be used in sudden (acute) liver disease.

Kidney Function: Those with significant kidney disease take a starting dose of 10 mg per day. Used with caution in kidney compromise.

Please Note: The information contained on this page is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs or following any treatment or regimen. Only your doctor, nurse or pharmacist can provide you with advice on what is safe and effective for you.

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