pravastatin (Pravichol)

Pravastatin is an oral drug for lowering the cholesterol in the blood that contributes to the formation of plaques in the walls of arteries that obstruct the flow of blood, known as arteriosclerotic vascular disease. Obstruction of the flow of blood to the heart causes heart attacks. Obstruction of flow to the brain causes strokes. Pravastatin has been shown to reduce the occurrence of heart attacks, strokes and death caused by arteriosclerotic vascular disease. It belongs to a class of drugs called HMG-CoA reductase inhibitors, commonly called "statins." Other statins include simvastatin (Zocor), lovastatin (Mevacor), atorvastatin (Lipitor), rosuvastatin (Crestor) and fluvastatin (Lescol). Statins reduce cholesterol by inhibiting an enzyme in the liver (HMG-CoA reductase) that is necessary for the production of cholesterol. In the blood, statins lower total and LDL ("bad") cholesterol as well as triglycerides. LDL cholesterol is believed to be an important cause of arteriosclerotic vascular disease. Lowering LDL cholesterol levels slows progression or reduces the size of cholesterol-containing plaques in the arteries of the heart and brain as well as other tissues. Statins also increase HDL ("good") cholesterol, and higher levels of HDL cholesterol are associated with reduced arteriosclerotic vascular disease. Raising HDL cholesterol levels may slow the progression of arteriosclerotic vascular disease.

Scientists have discovered that inflammation of the coronary arteries also may contribute to arteriosclerotic vascular disease. Inflammation is associated with elevated levels of a protein called C-reactive protein in the blood. This C-reactive protein can be measured by a test, referred to as the "highly-sensitive" C-reactive protein test (Hs-CRP). Elevated levels of Hs-CRP predict the occurrence of heart attacks, strokes, and death. In fact, Hs-CRP is a better predictor of heart attacks, strokes, and death than cholesterol levels. Statins reduce the levels of Hs-CRP, and it has been suggested that statins may reduce arteriosclerotic vascular disease by reducing inflammation in addition to lowering levels of cholesterol. Pravastatin was approved by the FDA in October 1991.

What brand names are available for pravastatin?

Pravachol, Pravigard PAC (discontinued)

Is pravastatin available as a generic drug?

Yes

Do I need a prescription for pravastatin?

Yes

Like most statins, the most common side effects of pravastatin are:

• headache,
• nausea,
• vomiting,
• diarrhea,
• muscle pain, and
• abnormal liver tests.

The most serious potential side effects are liver damage and muscle inflammation or breakdown. Serious liver damage with statins is rare, however. More often, statins cause abnormalities of liver tests. Abnormal tests usually return to normal even if a statin is continued, but if the abnormal test is greater than three times the upper limit of normal, the statin usually is stopped. Liver tests should be measured before therapy is started and whenever there is a medical concern.

Inflammation of the muscles caused by statins can lead to a serious breakdown of muscle cells called rhabdomyolysis. When used alone, statins cause rhabdomyolysis in less than one percent of patients. Rhabdomyolysis causes the release of proteins from muscle (myoglobin) into the blood. Myoglobin can cause kidney failure and even death. To prevent the development of rhabdomyolysis, patients taking statins, including pravastatin, should contact their health care professional immediately if they develop unexplained muscle pain, weakness, or tenderness.

Since pravastatin prevents heart attacks, strokes and death, its benefit usually outweighs its serious but rare side effects. Other important side effects include post-marketing reports such as:

• memory loss,
• forgetfulness,
• amnesia,
• confusion, and
• memory impairment.

Symptoms may start one day to years after starting treatment and resolve within a median of three weeks after stopping the statin.

The dose range of pravastatin is 10-80 mg daily. The usual starting dose in adults is 40 mg once daily. The maximum dose is 80 mg per day. The starting dose for patients with major liver or kidney dysfunction is 10 mg daily.

The dose for children (8-13 years old) is 20 mg daily, and the dose for adolescents (14-18 years old) is 40 mg daily.

Bile acid sequestrants such as cholestyramine (Questran) may reduce the absorption of pravastatin from the intestine and thereby reduce its effects. Therefore, pravastatin should be taken one hour before or four hours after bile acid sequestrants. The use of pravastatin with nicotinic acid, gemfibrozil (Lopid) or other drugs that cause liver or muscle problems may increase the risk of muscle problems.

Statins should not be used by pregnant women because they impair fetal development.

A small amount of pravastatin is excreted in breast milk. Because of the risk of toxicity to the infant, nursing mothers should not nurse while taking pravastatin.

What preparations of pravastatin are available?

Tablets: 10, 20, 40, and 80 mg

How should I keep pravastatin stored?

Pravastatin should be stored at room temperature, between 15-30 C (58-86 F).