Generic name: Atorvastatin
Product Brand Name: Lipitor

1. Drug class and mechanism: Atorvastatin is an oral drug that lowers the level of cholesterol in the blood. It belongs to a class of drugs referred to as statins which includes lovastatin (Mevacor), simvastatin, (Zocor), fluvastatin (Lescol0, and pravastatin (Pravachol). All statins, including atorvastatin, prevent the production of cholesterol by the liver by blocking the enzyme that makes cholesterol, HMGCoA reductase. They lower total blood cholesterol as well as LDL cholesterol levels. (LDL cholesterol is believed to be the \\\"bad\\\" cholesterol that is primarily responsible for the development of coronary artery disease.) Lowering LDL cholesterol levels retards progression and may even reverse coronary artery disease. Unlike the other drugs in this class, atorvastatin also can reduce the concentration of triglycerides in the blood. High blood concentrations of triglycerides also have been associated with coronary artery disease. Atorvastatin was approved by the FDA in December of 1996.

2. Preparations: Tablets of 10, 20, and 40 mg.

3. Storage: Tablets should be stored below or at room temperature, 15-30°C (59-86°F).

4. Prescribed for: Atorvastatin is used for the treatment of high cholesterol and triglyceride levels. High blood cholesterol is first treated with exercise, weight loss, and a diet low in cholesterol and saturated fats. When these measures fail to achieve enough cholesterol-lowering, medications such as atorvastatin may be added. The National Cholesterol Education Program (NCEP) has published treatment guidelines for use of these medications. These treatment guidelines take into account the level of LDL cholesterol as well as the presence of other factors that increase the risk for coronary artery disease such as diabetes, hypertension, cigarette smoking, low HDL cholesterol level, and family history of early coronary heart disease. The effectiveness of atorvastatin in lowering cholesterol is dose related, meaning that higher doses reduce cholesterol more. Blood cholesterol determinations are performed at regular intervals during treatment so that adjustments in doses can be made.

5. Dosing: Atorvastatin is prescribed once daily. Starting doses are 10-40 mg. daily. It may be taken with or without food and at any time of day.

6. Drug interactions: As with other drugs in this class, the risk of muscle breakdown (see \\\"Side Effects,\\\" below) is increased when atorvastatin is given together with other medications such as cyclosporine (Sandimmune), gemfibrozil (Lopid), erythromycin and nicotinic acid.

7. Pregnancy: It is not known if atorvastatin affects the fetus if taken during pregnancy. Atorvastatin may be used in pregnancy if the physician feels that its benefits outweigh the potential risks.

8. Nursing mothers: It is not known if atorvastatin is secreted in breast milk. Therefore, the physician must decide whether to instruct a pregnant woman to continue taking atorvastatin and nursing if the benefits of treatment are judged to outweigh the potential risks, or to discontinue either nursing or atorvastatin if the potential risks are judged to outweigh the benefits.

9. Side effects: Atorvastatin is generally well-tolerated, and side effects are rare. Minor side effects include constipation, diarrhea, fatigue, gas, heartburn, and headache. Atorvastatin should be used with caution in patients with alcohol or other liver diseases. Persistently abnormal liver tests during treatment are rare but may require discontinuation of the medication. Rare cases of muscle inflammation (myositis) and breakdown have been reported with other drugs in this class (HMGCoA reductase antagonists), and it is assumed that this side effect also may occur with atorvastatin. Muscle breakdown causes the release of muscle protein (myoglobin) into the blood and accumulation of the protein in the kidney tubules, resulting in kidney failure.

Caution! Before starting to take this medicine, it is vital that you should consult your doctor! Do not use it on your own initiative, without medical advice.

Useful information for budget customers.

A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at 30-80% discount from the branded price.

Are generic drugs as safe as brand-name drugs?
Yes. Since generic drugs use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts.

Are generic drugs as strong as brand-name drugs?
Yes. Generic drugs have the same quality, strength, purity, and stability as brand-name drugs.

Do generic drugs take longer to work in the body?
No. Generic drugs work in the same way and in the same amount of time as brand-name drugs.

Why are generic drugs less expensive?
Generic drugs are less expensive because generic manufacturers don't have the investment costs that the developer of a new drug has - including research, development, marketing, and promotion. Currently, almost half of all prescriptions are filled with generic drugs.

Are brand-name drugs made in more modern facilities than generic drugs?
No. Both brand-name and generic drug facilities meet the same standards of good manufacturing practices. Generic firms have facilities comparable to those of brand-name firms.

If brand-name drugs and generic drugs have the same active ingredients, why do they often look different?
Usually local country trademark laws do not allow a generic drug to look exactly like the brand-name drug. However, a generic drug must duplicate the active ingredient. Colors, flavors, and certain other inactive ingredients may be different.