HMG-CoA Reductase Inhibitors (Systemic)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For HMG-CoA reductase inhibitors, the following should be considered:

Allergies - Tell your doctor if you have ever had any unusual or allergic reaction to HMG-CoA reductase inhibitors. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Diet - Before prescribing medicines to lower your cholesterol, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet will be lower in total fat, particularly saturated fat, and dietary cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed.

Also, this medicine is less effective if you are greatly overweight. It may be very important for you to go on a reducing diet. However, check with your doctor before going on any diet.

Pregnancy - HMG-CoA reductase inhibitors should not be used during pregnancy or by women who plan to become pregnant in the near future. These medicines block formation of cholesterol, which is necessary for the fetus to develop properly. HMG-CoA reductase inhibitors may cause birth defects or other problems in the baby if taken during pregnancy. An effective form of birth control should be used during treatment with these medicines. Check with your doctor immediately if you think you have become pregnant while taking this medicine . Be sure you have discussed this with your doctor.

Breast-feeding - These medicines are not recommended for use during breast-feeding because they may cause unwanted effects in nursing babies.

Children - Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of HMG-CoA reductase inhibitors in children with use in other age groups. However, atorvastatin, lovastatin, and simvastatin have been used in a limited number of children under 18 years of age. Early information seems to show that these medicines may be effective in children, but their long-term safety has not been studied.

Older adults - This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines - Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking HMG-CoA reductase inhibitors, it is especially important that your health care professional know if you are taking any of the following:

• Cyclosporine (e.g., Sandimmune) or
• Gemfibrozil (e.g., Lopid) or
• Clofibrate (e.g., Atromid-S) or
• Fenofibrate (e.g., Tricor) or
• Niacin - Use of these medicines with an HMG-CoA reductase inhibitor may increase the risk of developing muscle problems and kidney failure

• Digoxin (e.g., Lanoxin) - Use with atorvastatin, fluvastatin, or simvastatin may increase blood levels of digoxin, increasing the risk of side effects

• Oral contraceptives, (birth control tablets) - Atorvastatin may increase the blood levels of the birth control hormones, increasing the risk of side effects

• HIV protease inhibitors (Amprenavir [e.g., Agenerase], Indinavir [e.g., Crixivan], Nelfinavir [e.g., Viracept], Ritonavir [e.g., Norvir], Saquinavir [e.g., Fortovase, Invirase]) or
• Nefazodone (e.g. Serzone) - Use with simvastatin may increase the risk of developing muscle problems and kidney failure

• Verapamil (e.g. Calan, Isoptin) - Use with simvastatin may increase the risk of muscle problems

Other medical problems - The presence of other medical problems may affect the use of HMG-CoA reductase inhibitors. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of) or
• Liver disease - Use of this medicine may make liver problems worse

• Convulsions (seizures), not well-controlled, or
• Organ transplant with therapy to prevent transplant rejection or
• If you have recently had major surgery - Patients with these conditions may be at risk of developing problems that may lead to kidney failure