Caduet

What you should know before using

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatrics

Studies on this combination medicine have been done only in adult patients, and there is no specific information comparing use of amlodipine and atorvastatin in children with use in other age groups.

Atorvastatin alone is safe to use in boys and some girls 10 to 17 years of age for treating certain types of high cholesterol.

Adolescent girls taking atorvastatin should be counseled on appropriate contraceptive methods.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. However, elderly people may be especially sensitive to the effects of amlodipine which may increase the chance of side effects during treatment.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone
• Atazanavir
• Bezafibrate
• Ciprofibrate
• Clarithromycin
• Clofibrate
• Cyclosporine
• Dalfopristin
• Diltiazem
• Droperidol
• Erythromycin
• Fenofibrate
• Fentanyl
• Fluconazole
• Fusidic Acid
• Gemfibrozil
• Indinavir
• Itraconazole
• Ketoconazole
• Lopinavir
• Mibefradil
• Nefazodone
• Nelfinavir
• Niacin
• Quinupristin
• Saquinavir
• Telithromycin
• Tipranavir
• Troleandomycin
• Verapamil

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of) or
• Liver disease (or history of) or
• Liver enzymes, persistently high levels—Use of this medicine may make liver problems worse

• Aortic stenosis, severe (abnormally narrow aorta)—Use of this medicine may increase the chance of low blood pressure

• Congestive heart failure—There is a small chance that amlodipine may make this condition worse

• Convulsions (seizures), not well-controlled, or
• Electrolyte or metabolic enzyme deficiencies or disorders or
• Infection, severe or
• Low blood pressure or
• Major surgery or trauma, recent or
• Myopathy (a disorder of muscle tissue or muscles)—Patients with these conditions may be at risk of developing muscle problems (causing the release of muscle pigment into the urine) that may lead to kidney failure

• Coronary artery disease, severe, obstructive—Use of this medicine may result in other heart problems