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CADUET® (amlodipine besilate, atorvastatin calcium) Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Information for Patients

Because of the risk of myopathy with statins, the drug class to which atorvastatin belongs, advise patients to report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.

Advise patients taking atorvastatin that cholesterol is a chronic condition and they should adhere to their medication along with their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program as appropriate, and periodic testing of a fasting lipid panel to determine goal attainment.

Advise patients about substances they should not take concomitantly with atorvastatin [see Warnings and Precautions (5.1)]. Patients should inform other healthcare professionals prescribing a new medication that they are taking CADUET.

Muscle Pain: Advise patients starting therapy with CADUET of the risk of myopathy and to report promptly any unexplained muscle pain, tenderness, or weakness particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing CADUET. The risk of this occurring is increased when taking certain types of medication or consuming larger quantities (> 1 liter) of grapefruit juice. They should discuss all medication, both prescription and over the counter, with their healthcare professional.

Liver Enzymes: Advise patients treated with CADUET to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.

Embryofetal Toxicity: Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment and to inform their healthcare provider of a known or suspected pregnancy while using CADUET [see Contraindications (4) and Use in Specific Populations (8.1, 8.3)].

Lactation: Advise women not to breastfeed during treatment with CADUET [see Contraindications (4) and Use in Specific Populations (8.2)].

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