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ATORVASTATIN CALCIUM tablet


Patient Information

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

Patients taking atorvastatin calcium should be advised 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.

Patients should be advised about substances they should not take concomitantly with atorvastatin [see Warnings and Precautions(5.1)]. Patients should also be advised to inform other healthcare professionals prescribing a new medication that they are taking atorvastatin calcium.

17.1 Muscle Pain

All patients starting therapy with atorvastatin calcium should be advised of the risk of myopathy and told 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 atorvastatin. 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.

17.2 Liver Enzymes

It is recommended that liver enzyme tests be performed before the initiation of atorvastatin calcium and if signs or symptoms of liver injury occur. All patients treated with atorvastatin calcium should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.

17.3 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 [seeContraindications (4) and Use in Specific Populations (8.1,8.3)].

17.4 Lactation

Advise women not to breastfeed during treatment with atorvastatin calcium [seeContraindications (4)and Use in Specific Populations (8.2)].

Manufactured by

Dr. Reddy s Laboratories Limited

Bachupally 500 090 INDIA

Revised: 0419



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