Label: ATORVASTATIN CALCIUM tablet, film coated

  • NDC Code(s): 69097-897-05, 69097-897-15, 69097-898-05, 69097-898-12, view more
  • Packager: Cipla USA Inc.,
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 13, 2018

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use atorvastatin calcium safely and effectively. See full prescribing information for atorvastatin calcium tablets. ATORVASTATIN ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Hyperlipidemia and Mixed Dyslipidemia - The recommended starting dose of atorvastatin calcium tablets is 10 or 20 mg once daily. Patients who require a large reduction in LDL-C (more than ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Atorvastatin calcium tablets are yellow, oval shape, biconvex, film coated, and are available in four strengths (see Table 1). Table 1: Atorvastatin Calcium Tablet Strengths and Identifying ...
  • 4 CONTRAINDICATIONS
    Active Liver Disease, Which May Include Unexplained Persistent Elevations in Hepatic Transaminase Levels - Hypersensitivity To Any Component of This Medication - Pregnancy [see Use in Specific ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Skeletal Muscle  - Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with atorvastatin calcium and with other drugs in this class. A history ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are discussed in greater detail in other sections of the label: Rhabdomyolysis and myopathy [see Warnings and Precautions (5.1)] Liver enzyme ...
  • 7 DRUG INTERACTIONS
    The risk of myopathy during treatment with statins is increased with concurrent administration of fibric acid derivatives, lipid-modifying doses of niacin, cyclosporine, or strong CYP 3A4 ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary  - Atorvastatin calcium is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no ...
  • 10 OVERDOSAGE
    There is no specific treatment for atorvastatin calcium overdosage. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Due ...
  • 11 DESCRIPTION
    Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Atorvastatin calcium is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A to ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In a 2-year carcinogenicity study in rats at dose levels of 10, 30, and 100 mg/kg/day, 2 rare tumors were found in muscle in high-dose ...
  • 14 CLINICAL STUDIES
    14.1 Prevention of Cardiovascular Disease - In the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT), the effect of atorvastatin calcium on fatal and non-fatal coronary heart disease was assessed ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    10 mg tablets: Yellow, oval shape, biconvex, film coated tablets, debossed with SG on one side and 152 on other side. Bottles of 90         NDC 69097-944-05 - Bottles of 1000        NDC ...
  • 17 PATIENT COUNSELING INFORMATION
    Advisethe 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 ...
  • SPL UNCLASSIFIED SECTION
    PATIENT INFORMATION - Atorvastatin Calcium Tablets - (a tor″ va stat′ in kal′ see um) Read the Patient Information that comes with atorvastatin calcium tablets before you ...
  • Package/Label Display Panel
    NDC 69097-897-05           Rx ONLY - Atorvastatin Calcium - Tablets - 10 mg* PHARMACIST: Dispense the accompanying - Patient Information to each patient. 90 ...
  • INGREDIENTS AND APPEARANCE
    Product Information