Label: ATORVASTATIN CALCIUM tablet, film coated

  • NDC Code(s): 63304-827-05, 63304-827-90, 63304-828-05, 63304-828-90, view more
  • Packager: Sun Pharmaceutical Industries Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 18, 2024

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Atorvastatin calcium tablets are indicated: • To reduce the risk of:    o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for ...
  • 2 DOSAGE & ADMINISTRATION
    2.1 Important Dosage Information - •Take atorvastatin calcium tablets orally once daily at any time of the day, with or without food. •Assess LDL-C when clinically appropriate, as early as 4 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Tablets: •10 mg of atorvastatin: white, elliptical, film-coated tablets, debossed with ‘RX 12’ on one side and plain on the other side. •20 mg of atorvastatin: white, elliptical, film-coated ...
  • 4 CONTRAINDICATIONS
    • Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3)] • Hypersensitivity to atorvastatin or any excipients in atorvastatin calcium tablets. Hypersensitivity ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Myopathy and Rhabdomyolysis - Atorvastatin calcium may cause myopathy (muscle pain, tenderness, or weakness associated with elevated creatine kinase [CK]) and rhabdomyolysis. Acute kidney ...
  • 6 ADVERSE REACTIONS
    The following important adverse reactions are described below and elsewhere in the labeling: • Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1)] • Immune-Mediated Necrotizing ...
  • 7 DRUG INTERACTIONS
    7.1 Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with Atorvastatin Calcium - Atorvastatin is a substrate of CYP3A4 and transporters (e.g., OATP1B1/1B3, P-gp, or ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Discontinue atorvastatin calcium when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Atorvastatin calcium ...
  • 10 OVERDOSAGE
    No specific antidotes for atorvastatin calcium are known. Contact Poison Control (1-800-222-1222) for latest recommendations. Due to extensive drug binding to plasma proteins, hemodialysis is not ...
  • 11 DESCRIPTION
    Atorvastatin calcium is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium trihydrate, USP is [R-(R*,R*)]-2-(4-fluorophenyl)-ß ...
  • 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
    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 in ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Atorvastatin calcium tablets, USP are supplied as follows: Strength - How Supplied - NDC - Tablet Description - 10 mg of atorvastatin - bottles of 90 - bottles of ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Myopathy and Rhabdomyolysis - Advise patients that atorvastatin calcium tablets may cause myopathy and ...
  • PATIENT INFORMATION
    Patient Information available at https://www.sunpharma.com/usa/products - Atorvastatin (a TORE va sta tin) Calcium Tablets - Rx only - What are Atorvastatin Calcium Tablets? Atorvastatin calcium ...
  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL
    63304-827-90 - Atorvastatin Calcium Tablets, USP - 10 mg* Rx only - 90 Tablets - SUN PHARMA
  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL
    63304-828-90 - Atorvastatin Calcium Tablets, USP - 20 mg* Rx only  - 90 Tablets - SUN PHARMA
  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL
    63304-829-90 - Atorvastatin Calcium Tablets, USP - 40 mg* Rx only - 90 Tablets - SUN PHARMA
  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL
    63304-830-90 - Atorvastatin Calcium Tablets, USP - 80 mg* Rx only - 90 Tablets - SUN PHARMA
  • INGREDIENTS AND APPEARANCE
    Product Information