Arimidex (Anastrozole) – Vital Supplements
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Arimidex (Anastrozole)

Arimidex (Anastrozole)

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Regular price Rs.7,500.00
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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ARIMIDEX safely and effectively. See full prescribing information for ARIMIDEX. ARIMIDEX® (anastrozole) tablet, for oral use ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Adjuvant Treatment - ARIMIDEX is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. 1.2 First-Line Treatment - ARIMIDEX is ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Dose - The dose of ARIMIDEX is one 1 mg tablet taken once a day. For patients with advanced breast cancer, ARIMIDEX should be continued until tumor progression. ARIMIDEX can be ...
  • 3 DOSAGE FORMS AND STRENGTHS
    The tablets are white, biconvex, film-coated containing 1 mg of anastrozole. The tablets are impressed on one side with a logo consisting of a letter “A” (upper case) with an arrowhead attached to ...
  • 4 CONTRAINDICATIONS
    Hypersensitivity - ARIMIDEX is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or to any of the excipients. Observed reactions include anaphylaxis, angioedema ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Ischemic Cardiovascular Events - In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events was observed with ARIMIDEX in the ATAC trial (17 ...
  • 6 ADVERSE REACTIONS
    Serious adverse reactions with ARIMIDEX occurring in less than 1 in 10,000 patients, are: 1) skin reactions such as lesions, ulcers, or blisters; 2) allergic reactions with swelling of the face ...
  • 7 DRUG INTERACTIONS
    7.1 Tamoxifen - Co-administration of anastrozole and tamoxifen in breast cancer patients reduced anastrozole plasma concentration by 27%. However, the co-administration of anastrozole and ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Based on findings from animal studies and its mechanism of action, ARIMIDEX may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ...
  • 10 OVERDOSAGE
    Clinical trials have been conducted with ARIMIDEX, up to 60 mg in a single dose given to healthy male volunteers and up to 10 mg daily given to postmenopausal women with advanced breast cancer ...
  • 11 DESCRIPTION
    ARIMIDEX (anastrozole) tablets for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a' ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The growth of many cancers of the breast is stimulated or maintained by estrogens. In postmenopausal women, estrogens are mainly derived from the action of the ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - A conventional carcinogenesis study in rats at doses of 1.0 to 25 mg/kg/day (about 10 to 243 times the daily maximum recommended human ...
  • 14 CLINICAL STUDIES
    14.1 Adjuvant Treatment of Breast Cancer in Postmenopausal Women - A multicenter, double-blind trial (ATAC) randomized 9,366 postmenopausal women with operable breast cancer to adjuvant ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    ARIMIDEX (anastrozole) Tablets, 1 mg are supplied in bottles of 30 tablets (NDC 62559-670-30). Storage - Store at controlled room temperature, 20 to 25°C (68 to 77°F) [see USP].
  • 17 PATIENT COUNSELING INFORMATION
    See FDA approved patient labeling (Patient Information). Hypersensitivity Reactions - Inform patients of the possibility of serious allergic reactions with swelling of the face, lips, tongue ...
  • Patient Information
    ARIMIDEX® A-rim-eh-dex - (anastrozole) tablets - What is the most important information I should know about ARIMIDEX? ARIMIDEX may cause serious side effects including: • heart disease. Women ...
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
    Arimidex® anastrozole tablets - 1 mg - NDC 62559-670-30 - Rx only - 30 Tablets
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