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Vital Supplements
Arimidex (Anastrozole)
Arimidex (Anastrozole)
Regular price
Rs.7,500.00
Regular price
Rs.8,000.00
Sale price
Rs.7,500.00
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per
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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 ...
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Table of Contents
Table of Contents
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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' ...
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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 ...
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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 ...
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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 ...
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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].
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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 ...
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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 ...
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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Arimidex® anastrozole tablets - 1 mg - NDC 62559-670-30 - Rx only - 30 Tablets
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