देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
EXEMESTANE (UNII: NY22HMQ4BX) (EXEMESTANE - UNII:NY22HMQ4BX)
Zydus Lifesciences Limited
ORAL
PRESCRIPTION DRUG
Exemestane tablets are indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets for completion of a total of five consecutive years of adjuvant hormonal therapy [see Clinical Studies (14.1)]. Exemestane tablets are indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see Clinical Studies (14.2) ]. Exemestane tablets are contraindicated in patients with a known hypersensitivity to the drug or to any of the excipients. Risk Summary Based on findings in animal studies and its mechanism of action, exemetane can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . Limited human data from case reports are insufficient to inform a drug-associated risk. In animal reproduction studies, administration of exemestane to pregnant rats and rabbits caused increased
Exemestane Tablets, 25 mg are white to off-white, round-shaped, film-coated tablets debossed with '383' on one side and plain on other side and are supplied as follows: NDC 70771-1374-3 in bottle of 30 tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
EXEMESTANE- EXEMESTANE TABLET Cadila Healthcare Limited ---------- FDA- Approved Patient Labeling Patient Information Exemestane (EX-e-MES-tane) Tablets 1 What are exemestane tablets? Exemestane tablets are used in women who are past menopause for the treatment of: • Early breast cancer (cancer that has not spread outside the breast) in women who: • have cancer that needs the female hormone estrogen to grow and • have had other treatments for breast cancer and • have taken tamoxifen for 2 to 3 years and • are switching to exemestane to complete 5 years in a row of hormonal therapy. • Advanced breast cancer (cancer that has spread), after treatment with tamoxifen and it did not work or is no longer working. It is not known if exemestane tablets are safe and effective in children. 2 Who should not take exemestane tablets? Do not take exemestane tablets if: you are allergic to exemestane or any of the ingredients in exemestane tablets. See end of this leaflet for complete list of ingredients in exemestane tablets. Before you take exemestane tablets, tell your doctor about all your medical conditions including if you: • are still having menstrual periods (are not past menopause). Exemestane is only for women who are past menopause. • Have liver or kidney problems. • have weak or brittle bones (osteoporosis) • are pregnant or plan to become pregnant. Taking exemestane during pregnancy or within 1 month of becoming pregnant can harm your unborn baby. • Females who are able to become pregnant should have a pregnancy test within 7 days before starting treatment with exemestane. • Females who are able to become pregnant should use effective birth control (contraceptive) during treatment with exemestane and for 1 month after your last dose of exemestane. Tell your doctor right away if you become pregnant or think you may be pregnant. • are breastfeeding or plan to breastfeed. It is not known if exemestane passes into your breast milk. Do not breast-feed during treatment with exemestane and for 1 m पूरा दस्तावेज़ पढ़ें
EXEMESTANE - EXEMESTANE TABLET ZYDUS LIFESCIENCES LIMITED ---------- EXEMESTANE TABLETS PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1374-3 in bottle of 30 tablets Exemestane Tablets, 25 mg R only 30 tablets EXEMESTANE exemestane tablet PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:70771-1374 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH EXEMESTANE (UNII: NY22HMQ4BX) (EXEMESTANE - UNII:NY22HMQ4BX) EXEMESTANE 25 mg x Zydus Lifesciences Limited INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM CARBONATE (UNII: 0E53J927NA) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 2S7830E561) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) PRODUCT CHARACTERISTICS COLOR WHITE (WHITE) SCORE no score SHAPE ROUND (ROUND) SIZE 6mm FLAVOR IMPRINT CODE 383 CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:70771- 1374-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2018 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE ANDA ANDA202602 10/08/2018 LABELER - Zydus Lifesciences Limited (918596198) REGISTRANT - Zydus Lifesciences Limited (863362789) ESTABLISHMENT NAME ADDRESS ID/FEI BUSINESS OPERATIONS Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1374) , MANUFACTURE(70771-1374) Revised: 8/2022 पूरा दस्तावेज़ पढ़ें