Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E), DROSPIRENONE (UNII: N295J34A25) (DROSPIRENONE - UNII:N295J34A25)
Physicians Total Care, Inc.
ESTRADIOL
ESTRADIOL 1 mg
ORAL
PRESCRIPTION DRUG
ANGELIQ is indicated in women who have a uterus for the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. Progestogens/estrogens should not be used in individuals with any of the following conditions: 1. Undiagnosed abnormal genital bleeding. 2. Known, suspected, or history of cancer of the breast. 3. Known or suspected estrogen-dependent neoplasia. 4. Active deep vein thrombosis, pulmonary embolism or history of these conditions. 5. Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). 6. Renal insufficiency. 7. Liver dysfunction or disease. 8. Adrenal insufficiency. 9. ANGELIQ should not be used in patients with known hypersensitivity to its ingredients. 10. Known or suspec
ANGELIQ TABLETS (drospirenone and estradiol) 0.5 mg/1 mg are available as round, biconvex pink film-coated tablets embossed with "CK" inside a hexagon, and supplied in the following packaging: 1 blisters of 28 tablets NDC 54868-6184-0 Storage Conditions Store at 25° C (77° F); excursions permitted to 15– 30° C (59– 86° F) [See USP Controlled Room Temperature]. REFERENCES FURNISHED UPON REQUEST
New Drug Application
ANGELIQ - DROSPIRENONE AND ESTRADIOL TABLET, FILM COATED PHYSICIANS TOTAL CARE, INC. ---------- ANGELIQ TABLETS (DROSPIRENONE AND ESTRADIOL) 0.5 MG/1 MG RX ONLY PRESCRIBING INFORMATION BOXED WARNINGS Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. (See WARNINGS, Cardiovascular disorders and Dementia.) The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated equine estrogens (CE 0.625mg) combined with medroxyprogesterone acetate (MPA 2.5mg) relative to placebo (see CLINICAL PHARMACOLOGY, Clinical Studies and WARNINGS, Cardiovascular disorders and Malignant neoplasms, Breast cancer.) The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with conjugated estrogens alone and during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL PHARMACOLOGY, Clinical Studies, WARNINGS, Dementia and PRECAUTIONS, Geriatric Use.) Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials, and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. DES CRIPTION ANGELIQ TABLETS provide a hormone regimen consisting of film coated tablets each containing 0.5 mg of drospirenone and 1 mg of estradiol. The inactive ingredie সম্পূর্ণ নথি পড়ুন