Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)
Physicians Total Care, Inc.
ESTRADIOL
ESTRADIOL 1.0 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Divigel® (estradiol gel) 0.1% is indicated in the treatment of moderate to severe vasomotor symptoms associated with menopause. Estrogen products, including Divigel® (estradiol gel) 0.1%, should not be used in women with any of the following conditions: - Undiagnosed abnormal genital bleeding. - Known, suspected, or history of cancer of the breast. - Known or suspected estrogen-dependent neoplasia. - Active deep vein thrombosis, pulmonary embolism, or history of these conditions. - Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). - Liver dysfunction or disease. - Known hypersensitivity to the ingredients of Divigel® . - Known or suspected pregnancy. There is no indication for Divigel® in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy. (See PRECAUTIONS .)
Divigel® (estradiol gel) 0.1% is a clear, colorless, smooth, opalescent gel supplied in single-dose foil packets of 1.0 g, corresponding to 1.0 mg estradiol, respectively. NDC 54868-6056-0 , carton of 30 packets, 1.0 mg estradiol per single-dose foil packet Keep out of the reach of children. Store at 20 to 25°C (68 to 77°F). Excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature.] Manufactured by Orion Corporation Orion Pharma Tengströminkatu 8 FI-20360 Turku Finland Distributed by Upsher-Smith Laboratories, Inc. Minneapolis, MN 55447 1-800-654-2299 Product of Finland Revised June 2007 Relabeling of "Additional Barcode" by Physicians Total Care, Inc. Tulsa, OK 74146
New Drug Application
DIVIGEL - ESTRADIOL GEL PHYSICIANS TOTAL CARE, INC. ---------- DIVIGEL (ESTRADIOL GEL) 0.1% RX ONLY ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses. (See WARNINGS, MALIGNANT NEOPLASMS, ENDOMETRIAL CANCER.) CARDIOVASCULAR AND OTHER RISKS Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR DISORDERS and DEMENTIA.) The estrogen-alone substudy of the Women's Health Initiative (WHI) reported increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with oral conjugated estrogens (CE 0.625 mg) alone per day, relative to placebo. (See CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR DISORDERS.) The estrogen-plus-progestin substudy of the WHI reported increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) per day, relative to placebo. (See CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR DISORDERS and MALIGNANT NEOPLASMS, _BREAST CANCER_.) The Women's Health Initiative Memory Study (WHIMS), a substudy of the WHI, reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with CE 0.625 mg alone and during 4 years of treatment with CE 0.625 mg combined with MPA 2.5 mg, relative to pl Lesen Sie das vollständige Dokument