国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
ESTRADIOL VALERATE (UNII: OKG364O896) (ESTRADIOL - UNII:4TI98Z838E)
Xiromed, LLC
INTRAMUSCULAR
PRESCRIPTION DRUG
Estradiol valerate injection, USP is indicated in the: - Treatment of moderate to severe vasomotor symptoms associated with the menopause. - 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. - Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. - Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). Estradiol valerate injection, USP 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 a 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. - Estradiol valerate injection, USP should not be used in patients with known hypersensitivity to its ingredients. - Known or suspected pregnancy. There is no indication for Estradiol valerate injection, USP 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 ).
Estradiol valerate injection, USP Multiple Dose Vials Store between 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Keep out of reach of children. Revised: 04/2024
Abbreviated New Drug Application
ESTRADIOL VALERATE- ESTRADIOL VALERATE INJECTION XIROMED, LLC ---------- ESTRADIOL VALERATE INJECTION, USP 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 and progestins should not be used for the prevention of cardiovascular disease. (See WARNINGS, CARDIOVASCULAR DISORDERS). 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 estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL PHARMACOLOGY, CLINICAL STUDIES). 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 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 or to women taking estrogen alone therapy. (See CLINICAL PHARMACOLOGY, CLINICAL STUDIES). 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 完全なドキュメントを読む