ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

ESTROGENS, ESTERIFIED (UNII: 3ASP8Q3768) (ESTROGENS, ESTERIFIED - UNII:3ASP8Q3768), METHYLTESTOSTERONE (UNII: V9EFU16ZIF) (METHYLTESTOSTERONE - UNII:V9EFU16ZIF)

Disponible des:

Bryant Ranch Prepack

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets are indicated in the: - Treatment of moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.) - Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets have not been shown to be effective for any purpose during pregnancy and its use may cause severe harm to the fetus. Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets 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)

Resumen del producto:

Esterified Estrogens and Methyltestosterone Half-Strength Tablets (Imprinted “1507”) Bottles of 100 ……………………………………………………..NDC 72162-1748-1 Esterified Estrogens and Methyltestosterone Half-Strength Tablets (light green, capsule shaped, sugar-coated oral tablets) contain: 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP.

Estat d'Autorització:

unapproved drug other

Fitxa tècnica

ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE- ESTERIFIED ESTROGENS
AND METHYLTESTOSTERONE TABLET
BRYANT RANCH PREPACK
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLETS, 1.25 MG/2.5 MG
ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLETS, 0.625 MG/1.25 MG
(HALF-STRENGTH) CIII
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. (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