ESTERIFIED ESTROGENS AND METHYTESTESTERONE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Creekwood Pharmaceuticals LLC

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Esterified Estrogens and Methyltestosterone Tablets and Esterified Estrogens and Methyltestosterone Tablets H.S. 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 Tablets and Esterified Estrogens and Methyltestosterone Tablets H.S. 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 Tablets and Esterified Estrogens and Methyltestosterone Tablets H.S. 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

Produkt oppsummering:

Esterified Estrogens and Methyltestosterone Tablets, a combination of Esterified Estrogens and Methyltestosterone. Each light green, oval-shaped, biconvex tablet debossed with "830" on one side and plain on other side contains: 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP. NDC 82619-104-01: Available in bottles of 100 Esterified Estrogens and Methyltestosterone Tablets H.S. "Half Strength", a combination of Esterified Estrogens and Methyltestosterone. Each dark green, oval-shaped, biconvex tablet debossed with "829" on one side and scripted plain on other side contains: 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP. NDC 82619-103-01: Available in bottles of 100 Keep Esterified Estrogens and Methyltestosterone Tablets and Esterified Estrogens and Methyltestosterone Tablets H.S. out of 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.] Distributed By: Creekwood Pharmaceuticals LLC Parsippany, NJ 07054

Autorisasjon status:

unapproved drug other

Preparatomtale

ESTERIFIED ESTROGENS AND METHYTESTESTERONE - ESTERIFIED ESTROGENS
AND METHYTESTESTERONE TABLET
CREEKWOOD PHARMACEUTICALS LLC
_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
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. (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