ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE 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:

ANI Pharmaceuticals, Inc.

INN (International Name):

ESTROGENS, ESTERIFIED

Sammensetning:

ESTROGENS, ESTERIFIED 1.25 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets are indicated in the: Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets should not be used in women with any of the following conditions: Methyltestosterone should not be used in: Methyltestosterone is classified as a schedule III Controlled Substance under the Anabolic Steroids Act of 1990.

Produkt oppsummering:

Esterified Estrogens and Methyltestosterone Tablets (Imprinted “1490”) Bottles of 100 ……………………………………………………..NDC 62559-149-01 Esterified Estrogens and Methyltestosterone Tablets (dark green, capsule shaped, sugar-coated oral tablets) contain: 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP. Esterified Estrogens and Methyltestosterone Half-Strength Tablets (Imprinted “1507”) Bottles of 100 ……………………………………………………..NDC 62559-150-01 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. Keep Esterified Estrogens and Methyltestosterone Tablets and Esterified Estrogens and Methyltestosterone Half-Strength Tablets out of reach of children . Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature] † This product has not obtained FDA pre-market approval applicable for new drugs.

Autorisasjon status:

unapproved drug other

Preparatomtale

ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE- ESTERIFIED ESTROGENS AND
METHYLTESTOSTERONE TABLET
ANI PHARMACEUTICALS, INC.
_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,
CLINI