MEDROXYPROGESTERONE ACETATE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

MEDROXYPROGESTERONE ACETATE (UNII: C2QI4IOI2G) (MEDROXYPROGESTERONE - UNII:HSU1C9YRES)

Tilgjengelig fra:

Rebel Distributors Corp.

INN (International Name):

MEDROXYPROGESTERONE ACETATE

Sammensetning:

MEDROXYPROGESTERONE ACETATE 10 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Medroxyprogesterone Acetate Tablets are a progestin indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. Medroxyprogesterone Acetate Tablets are also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg tablets. Medroxyprogesterone Acetate 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- or progesterone-dependent neoplasia. - Active deep vein thrombosis, pulmonary embolism or a history of these conditions. - Active or recent (within the past year) arterial thromboembolic disease (for example, stroke and myocardial infarction). - Known liver dysfunction or disease. - Missed abortion. - As a diagnostic test for pregnancy. - Known hypersensitiv

Produkt oppsummering:

Medroxyprogesterone Acetate Tablets, USP are available as: Dispense with a child-resistant closure in a tight container. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

MEDROXYPROGESTERONE ACETATE- MEDROXYPROGESTERONE ACETATE TABLET
REBEL DISTRIBUTORS CORP.
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MEDROXYPROGESTERONE ACETATE TABLETS, USP
RX ONLY
WARNINGS
CARDIOVASCULAR AND OTHER RISKS
Estrogens with progestins should not be used for the prevention of
cardiovascular disease or
dementia. (See CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders
and Dementia.)
The Women’s Health Initiative (WHI) estrogen plus progestin substudy
reported increased risks
of myocardial infarction, stroke, invasive breast cancer, pulmonary
emboli, and deep vein
thrombosis (DVT) in postmenopausal women (50 to 79 years of age)
during 5.6 years of treatment
with daily oral conjugated estrogens (CE 0.625 mg) combined with
medroxyprogesterone acetate
(MPA 2.5 mg) 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 study, reported
increased risk of developing probable dementia in postmenopausal women
65 years of age or
older during 4 years of treatment with daily CE 0.625 mg combined with
MPA 2.5 mg, relative to
placebo. It is unknown whether this finding applies to younger
postmenopausal women. (See
CLINICAL STUDIES and WARNINGS, Dementia, and PRECAUTIONS, Geriatric
Use.)
In the absence of comparable data, these risks should be assumed to be
similar for other doses of
CE and MPA and other combinations and dosage forms of estrogens and
progestins. Because of
these risks, estrogens with or without progestins should be prescribed
at the lowest effective
doses and for the shortest duration consistent with treatment goals
and risks for the individual
woman.
DESCRIPTION
Medroxyprogesterone acetate tablets contain medroxyprogesterone
acetate, which is a derivative of
progesterone. It is a white to off-white, odorless crystalline powder,
stable in air, melting between 200
and 210°C. It is freely soluble in chloroform, soluble in acetone and
in dioxane, sparingly soluble in
alcohol and in methan