MEDROXYPROGESTERONE ACETATE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Dispensing Solutions, Inc.

INN (국제 이름):

MEDROXYPROGESTERONE ACETATE

구성:

MEDROXYPROGESTERONE ACETATE 5 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Medroxyprogesterone Acetate Tablets USP 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 USP 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 Tablets 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- 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. -

제품 요약:

Medroxyprogesterone Acetate Tablets, USP are available as: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Iss. 4/2010

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

MEDROXYPROGESTERONE ACETATE- MEDROXYPROGESTERONE ACETATE TABLET
DISPENSING SOLUTIONS, INC.
----------
MEDROXYPROGESTERONE ACETATE TABLETS USP
Iss. 4/2010
11001645
RX ONLY
(THREE PATIENT INFORMATION LEAFLET ENCLOSED-TEAR AT PERFORATION)
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 USP contain medroxyprogesterone
acetate, USP 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 solub