MEDROXYPROGESTERONE ACETATE- medroxyprogesterone acetate tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

NuCare Pharmaceuticals, Inc.

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Medroxyprogesterone Acetate Tablets USP are 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. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets. Medroxyprogesterone acetate is contraindicated in women with any of the following conditions: - Undiagnosed abnormal genital bleeding. - Known, suspected, or history of breast cancer. - Known or suspected estrogen- or progesterone-dependent neoplasia. - Active DVT, PE, or a history of these conditions - Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions. - Known anaphylactic reaction or angioedema to medroxyprogesterone acetate. - Known liver impairment or disease. - Known or suspected pregnancy.

Ապրանքի ամփոփագիր:

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, INC. North Wales, PA 19454 Rev. A 5/2015

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

MEDROXYPROGESTERONE ACETATE- MEDROXYPROGESTERONE ACETATE TABLET
NUCARE PHARMACEUTICALS, INC.
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MEDROXYPROGESTERONE ACETATE TABLETS USP
0872
0873
0779
RX ONLY
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE
DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY
CARDIOVASCULAR DISORDERS AND PROBABLE DEMENTIA
Estrogen plus progestin therapy should not be used for the prevention
of cardiovascular disease
or dementia. ( SEE CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR
DISORDERS and
PROBABLE DEMENTIA.)
The Women’s Health Initiative (WHI) estrogen plus progestin substudy
reported an increased risk
of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and
myocardial infarction (MI)
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
DIS ORDERS .)
The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study
reported an 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, PROBABLE DEMENTIA and PRECAUTIONS, GERIATRIC
USE. )
BREAST CANCER
The WHI estrogen plus progestin substudy demonstrated an increased
risk of invasive breast
cancer. (See CLINICAL STUDIES and WARNINGS, MALIGNANT NEOPLASM,BREAST
CANCER. )
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.
Progestins with estrogens 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
ac