MEDROXYPROGESTERONE ACETATE- medroxyprogesterone acetate tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Bryant Ranch Prepack

INN (Internationale Bezeichnung):

MEDROXYPROGESTERONE ACETATE

Zusammensetzung:

MEDROXYPROGESTERONE ACETATE 5 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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.

Produktbesonderheiten:

Product: 63629-2614 NDC: 63629-2614-1 30 TABLET in a BOTTLE NDC: 63629-2614-2 100 TABLET in a BOTTLE NDC: 63629-2614-3 60 TABLET in a BOTTLE NDC: 63629-2614-4 7 TABLET in a BOTTLE NDC: 63629-2614-5 10 TABLET in a BOTTLE Product: 63629-6812

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

MEDROXYPROGESTERONE ACETATE- MEDROXYPROGESTERONE ACETATE TABLET
BRYANT RANCH PREPACK
----------
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
acetate, USP whi