MEDROXYPROGESTERONE ACETATE- medroxyprogesterone acetate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

MEDROXYPROGESTERONE ACETATE

Composition:

MEDROXYPROGESTERONE ACETATE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Medroxyprogesterone acetate tablets 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. MPA tablets 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 MPA. - Known liver impairment or disease. - Known or suspected pregnancy.

Product summary:

Medroxyprogesterone acetate tablets are available in the following strengths and package sizes: 2.5 mg tablets Bottles of 100: NDC 59762-3740-1 (scored, round, orange, imprinted G3740) Bottles of 100: NDC 59762-0055-1 (scored, round, orange, imprinted PROVERA 2.5) Bottles of 1000: NDC 59762-3740-5 (scored, round, orange, imprinted G3740) Bottles of 1000: NDC 59762-0055-2 (scored, round, orange, imprinted PROVERA 2.5) 5 mg tablets Bottles of 100: NDC 59762-3741-1 (scored, hexagonal, white, imprinted G3741) Bottles of 100: NDC 59762-0058-1 (scored, round, blue, imprinted PROVERA 5) Bottles of 1000: NDC 59762-3741-4 (scored, hexagonal, white, imprinted G3741) Bottles of 1000: NDC 59762-0058-2 (scored, round, blue, imprinted PROVERA 5) 10 mg tablets Bottles of 100: NDC 59762-3742-2 (scored, round, white, imprinted G3742) Bottles of 100: NDC 59762-0056-1 (scored, round, white, imprinted PROVERA 10) Bottles of 1000: NDC 59762-3742-8 (scored, round, white, imprinted G3742) Bottles of 1000: NDC 59762-0056-2 (scored, round, white, imprinted PROVERA 10) Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. "Keep out of reach of children"

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

MEDROXYPROGESTERONE ACETATE- MEDROXYPROGESTERONE ACETATE TABLET
REMEDYREPACK INC.
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MEDROXYPROGESTERONE
ACETATE TABLETS, USP
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 contain medroxyprogesterone
acetate, which is a derivative of
progeste