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:

RedPharm Drug, Inc.

INN (International Name):

MEDROXYPROGESTERONE ACETATE

Composition:

MEDROXYPROGESTERONE ACETATE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: 1. Undiagnosed abnormal genital bleeding. 2. Known, suspected, or history of breast cancer. 3. Known or suspected estrogen- or progesterone-dependent neoplasia. 4. Active DVT, PE, or a history of these conditions 5. Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions. 6. Known anaphylactic reaction or angioedema to medroxyprogesterone acetate. 7. Known liver impairment or disease. 8. Known

Product summary:

Medroxyprogesterone Acetate Tablets USP are available as: 2.5 mg: White, round, scored, biconvex tablet. Debossed with 555/872 on the scored side and stylized b on the other side, available in bottles of 100 (NDC 0555-0872-02) and 500 (NDC 0555-0872-04). 5 mg: White, round, scored, biconvex tablet. Debossed with 555/873 on the scored side and stylized b on the other side, available in bottles of 100 (NDC 0555-0873-02) and 500 (NDC 0555-0873-04). 10 mg: White, round, scored, biconvex tablet. Debossed with 555/779 on the scored side and stylized b on the other side, available in bottles of 100 (NDC 0555-0779-02) and 500 (NDC 0555-0779-04). 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEDROXYPROGESTERONE ACETATE- MEDROXYPROGESTERONE ACETATE TABLET
REDPHARM DRUG, INC.
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SPL UNCLASSIFIED SECTION
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 DISORDERS.)
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 STUDIESand 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
which is a derivative