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:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

MEDROXYPROGESTERONE ACETATE

Composition:

MEDROXYPROGESTERONE ACETATE 2.5 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: - 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.

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. Manufactured For: Teva Pharmaceuticals   Parsippany, NJ 07054 Rev. B 10/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEDROXYPROGESTERONE ACETATE- MEDROXYPROGESTERONE ACETATE TABLET
TEVA PHARMACEUTICALS USA, INC.
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MEDROXYPROGESTERONE ACETATE TABLETS, USP
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 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
which is