PROVERA- medroxyprogesterone acetate tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Pharmacia & Upjohn Company LLC

INN (Tên quốc tế):

MEDROXYPROGESTERONE ACETATE

Thành phần:

MEDROXYPROGESTERONE ACETATE 2.5 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

PROVERA 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. PROVERA is contraindicated in women with any of the following conditions:

Tóm tắt sản phẩm:

PROVERA Tablets are available in the following strengths and package sizes: 2.5 mg tablets (scored, round, orange, imprinted PROVERA 2.5) 5 mg tablets (scored, round, blue, imprinted PROVERA 5) 10 mg tablets (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"

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

PROVERA- MEDROXYPROGESTERONE ACETATE TABLET
PHARMACIA & UPJOHN COMPANY LLC
----------
PROVERA®
(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 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
PROVERA tablets contain medroxyprogesterone acetate, which is a
derivative of
progesterone. It is a whi