PREMPRO- conjugated estrogens and medroxyprogesterone acetate tablet, sugar coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

ESTROGENS, CONJUGATED (UNII: IU5QR144QX) (ESTROGENS, CONJUGATED - UNII:IU5QR144QX), MEDROXYPROGESTERONE ACETATE (UNII: C2QI4IOI2G) (MEDROXYPROGESTERONE - UNII:HSU1C9YRES)

Διαθέσιμο από:

Physicians Total Care, Inc.

INN (Διεθνής Όνομα):

ESTROGENS, CONJUGATED

Σύνθεση:

ESTROGENS, CONJUGATED 0.3 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

PREMPRO or PREMPHASE therapy should not be used in women with any of the following conditions: - Undiagnosed abnormal genital bleeding - Known, suspected, or history of breast cancer - Known or suspected estrogen-dependent neoplasia - Active deep vein thrombosis, pulmonary embolism or a history of these conditions - Active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions - Known liver dysfunction or disease - Known thrombophilic disorders (e.g., protein C, protein S, or antithrombin deficiency) - Known or suspected pregnancy PREMPRO and PREMPHASE should not be used during pregnancy [see Contraindications (4)] . There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy. PREMPRO and PREMPHASE should not be used during lactation. Estrogen administration to nursing mothers has been shown to decrease the quanti

Περίληψη προϊόντος:

PREMPRO therapy consists of a single tablet to be taken once daily. NDC 54868-5047-0, carton includes 1 blister card containing 28 oval, cream tablets. NDC 54868-4866-0, carton includes 1 blister card containing 28 oval, gold tablets. NDC 54868-3799-0, carton includes 1 blister card containing 28 oval, peach tablets. Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

PREMPRO - CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE TABLET,
SUGAR COATED
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PREMPRO/PREMPHASE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PREMPRO/PREMPHASE.
PREMPRO (CONJUGATED ESTROGENS/MEDROXYPROGESTERONE ACETATE TABLETS)
PREMPHASE (CONJUGATED ESTROGENS PLUS MEDROXYPROGESTERONE ACETATE
TABLETS)
INITIAL U.S. APPROVAL: 1995
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER
AND
PROBABLE DEMENTIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ESTROGEN PLUS PROGESTIN THERAPY
ESTROGEN PLUS PROGESTIN THERAPY SHOULD NOT BE USED FOR THE PREVENTION
OF CARDIOVASCULAR DISEASE OR
DEMENTIA (5.1, 5.3)
THE WOMEN’S HEALTH INITIATIVE (WHI) ESTROGEN PLUS PROGESTIN SUBSTUDY
REPORTED INCREASED RISKS OF
STROKE, DEEP VEIN THROMBOSIS (DVT), PULMONARY EMBOLISM, AND MYOCARDIAL
INFARCTION (5.1)
THE WHI ESTROGEN PLUS PROGESTIN SUBSTUDY REPORTED INCREASED RISKS OF
INVASIVE BREAST CANCER (5.2)
THE WHI MEMORY STUDY (WHIMS) ESTROGEN PLUS PROGESTIN ANCILLARY STUDY
OF WHI REPORTED AN
INCREASED RISK OF PROBABLE DEMENTIA IN POSTMENOPAUSAL WOMEN 65 YEARS
OF AGE AND OLDER (5.3)
ESTROGEN-ALONE THERAPY
THERE IS AN INCREASED RISK OF ENDOMETRIAL CANCER IN A WOMAN WITH A
UTERUS WHO USES UNOPPOSED
ESTROGENS (5.2)
ESTROGEN-ALONE THERAPY SHOULD NOT BE USED FOR THE PREVENTION OF
CARDIOVASCULAR DISEASE OR DEMENTIA
(5.1, 5.3)
THE WHI ESTROGEN-ALONE SUBSTUDY REPORTED INCREASED RISKS OF STROKE AND
DVT (5.1)
THE WHIMS ESTROGEN-ALONE ANCILLARY STUDY OF WHI REPORTED AN INCREASED
RISK OF PROBABLE DEMENTIA IN
POSTMENOPAUSAL WOMEN 65 YEARS OF AGE AND OLDER (5.3)
RECENT MAJOR CHANGES
Contraindications (4) 05/2010
INDICATIONS AND USAGE
PREMPRO/PREMPHASE is an estrogen/progestin indicated in women with
intact uteri for:
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
(1.1)
Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to
Menopause (