PREMPRO- conjugated estrogens and medroxyprogesterone acetate tablet, sugar coated

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

A-S Medication Solutions

INN:

ESTROGENS, CONJUGATED

composition:

ESTROGENS, CONJUGATED 0.625 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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 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 PREMPRO/PREMPHASE - Known liver dysfunction or disease - Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders - 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 women has been shown t

leaflet_short:

Product: 50090-0573 NDC: 50090-0573-0 28 TABLET, SUGAR COATED in a BLISTER PACK / 1 in a CARTON

authorization_status:

New Drug Application

SPC

PREMPRO- CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE TABLET,
SUGAR COATED
A-S MEDICATION SOLUTIONS
----------
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 (PE), AND
MYOCARDIAL INFARCTION (MI) (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)
INDICATIONS AND USAGE
PREMPRO/PREMPHASE is an estrogen plus progestin indicated in a woman
with a uterus 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 (1.2)
Prevention of Postmenopausal Osteoporos