Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
ESTROGENS, CONJUGATED (UNII: IU5QR144QX) (ESTROGENS, CONJUGATED - UNII:IU5QR144QX), MEDROXYPROGESTERONE ACETATE (UNII: C2QI4IOI2G) (MEDROXYPROGESTERONE - UNII:HSU1C9YRES)
Physicians Total Care, Inc.
ESTROGENS, CONJUGATED
ESTROGENS, CONJUGATED 0.3 mg
ORAL
PRESCRIPTION DRUG
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
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].
New Drug Application
PREMPRO - CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE TABLET, SUGAR COATED PHYSICIANS TOTAL CARE, INC. ---------- 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 ( Citiți documentul complet