PREMARIN estrogens conjugated tablet film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

ESTROGENS, CONJUGATED (UNII: IU5QR144QX) (ESTROGENS, CONJUGATED - UNII:IU5QR144QX)

Disponible depuis:

Avera McKennan Hospital

DCI (Dénomination commune internationale):

ESTROGENS, CONJUGATED

Composition:

ESTROGENS, CONJUGATED 0.9 mg

Type d'ordonnance:

PRESCRIPTION DRUG

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

PREMARIN- ESTROGENS, CONJUGATED TABLET, FILM COATED
AVERA MCKENNAN HOSPITAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PREMARIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PREMARIN.
PREMARIN® (CONJUGATED ESTROGENS) TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1942
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER
AND
PROBABLE DEMENTIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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)
WOMEN'S HEALTH INITIATIVE (WHI) ESTROGEN-ALONE SUBSTUDY REPORTED
INCREASED RISKS OF STROKE AND DEEP
VEIN THROMBOSIS (DVT) (5.1)
THE WHI MEMORY STUDY (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)
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 WHI ESTROGEN PLUS PROGESTIN SUBSTUDY REPORTED INCREASED RISKS OF
STROKE, 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 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)
INDICATIONS AND USAGE
PREMARIN is a mixture of estrogens indicated 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)
Treatment of Hypoestrogenism due to Hypogonadism, Castration or
Primary Ovarian Failure (1.3)
Treatment of Breast Cancer (for Palliation Only) in Appropriately
Selected Women and Men with Metastatic Disease
(1.4)