PREMARIN- estrogens, conjugated tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

INN (International Name):

ESTROGENS, CONJUGATED

Composition:

ESTROGENS, CONJUGATED 0.45 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Limitation of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered. Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered PREMARIN therapy is contraindicated in individuals with any of the following conditions: PREMARIN 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. PREMARIN should not be used during lactation. Estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. Detectable amounts of estrogens have been identified in the breast milk of mothers receiving estrogen-alone therapy. Caution should be exercised when PREMARIN is administered to a nursing woman. Estrogen therapy has been used for the induction of puberty in adolescents with some forms of pubertal delay. Safety and effectiveness in pediatric patients have not otherwise been established. Large and repeated doses of estrogen over an extended time period have been shown to accelerate epiphyseal closure, which could result in short stature if treatment is initiated before the completion of physiologic puberty in normally developing children. If estrogen is administered to patients whose bone growth is not complete, periodic monitoring of bone maturation and effects on epiphyseal centers is recommended during estrogen administration. Estrogen treatment of prepubertal girls also induces premature breast development and vaginal cornification, and may induce vaginal bleeding. In boys, estrogen treatment may modify the normal pubertal process and induce gynecomastia. There have not been sufficient numbers of geriatric patients involved in studies utilizing PREMARIN to determine whether those over 65 years of age differ from younger subjects in their response to PREMARIN. The Women's Health Initiative Study In the WHI estrogen-alone substudy (daily CE 0.625 mg-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see Clinical Studies (14.5)] . In the WHI estrogen plus progestin substudy (daily CE [0.625 mg] plus MPA [2.5 mg]), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see Clinical Studies (14.5)] . The Women's Health Initiative Memory Study In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo [see Warnings and Precautions (5.3), and Clinical Studies (14.6)] . Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8 [see Warnings and Precautions (5.3), and Clinical Studies (14.6)]. The effect of renal impairment on the pharmacokinetics of PREMARIN has not been studied. The effect of hepatic impairment on the pharmacokinetics of PREMARIN has not been studied.

Product summary:

PREMARIN (conjugated estrogens tablets, USP) The appearance of these tablets is a trademark of Wyeth LLC. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container, as defined in the USP.

Authorization status:

New Drug Application

Summary of Product characteristics

PREMARIN- ESTROGENS, CONJUGATED TABLET, FILM COATED
WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.
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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
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ESTROGEN PLUS PROGESTIN THERAPY
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RECENT MAJOR CHANGES
Warnings and Precautions, Malignant Neoplasms
(5.2)
02/2024
INDICATIONS AND USAGE
PREMARIN is a mixture of estrogens indicated for:
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DOSAGE AND ADMINISTRATION
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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 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)
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