PREMARIN VAGINAL- conjugated estrogens cream

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 0.625 mg in 1 g

Administration route:

VAGINAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

            PREMARIN Vaginal Cream therapy should not be used in women with any of the following conditions: PREMARIN Vaginal Cream 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 Vaginal Cream 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 women receiving estrogen therapy. Caution should be exercised when PREMARIN Vaginal Cream is administered to a nursing woman. PREMARIN Vaginal Cream is not indicated in children. Clinical studies have not been conducted in the pediatric population. There have not been sufficient numbers of geriatric women involved in clinical studies utilizing PREMARIN Vaginal Cream to determine whether those over 65 years of age differ from younger subjects in their response to PREMARIN Vaginal Cream. The Women's Health Initiative Studies 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 Warnings and Precautions (5.2), and Clinical Studies (14.2)] . In the WHI estrogen plus progestin substudy (daily CE [0.625 mg] plus MPA [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see Warnings and Precautions (5.2, 5.3), and Clinical Studies (14.2)] . 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 (5.4), and Clinical Studies (14.3)] . 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 (5.4), and Clinical Studies (14.3)] . The effect of renal impairment on the pharmacokinetics of PREMARIN Vaginal Cream has not been studied. The effect of hepatic impairment on the pharmacokinetics of PREMARIN Vaginal Cream has not been studied.

Product summary:

PREMARIN (conjugated estrogens) Vaginal Cream—Each gram contains 0.625 mg conjugated estrogens, USP. Combination package: Each contains a net wt. of 1.06 oz (30 g) tube with plastic applicator(s) calibrated in 0.5 g increments to a maximum of 2 g (NDC 0046-0872-21). 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].

Authorization status:

New Drug Application

Summary of Product characteristics

PREMARIN VAGINAL- CONJUGATED ESTROGENS CREAM
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® VAGINAL
CREAM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PREMARIN VAGINAL
CREAM.
PREMARIN (CONJUGATED ESTROGENS) VAGINAL CREAM.
INITIAL U.S. APPROVAL: 1946
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER
AND PROBABLE DEMENTIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ESTROGEN-ALONE THERAPy
•
•
•
•
ESTROGEN PLUS PROGESTIN THERAPY
•
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions, Malignant Neoplasms
(5.3)
02/2024
INDICATIONS AND USAGE
PREMARIN (conjugated estrogens) Vaginal Cream is a mixture of
estrogens indicated for:
•
•
DOSAGE AND ADMINISTRATION
•
•
THERE IS AN INCREASED RISK OF ENDOMETRIAL CANCER IN A WOMAN WITH A
UTERUS WHO
USES UNOPPOSED ESTROGENS (5.3)
ESTROGEN-ALONE THERAPY SHOULD NOT BE USED FOR THE PREVENTION OF
CARDIOVASCULAR
DISEASE OR DEMENTIA (5.2, 5.4)
THE WOMEN'S HEALTH INITIATIVE (WHI) ESTROGEN-ALONE SUBSTUDY REPORTED
INCREASED
RISKS OF STROKE AND DEEP VEIN THROMBOSIS (DVT) (5.2)
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 (5.4)
ESTROGEN PLUS PROGESTIN THERAPY SHOULD NOT BE USED FOR THE PREVENTION
OF
CARDIOVASCULAR DISEASE OR DEMENTIA (5.2, 5.4)
THE WHI ESTROGEN PLUS PROGESTIN SUBSTUDY REPORTED INCREASED RISKS OF
STROKE, DVT,
PULMONARY EMBOLISM (PE), AND MYOCARDIAL INFARCTION (MI) (5.2)
THE WHI ESTROGEN PLUS PROGESTIN SUBSTUDY REPORTED INCREASED RISKS OF
INVASIVE
BREAST CANCER (5.3)
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
(5.4)
Treatment of Atrophic Vaginitis and Kraurosis Vulvae (1.1)
Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and
Vag