(conjugated estrogens)
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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: 1942 WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIASee full prescribing information for complete boxed warning.Estrogen-Alone Therapy
Estrogen Plus Progestin Therapy
INDICATIONS AND USAGEDOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHSCONTRAINDICATIONS
WARNINGS AND PRECAUTIONSADVERSE REACTIONSIn a prospective, randomized, placebo-controlled, double-blind study, the most common adverse reactions ≥ 2% are headache, pelvic pain, vasodilation, breast pain, leucorrhea, metrorrhagia, vaginitis, vulvovaginal disorder (6.1)
DRUG INTERACTIONSInducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism (7.1) USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 4/2025 |
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