Please scroll for PREMARIN Vaginal Cream Important Safety Information and Indications

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

The Women's Health Initiative (WHI) estrogen alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women during 7.1 years of treatment with daily oral conjugated estrogens (CE) alone, relative to placebo. The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism, stroke, and myocardial infarction in postmenopausal women during 5.6 years of treatment with daily oral CE combined with medroxyprogesterone acetate (MPA), relative to placebo. In the absence of comparable data, these risks should be assumed to be similar for other dosage forms of estrogens.

The WHI Memory Study (WHIMS) estrogen alone study reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE alone, relative to placebo. The WHIMS estrogen plus progestin study reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE combined with MPA, relative to placebo. It is unknown whether these findings apply to younger postmenopausal women.

The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer.

Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia.

Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

PREMARIN Vaginal Cream should not be used in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or a 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 (ie, stroke, myocardial infarction), or a history of these conditions; anaphylactic reaction or angioedema to PREMARIN Vaginal Cream; liver dysfunction or disease; thrombophilic disorders; pregnancy.

In a prospective, randomized, placebo-controlled, double-blind study, the most common adverse reactions (≥2%) were headache, pelvic pain, vasodilation, breast pain, leucorrhea, metrorrhagia, vaginitis, and vulvovaginal disorder.

INDICATIONS

PREMARIN Vaginal Cream is indicated for the treatment of atrophic vaginitis and kraurosis vulvae; and for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

References: 1. Bachmann G, Bouchard C, Hoppe D, et al. Efficacy and safety of low-dose regimens of conjugated estrogens cream administered vaginally. Menopause. 2009;16(4):719-727. 2. Bachmann GA, Nevadunsky NS. Diagnosis and treatment of atrophic vaginitis. Am Fam Phys. 2000;61(10):3090-3096. 3. Data on file, Pfizer Inc. 4. Dorr MB, Nelson AL, Mayer P, et al. Plasma estrogen concentrations after oral and vaginal estrogen administration in women with atrophic vaginitis. Fertil Steril. 2010;94(6):2365-2368. 5. Lynch C. Vaginal estrogen therapy for the treatment of atrophic vaginitis. J Women's Health. 2009;18(10):1595-1606. 6. Pandit L, Ouslander J. Postmenopausal vaginal atrophy and atrophic vaginitis. Am J Med Sci. 1997;314(4):228-231. 7. Reimer A, Johnson L. Atrophic vaginitis: signs, symptoms, and better outcomes. Nurse Pract. 2011;36(1):22-28.

Important Safety Information

Please scroll for PREMARIN Vaginal Cream Important Safety Information and Indications

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

The Women's Health Initiative (WHI) estrogen alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women during 7.1 years of treatment with daily oral conjugated estrogens (CE) alone, relative to placebo. The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism, stroke, and myocardial infarction in postmenopausal women during 5.6 years of treatment with daily oral CE combined with medroxyprogesterone acetate (MPA), relative to placebo. In the absence of comparable data, these risks should be assumed to be similar for other dosage forms of estrogens.

The WHI Memory Study (WHIMS) estrogen alone study reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE alone, relative to placebo. The WHIMS estrogen plus progestin study reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE combined with MPA, relative to placebo. It is unknown whether these findings apply to younger postmenopausal women.

The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer.

Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia.

Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

PREMARIN Vaginal Cream should not be used in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or a 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 (ie, stroke, myocardial infarction), or a history of these conditions; anaphylactic reaction or angioedema to PREMARIN Vaginal Cream; liver dysfunction or disease; thrombophilic disorders; pregnancy.

In a prospective, randomized, placebo-controlled, double-blind study, the most common adverse reactions (≥2%) were headache, pelvic pain, vasodilation, breast pain, leucorrhea, metrorrhagia, vaginitis, and vulvovaginal disorder.

INDICATIONS

PREMARIN Vaginal Cream is indicated for the treatment of atrophic vaginitis and kraurosis vulvae; and for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.