PREMARIN (conjugated estrogens) Vaginal Cream is a mixture of estrogens indicated for:

• Treatment of Atrophic Vaginitis and Kraurosis Vulvae (1.1)
• Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause (1.2)

• Cyclic administration of 0.5 to 2 g intravaginally [daily for 21 days then off for 7 days] for Treatment of Atrophic Vaginitis and Kraurosis Vulvae (2. 1)
• Cyclic administration of 0.5 g intravaginally [daily for 21 days then off for 7 days] for Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause (2. 2)
• Twice-weekly administration of 0.5 g intravaginally [for example, Monday and Thursday] for Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause (2. 2)

• Each gram contains 0.625 mg conjugated estrogens, USP (3)
• Combination package: Each contains a net wt. 1.06 oz (30 g) tube with plastic applicator(s) calibrated in 0.5 g increments to a maximum of 2 g (3)

• Undiagnosed abnormal genital bleeding (4)
• Known, suspected, or history of breast cancer (4, 5.3)
• Known or suspected estrogen-dependent neoplasia (4, 5.3)
• Active DVT, PE, or a history of these conditions (4, 5.2)
• Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions (4, 5.2)
• Known anaphylactic reaction or angioedema to PREMARIN Vaginal Cream (5.16, 5.17)
• Known liver dysfunction or disease (4, 5.10)
• Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders (4)
• Known or suspected pregnancy (4, 8.1)

• Estrogens increase the risk of gallbladder disease (5.5)
• Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs (5.6, 5.7, 5.10, 5.11)
• Monitor thyroid function in women on thyroid replacement therapy (5.12, 5.21)

In a prospective, randomized, placebo-controlled, double-blind study, the most common adverse reactions ≥ 2 percent are headache, pelvic pain, vasodilation, breast pain, leucorrhea, metrorrhagia, vaginitis, vulvovaginal disorder (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Inducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism (7.1)

• Nursing Mothers: Estrogen administration to nursing women has been shown to decrease the quantity and quality of breast milk (8.3)
• Geriatric Use: An increased risk of probable dementia in women over 65 years of age was reported in the Women's Health Initiative Memory ancillary studies of the Women's Health Initiative (5.4, 8.5)