ANGELIQ (drospirenone and estradiol) is indicated in women who have a uterus for the:

1. Treatment of moderate to severe vasomotor symptoms associated with the menopause.
2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

The dosage of ANGELIQ (drospirenone and estradiol) is one tablet daily. Women who are already using a product containing estrogen should stop taking that product before starting ANGELIQ (drospirenone and estradiol) .

Use of estrogen, alone or in combination with a progestin, should be limited to the lowest effective dose available and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (see BOXED WARNINGS and WARNINGS sections). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

The lowest effective dose of ANGELIQ (drospirenone and estradiol) has not been determined.

ANGELIQ TABLETS (drospirenone and estradiol) 0.5 mg/1 mg are available as round, biconvex pink film-coated tablets embossed with “CK” inside a hexagon, and supplied in the following packaging:

3 blisters of 28 tablets NDC 50419-483-03

Storage Conditions

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)

[See USP Controlled Room Temperature].

Manufactured for: Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ 07470. Manufactured in Germany. FDA revision date: 9/28/2005

Last reviewed on RxList: 1/16/2009
This monograph has been modified to include the generic and brand name in many instances.