Angeliq (Estradiol / Drospirenone) - Indications and Dosage

Indications and Usage

ANGELIQ 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.

Dosage and Administration

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

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 has not been determined.

How Supplied

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].

REFERENCES FURNISHED UPON REQUEST

PATIENT INFORMATION

September 2005

ANGELIQ® TABLETS

(drospirenone and estradiol)

(an"ju – le – k')

Read this PATIENT INFORMATION before you start taking ANGELIQ and read what you get each time you refill ANGELIQ . There may be new information. This information does not take the place of talking to your health care provider about your medical condition or your treatment.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ANGELIQ (a combination of estrogen and a progestin)?

Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes.

Using estrogens with or without progestins may increase your chances of getting heart attack, strokes, breast cancer, and blood clots. Using estrogens with or without progestins may increase your risk of dementia. You and your healthcare provider should talk regularly about whether you still need treatment with ANGELIQ .