PROMETRIUM Capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.

Prevention of Endometrial Hyperplasia: PROMETRIUM Capsules should be given as a single daily dose at bedtime, 200 mg orally for 12 days sequentially per 28-day cycle, to postmenopausal women with a uterus who are receiving daily conjugated estrogens tablets.

Secondary Amenorrhea: PROMETRIUM Capsules may be given as a single daily dose of 400 mg at bedtime for 10 days.

Some women may experience difficulty swallowing PROMETRIUM Capsules. For these women, PROMETRIUM Capsules should be taken with a glass of water while in the standing position.

PROMETRIUM® (progesterone, USP) Capsules 100 mg are round, peach-colored capsules branded with black imprint “SV.”

NDC 0032-1708-01 ............................................................................... (Bottle of 100)

PROMETRIUM® (progesterone, USP) Capsules 200 mg are oval, pale yellow-colored capsules branded with black imprint “SV2.”

NDC 0032-1711-01 ............................................................................... (Bottle of 100)

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Dispense in tight, light-resistant container as defined in USP/NF, accompanied by a Patient Insert.

Protect from excessive moisture.

Keep out of reach of children.

Manufactured by: Cardinal Health Encapsulation Technologies St. Petersburg, FL 33716
Marketed by: Solvay Pharmaceuticals, Inc. Marietta, GA 30062
All rights reserved.
Rev Dec 2004
FDA rev date: 3/4/2004

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