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Prometrium

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Prometrium

Prometrium

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

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 a postmenopausal woman with a uterus who is receiving daily conjugated estrogens tablets.

Treatment of 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.

HOW SUPPLIED

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

NDC 0032-1708-01 (Bottle of 100)

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

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].

Protect from excessive moisture.

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

Keep out of reach of children.

Manufactured by: Catalent Pharma Solutions St. Petersburg, FL 33716. Marketed by: Abbott Laboratories North Chicago, IL 60064, U.S.A.

Last reviewed on RxList: 1/19/2012
This monograph has been modified to include the generic and brand name in many instances.

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