Source: FDA, National Drug Code (US) Revision Year: 2019
PROMETRIUM (progesterone, USP) 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.
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.
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.
No studies on overdosage have been conducted in humans. In the case of overdosage, PROMETRIUM (progesterone, USP) Capsules should be discontinued and the patient should be treated symptomatically.
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.
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