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PROMETRIUM
Menopause and HRT
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Drug Name:

PROMETRIUM Rx

Generic Name and Formulations:
Progesterone (micronized) 100mg, 200mg; caps; contains peanut oil.

Company:
Virtus Pharmaceuticals, Inc.

Therapeutic Use:

Indications for PROMETRIUM:

To prevent endometrial hyperplasia in postmenopausal women with an intact uterus receiving conjugated estrogens. Secondary amenorrhea.

Adult:

Endometrial hyperplasia prevention: 200mg once daily in the PM for 12 sequential days of each 28-day cycle. Amenorrhea: 400mg once daily in the PM for 10 days.

Children:

Not recommended.

Contraindications:

Undiagnosed vaginal bleeding. Breast or genital carcinoma. Severe liver dysfunction or disease. Missed abortion. Thrombophlebitis, thromboembolic disorders, cerebral apoplexy. Not for use as a diagnostic test for pregnancy. Peanut allergy. Pregnancy (Cat.B).

Warnings/Precautions:

Conditions that may be aggravated by fluid retention. Renal or hepatic dysfunction. Depression. Discontinue if thrombotic disorders, papilledema, or retinal vascular lesions occur. Do initial and annual physical exam (include BP, PAP smear, mammogram). Discontinue pending exam if visual disturbances or migraine occurs. Monitor diabetics. Nursing mothers: not recommended.

Adverse Reactions:

Dizziness, mastodynia, headache, abdominal pain/bloating, fatigue, musculoskeletal pain, emotional lability, GI upset, vaginal discharge.

How Supplied:

Caps—100

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