PROMETRIUM Dosage & Rx Info | Uses, Side Effects

Prometrium Generic Name & Formulations

Legal Class

General Description

Progesterone (micronized) 100mg, 200mg; caps; contains peanut oil.

How Supplied

Caps—100

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from excessive moisture.

Manufacturer

Virtus Pharmaceuticals, Inc.

Generic Availability

YES

Mechanism of Action

Prometrium is an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin. The oral bioavailability of progesterone is increased through micronization.

Prometrium Indications

Indications

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

Prometrium Dosage and Administration

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 established.

Prometrium Contraindications

Contraindications

Undiagnosed vaginal bleeding. Breast carcinoma or history of. Active DVT, PE, arterial thromboembolic disease (eg, stroke, MI) or a history of. Hepatic dysfunction or disease. Peanut allergy. Pregnancy.

Prometrium Boxed Warnings

Boxed Warning

Cardiovascular disorders, probable dementia, and breast cancer for estrogen plus progestin therapy.

Prometrium Warnings/Precautions

Warnings/Precautions

Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular disorders (eg, stroke, MI, VTE); discontinue if occurs or suspected. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of breast or ovarian cancer. Risk of probable dementia in women ≥65yrs of age. Visual abnormalities. Permanently discontinue if exam reveals papilledema or retinal vascular lesions. Monitor conditions that may predispose to fluid retention. Do initial and annual physical exam (include BP, PAP smear, mammogram). Monitor diabetics. Renal or hepatic impairment. Nursing mothers.

Prometrium Pharmacokinetics

Distribution

Serum protein bound: ~96–99% (primarily albumin and transcortin).

Metabolism

Hepatic.

Elimination

Renal.

Prometrium Interactions

Interactions

Concomitant estrogen may interfere with lab tests (eg, hepatic function, coagulation factors, pregnanediol determination, thyroid function).

Prometrium Adverse Reactions

Adverse Reactions

Headache, breast tenderness/pain/carcinoma, joint pain, depression, dizziness, abdominal bloating/pain, hot flashes, urinary problems, vaginal discharge, nausea, vomiting, worry, chest pain, diarrhea, night sweats, swelling of hands and feet, vaginal dryness, constipation, breast excisional biopsy, cholecysectomy.

Prometrium Clinical Trials

See Literature

Prometrium Note

Not Applicable

Prometrium Patient Counseling