Prometrium Generic Name & Formulations
Legal Class
Rx
General Description
Progesterone (micronized) 100mg, 200mg; caps; contains peanut oil.
How Supplied
Caps—100
Manufacturer
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 history of. Known liver dysfunction or disease. Peanut allergy. Pregnancy (Cat.B).
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, DVT, 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. Conditions that may be aggravated by fluid retention. Discontinue pending exam if sudden loss of vision, proptosis, diplopia or migraine occurs. Permanently discontinue if exam reveal papilledema or retinal vascular lesions. Do initial and annual physical exam (include BP, PAP smear, mammogram). Monitor diabetics. Renal or hepatic dysfunction. Nursing mothers.
Prometrium Pharmacokinetics
See Literature
Prometrium Interactions
Not Applicable
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
See Literature