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Indications
PROMETRIUM® (progesterone, USP) Capsules are indicated for use in:
- The prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogen tablets
- Secondary amenorrhea
Important Safety Information
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA
FOR ESTROGEN PLUS PROGESTIN THERAPY
Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.
The Women's Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of stroke, deep vein thrombosis (DVT), pulmonary embolism, and myocardial infarction in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.
The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.
The Women's Health Initiative Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age or older.
PROMETRIUM® Capsules are contraindicated in women with the following conditions:
- Allergy to peanuts (PROMETRIUM® Capsules contain peanut oil) or other ingredients
- Undiagnosed abnormal vaginal bleeding
- Known, suspected, or history of breast cancer
- Active deep vein thrombosis, pulmonary embolism or history of these conditions
- History of arterial thromboembolic disease (for example, stroke and myocardial infarction)
- Known liver dysfunction or disease
- Known or suspected pregnancy
Estrogen plus progestin therapy should be discontinued immediately if pulmonary embolism, deep vein thrombosis (DVT), stroke or myocardial infarction occur or are suspected.
Estrogens with progestins should be discontinued at least 4 to 6 weeks prior to surgery with an increased risk of thromboembolism or during periods of prolonged immobilization.
Estrogen plus progestin therapy can result in an increase in abnormal mammograms requiring further evaluation. Women should perform monthly breast exams and have an annual exam by a healthcare provider.
Clinical surveillance and adequate diagnostic measures of all women using estrogen plus progestin therapy is important to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Discontinue this medication if sudden partial or complete loss of vision occurs, or if there is a sudden onset of proptosis, diplopia or migraine. If examination reveals papilledema or retinal vascular lesions, permanently discontinue this medication.
Observe women with cardiac and renal dysfunction carefully, as fluid retention may occur.
Dizziness and/or drowsiness are common. Patients should take a single dose at bedtime and use caution while driving or operating machinery.
The most common adverse experiences reported by ≥10% of patients receiving PROMETRIUM® alone or in combination with conjugated estrogens and greater than placebo include dizziness, abdominal pain (cramping), headache, breast tenderness/pain, musculoskeletal pain, viral infection, depression, urinary problems, abdominal distension (bloating) and vaginal discharge.
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