Progesterone (Oral)
Brand Name: Prometrium
Generic Available
Common Dosage Forms:
Capsules: 100 mg, 200 mg of micronized progesterone. Inactive ingredients include peanut oil.
FDA Indications/Dosages:
For the prevention of endometrial hyperplasia in non hysterectomized postmenopausal women who are receiving conjugated estrogen tablets: Give 200 mg as a single daily dose in the evening for 12 days sequentially per 28-day cycle.
For the treatment of the signs and symptoms of secondary amenorrhea: Give 400 mg as a single daily dose in the evening for 10 days.
Pharmacology/Pharmacokinetics: Progestins increase the synthesis of RNA by interacting with chromatin (DNA), causing the transformation of proliferative endometrium into secretory endometrium in women with adequate endogenous estrogen. Peak plasma levels are reached in 3 hours post dose. Food increases bioavailability. Metabolism to pregnanediol and pregnanolones occur in the liver with excretion in the feces and urine.
Drug Interactions: Ketoconazole may inhibit metabolism.
Contraindications/Precautions: Contraindicated in patients allergic to peanuts; in known or suspected pregnancy; in patients with a history of thrombophlebitis, thromboembolic disorders, or cerebral apoplexy; in severe liver dysfunction or disease; in known or suspected malignancy of breast or genital organs; in undiagnosed vaginal bleeding; in missed abortions; as a diagnostic test for pregnancy. ESTROGENS PLUS PROGESTIN THERAPY INCREASES THE RISK OF CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER, AND IN WOMEN OVER 65 YEARS OF AGE, PROBABLE DEMENTIA. May cause papilledema or retinal vascular lesions. Use with caution in conditions where fluid retention can be detrimental, such as epilepsy, migraine, asthma, cardiac or renal dysfunction. May precipitate psychic depression. Use with caution in diabetic patients because glucose tolerance may be decreased.
Adverse Effects: Most frequent adverse effects include dizziness, headache, abdominal pain, musculoskeletal pain, viral infection, breast pain, nausea, diarrhea, fatigue, cough, and irritability. Less common but severe adverse effects include thromboembolic disorders, blurred or loss of vision.
Patient Consultation:
Do not take if allergic to peanuts.
May cause dizziness or drowsiness. Use caution when performing activities requiring alertness.
May be taken with food or milk if GI upset occurs.
Store in a cool, dry place away from sunlight and children.
If a dose is missed, take it as soon as possible. If it is closer to the time of your next dose than the dose you missed, skip the missed dose and return to your dosing schedule. Do not double doses.
Contact a physician if you experience leg or calf pain, loss of vision, difficulty in breathing, breast lumps, abnormal vaginal bleeding, severe headaches, vomiting, changes in speech, or numbness in an arm or leg.
