Generic Name and Formulations:
Medroxyprogesterone acetate 2.5mg, 5mg, 10mg; scored tabs.
Indications for PROVERA:
To prevent endometrial hyperplasia in postmenopausal women with an intact uterus receiving conjugated estrogens. Secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance without organic pathology.
Use lowest effective dose for shortest duration. Reevaluate periodically. Endometrial hyperplasia prophylaxis: 5–10mg daily for 12–14 days per month starting on Day 1 or Day 16. Amenorrhea: 5–10mg daily for 5–10 days; to induce optimum secretory transformation of primed endometrium: 10mg daily for 10 days; may start at any time. Abnormal bleeding: 5–10mg daily for 5–10 days starting on Day 16 or 21 of menstrual cycle; to induce optimum secretory transformation of primed endometrium: 10mg daily for 10 days starting on Day 16.
Undiagnosed abnormal genital bleeding. Known, suspected, or history of breast cancer. Known or suspected estrogen-dependent neoplasia. Active DVT, PE, or history of. Active arterial thromboembolic disease (eg, stroke, MI) or a history of. Hepatic impairment. Pregnancy (Cat.X).
Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular disorders (eg, stroke, MI, DVT, VTE); discontinue if occurs or suspected. Manage risk factors for CVD and VTE appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Endometrial, breast, or ovarian cancer. Risk of probable dementia in women ≥65yrs of age. Visual abnormalities. Hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, or loss of vision occurs. Conditions aggravated by fluid retention (eg, cardiac or renal impairment). Hypoparathyroidism. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical (include Pap smear, mammogram, BP) and repeat annually. Nursing mothers: not recommended.
Medroxyprogesterone metabolism may be affected by CYP3A4 inducers/inhibitors. Thyroid replacement therapy (may need dose adjustment). May interfere with lab tests (eg, PT, thyroid, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding proteins).
Abnormal uterine bleeding, weight or menstrual or cervical changes, breast tenderness, mastodynia, galactorrhea, thromboembolic disorders, acne, hirsutism, alopecia, edema, neuro-ocular lesions, depression, insomnia, somnolence, dizziness, headache, rash, pyrexia, fatigue, decreased glucose tolerance.
Tabs 2.5mg—30, 100; 5mg—100; 10mg—100, 500