Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
Provera Generic Name & Formulations
Legal Class
Rx
General Description
Medroxyprogesterone acetate 2.5mg, 5mg, 10mg; scored tabs.
Pharmacological Class
Progestin.
How Supplied
Tabs 2.5mg—30, 100; 5mg—100; 10mg—100, 500
Manufacturer
Generic Availability
YES
Provera Indications
Indications
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.
Provera Dosage and Administration
Adult
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.
Children
Not applicable.
Provera Contraindications
Contraindications
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.
Provera Boxed Warnings
Boxed Warning
Cardiovascular disorders, probable dementia, and breast cancer for estrogen plus progestin therapy.
Provera Warnings/Precautions
Warnings/Precautions
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 arterial vascular disease and/or 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.
Provera Pharmacokinetics
See Literature
Provera Interactions
Interactions
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).
Provera Adverse Reactions
Adverse Reactions
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.
Provera Clinical Trials
See Literature
Provera Note
Not Applicable
Provera Patient Counseling
See Literature
