PROVERA Dosage & Rx Info | Uses, Side Effects

Provera Generic Name & Formulations

Legal Class

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

Pfizer Inc.

Generic Availability

YES

Mechanism of Action

Medroxyprogesterone acetate (MPA) administered orally or parenterally in the recommended doses to women with adequate endogenous estrogen, transforms proliferative into secretory endometrium. Androgenic and anabolic effects have been noted, but the drug is apparently devoid of significant estrogenic activity.

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 or disease. 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, 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. Permanently discontinue if exam reveals papilledema or retinal vascular lesions. Preexisting hypertriglyceridemia. History of cholestatic jaundice. Discontinue if pancreatitis or recurrence of cholestatic jaundice occurs. Monitor thyroid function. Conditions aggravated by fluid retention (eg, cardiac or renal impairment). Hypoparathyroidism. Hypocalcemia. 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

Absorption

MPA is rapidly absorbed from the GI tract. Maximum MPA concentrations are obtained between 2–4 hours after oral administration. Administration with food increases the bioavailability of MPA.

Distribution

Plasma protein bound: ~90%.

Metabolism

Hepatic.

Elimination

Renal.

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