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Medications and Drugs

Pharmacy Author: Omudhome Ogbru, PharmD
Medical and Pharmacy Editor: Jay W. Marks, MD

GENERIC NAME: medroxyprogesterone acetate

BRAND NAME: Provera, Depo-Provera, Depo-Sub Q Provera 104

DRUG CLASS AND MECHANISM: Progestins and estrogens are the two major classes of female hormones. Medroxyprogesterone is a derivative of the naturally occurring female progestin, progesterone. Progestins are responsible for changes in the mucus and inner lining of the uterus (endometrium) during the second half (secretory phase) of the menstrual cycle. Progestins prepare the endometrium for implantation of the embryo. Once an embryo implants in the endometrium, for example, pregnancy occurs, progestins help maintain the pregnancy. At high doses, progestins can prevent ovulation (release of the egg from the ovary) and thereby prevent pregnancy. Progestins were first isolated in 1933, and progesterone itself was synthesized in the 1940s.

PRESCRIPTION: Yes

GENERIC AVAILABLE: Yes

PREPARATIONS: Tablets: 2.5, 5, and 10 mg. Intramuscular injection: 150, 160, and 400 mg/ml.

STORAGE: Medroxyprogesterone should be stored at room temperature, between 20-25 C (68-77 F).

PRESCRIBED FOR: Medroxyprogesterone tablets are used for treating secondary amenorrhea (cessation of menstruation); abnormal bleeding from the uterus due to hormonal imbalance and not due to fibroids, or cancer; and to prevent endometrial hyperplasia (overgrowth in the endometrial lining) in postmenopausal women who have not undergone a hysterectomy and are receiving conjugated estrogens. Medroxyprogesterone injection is used for contraception and for treating endometrial or renal cancer.

DOSING: The usual dose of medroxyprogesterone tablets is 5 or 10 mg daily. Secondary amenorrhea is treated for 5 to 10 days. Uterine bleeding is treated for 5 to 10 days beginning on day 16 or 21 of the menstrual cycle. Endometrial hyperplasia is treated for 12 to 14 consecutive days beginning on day 1 or 16 of the menstrual cycle.

The dose for contraception is 150 mg every 3 months injected intramuscularly or 104 mg injected subcutaneously every 3 months. The dose for endometrial or renal cancer is 400-1000 mg weekly initially followed by monthly maintenance doses.

DRUG INTERACTIONS: Aminoglutethimide (Cytadren) may increase the elimination of medroxyprogesterone by the liver leading to a decrease in the concentration of medroxyprogesterone in blood and possibly a reduction in the effectiveness of the medroxyprogesterone.

PREGNANCY: Medroxyprogesterone inhibits fertility at high doses. It should not be given during pregnancy.

NURSING MOTHERS: Medroxyprogesterone is secreted in breast milk. The effect on the infant has not been determined.

SIDE EFFECTS: Breast tenderness and leakage of liquid from the nipple occur rarely with medroxyprogesterone. Various skin reactions, including hives, acne, hair growth and hair loss, also have been reported occasionally. Break-through bleeding (menstrual-like bleeding in the middle of the menstrual cycle), vaginal spotting of blood, changes in menstrual flow, increased or decreased weight, nausea, fever, insomnia, and jaundice have all been reported.

Blood clots are an occasional serious side effect of progestin therapy, and cigarette smokers are at a higher risk for clots. Therefore, patients requiring progestin therapy are strongly encouraged to quit smoking.

Diabetic patients may experience difficulty controlling blood glucose when taking medroxyprogesterone for unclear reasons. Therefore, increased monitoring of blood sugar and adjustment of medications for diabetes is recommended.

The Women's Health Initiative (WHI) study found an increased risk of heart attacks, stroke, breast cancer, blood clots, and pulmonary emboli (blood clots that lodge in the lungs) in postmenopausal women (50-79 years old) who took medroxyprogesterone in combination with estrogens for 5 years, as well as an increased risk of dementia in the women over age 65. Therefore, medroxyprogesterone should not be used for the prevention of heart disease or dementia. Although medroxyprogesterone alone has not been demonstrated to promote breast cancer, since breast cancer has progesterone receptors, physicians usually avoid using progestins in women who have had breast cancer.

Reference: FDA Prescribing Information


Last Editorial Review: 12/10/2008




Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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Normal vaginal bleeding is the periodic blood that flows as a discharge from the woman's uterus. Normal vaginal bleeding is also called menorrhea. The process by which menorrhea occurs is called menstruation.

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