PROVERA (medroxyprogesterone acetate tablets) tablets (medroxyprogesterone acetate tablet) is a progestin indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. PROVERA (medroxyprogesterone acetate tablets) is also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg tablets.

Secondary Amenorrhea

PROVERA (medroxyprogesterone acetate tablets) tablets may be given in dosages of 5 or 10 mg daily for 5 to 10 days. A dose for inducing an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen is 10 mg of PROVERA (medroxyprogesterone acetate tablets) daily for 10 days. In cases of secondary amenorrhea, therapy may be started at any time. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing PROVERA (medroxyprogesterone acetate tablets) therapy.

Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology

Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of PROVERA (medroxyprogesterone acetate tablets) may be given daily for 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of PROVERA (medroxyprogesterone acetate tablets) daily for 10 days beginning on the 16th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with PROVERA (medroxyprogesterone acetate tablets) . Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with PROVERA (medroxyprogesterone acetate tablets) .

Reduction of Endometrial Hyperplasia in Postmenopausal Women Receiving Daily 0.625 mg Conjugated Estrogens

When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example, 3-month to 6-month intervals) to determine if treatment is still necessary (see WARNINGS). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

PROVERA (medroxyprogesterone acetate tablets) tablets may be given in dosages of 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16th day of the cycle.

Patients should be started at the lowest dose.

The lowest effective dose of PROVERA (medroxyprogesterone acetate tablets) has not been determined.

PROVERA (medroxyprogesterone acetate tablets) Tablets are available in the following strengths and package sizes:

2.5 mg (scored, round, orange)

Bottles of 30..................................................NDC 0009-0064-06
Bottles of 100..................................................NDC 0009-0064-04

5 mg (scored, hexagonal, white)

Bottles of 100..................................................NDC 0009-0286-03

10 mg (scored, round, white)

Bottles of 100..................................................NDC 0009-0050-02
Bottles of 500..................................................NDC 0009-0050-11

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. "Keep out of reach of children"

Distributed by Pharmacia & Upjohn Company, Division of Pfizer Inc, NY 101017, Revised September 2007. FDA rev date: 9/28/2007

Last reviewed on RxList: 4/10/2008
This monograph has been modified to include the generic and brand name in many instances.