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Medroxyprogesterone (Medroxyprogesterone Acetate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Medroxyprogesterone Acetate Tablets are 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. Medroxyprogesterone Acetate Tablets are also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg tablets.

DOSAGE AND ADMINISTRATION

Secondary Amenorrhea

Medroxyprogesterone acetate 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 medroxyprogesterone acetate 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 medroxyprogesterone acetate 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 medroxyprogesterone acetate 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 medroxyprogesterone acetate 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 medroxyprogesterone acetate. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with medroxyprogesterone acetate.

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.

Medroxyprogesterone acetate 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 medroxyprogesterone acetate has not been determined.

HOW SUPPLIED

Medroxyprogesterone Acetate Tablets, USP are available as:

2.5 mg:White, round, scored, biconvex tablet. Debossed with 555/872 on the scored side and stylized b on the other side.
Available in bottles of:
30 TabletsNDC 0555-0872-01
100 TabletsNDC 0555-0872-02
500 TabletsNDC 0555-0872-04
1000 TabletsNDC 0555-0872-05
5 mg:White, round, scored, biconvex tablet. Debossed with 555/873 on the scored side and stylized b on the other side.
Available in bottles of:
30 TabletsNDC 0555-0873-01
100 TabletsNDC 0555-0873-02
500 TabletsNDC 0555-0873-04
1000 TabletsNDC 0555-0873-05
10 mg:White, round, scored, biconvex tablet. Debossed with 555/779 on the scored side and stylized b on the other side.
Available in bottles of:
30 TabletsNDC 0555-0779-01
100 TabletsNDC 0555-0779-02
500 TabletsNDC 0555-0779-04
1000 TabletsNDC 0555-0779-05

Dispense with a child-resistant closure in a tight container.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

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