PROVERA TABLET 5 MG [SIN10513P]

Product Info

PROVERA TABLET 5 MG

[SIN10513P]

4.1 Therapeutic Indication

Gynecology
Medroxyprogesterone acetate (MPA) tablets are indicated for:

• Treatment of secondary amenorrhea.

• Treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer.

4.2 Posology and Method of Administration

Gynecology
Use of combined estrogen/progestin therapy should be limited to the lowest effective dose and shortest duration consistent with treatment goals and risks for the individual woman, and should be periodically evaluated (see Section 4.4. Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Periodic check-ups are recommended of a frequency and nature adapted to the individual woman (see Section 4.4. Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestin in a woman without an intact uterus.

Secondary Amenorrhea – MPA may be given in dosages of 5 mg to 10 mg daily for 5 to 10 days. A dose of inducing an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen is 10 mg of MPA 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 MPA therapy.

Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology – Beginning on the calculated 16^th or 21^st day of the menstrual cycle, 5 to 10 mg of MPA 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 MPA daily for 10 days beginning on the 16^th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with MPA. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with MPA.

4.3 Contraindications

MPA is contraindicated in patients with the following conditions:

• Known or suspected pregnancy

• Undiagnosed vaginal bleeding

• Severe liver dysfunction

• Known hypersensitivity to MPA or any component of the drug

• Thrombophlebitis

• Thromboembolic disorders

• Cerebral apoplexy or patients with a past history of these conditions

• Missed abortion

• Known or suspected malignancy of the breast