It 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. It Is also IndIcated to reduce the IncIdence of endometrIal hyperplasIa In nonhysterectomIzed postmenopausal women receIvIng daIly oral conjugated estrogens 0.625 mg tablets.
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. While parenterally administered MPA inhibits gonadotropin production, which in turn prevents follicular maturation and ovulation, available data indicate that this does not occur when the usually recommended oral dosage is given as single daily doses.
Secondary Amenorrhea It 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 It 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 It 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 It 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 It 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 It. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with It. 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. It 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 It has not been determined
Medroxyprogesterone acetate (MPA) is metabolized in-vitro primarily by hydroxylation via the CYP3A4. Specific drug-drug
interaction studies evaluating the clinical effects with CYP3A4 inducers or inhibitors on MPA have not been conducted.
Inducers and/or inhibitors of CYP3A4 may affect the metabolism of MPA.
OVERA should not be used in women with any of the following conditions: 1. Undiagnosed abnormal genital bleeding 2. Known, suspected, or history of cancer of the breast 3. Known or suspected estrogen- or progesterone-dependent neoplasia 4. Active deep vein thrombosis, pulmonary embolism or a history of these conditions 5. Active or recent (within the past year) arterial thromboembolic disease (for example, stroke and myocardial infarction) 6. Known liver dysfunction or disease 7. Missed abortion 8. As a diagnostic test for pregnancy 9. Known hypersensitivity to the ingredients in It tablets 10. Known or suspected pregnancy.
1. Genitourinary system Abnormal uterine bleeding (irregular, increase, decrease), change in menstrual flow, breakthrough bleeding, spotting, amenorrhea, changes in cervical erosion and cervical secretions. 2. Breasts Breast tenderness, mastodynia or galactorrhea has been reported. 3. Cardiovascular Thromboembolic disorders including thrombophlebitis and pulmonary embolism have been reported. 4. Gastrointestinal Nausea, cholestatic jaundice. 5. Skin Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred. Acne, alopecia and hirsutism have been reported. 6. Eyes Neuro-ocular lesions, for example, retinal thrombosis, and optic neuritis. 7. Central nervous system Mental depression, insomnia, somnolence, dizziness, headache, nervousness. 8. Miscellaneous Hypersensitivity reactions (for example, anaphylaxis and anaphylactoid reactions, angioedema), rash (allergic) with and without pruritus, change in weight (increase or decrease), pyrexia, edema/fluid retention, fatigue, decreased glucose .
Pregnancy Category X: It should not be used during pregnancy. There may be increased risks for hypospadias, clitoral enlargement and labial fusion in children whose mothers are exposed to It during the first trimester of pregnancy. However, a clear association between these conditions with use of It has not been established. Nursing Mothers It should not be used during lactation. Detectable amounts of progestin have been identified in the milk of nursing mothers receiving progestins.
Overdosage of estrogen plus progestin therapy may cause nausea and vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of CE plus MPA together with institution of appropriate symptomatic care.
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
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