Product Name :Medroxyprogesterone tablets
Nombre del Producto : Medroxiprogesterona comprimido
Standard: Internal method
sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water.
Each tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate. In addition, each tablet contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, methylcellulose, pregelatinized starch, and sodium lauryl sulfate.
Pregnancy Category X:
Medroxyprogesterone acetate tablets are contraindicated during pregnancy. Several reports suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and genital abnormalities in male and female fetuses. The risk of hypospadias in male fetuses may be doubled with exposure to these drugs. Some progestational drugs induce mild virilization of the external genitalia of female fetuses.
The administration of any drug to nursing mothers should be done only when clearly necessary since many drugs are excreted in human milk. Detectable amounts of progestin have been identified in the milk of nursing mothers receiving progestins. The effect of this on the nursing infant has not been determined.
The safety and effectiveness of medroxyprogesterone acetate tablets in pediatric patients has not been established.
INDICATIONS AND USAGE:
Medroxyprogesterone Acetate Tablets are indicated for secondary amenorrhea and for 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 0.625 mg conjugated estrogen.
Thrombophlebitis, thromboembolic disorders, cerebral apoplexy or patients with a past history of these conditions.
Liver dysfunction or disease.
Known or suspected malignancy of breast or genital organs.
Undiagnosed vaginal bleeding.
As a diagnostic test for pregnancy.
Known sensitivity to medroxyprogesterone acetate tablets.
Known or suspected pregnancy.
The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately.
Beagle dogs treated with medroxyprogesterone acetate developed mammary nodules some of which were malignant. Although nodules occasionally appeared in control animals, they were intermittent in nature, whereas the nodules in the drug-treated animals were larger, more numerous, persistent, and there were some breast malignancies with metastases. Their significance with respect to humans has not been established.
Discontinue medication pending examination if there is sudden partial or complete loss of vision, or if there is a sudden onset of proptosis, diplopia or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be withdrawn.
Detectable amounts of progestin have been identified in the milk of mothers receiving the drug. The effect of this on the nursing neonate and infant has not been determined.
Usage in pregnancy is contraindicated.
Retrospective studies of morbidity and mortality in Great Britain and studies of morbidity in the United States have shown a statistically significant association between thrombophlebitis, pulmonary embolism, and cerebral thrombosis and embolism and the use of oral contraceptives.4‑7 The estimate of the relative risk of thromboembolism in the study by Vessey and Doll6 was about sevenfold, while Sartwell and associates7 in the United States found a relative risk of 4.4, meaning that the users are several times as likely to undergo thromboembolic disease without evident cause as nonusers. The American study also indicated that the risk did not persist after discontinuation of administration, and that it was not enhanced by long continued administration. The American study was not designed to evaluate a difference between products.
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