Secondary lack of menstruation. Functional (anovulatory) uterine bleeding caused by hormonal imbalance. Mild to moderate endometriosis. Prevention of endometrial hyperplasia in women taking estrogens.
Composition:
1 tabl contains 5 mg or 10 mg of medroxyprogesterone acetate. The drug contains lactose.
Action:
Synthetic derivative of progesterone. Inhibits the secretion of pituitary gonadotropins (FSH and LH), reduces ACTH and Hydrocortisone levels in blood, reduces peripheral blood testosterone, decreases estrogen (both by inhibiting FSH and enzymatic hepatic reductase induction, leading to increased testosterone clearance and associated with it, reduce conversion of androgens to estrogens) in the peripheral blood. It changes the proliferative phase of the uterine mucosa into the secretory phase. Androgenic and anabolic activities were found. It does not show estrogenic activity. It is rapidly absorbed from the gastrointestinal tract, reaching a maximum concentration in 2-4 h. Food increases the bioavailability of medroxy Progesterone, does not increase the half-life. It binds 90% of plasma proteins. It is mainly excreted in the urine. T0,5 is about 17 hours.
Contraindications:
Hypersensitivity to the components of the preparation. Pregnancy or its suspicion. In the diagnosis of pregnancy. Bleeding from the genital or urinary tract of unknown cause. Thrombotic disease veins. A stroke in an interview. Severe hepatic failure. Diagnosis or suspicion of malignancy of the breast or reproductive organ. The miscarriage has been stopped.
Precautions:
Before beginning, a full interview should be collected (including family history). Tests performed before treatment and periodically after its commencement should include, in particular, blood pressure, breast, abdominal and pelvic parameters, including cytological examination of the cervix. It is not recommended to give progestagens in women with uterus removed, except when a woman is diagnosed with endometriosis. Particularly cautiously used in case of hypersensitivity to steroids other than medroxyprogesterone acetate. You should diagnose any unexplained genital bleeding that occurs during treatment with medroxsprogesterone. Due to the risk of fluid retention, caution should be exercised when using the product in patients with co-morbid conditions such as epilepsy, migraine, asthma, cardiac or renal dysfunction, in which weight gain or fluid retention may result in worsening of the patient's condition. Patients with depression and with diabetes in an interview should be carefully observed. In the case of transmission of the endometrial tissue or a section from the cervical canal for histopathological examination, the histopathologist should be informed about the use of medroxyprogesterone. It is not recommended for patients with a history of thromboembolic or thromboembolic disorders. Treatment should be discontinued in patients who develop venous thromboembolism during treatment. Estrogens should not be used as monotherapy or in combination with progestagens in the prevention of cardiovascular disease. In studies on the long-term effects of the combined estrogen / progestogen regimen in postmenopausal women, there was an increased risk of cardiovascular events such as myocardial infarction, ischemic heart disease, stroke and venous thromboembolism. Decreased plasma levels of estrogen due to the use of medroxyprogesterone acetate may lead to a decrease in bone mineral density (BMD) in pre-menopausal women and may increase the risk of developing osteoporosis later in life. It is recommended that all patients take Calcium and vitamin D. In some patients who use medroxyprogesterone acetate for a long time, BMD assessment may be indicated. The simultaneous use of estrogen / progestagen by postmenopausal women increases the risk of developing breast cancer. The use of conjugated horse estrogen / medroxyprogesterone acetate increases the risk of dementia-related symptoms and the risk of mild cognitive impairment in postmenopausal women 65 years of age or older.Medroxyprogesterone acetate is not recommended for the prevention of dementia or mild cognitive impairment in women. It was found that the simultaneous use of estrogen with progestagen increases the risk of ovarian cancer, however, the risk was not statistically significant. If the patient experiences sudden partial or complete loss of vision or suddenly exophthalmos, diplopia or migraine, the administration should be discontinued and thorough ophthalmologic examinations should be performed. If the edema of the optic disc is diagnosed or if changes in the retinal vessels are diagnosed, the preparation should not be continued. The drug contains lactose - should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.
Pregnancy and lactation:
The drug is contraindicated in pregnancy. There are data indicating the existence of a relationship between the use of progestagen preparations in the first trimester of pregnancy and the occurrence of developmental disorders within the genital system in fetuses of both sexes. The use of the drug during breastfeeding is not recommended.
Side effects:
Hypersensitivity reactions (eg, anaphylactic and anaphylactoid reactions, angioneurotic edema), prolonged periods of ovulation, swelling and / or fluid retention, changes in body weight, insomnia, depression, headache and dizziness, nervousness, drowsiness, thrombotic disorders may occur. embolism, nausea, jaundice, acne, alopecia, hirsutism, pruritus, rash, urticaria, abnormal uterine bleeding (irregular, excessively abundant, too skimpy), lack of menstruation, cervical erosion, mycotoxicity, breast pain, breast tenderness, fatigue, injection site reactions, fever, abnormal discharge from the cervix, decreased Glucose tolerance. In addition, you may have symptoms that correspond to premenstrual depression.
Dosage:
Orally.Secondary lack of menstruation5-10 mg daily for 5-10 days. Bleeding should occur within 3-7 days after discontinuation.Functional uterine bleeding caused by hormonal imbalance5-10 mg daily for 5-10 days, administered from about the 16th to the 21st day of the cycle. Bleeding should occur within 3-7 days after discontinuation. The dose (5-10 mg) can be repeated starting from the 16th day of the cycle, through 2-3 consecutive cycles, then the treatment should be discontinued to see if the functional abnormalities have disappeared.Mild to moderate endometriosis: 10 mg 3 times a day for 90 days, starting from the first day of the menstrual cycle. In 30-40% of patients, self-limiting spotting may occur. In this case, no additional hormonotherapy is recommended.Prevention of endometrial hyperplasia in women taking estrogens: dosage is determined individually; the most common is 2.5-5 mg daily or sequentially 5-10 mg daily for 10-14 consecutive days of a 28-day cycle; bleeding or discontinuation of withdrawal occurs in 75-80% of women. The use of estrogen / progestagen combined therapy in the treatment of menopausal symptoms should be limited to the lowest effective dose and carried out for the shortest time.