DEPO-PROVERA CONTRACEPTIVE 150MG/ML 1 ML BOTTLE

pharmachologic effect

The progestogen, which has a long-lasting effect when i / m is administered, and does not possess at the same time androgenic and estrogenic activity. It suppresses the secretion of pituitary gonadotropins (especially luteinizing), as a result of which follicle maturation is prevented in women and prolonged anovulation is observed. Reduces vasomotor symptoms in the period of menopause, inhibits endometrial secretory changes, increases the viscosity of the cervical mucus, increases the number of intermediate cells in the maturation index of the vaginal epithelium, does not affect lactation. In men, progestogens inhibit testosterone production. Possible manifestation of androgenic and anabolic effects. When taken for contraception reduces the risk of inflammatory diseases of the genital organs, vulvovaginal candidiasis. Most women with endometrial hyperplastic processes experience partial or complete regression. When administered parenterally in high doses has an antitumor effect in hormone-sensitive tumors. The antitumor effect is determined by the complex effect on the pituitary gland, estrogen receptors and the metabolism of steroid hormones at the tissue level.In breast cancer, there is a correlation between the effectiveness of therapy and the concentration of estrogen and Progesterone receptors in the tumor tissue. In large doses, has GKS activity.

Communication with plasma proteins - 90-95%. It penetrates the BBB, is excreted in breast milk. Metabolized in the liver. T1 / 2 - about 30 hours. It is excreted in bile and kidneys as metabolites and unchanged.

Indications and usage

Contraception, especially in women of late reproductive age, endometriosis, differential diagnosis of primary and secondary amenorrhea, correction of side effects from the endometrium during estrogen therapy in menopause, anovulatory metrorrhagia, secondary amenorrhea, premenstrual syndrome, vasomotor symptoms during menopause, prevention and treatment. postmenopausal period (in combination with estrogen and Calcium supplements). Additional and palliative treatment: kidney cancer (recurrent and metastatic), breast cancer (hormone-dependent, recurrent, postmenopausal), endometrial cancer (including metastatic), prostate cancer, prostate adenoma (some forms), cancerous cachexia with advanced tumors of various localization.

Hypersensitivity, pregnancy, tumors of the genital organs or the mammary gland (except for cases of antitumor therapy), bleeding from the genital tract of unknown origin, the period of lactation.With caution - thrombophlebitis, thromboembolism or stroke (increased risk of development or history), liver failure, hypercalcemia, epilepsy, migraine, bronchial asthma, cardiac or renal failure, diabetes, depressive states.

Suppression of ovulation (contraception): recommended dose - 150 mg every 3 months (deep i / m injection). To ensure that the patient is not pregnant at the time of the initial use of the drug, it is recommended that the first injection be made within the first 5 days after the start of the next menstruation or earlier than 6 weeks after delivery. Dysfunctional (anovulatory) uterine bleeding: by mouth, 5-10 mg / day for 10 days. During this time, the bleeding gradually stops. 3–7 days after discontinuation, progestin “withdrawal” begins to bleed. After this, the therapy can be repeated starting from the 16th day of the cycle for 2-3 cycles. Endometriosis: intramuscularly, the recommended dose is 50 mg 1 time per week, or 100 mg 1 time per 2 weeks for at least 6 months. Due to the long-term effect, recovery of the menstrual cycle after such therapy may occur some time later. In addition to i / m administration, it is possible to treat endometriosis by oral administration, 10 mg 3 times a day for 90 days, starting from the first day of the cycle. Differential diagnosis of primary and secondary amenorrhea: the drug is prescribed for 5-10 mg / day for 10 days.For the prevention of endometrial hyperplasia with estrogen therapy in menopause: 5-10 mg / day for at least 10 days, starting from the 16th day of the 25-day course of treatment with estrogen. Additional and palliative treatment of recurrent and metastatic endometrial cancer or kidney cancer: 200-600 mg / day, by mouth; with the / m injection of the depot form prescribed by 500-1000 mg / week, maintenance dose - 500 mg / week. Breast cancer: by mouth, 400-1200 mg / day; V / m - 500 mg / day for 28 days, then switch to a maintenance dose - 500 mg 1 time in 2 weeks. The results of treatment can appear in 8-10 weeks. For the prevention and treatment of osteoporosis in postmenopausal women, from 12-15 to 25 days of the month, 5-10 mg 1 time per day.

Adverse reactions

From the nervous system: headache, dizziness, irritability, insomnia, drowsiness, fatigue, depression. On the part of the digestive system: nausea, pain and discomfort in the abdomen. On the part of the hemostatic system: thromboembolic disorders (thrombophlebitis, cerebrovascular disorders, thromboembolism of the branches of the pulmonary artery, renal thrombosis). Allergic reactions: urticaria, pruritus, rash, anaphylactoid reactions. On the part of the endocrine system: increased sensitivity of the nipples of the mammary glands, galactorrhea, cervical erosion, dysmenorrhea, blood-thinning, decreased glucose tolerance. When applied in a dose of more than 500 mg / day - "vulgar" acne, hirsutism, weight change, moon-shaped face.Other: hyperthermia, alopecia. Local reactions: at the injection site - pain, residual induration, change in skin color.

Special notes

When conducting histopathological studies of certain organs and tissues, it is necessary to warn the histologist about the previous treatment with gestagens. During the treatment, changes are possible during the following studies: determination of the content of gonadotropins, gestagen, cortisol, testosterone (in men), estrogen (in women) in plasma; determination of the content of pregnandiol in the urine; carrying out test with sugar loading; Conducting a test with a metapiron. In the presence of depressive conditions in history, careful monitoring is necessary during the treatment period. Before starting therapy, erosion of the cervix should be sanitized. With continued erosion - careful medical supervision. When dysfunctional uterine bleeding necessarily exclude cancer of the uterus and other organic lesions. Suspicion of the development of thrombophilic conditions requires immediate cancellation.

Aminoglutethimide reduces plasma concentration and decreases efficacy.