Depo-provera suspension for intramuscular injection. 500mg 3.3ml N3 fl3.3ml
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Description
Depo Provera is an antitumor drug, the gestagen is a depot form. Does not possess androgenic and estrogenic activity. Depo-Provera inhibits the secretion of gonadotropic hormones (especially LH). In small doses, inhibits ovulation. It has an inhibitory effect on the changes necessary to prepare the endometrium for implantation of a fertilized egg and increases the viscosity of the mucus of the cervix. Depo-Provera in higher doses has an antitumor effect in hormone-sensitive malignant tumors. This effect is due, apparently, to the action on the receptors of steroid hormones and on the pituitary-gonadal system.
Active ingredients
Medroxyprogesterone
Release form
Suspension
Composition
Medroxyprogesterone, sodium chloride, methyl parahydroxybenzoate, propyl parahydroxybenzoate, polysorbate 80, macrogol 3350, sodium hydroxide (to bring the pH), hydrochloric acid (to bring the pH), water for injection.
Indications
Additional and palliative treatment of recurrent and metastatic endometrial cancer or kidney cancer, palliative treatment for hormone-dependent forms of recurrent breast cancer in postmenopausal women.
Use during pregnancy and lactation
Medroxyprogesterone is contraindicated in pregnancy. There are reports that, under certain conditions, there is a link between the use of progestogens during the first trimester of pregnancy and fetal genital developmental disorders. Newborns, in the case of an unplanned pregnancy that occurs within 1-2 months after the injection of medroxyprogesterone, have a greater risk of developing malnutrition, which, in turn, increases the risk of intranatal and neonatal mortality. The risk of developing such complications is relatively low, since pregnancy with medroxyprogesterone is rarely developed. If pregnancy has developed during the use of medroxyprogesterone, the patient should be warned of the possible risk to the fetus. Medroxyprogesterone is excreted in breast milk. There is no evidence that this may cause any harm to the newborn who is breastfed.However, medroxyprogesterone is not recommended for the first six weeks of the postpartum period.
Dosage and administration
Set individually, depending on the evidence, the stage of the disease, treatment regimens. In endometrial cancer and kidney cancer, the initial dose is 400-1000 mg per week intramuscularly. If within a few weeks or months there is an improvement and stabilization of the process has been achieved, then maintenance therapy is prescribed at a dose of 400 mg per month. In breast cancer, the drug is administered intramuscularly at an initial dose of 500 mg per day for 28 days. Then use maintenance doses - 500 mg 2 times a week. Treatment continues until signs of disease progression appear. Immediately before use, the vial should be shaken well, so that the injected drug takes on the appearance of a homogeneous suspension.
Side effects
Allergic reactions: anaphylaxis and anaphylactoid reactions, urticaria. From the blood coagulation system: thromboembolism, thrombophlebitis. From the side of the central nervous system: increased nervous irritability, insomnia, drowsiness, fatigue, depression, dizziness, headache. Dermatological reactions: itching, rash, acne, hirsutism and alopecia. On the part of the reproductive system: dysfunctional uterine bleeding, bleeding from the genital tract, amenorrhea, decreased libido or anorgasmia, vaginitis, leucorrhea, hot flashes, pain in the lower abdomen, breast pain, galactorrhea. On the part of the digestive system: pain or discomfort in the stomach, nausea, flatulence. On the part of the musculoskeletal system: cramps of the gastrocnemius muscles, pain in the back and joints. Other: asthenia, hyperthermia, change in body weight and moon-like face.
Overdose
The use of very high doses of the drug can cause a number of symptoms, including an increase in body weight (with some fluid retention in the body), increased fatigue, and in some cases effects inherent to glucocorticosteroids are observed. It should stop using the drug. No specific treatment is required.
special instructions
It is necessary to strictly observe the compliance of the used dosage form of the drug with indications for use. Medroxyprogesterone should be used with extreme caution in patients with thrombophlebitis, thromboembolic complications, severe impaired liver function, and hypercalcemia.Before using medroxyprogesterone for the treatment of gynecological diseases and contraception, it is necessary to exclude the presence in the patient of a tumor of the genitals or mammary glands. When conducting histopathological studies of certain organs and tissues, it is necessary to warn the histologist about the previous treatment with progestogens. Against the background of medroxyprogesterone, changes in the results of the following studies are possible: determining the level of gonadotropins, determining the level of progesterone, cortisol, testosterone (in men), estrogen (in women) in blood plasma, determining the level of pregnandiol in the urine, testing with sugar load, conducting a test with metapyronom.