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In 1 ml of a concentrate of a mitoksantron of 2 mg. Acetic acid; sodium acetate; sodium chloride; sodium pyrosulphite, water as excipients.
Concentrate of 2 mg/ml in bottles of 5 ml for preparation of the solution entered intravenously.
Pharmacodynamics and pharmacokinetics
Antimetabolite of group of synthetic anthracyclines. Blocks topoisomerase II and processes of replication and a transcription of RNA and DNA, inhibits a mitosis of cells in a S-phase of the proliferating and not proliferating cells. Cross resistance with cytostatics therefore it can be used in a combination with them is not noted. The scale of interferon and the FNO-alpha suppresses proliferation of T-and B-lymphocytes, secretion. Myelosuppressive action is shown in 10 days.
Quickly gets into fabrics after intravenous administration. High concentration is reached (in the decreasing order) in a liver, lungs in marrow, a thyroid gland, a pancreas and kidneys). Communication with proteins — 78%. In a liver is oxidized to mono - and dicarboxylic acids. It is removed slowly: to 25% with a fecal masses and 6-11% kidneys. The moderate abnormal liver function does not influence pharmacokinetics, at expressed — the plasma clearance decreases. It is not removed at a hemodialysis.
Indications to use
- nekhodzhkinsky lymphoma;
- breast cancer;
- acute miyeloblastny leukosis;
- promiyelotsitarny leukosis;
- liver cancer;
- erythroidal leukosis;
- gormonorezistentny prostate cancer;
- the progressing multiple sclerosis.
- pregnancy and lactation.
With care it is appointed in the acute period of a myocardial infarction, heavy stenocardia, dekompensirovanny HSN, takhisistolichesky arrhythmia, acute infections of the fungal, virus and bacterial nature, a liver failure, oppression of a marrowy hemopoiesis, HPN.
- hemopoiesis oppression (neutropenia, leukopenia, thrombocytopenia);
- nausea, vomiting, diarrhea, loss of appetite, abdominal pain, bleedings, abnormal liver function;
- tachycardia, ischemia of a myocardium, arrhythmia, decrease in the ABP, aggravation of SN;
- the skin itch, the small tortoiseshell, asthma, rash, is possible an acute anaphylaxis;
- intersticial pneumonitis;
- hair loss;
- temperature increase;
- disturbance of a menstrual cycle;
- amenorrhea, seldom;
- coloring of scleras, skin and nails in blue color;
- consecutive infections;
- local reactions: hypostasis and pain in an injection site, burning, phlebitis.
Mitoksantron, application instruction (Way and dosage)
The drug is administered only in/in struyno or kapelno, vnutriplevralno or intraperitoneally. For in/in introductions the necessary quantity is dissolved in 100 ml of NaCl solution or a dextrose. A total course dose — 200 mg/sq.m of a body surface.
Doses and schemes of introduction rather difficult at various diseases are also defined only by the specialist.
Breast cancer — at monotherapy a dose of 14 mg/sq.m, in/in kapelno, 1 time in 4 weeks. Doses at repeated courses of treatment depend on neutropenia level. At a combination therapy of this disease and a nekhodzhkinsky lymphoma the dose is increased by 12-10 mg/sq.m.
Acute leukosis — 10-12 mg/sq.m daily 2-3 days, combining with Cytarabinum.
Gormonorezistentny prostate cancer — 12-14 mg/sq.m of 1 times in 3 weeks, combining with GKS.
At multiple sclerosis — 12 mg/sq.m, in/in struyno, once in 3 months.
At administration of drug urine can be painted in blue-green color. During treatment and after the termination of a course within 6 months it is necessary to use contraception methods. It is necessary to control hematologic and biochemical indicators, an ECG, EhoKG. The risk of cardiotoxicity is observed when exceeding the general dose of 140 mg/sq.m, but happens also at lower doses. The neutropenia often develops for 7-15 day. If the patient has a hyperuricemia — appoint uricosuric drugs.
Mitoksantron Lens released by LLC Lens-Farm (Russia) differs only in the fact that has broader range of packaging of a concentrate — 5 ml; 10 ml; 12,5 ml and 15 ml in a bottle. Indications and route of administration same.
At overdose side effects quickly accrue and develop, and they are more expressed. Treatment consists in carrying out symptomatic therapy as the hemodialysis is inefficient.
Other antineoplastic drugs when sharing raise kardio-and a miyelotoksichnost. So, doxorubicine increases risk of cardiotoxicity. At simultaneous purpose of the drugs blocking canalicular secretion (uricosuric, antigouty, Sulfinpyrazonum) increases risk of a nephropathy. Mitoksantron is incompatible with heparin and thiamin (pharmaceutical).
Terms of sale
According to the recipe.
Temperature is up to 25 °C.
Period of validity
Coincidence on the ATH code of the 4th level:
Mitolek, Onkotron, Novatron.
Responses of patients most often contain information on drug use Mitoksantron at multiple sclerosis. This drug is carried to medicines which use slows down progressing of a disease and increase of an invalidism, allows to reduce weight and frequency of aggravations. It was appointed to many patients once in three months, in general patients received 8-12 infusions for 2-3 flyings. Responses are ambiguous, however it is correct to estimate efficiency of treatment at least in a year or upon termination of a course.
- "… I was obviously helped by this drug. After two droppers there was a result. Now there passed enough time, and the state does not worsen".
- "… Received treatment complex, including in parallel completed a course from 7 droppers of Mitoksantron. The state did not improve, but also does not progress".
By results of 2 years' research on use of this drug for patients reduction of number of recurrence and reduction in the rate of increase of neurologic symptomatology is noted. There are data on efficiency of a combination of a mitoksantron + a kopaksona.
Therapy by Mitoksantron sometimes became the reason of female infertility and caused complications from heart. In this regard prior to treatment the assessment of a condition of cardiovascular system was surely carried out. Drug suppresses immune system therefore the risk of development of infections increases.
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