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Temozolomid, silicon dioxide colloid, tartaric acid, sodium carboxymethylstarch, anhydrous lactose, stearic acid, titanium dioxide, gelatin, isopropanol, propylene glycol, indigo carmine, oxide yellow.
Capsules gelatinous dark-blue color 5, 20, 100, 140, 250 of mg in plastic bottles in cardboard packaging No. 5, 20.
Pharmacodynamics and pharmacokinetics
The means with imidazotetrazinovy structure with antineoplastic effect caused by the alkylating action. Getting in system a blood-groove quickly turns into the MTIK active connection (monometiltriazenoimidazolkarboksamid) which cytotoxicity is caused by alkylation of guanine in various situation. Allegedly such cytotoxic damages, start the mechanism of recovery of the methyl rest.
Drug is quickly soaked up from a gastrointestinal tract. Cmax in blood is reached in one hour after reception of a dose. Administration of drug together with food reduces the size of the maximum concentration. Gets through GEB. Communication with proteins of plasma at the level of 10-20%. It is brought out of an organism with urine. Elimination half-life 2 hours.
Indications to use
- In therapy of malignant gliomas at recurrence or progressing of a disease after a course of standard therapy;
- Treatment of a widespread malignant melanoma with existence of metastasises (as drug of the first row).
High sensitivity to drug, a miyelosupressiya, the period of pregnancy and a lactation. To take with caution to patients after 70 flyings and existence of renal failures and a liver, to patients whose professional activity demands high concentration of attention.
Dizziness, fatigue, drowsiness, headache, paresthesias, nausea, a lock, anorexia, vomiting, diarrhea, pains in a stomach, taste disturbance, dyspepsia, a skin itch, rashes, an alopecia, an asthma, anemia, a leukopenia, thrombocytopenia, an adynamy, a fever, weight reduction of a body, fever, an indisposition.
Temozolomid, application instruction (Way and dosage)
To accept to swallow, on an empty stomach, capsules entirely in one hour prior to meal, washing down with water.
Initial dose for adults — 200 mg/sq.m once a day for 5 days in a row during a 28-day therapeutic cycle. To the patients taking a chemotherapy course earlier the initial dose is reduced to 150 mg/sq.m with the subsequent increase of a dosage in the second cycle to 200 mg/sq.m. Duration of a course is individual.
Overdose symptoms — a neutropenia, at administration of drug in single doses more than 1000/sq.m mg development of thrombocytopenia is possible.
Simultaneous use of drug with Valproic acid promotes decrease in clearance of Temozolomid. At joint reception of Temozolomid with other medicines oppressing function of marrow the risk of development of a miyelosupressiya increases.
Terms of sale
At a temperature up to 25 °C.
Period of validity
Coincidence on the ATH code of the 4th level:
Tezal, Temodal, Temozolomid-Teva, Temomid, Temozolomid-TL, Temtsital, Temozolomid-Russian.
Temozolomid/temodal in therapy of patients with an anaplastic astrocytoma is rather effective. Drug is also used during radiation therapy and after it, at treatment for the first time of the diagnosed multiformny glioblastoma. Now for patients with glioblastomy a combination of radiotheraphy and Temozolomid is therapy of the first line.
Side effects of drug rather easy as its cumulative toxicity is rather small. However, use of drug is justified only in the presence of the revealed factors of the forecast of efficiency of drug, the most proved among which extent of methylation of MGMT is.
Temozolomid's appointment at tumors "blindly", in the absence of researches on existence of markers of efficiency, and also, tumors, unconfirmed morphologically neither with clinical, nor from the economic parties is not justified.
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