Temomedac capsules 20 mg bottle No. 5

Temomedac capsules are used to treat:

Composition

Active ingredient: temozolomide;

1 capsule contains 20 mg of temozolomide;

Excipients: lactose, sodium starch glycolate (type A), colloidal silicon dioxide, tartaric acid, stearic acid, titanium dioxide (E 171), gelatin, shellac, propylene glycol, sunset yellow FCF (E 110).

Contraindication

Method of application

Temomedac should only be prescribed by a doctor with experience in oncological therapy of brain tumors.

Temomedac (capsules) should be taken on an empty stomach.

Swallow the capsule whole with a glass of water. Do not open or chew the capsule.

If vomiting occurs after taking the drug, you should not take a second dose of the drug on the same day.

At the same time, antiemetic therapy can be administered.

Application features

Pregnant women

Temomedac should not be administered to pregnant women. If it is necessary to use the drug during pregnancy, the woman should be informed of the potential risk to the fetus. Women of childbearing potential should be advised to use effective contraception to prevent pregnancy during treatment with Temomedac.

Drivers

The ability to drive and use machines may be slightly impaired when taking Temomedac due to the possibility of fatigue and drowsiness.

Overdose

Doses of 500, 750, 1000 and 1250 mg/m2 (total dose per 5-day cycle) were clinically evaluated. Dose-dependent hematological toxicity developed at all doses used, but, as expected, was more pronounced at the high doses used. An overdose of 10,000 mg (total dose in one cycle for 5 days) was allowed by one patient, which resulted in pancytopenia, Pyrex, multiorgan failure and death. Patients who used the recommended doses (150-200 mg/m2) for more than 5 days (up to 64 days) have been reported to develop bone marrow suppression (with or without infection), in some cases severe and prolonged, with fatal outcome.

In case of overdose, it is recommended to perform a hematological study and, if necessary, conduct supportive therapy.

Side effects

In patients receiving temozolomide, both as part of combination therapy with radiotherapy and as subsequent monotherapy in the treatment of newly diagnosed glioblastoma multiforme or as monotherapy in the treatment of recurrent or progressive malignant glioma, the following adverse reactions most often occurred: nausea, vomiting, constipation, anorexia, headache and fatigue.

Interactions

Administration of Temomedac with food resulted in a 33% decrease in Cmax and a 9% decrease in AUC. Since it cannot be excluded that the change in Cmax is clinically significant, Temomedac should not be taken with food.

Co-administration of dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, histamine H2 receptor antagonists or phenobarbital does not alter the clearance of Temomedac. Co-administration of valproic acid caused a slight but statistically significant decrease in temozolomide clearance.

Storage conditions

Store below 30°C in the original, tightly closed bottle to protect from moisture.

Keep out of reach of children.

Shelf life - 3 years.