Temomedac capsules 250mg No. 5

Temomedac capsules are used to treat:

Composition

The active substance is temozolomide (one capsule contains 250 mg of temozolomide).

Excipients: anhydrous lactose, sodium starch glycolate (type A), colloidal anhydrous silicon dioxide, tartaric acid, stearic acid; titanium dioxide (E 171), gelatin, shellac, propylene glycol, black iron oxide (E 172).

Contraindication

Method of application

The drug "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

There are no data on the use of the drug in pregnant women. "Temomedak" should not be prescribed 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 reproductive age should be advised to use effective methods of contraception to prevent pregnancy during treatment with the drug "Temomedak".

It is not known whether Temomedac passes into breast milk, so breastfeeding should be discontinued during treatment.

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, resulting 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.

Storage conditions

Store below 30°C in the original, tightly closed bottle in order to protect from moisture. Keep out of the reach of children.

Shelf life - 3 years.