Uromitexan (mesna) 400 mg. solution for injections 100 mg/ml. 4 ml. (400 mg.) ampoules №15

Description

Uromitexan (mesna) 400 mg. solution for injections 100 mg/ml. 4 ml. (400 mg.) ampoules №15

Composition

active substance: mesna;

1 ml of solution contains meat 100 mg;

Excipients: edetate disodium, sodium hydroxide, water for injections.

Dosage form

Solution for injection.

Main physical and chemical properties: clear, colorless solution in ampoules of clear colorless glass with a volume of 5 ml with a breakpoint and two colored coding rings (upper – blue, lower – green).

Pharmacotherapeutic group

Means used to eliminate the toxic effects of antitumor therapy.

ATX code V03A F01.

Pharmacological properties

This drug belongs to the group of drugs used in the complex treatment of oncological diseases as an adjunct to prevent excessive intoxication.
The main active component of the drug is mesna, which is used as a sodium salt, which is two-mercaptoethanesulfonic acid.
It has the ability to reduce nephrotoxicity, as well as the urotoxic activity of drugs that produce an alkylating effect.
Uroprotector, which is able to inactivate the urotoxic effects from the use of drugs such as cyclophosphamides and ifosfamides.
Mesna is capable of rapidly oxidizing, turning into a metabolite of Dimesna. Mesna disulfide is able to remain in the vascular bed, entering the kidneys, where it again becomes a free thiol compound – local. Then this substance, as a result of metabolic and chemical processes, detoxifies urotoxic decay products – metabolites.
Thus, the drug produces a strong cytotoxic effect.

Indications

This drug can be recommended and used as a cytotoxic drug, in particular:

•  in the prevention of the urotoxic effect of oxazaphosphorins during cytostatic therapy;
•  in the treatment of cyclophosphamide in high doses (more than 10 mg / kg) of patients at risk, in particular, in a state after radiation therapy of the pelvic organs, cystitis during previous treatment with oxazaphosphorines, a history of urinary tract diseases.

Contraindications

The drug in question is contraindicated for use in cases where the patient has severe hypersensitivity (allergy) to the main or to one of the auxiliary components, bee products.
It is permissible to use this drug in conjunction with antibiotics, except for amine glycosides, which reduce its effectiveness. Incompatible with cisplatin and carboplatin.

Application during pregnancy and lactation

This drug is not used in the treatment of pregnant women and women during lactation.

Method of administration and dosage

Uromitexan is usually injected into / in a jet (slowly). A single dose for adults is 20% of a single dose of oxazaphosphorine. The first injection is carried out simultaneously with the first injection of oxazaphosphorine, the second and third injections – 4 hours and 8 hours after the administration of oxazaphosphorine.

In children, a single dose of Uromitexan is 60% of the cytostatic dose, the drug is continued every 3 hours.

With continuous infusion (24 hours) of ifosfamide or cyclophosphamide, Uromitexan should be administered at a dose of 20% of the cytostatic dose at the beginning of the infusion, then at a dose of 100% of the cytostatic dose in the form of a 24-hour infusion, and after the end of the cytostatic administration, Uromitexan should be continued for another 6 -12 hours at the same dose.

In the case of very high doses of oxazaphosphorins, for example, before bone marrow transplantation, the total dose of Uromitexan can be increased to 120-160% of the dose of oxazaphosphorine. After the introduction of 20% Uromitexan at the beginning of the administration of the cytostatic, the remaining calculated dose is recommended to be administered intravenously for a long time, for 24 hours using a perfusor. Alternatively, a fractional bolus injection is possible: for adults, 3 × 40% (time 0, 4, 8 hours) or 4 × 40% (time 0, 3, 6, 9 hours). Instead of bolus injections, it is possible to carry out short infusions lasting 15 minutes.

Overdose

Overdose can increase side effects, in particular:

•  diarrhea;
•  tremor;
•  convulsions;
•  cyanosis;
•  shortness of breath.

There is no specific antidote.
Means must be provided to respond to a possible anaphylactic reaction.

Side effects

In general, the use of this drug can cause adverse reactions, such as:

•  arterial hypotension;
•  leukopenia, thrombocytopenia, anemia;
•  cough;
•  nausea, vomiting, diarrhea, increased transaminase activity;
•  weakness, headache;
•  rash, exanthema;
•  allergies – itching, urticaria, anaphylactoid reactions;
•  phlebitis at the injection site, pain in the limbs.