Sehydrin, 60 mg 50 pcs.

Pharmacodynamics

The drug inhibits tumor growth, affects a number of biochemical parameters: inhibits monoamine oxidase activity, reduces cell membrane permeability and biomembranes of subcellular structures, is an inhibitor of xenobiotic metabolism. It has symptomatic therapeutic effect in malignant neoplasms in advanced stages. It does not have myelodepressive and other side effects which are typical for many other antitumor drugs.

Pharmacokinetics

The drug content in the blood of patients reaches a maximum 2 hours after taking 60 mg (1 tablet); 24 hours later small amounts are still detected in the serum. Blood sampling 9 hours after the end of the 30-day treatment course detects 0 to 89 ng/ml of Sehydrin® in different patients.

The pharmacokinetics of Sehydrin® has also been studied in unbred intact rats and animals with sarcoma 45. The drug is rapidly absorbed from the gastrointestinal tract; blood clearance is complete by 25-28 hours after intragastric administration at a dose of 100 mg/kg.

The maximum concentration in the blood of intact animals occurs approximately 50 minutes after administration; in tumor-bearing animals (sarcoma 45), 3 hours later.

A 3-5 times higher accumulation of the substance in the liver, kidneys and lungs compared to the blood, but not in the tumor; clearance of intact organs of healthy animals and tumor carriers ends by the end of 4 days. Urinary excretion in healthy animals lasts up to 3 days and is approximately 50% of the administered amount; in tumor carriers excretion ends between the first and second day, with only 25% of the drug excreted. The volume of distribution, in intact rats, is 14 ml, in the presence of a tumor it is 29.4 ml. Tumor carriers are prone to cumulation of Sehydrin. Sehydrin® is oxidized in the body and its undegraded part is excreted with urine, partially in acetylated form (in rats and rabbits).

Indications

In this case Sehydrin® has a pronounced symptomatic effect: reduction or elimination of pain syndrome (up to withdrawal), weakness, respiratory failure phenomena (dyspnea), cough, fever, improved appetite, increased motor activity. The drug is prescribed to patients with malignant tumors in advanced stages (including in the preterminal phase of the process).

Active ingredient

Composition

1 tablet contains:

Active substances:

Hydrazine sulfate 60 mg.

Associates:

calcium phosphate displaced,

polyvinylpyrrolidone,

magnesium stearate,

silicon dioxide highly dispersed,

/p>

dimethicone,

talc,

polymethacrylate,

polyethylene glycol 600,

Red iron oxide (E172),

Titanium dioxide.

There are 10 tablets in the blister. The pack contains 5 blisters.

How to take, the dosage

Sehydrin® is administered orally 1-2 hours before or 1-2 hours after meals or other drugs. Adults take 1 tablet 3 times a day. The course dose is 100 tablets. If tolerance is unsatisfactory, the daily dose is reduced to 2 tablets a day. The dose for the course of treatment in this case may not change.

The course of treatment is repeated at intervals of at least 14 days. There is no limit to the number of courses, and the intervals between courses are increased by 1-2 weeks.

Interaction

The simultaneous administration of Sehydrin with barbiturates, ethanol, tranquilizers, antipsychotic drugs (neuroleptics) may lead to a sharp increase in Sehydrin toxicity.

In experiments on laboratory animals the efficacy of treatment with many antitumor drugs is increased if Sehydrin is taken beforehand (cyclophosphamide is the exception).

Special Instructions

Treatment with Sehydrin should be done under the supervision of a physician experienced in the use of antitumor drugs.

The drug is prescribed with caution in patients with significant liver and kidney dysfunction. Administration of the drug in case of jaundice caused by liver metastases (especially obturation) is not contraindicated.

It is necessary to avoid consumption of ethanol-containing drinks, as well as foods rich in tyramine: cheese, raisins, canned foods, sausages, yogurt.

Because of absence of myelotoxicity Sehydrin® is used in patients with cytopenia caused by radiotherapy and chemotherapy.

Contraindications

With caution: with marked hepatic and renal dysfunction.

Side effects

Dyspeptic phenomena (nausea, vomiting, belching) may occur, which quickly disappear with dose reduction or a short (two-, three-day) break in treatment. Rare complications are insomnia, general agitation, not sharply expressed and transient effects of polyneuritis.

In case of dyspeptic phenomena prescribe oral astringents and anti-inflammatory drugs (infusion of chamomile, romazulan, vicalin), antispasmodics and antiemetics. If the neurotoxic effects are observed it is advisable to use pyridoxine hydrochloride (5% solution of vitamin B6 – 1 ml intramuscularly 1-2 times a day), thiamine chloride (vitamin B1), multivitamin preparations orally and intravenous injection of 20-40% dextrose (glucose) solution.

Pregnancy use

It is contraindicated during pregnancy and lactation.