Sehydrin enteric-Soluble tablets 60mg, 50pcs

Composition

1 tablet contains:

Active ingredients:

hydrazine sulfate 60 mg.

Auxiliary substances:

two-substituted calcium phosphate,

polyvinylpyrrolidone,

magnesium stearate,

highly dispersed silicon dioxide,

dimethicone,

talc,

polymethacrylate,

polyethylene glycol 600,

red iron oxide (E 172),

titanium dioxide.

The blister contains 10 tablets. The package contains 5 blisters.

Pharmacological action

Pharmacodynamics

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

Pharmacokinetics

The content of the drug in the blood of sick people reaches a maximum 2 hours after taking 60 mg (1 tablet); after a day, small amounts of it are still detected in the serum. Blood samples taken 9 hours after the end of the 30-day course of treatment show from 0 to 89 ng/ml of Sehydrin®in different patients.

The pharmacokinetics of Segydrin® were also studied in outbred intact rats and animals with sarcoma 45. The drug is rapidly absorbed from the gastrointestinal tract; blood purification from it ends by 25-28 hours after intragastric use at a dose of 100 mg / kg.

The maximum concentration in the blood of intact animals occurs approximately 50 minutes after use, in tumor carriers (sarcoma 45) – after 3 hours.

A 3-5-fold increased accumulation of the substance in the liver, kidneys, and lungs compared to blood was recorded, but not in the tumor; purification 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 days, and only 25% of the drug is excreted. The volume of distribution, in intact rats, is 14 ml, in the presence of a tumor-29.4 ml. Tumor carriers tend to accumulate Sehydrin. Sehydrin ® is oxidized in the body, and its undisturbed part is excreted in the urine, partly in acetylated form (in rats and rabbits).

Indications

• Symptomatic treatment of locally advanced and disseminated forms of malignant neoplasms.

At the same time, the drug Sehydrin ® has a pronounced symptomatic effect: reduction or elimination of pain syndrome (up to drug withdrawal), feelings of weakness, respiratory failure (shortness of breath), cough, fever, improvement of appetite, increased motor activity. The drug is prescribed to patients with malignant neoplasms in advanced stages (including in the preterminal phase of the process).

Use during pregnancy and lactation

It is contraindicated during pregnancy and lactation.

Contraindications

• Hypersensitivity to hydrazine sulfate and other components of the drug;
• simultaneous use with all types of alcohol and barbiturates;
• pregnancy and lactation;
• children’s age (due to lack of experience in using).

With caution: with severe violations of liver and kidney function.

Side effects

Dyspeptic symptoms (nausea, vomiting, belching) are possible, which quickly pass with a dose reduction or a short (two-, three-day) break in treatment. Rare complications include insomnia, general agitation, and mild and transient polyneuritis.

For dyspeptic phenomena, astringents and anti-inflammatory drugs (chamomile infusion, romazulan, vikalin), antispasmodics and antiemetics are prescribed inside. In case of neurotoxic effects, it is advisable to use pyridoxine hydrochloride (5% solution of vitamin B6 1 ml intramuscularly 1-2 times a day), thiamine chloride (vitamin B 1), multivitamin preparations inside and intravenous use of 20-40% dextrose (glucose) solution.

Interaction

Concomitant use of Sehydrin with barbiturates, ethanol, tranquilizers, antipsychotic drugs (neuroleptics) can lead to a sharp increase in the toxicity of Sehydrin.

In experiments on laboratory animals, in the case of preliminary use of Sehydrin, the effectiveness of treatment with many antitumor drugs increases (with the exception of cyclophosphamide).

How to take, course of use and dosage

Sehydrin® is administered orally 1-2 hours before or 1-2 hours after a meal or taking other medications. Adults take the drug 1 tablet 3 times a day. The course dose is 100 tablets. In case of unsatisfactory tolerability, the daily dose is reduced to 2 tablets per day. The dose for the course of treatment may not change.

Repeated treatment is performed at intervals of at least 14 days. The number of courses is not limited, and the intervals between courses are increased by 1-2 weeks.

Special instructions

Treatment with Sehydrin should be carried out under the supervision of a doctor who has experience in the use of antitumor drugs.

The drug should be used with caution in patients with severe liver and kidney function disorders. The use of the drug in jaundice caused by liver metastases (especially obturation) is not contraindicated.

It is necessary to exclude the use of ethanol-containing beverages, as well as products rich in tyramine: cheese, raisins, canned food, sausages, yoghurts.

Due to the absence of myelotoxicity, Segydrin® is used in patients with cytopenia resulting from radiation therapy and chemotherapy.

Form of production

Enteric coated tablets

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Hydrazine Sulfate

Conditions of release from pharmacies

By prescription

Dosage form

Tablets