Sehydrin - instructions for use, dose, side effects, contraindications

Active substanceHydrazine sulfateHydrazine sulfate

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Sehydrin®

pills inwards

FARMSINTEZ, PAO Russia

Dosage form: & nbspenteric coated tablets

Composition:

1 tablet, coated with enteric coating, contains:

active substance: hydrazine sulphate (Sehydrin®) 60 mg;

Excipients: calcium hydrophosphate 304 mg, povidone low molecular weight 24 mg, magnesium stearate 4 mg, silicon dioxide colloid (aerosil) 8 mg, methacrylic acid copolymer 131 mg, talc 3.3 mg, macrogol 400 1.3 mg, titanium dioxide 1.3 mg, iron dye red oxide (iron {III} oxide) (E 172) 0.65 mg, dimethicone 0.45 mg.

Description:

The tablets covered with a film membrane of red-brown color, round, biconcave. On the fracture is white.

Pharmacotherapeutic group:antitumor agent

ATX: & nbsp

L.01.X.B Methylhydrazines

Pharmacodynamics:

The drug suppresses the growth of tumors, affects a number of biochemical indicators: inhibits monoamine oxidase activity, reduces the permeability of cell membranes and biomembranes of subcellular structures, is an inhibitor of xenobiotic metabolism. Has a symptomatic therapeutic effect in malignant neoplasms in the far advanced stages. It does not have mielodepressive 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); in a day in the serum its small amounts are still determined. In the selection of blood 9 hours after the end of the 30-day course of treatment, 0 to 89 ng / ml of Sehydrin® is detected in different patients.

The study of the pharmacokinetics of Sehydrin® was also performed on non-native intact rats and animals with sarcoma 45. The drug is rapidly absorbed from the gastrointestinal tract; the purification of blood from him ends by the 25-28th hour after intragastric administration at a dose of 100 mg / kg.

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

The accumulation of substance in the liver, kidneys and lungs increased in 3-5 times in comparison with blood, but not in the tumor; purification of intact organs of healthy animals and tumor carriers ends by the end of 4 days. Excretion in urine in healthy animals lasts up to 3 days and is approximately 50% from the input quantity; in tumor-bearing animals, 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.Tumors tend to accumulate Sehydrin®.

Sehydrin ® in the body is oxidized, and its undivided part is excreted in urine, partly in acetylated form (in rats and rabbits).

Indications:

Symptomatic treatment of locally advanced and disseminated forms of malignant neoplasms. In this case, the drug Sehydrin® has a pronounced symptomatic effect: the reduction or elimination of pain syndrome (up to the rejection of drugs), feelings of weakness, respiratory insufficiency (dyspnea), cough, fever, appetite, motor activity. The drug is prescribed to patients with malignant neoplasms in the far advanced stages (including in the preterminal phase of the process).

Contraindications:

- Hypersensitivity to hydrazine sulfate and other constituents of the drug;

- aboutsimultaneous use with all types of alcohol and barbiturates;

- bPregnancy and period of breastfeeding;

- d(due to a lack of experience).

Carefully:With severe violations of the liver and kidneys.

Dosing and Administration:

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

The repeated course of treatment is carried out with an interval of not less than 14 days. The number of courses is not limited, while the intervals between courses are increased by 1-2 weeks.

Side effects:

Dyspeptic phenomena are possible (nausea, vomiting, belching), rapidly passing with a reduced dose or a short (two-, three-day) break in treatment.

Rare complications are insomnia, general arousal, indistinctly expressed and transient phenomena of polyneuritis.

With dyspeptic phenomena, astringents and anti-inflammatory agents are prescribed (chamomile infusion, romazulan, vikalin), antispasmodics and antiemetics.

With neurotoxic effects, the use of pyridoxine hydrochloride (5% solution of vitamin B₆ 1 ml intramuscularly 1-2 times a day), thiamine chloride (vitamin B₁), multivitamin preparations inside and intravenous administration of 20-40% solution of dextrose (glucose).

Interaction:

Simultaneous reception of Sehydrin® with barbiturates, ethanol, tranquilizers, antipsychotic drugs (neuroleptics) can lead to a dramatic increase in the toxicity of Sehydrin®.

In experiments on laboratory animals, in the case of prior administration of Sehydrin®, the effectiveness of treatment with many antineoplastic agents increases (except for - cyclophosphamide).

Special instructions:

Treatment with Sehydrin® should be performed under the supervision of a physician with experience in the use of antitumor drugs.

The drug with caution prescribed to patients with severe violations of the liver and kidneys. The use of the drug for jaundice caused by metastases in the liver (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 foods, sausages, yoghurts.

In the absence of myelotoxicity, Sehydrin® is used in patients with cytopenia resulting from radiation therapy and chemotherapy.

Form release / dosage:

Tablets, coated with enteric coating, 60 mg.

Packaging:

10 tablets in a planar cell package; 50 tablets in polymer cans.

By 5 contour packs or 1 bank along with instructions for use in a cardboard bundle.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N003061 / 01

Date of registration:18.11.2008 / 11.09.2012

The owner of the registration certificate:FARMSINTEZ, PAO FARMSINTEZ, PAO Russia

Manufacturer: & nbsp

FARMSINTEZ, JSC Russia

Representation: & nbspFARMSINTEZ, PAO FARMSINTEZ, PAO Russia

Information update date: & nbsp16.01.2016

Illustrated instructions

Instructions

Sehydrin® (Segidrin®)