Composition, form of production and packaging
Tablets covered with an enteric -soluble shell of a red-brown color; the core of the tablet is white; Two layers are visible on the cross-section.
1 tab.
hydrazine sulfate 60 mg
[PRING] calcium phosphate disubstituted, polyvinylpyrrolidone, magnesium stearate, silicon dioxide, finely dispersed, dimethicone, talc, polymethacrylate, polyethylene glycol 600, iron oxide red (E172), titanium dioxide.
10 pieces. - packings cellular planimetric (5) - packs cardboard.
50 pcs. - polymer cans (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
The drug inhibits the growth of tumors, affects a number of biochemical parameters: inhibits monoamine oxidase activity, reduces the permeability of cell membranes and biomembranes of subcellular structures, inhibits the metabolism of xenobiotics. 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 in different patients is detected from 0 to 89 ng / ml Sehydrin В® .
The study of the pharmacokinetics of Sehydrin В® 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% of the administered amount; 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 В® in the body is oxidized, and its undivided part is excreted in the urine, partly in the acetylated form (in rats and rabbits).
INDICATIONS
- symptomatic treatment of locally advanced and disseminated forms of malignant neoplasms.
In this case, the drug Sehydrin В® has a marked symptomatic effect: the reduction or elimination of pain syndrome (up to the rejection of drugs), feelings of weakness, the phenomena of respiratory failure (dyspnea), cough, fever, appetite improvement, increased motor activity. The drug is prescribed to patients with malignant neoplasms in the far advanced stages (including in the preterminal phase of the process).
DOSING MODE
Sehydrin В® is prescribed by mouth 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 EFFECT
Dyspeptic phenomena are possible (nausea, vomiting, belching), rapidly passing with a decrease in dose or a short (two-, three-day) break in treatment. Rare complications are insomnia, general arousal, not pronounced 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, it is advisable to use pyridoxine hydrochloride (5% solution of vitamin B 6 1 ml intramuscularly 1-2 times a day), thiamine chloride (vitamin B 1 ), multivitamin preparations inside and intravenous administration of 20-40% dextrose (glucose) solution.
CONTRAINDICATIONS
- hypersensitivity to hydrazine sulfate and other constituents of the drug;
- simultaneous use with all types of alcohol and barbiturates;
- pregnancy and the period of breastfeeding;
- Children's age (due to lack of experience in the application).
With caution: with severe violations of the liver and kidneys.
PREGNANCY AND LACTATION
Contraindicated in pregnancy and lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution in severe impairment of kidney function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution in severe violations of the liver.
APPLICATION FOR CHILDREN
Contraindicated in children.
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 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.
Due to the absence of myelotoxicity, Sehydrin В® is used in patients with cytopenia resulting from radiation therapy and chemotherapy.
DRUG INTERACTION
Simultaneous reception 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 prior administration of Sehydrin, the effectiveness of treatment with many antitumor drugs is increased (except for cyclophosphamide).
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
List B. In a dry, the dark place at a temperature of no higher than 25 В° C. Keep out of the reach of children! Shelf life - 3 years.
