Segidrin

General characteristics. Structure:

Active agent: a hydrazine sulfate (Сегидрин®) — 60 mg

excipients: calcium hydrophosphate — 304 mg, povidone low-molecular — 24 mg, magnesium stearate — 4 mg, silicon dioxide colloid (aerosil) — 8 mg, copolymer of methacrylic acid — 13 mg, talc — 3,3 mg, a macrogoal of 400 — 1,3 mg, titanium dioxide — 1,3 mg, dye ferrous oxide red (gland {III} oxide) (Е 172) — 0,65 mg, диметикон — 0,45 mg.

Pharmacological properties:

Pharmacodynamics. Drug suppresses growth of tumors, exerts impact on a number of biochemical indicators: inhibits monoaminooksidazny activity, reduces permeability of membranes of cells and biomembranes of subcellular structures, is inhibitor of metabolism of xenobiotics. Has symptomatic medical effect at malignant new growths in far come stages. Does not possess the miyelodepressivny and other side effects characteristic of many other antineoplastic drugs.

Pharmacokinetics. Content of drug in blood of sick people reaches a maximum in 2 hours after reception of 60 mg (1 tablet); in a day in serum its small amounts still are defined. At selection of blood in 9 hours after the termination of a 30-day course of treatment from 0 to 89 ng/ml of Segidrina® are found in different patients. Studying of pharmacokinetics of Segidrina® was executed also on not purebred intact rats and animals with sarcoma 45. Drug is quickly soaked up from digestive tract; clarification of blood from it comes to an end by the 25-28th o'clock after intragastric introduction in a dose of 100 mg/kg. The maximum concentration in blood of intact animals comes approximately in 50 minutes after introduction, at opukholenositel (sarcoma 45) — in 3 hours. The accumulation of substance in a liver, kidneys and lungs increased by 3–5 times in comparison with blood, but not in a tumor is registered; clarification of intact bodies of healthy animals and opukholenositel comes to an end by the end of 4 days. Removal with urine at healthy animals continues up to 3 days and makes about 50% of the entered quantity; at opukholenositel removal comes to an end between the first and second day, and only 25% of drug are removed. Distribution volume, at intact rats, makes 14 ml, in the presence of a tumor — 29,4 ml. Opukholenositeli are inclined to cumulation of Segidrina®. Сегидрин® in an organism is oxidized, and its not destroyed part is allocated with urine, partially in an acetylized form (at rats and rabbits).

Indications to use:

Symptomatic treatment of the locally-spread and disseminated forms of malignant new growths. At the same time the drug Segidrin® has the expressed symptomatic effect: decrease or elimination of a pain syndrome (up to refusal of drugs), feelings of weakness, the phenomena of respiratory insufficiency (asthma), cough, fever, appetite improvement, increase in a physical activity. Drug is appointed the patient with malignant new growths in far come stages (including in a preterminalyiy phase of process).

Route of administration and doses:

Сегидрин® appoint inside in 1–2 hours prior to or in 1–2 hours after food or reception of other drugs. Adults accept drug on 1 tablet 3 times a day. A course dose — 100 tablets. At unsatisfactory portability the daily dose is reduced to 2 tablets a day. The dose on a course of treatment at the same time can not change.

The repeated course of treatment is carried out with an interval not less than 14 days. The number of courses is not limited, at the same time intervals between courses increase by 1–2 weeks.

Features of use:

Treatment of Segidrinom® should be carried out under observation of the doctor having experience of use of antineoplastic drugs.

Drug with care is appointed the patient at the expressed abnormal liver functions and kidneys. Use of drug at the jaundice caused by metastasises in a liver (in particular, obturatsionny) is not contraindicated.

It is necessary to exclude the use of etanolsoderzhashchy drinks, and also the products rich with tyramine: cheese, raisin, preserved foods, sausages, yogurts.

In view of lack of a miyelotoksichnost of Segidrin® apply the patient with the cytopenia which resulted from radiation therapy and chemotherapy.

Side effects:

The dispeptic phenomena (nausea, vomitings, eructation) which are quickly passing at a dose decline or short-term (two - three-day) a break in treatment are possible.

Rare complications — the sleeplessness, the general excitement which are not sharply expressed and the passing phenomena of a polyneuritis.

At the dispeptic phenomena appoint inside the knitting and anti-inflammatory drugs (camomile infusion, Romasulonum, Vicalinum), spasmolysants and antiemetik. At neurotoxic effects use of a pyridoxine of a hydrochloride (5% B6 vitamin solution on 1 ml intramusculary 1–2 times a day), Thiamini chloridum (B1 vitamin), polyvitaminic drugs inside and intravenous administration of 20-40% of solution of a dextrose (glucose) is reasonable.

Interaction with other medicines:

The concomitant use of Segidrina® with barbiturates, ethanol, tranquilizers, antipsychotic medicines (neuroleptics) can lead to sharp strengthening of toxicity of Segidrina®.

In experiments in case of preliminary reception of Segidrina® efficiency of treatment by many antineoplastic drugs increases by laboratory animals (an exception — cyclophosphamide).

Contraindications:

- hypersensitivity to a hydrazine to sulfate and other components of drug

- simultaneous use with all types of alcohol and barbiturates

- pregnancy and period of feeding by a breast

- children's age (due to the lack of experience of use)

With care: at the expressed abnormal liver functions and kidneys.

Overdose:

Data on overdose of the drug Segidrin® are not provided.

Storage conditions:

In the dry place protected from light at a temperature not above 25 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

The tablets covered with a kishechnorastvorimy cover of 60 mg.

On 10 tablets in a blister strip packaging; on 50 tablets in banks polymeric.

On 5 planimetric packagings or 1 bank together with the application instruction in a cardboard pack.