Sodium thiosulfate - instructions for use, dose, side effects, contraindications

Sodium thiosulfate is a complexing agent. When introduced into the body has detoxification effect. Forms non-toxic or low-toxic compounds with cyanides. The main mechanism of detoxification in the case of poisoning with hydrocyanic acid and its salts (cyanides) is the formation of less toxic rhodanous compounds (thiocyanate) with the participation of the enzyme rhodonase - thiosulfate cyanide sulfate (found in many tissues,but the maximum activity is manifested in the liver). The human body has the ability to endogenously detoxify cyanide, but the rhodon system works slowly, and when cyanide is poisoned, its activity is not enough to detoxify, and in order to accelerate the reaction catalyzed by rhodonase, the introduction of sodium thiosulfate, which is a sulfur donor, is necessary.

Pharmacokinetics:

After intravenous administration sodium thiosulfate is distributed into the extracellular fluid. The volume of distribution is 0.15 l / kg. 20-50% of the exogenously introduced sodium thiosulfate is excreted by the kidneys unchanged. The half-life (T_1/2) after intravenous administration of 1 g of sodium thiosulfate is approximately 20 minutes, with the introduction of higher doses in healthy volunteers (150 mg / kg, ie 9 g per 60 kg body weight) T_1/2is 182 minutes.

Indications:

As an antidote for cyanide poisoning.

Contraindications:

Hypersensitivity to sodium thiosulfate.

Carefully:

Renal failure (delayed excretion of the resulting compounds), elderly age (due to possible renal dysfunction),Children under 18 years of age (clinical studies on the safety and efficacy of sodium thiosulfate in the pediatric population are not available, but there are reports in the medical literature on the use of sodium thiosulfate in combination with sodium nitrite in pediatric patients for cyanide poisoning, and therefore recommendations for dosing for pediatric patients are based on theoretical calculations of the potential detoxification effect of the antidote, by extrapolating data from animal experiments, and e small number of case histories).

Pregnancy and lactation:

Adequate and strictly controlled studies in pregnant women are absent. The use of sodium thiosulfate during pregnancy is possible if the potential benefit to the mother exceeds the potential risk to the fetus. In the epidemiological studies conducted, there were no congenital anomalies in children born to mothers who received sodium thiosulfate during pregnancy.

In studies in animals, there were no teratogenic effects in the offspring of rodents,exposed to sodium thiosulfate during pregnancy at doses similar to those administered intravenously in cyanide poisoning in humans.

Other studies in rodents show that the treatment of sodium with thiosulphate during mother poisoning levels teratogenic effects of cyanides. In studies in mice, rats, hamsters and rabbits sodium thiosulfate when applied in maternal doses up to 550, 400, 400 and 580 mg / kg / day, respectively, had no embryotoxic or teratogenic effect.

It is not known whether the sodium thiosulfate in human milk. Because the sodium thiosulfate injected only in life-threatening conditions, breast-feeding is not a contraindication to its use. Due to the fact that many drugs penetrate into breast milk, caution should be exercised when using sodium thiosulfate in lactating women. There is no data on the time to safely resume breastfeeding after the administration of sodium thiosulfate.

Dosing and Administration:

Intravenously slow. Treatment should be started as soon as possible after diagnosis.

Adults injected in a single dose of 50 ml of the solution, children at the rate of 250 mg / kg body weight.

If the symptoms of cyanide poisoning reappear, it is necessary to repeat the introduction of the drug at a dose of 50% of the original.

During the introduction, it is necessary to control blood pressure; in the case of a pronounced decrease in blood pressure, it is necessary to reduce the rate of administration.

Side effects:

Since strictly controlled studies to assess the profile of adverse events of sodium thiosulfate are absent, the incidence of side effects reported in the medical literature can not be estimated.

Allergic reactions, lowering of blood pressure, headache, disorientation, nausea, vomiting, lengthening bleeding time, salty taste in the mouth, sensation of heat throughout the body.

The rapid administration or administration of large doses of sodium thiosulfate was accompanied by a higher incidence of nausea and vomiting.

Overdose:

Data on sodium thiosulfate overdose are limited. Oral intake of 3 g of sodium thiosulfate per day for 1-2 weeks in humans was accompanied by a decrease in the degree of saturation of arterial blood with oxygen below 75%, which was due to a shift to the right of the oxygen dissociation curve and hemoglobin.Restoration of the degree of saturation of arterial blood with oxygen to the baseline was observed 1 week after the termination of sodium thiosulfate administration. It was reported that a single injection of 20 ml of a 20% sodium thiosulfate solution did not change the saturation of the blood with oxygen.

Interaction:

Strongly forbid contact of sodium thiosulfate with nitrates, potassium permanganate.

It is chemically incompatible with hydroxycobalamin, so they can not be administered through the same device for intravenous administration.

The chemical incompatibility of sodium thiosulfate and sodium nitrite, introduced sequentially through the same line for intravenous administration, has not been reported.

Studies of the interaction of sodium thiosulfate with other drugs have not been conducted.

Special instructions:

When cyanide poisoning is recommended, the simultaneous administration of sodium nitrite, while sodium thiosulfate is introduced after sodium nitrite.

When cyanide intoxication, delay should be avoided with the introduction of an antidote (a possible lethal outcome is possible). It is necessary to carefully monitor the patient within 24-48 h due to the possible return of symptoms of cyanide poisoning.If symptoms return, the sodium thiosulfate should be repeated in a half dose.

During the treatment it is necessary to monitor the hemoglobin and hematocrit.

In the presence of methemoglobinemia, oxygen saturation measurements using standard pulse oximetry and calculated oxygen saturation values based on the measured RO₂unreliable.

Effect on the ability to drive transp. cf. and fur:

During the treatment period, care must be taken when driving a car and engaging in potentially dangerous activities that require concentration and speed of psychomotor reactions.

Form release / dosage:

Solution for intravenous administration, 300 mg / ml.

Packaging:

5 ml, 10 ml into ampoules of colorless neutral glass.

For 10 ampoules with instructions for use and scarifier ampoule in a box of cardboard.

By 5 or 10 ampoules per contour cell packaging made of polyvinylchloride film and aluminum foil printed lacquered or foil-free.

1 or 2 contourcell packs with instructions for use and a scapegrator ampoule in a pack of cardboard.

When packing ampoules with a ring of fracture or with a notch and a point, the ampoule scaper is not inserted.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:

5 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-003450

Date of registration:09.02.2016

Expiration Date:09.02.2021

The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia

Manufacturer: & nbsp

SYNTHESIS, OJSC Russia

Representation: & nbspSYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products SYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products Russia

Information update date: & nbsp25.05.2018

Illustrated instructions

Instructions

Sodium thiosulfate (Sodium thiosulfate)