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

When introduced into the body has detoxification effect. Forms non-toxic or low-toxic compounds with cyanides. The main mechanism of detoxification in 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 shows maximum activity in the liver).The human body has the ability to endogenously detoxify cyanide, however, the rhodonase system works slowly, and when cyanide poisoning its activity is not enough to detoxify, in order to accelerate the reaction catalyzed by rhodonase, it is necessary to administer sodium thiosulfate, which is a sulfur donor.

Pharmacokinetics:After intravenous administration, 20-50% of the exogenously introduced sodium thiosulfate is excreted by the kidneys unchanged. The volume of distribution is 0.15 l / kg. 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 of 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), advanced age (due to possible renal dysfunction), childhood (clinical studies on the safety and efficacy of sodium thiosulphate in the pediatric population are not available, however,there are reports in the medical literature on the use of sodium thiosulfate in combination with sodium nitrite in pediatric patients with 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 also a 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 offspring of rodents exposed to sodium thiosulfate during pregnancy at doses similar to those administered intravenously by 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 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 a 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 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 introduction of 20 ml of a 20% solution of sodium thiosulfate did not change the saturation blood oxygen.

Interaction:

It is necessary to avoid categorically contacting sodium thiosulfate with nitrates, potassium permanganate.

Chemically incompatible with hydroxy cobalamin, therefore, 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 methaemoglobinemia, measurements of oxygen saturation using standard pulse oximetry and calculated oxygen saturation values based on the measured ROh are unreliable.

Effect on the ability to drive transp. cf. and fur:Negative impact on the ability to drive vehicles and work with mechanisms is not revealed.

Form release / dosage:

Solution for intravenous administration 300 mg / ml.

Packaging:

For 5 or 10 ml in ampoules of colorless neutral glass type I with a colored break ring or with a colored dot and a notch, or without a kink ring, a colored dot and a notch. One, two or three color rings and / or a two-dimensional barcode, and / or alphanumeric coding or without additional color rings, two-dimensional, may be applied to the ampoules. bar code, alphanumeric coding.

5 ampoules per circuit cell packaging made of polyvinylchloride film and aluminum foil foil or polymer film or without foil and without film. Or 5 ampoules are placed in a prefabricated form (tray) made of cardboard with cells for laying ampoules.

One or two contour squares or cardboard trays, together with an instruction for use and a scarifier or knife, ampoule, or without a scarifier and a knife ampoule, are placed in a cardboard package (bundle).

Storage conditions:

AT protected from light at a temperature of no higher than 25 ° C. Do not freeze. 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:LP-002559

Date of registration:04.08.2014 / 07.08.2015

Expiration Date:04.08.2019

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZON PHARM, LLC Russia

Information update date: & nbsp25.05.2018

Illustrated instructions

Instructions

Sodium thiosulfate (Sodium thiosulfate)