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Sodium thiosulphate (Solution) Instructions for Use

ATC Code

V03AB06 (Sodium thiosulphate)

Active Substance

Sodium thiosulphate (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antidote. Complexing agent

Pharmacotherapeutic Group

Other therapeutic products; antidotes

Pharmacological Action

Antidote. In case of poisoning with compounds of arsenic, mercury, and lead, the drug forms non-toxic sulfites.

In case of cyanide poisoning, it forms less toxic thiocyanate compounds.

It also has some anti-inflammatory and desensitizing action.

Pharmacokinetics

After intravenous administration, Sodium thiosulphate is distributed into the extracellular fluid.

The Vd is 0.15 L/kg.

20-50% of exogenously administered sodium thiosulphate is excreted by the kidneys unchanged.

The T1/2 after intravenous administration of 1 g of sodium thiosulphate is approximately 20 minutes.

Indications

Poisoning with compounds of arsenic, mercury, lead, cyanides, salts of iodine, bromine. As part of combination therapy for allergic diseases, arthritis, neuralgia.

ICD codes

ICD-10 code Indication
M13.9 Arthritis, unspecified
M79.2 Neuralgia and neuritis, unspecified
T50.9 Other and unspecified drugs, medicaments and biological substances
T56 Toxic effect of metals
T56.0 Lead and its compounds
T56.1 Mercury and its compounds
T57.0 Arsenic and its compounds
T65.0 Toxic effect of cyanides
T78.4 Allergy, unspecified
ICD-11 code Indication
4A8Z Allergic conditions or hypersensitivity conditions of unspecified type
8D43.1 Cognitive impairments due to toxic effects
8E4A.1 Paraneoplastic or autoimmune diseases of the peripheral or autonomic nervous system
FA2Z Inflammatory arthropathies, unspecified
FB56 Specified soft tissue diseases, not elsewhere classified
NE60 Poisoning by drugs, medicaments or biological substances, not elsewhere classified
NE61 Toxic effect of poisonous substances, chiefly nonmedicinal, not elsewhere classified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer intravenously only. Determine the dose individually based on the toxic agent, severity of poisoning, and patient’s clinical status.

For acute cyanide poisoning, use in conjunction with sodium nitrite. Administer sodium nitrite first, followed immediately by sodium thiosulfate. For adults, administer 12.5 grams (50 mL of a 25% solution) intravenously. For pediatric patients, administer 7 grams per square meter of body surface area, not to exceed 12.5 grams total dose.

If symptoms of cyanide poisoning recur, repeat the administration at half the initial dose.

For arsenic, mercury, or lead poisoning, administer 5-10 mL of a 30% solution intravenously.

For allergic diseases or neuralgia as part of combination therapy, administer 5-10 mL of a 30% solution intravenously daily or every other day, typically for a course of 10-15 injections.

Inject slowly, at a rate of 2-5 mL per minute. Monitor blood pressure closely during and after infusion due to risk of hypotension.

In patients with renal impairment, use with caution and consider dose adjustment due to slowed excretion of formed complexes.

Adverse Reactions

From the cardiovascular system: decreased blood pressure.

From the nervous system: headache, disorientation, salty taste in the mouth, sensation of warmth throughout the body.

From the digestive system: nausea, vomiting.

From the blood coagulation system: prolonged bleeding time.

Other: allergic reactions.

Contraindications

Hypersensitivity to sodium thiosulphate.

With caution renal insufficiency (slowed excretion of formed compounds), elderly age (due to possible impaired renal function); children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

During pregnancy, use is possible according to indications in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

There are no data on the safe time to resume breastfeeding after administration of sodium thiosulphate. During breastfeeding, it should be used with caution, for vital indications.

Use in Renal Impairment

Should be used with caution in renal insufficiency.

Pediatric Use

Should be used with caution in children and adolescents under 18 years of age.

Geriatric Use

Should be used with caution in elderly patients.

Special Precautions

In case of cyanide poisoning, simultaneous administration of sodium nitrite is recommended, with Sodium thiosulphate administered after sodium nitrite.

In case of cyanide intoxication, delay in administering the antidote should be avoided (a rapid fatal outcome is possible). The patient should be closely monitored for 24-48 hours due to the possible return of cyanide poisoning symptoms. If symptoms recur, the administration of sodium thiosulphate should be repeated at half the dose.

During treatment, hemoglobin and hematocrit levels should be monitored.

In the presence of methemoglobinemia, oxygen saturation measurements using standard pulse oximetry techniques and calculated oxygen saturation values based on measured PO2 are unreliable.

Effect on ability to drive vehicles and operate machinery

During treatment, caution should be exercised when driving and engaging in other potentially hazardous activities that require concentration and speed of psychomotor reactions.

Drug Interactions

Contact of sodium thiosulphate with nitrates and potassium permanganate is strictly prohibited.

Chemically incompatible with hydroxocobalamin, therefore they should not be administered through the same intravenous administration device.

No chemical incompatibility has been reported between sodium thiosulphate and sodium nitrite when administered sequentially through the same intravenous line.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Alvils, LLC (Russia)

Dosage Forms

Bottle Rx Icon Sodium thiosulphate Solution for intravenous administration 1.5 g/5 ml: 10 amp.
Solution for intravenous administration 3 g/10 ml: 10 amp.

Dosage Form, Packaging, and Composition

Solution for intravenous administration transparent, colorless.

1 ml 1 amp.
Sodium thiosulphate 300 mg 1.5 g

Excipients: sodium bicarbonate, water for injections.

5 ml – ampoules (5) – contour cell packaging (2) – cardboard packs.

Solution for intravenous administration transparent, colorless.

1 ml 1 amp.
Sodium thiosulphate 300 mg 3 g

Excipients: sodium bicarbonate, water for injections.

10 ml – ampoules (10) – cardboard boxes.

Marketing Authorization Holder

Atoll LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium thiosulphate Solution for intravenous administration 300 mg/ml: 5 ml or 10 ml amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous administration transparent, colorless.

1 ml
Sodium thiosulphate 300 mg

Excipients: sodium bicarbonate 20 mg, water for injections up to 1 ml.

5 ml – glass ampoules (5) – contour cell packaging (1) – cardboard packs.
5 ml – glass ampoules (5) – contour cell packaging (2) – cardboard packs.
5 ml – glass ampoules (5) – cardboard trays (1) – cardboard packs.
5 ml – glass ampoules (5) – cardboard trays (2) – cardboard packs.
10 ml – glass ampoules (5) – contour cell packaging (1) – cardboard packs.
10 ml – glass ampoules (5) – contour cell packaging (2) – cardboard packs.
10 ml – glass ampoules (5) – cardboard trays (1) – cardboard packs.
10 ml – glass ampoules (5) – cardboard trays (2) – cardboard packs.

Marketing Authorization Holder

Binnopharm JSC (Russia)

Dosage Form

Bottle Rx Icon Sodium thiosulphate Solution for intravenous administration 300 mg/ml: 5 ml or 10 ml amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous administration transparent, colorless.

1 ml 1 amp.
Sodium thiosulphate 300 mg 1.5 g

Excipients: sodium bicarbonate, water for injections.

5 ml – ampoules (5) – contour plastic packaging (1) – cardboard packs.
5 ml – ampoules (5) – contour plastic packaging (2) – cardboard packs.

Marketing Authorization Holder

Velpharm, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium thiosulphate Solution for intravenous administration 300 mg/ml: 5 ml or 10 ml amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous administration transparent, colorless.

1 ml
Sodium thiosulphate pentahydrate 300 mg

Excipients: sodium bicarbonate (sodium hydrogen carbonate), water for injections.

5 ml – ampoules (5) – cardboard packs.
5 ml – ampoules (10) – cardboard packs.
10 ml – ampoules (5) – cardboard packs.
10 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Sodium thiosulphate Solution for intravenous administration 300 mg/ml: 5 ml or 10 ml amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous administration transparent, colorless.

1 ml
Sodium thiosulphate 300 mg

Excipients: sodium bicarbonate – 6 mg, water for injections – up to 1 ml.

5 ml – neutral glass ampoules (10) – cardboard boxes.
5 ml – neutral glass ampoules (5) – contour cell packaging (2) – cardboard packs.
10 ml – neutral glass ampoules (10) – cardboard boxes.
10 ml – neutral glass ampoules (5) – contour cell packaging (2) – cardboard packs.

Marketing Authorization Holder

Novosibkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Sodium thiosulphate Solution for intravenous administration 300 mg/1 ml: 10 ml amp. 5, 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous administration in the form of a transparent, colorless liquid.

1 ml 1 amp.
Sodium thiosulphate pentahydrate 300 mg 3 g

Excipients: sodium bicarbonate – 20 mg, water for injections – up to 1 ml.

10 ml – neutral glass ampoules (5) – contour cell packaging (1) – cardboard packs.
10 ml – neutral glass ampoules (5) – contour cell packaging (2) – cardboard packs.
10 ml – neutral glass ampoules (10) – contour cell packaging (1) – cardboard packs.
10 ml – neutral glass ampoules (10) – contour cell packaging (2) – cardboard packs.

Marketing Authorization Holder

Novosibkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Sodium thiosulphate Solution for intravenous administration 300 mg/1 ml: 5 ml amp. 5, 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous administration in the form of a transparent, colorless liquid.

1 ml 1 amp.
Sodium thiosulphate pentahydrate 300 mg 1.5 g

Excipients: sodium bicarbonate – 20 mg, water for injections – up to 1 ml.

5 ml – neutral glass ampoules (5) – contour cell packaging (1) – cardboard packs.
5 ml – neutral glass ampoules (5) – contour cell packaging (2) – cardboard packs.
5 ml – neutral glass ampoules (10) – contour cell packaging (1) – cardboard packs.
5 ml – neutral glass ampoules (10) – contour cell packaging (2) – cardboard packs.

Marketing Authorization Holder

Pharmstandard-Ufimsky Vitaminny Zavod OJSC (Russia)

Dosage Form

Bottle Rx Icon Sodium thiosulphate Solution for intravenous administration 30% (1.5 g/5 ml): amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous administration 30% 1 ml 1 amp.
Sodium thiosulphate 300 mg 1.5 g

5 ml – ampoules (10) – cardboard boxes.

Marketing Authorization Holder

Pharmstandard-Ufimsky Vitaminny Zavod OJSC (Russia)

Dosage Form

Bottle Rx Icon Sodium thiosulphate Solution for intravenous administration 30% (3 g/10 ml): amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous administration 30% 1 ml 1 amp.
Sodium thiosulphate 300 mg 3 g

10 ml – ampoules (10) – cardboard boxes.

Marketing Authorization Holder

Mir Chemical and Pharmaceutical Concern, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium thiosulphate Solution for intravenous administration 3 g/10 ml: 10 amp.

Dosage Form, Packaging, and Composition

Solution for intravenous administration 1 ml 1 amp.
Sodium thiosulphate 300 mg 3 g

10 ml – ampoules (5) – contour plastic packaging (1) – cardboard packs.
10 ml – ampoules (5) – contour plastic packaging (2) – cardboard packs.
10 ml – ampoules (10) – contour plastic packaging (1) – cardboard packs.
10 ml – ampoules (10) – contour plastic packaging (2) – cardboard packs.
10 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Velpharm, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium thiosulphate Velpharm Solution for intravenous administration 300 mg/ml

Dosage Form, Packaging, and Composition

Solution for intravenous administration

Sodium thiosulphate 300 mg/ml

10 ml – ampoules (10 pcs.) – cardboard packs – By prescription
10 ml – ampoules (5 pcs.) – cardboard packs – By prescription
5 ml – ampoules (10 pcs.) – cardboard packs – By prescription
5 ml – ampoules (5 pcs.) – cardboard packs – By prescription

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