Instructions for Sodium Thiosulfate-Darnitsa solution for injection 300 mg/ml ampoule 5 ml No. 10
Composition
active ingredient: sodium thiosulfate;
1 ml of solution contains 300 mg of sodium thiosulfate;
Excipients: sodium bicarbonate, disodium edetate, water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: clear colorless or slightly colored liquid.
Pharmacotherapeutic group
Antidotes. ATX code V03A B06.
Pharmacological properties
Pharmacodynamics
Sodium thiosulfate exhibits antitoxic, anti-inflammatory and desensitizing effects. It is a donor of sulfur ions. It is used as a substrate by the body's rhodanide system for the synthesis of non-toxic thio compounds. It is an antidote for poisoning with hydrocyanic acid and cyanides, arsenic, lead, mercury, iodine and bromine compounds. In poisoning with arsenic, mercury and lead compounds, it forms non-toxic sulfites. In poisoning with cyanides, it forms less toxic rhodanide compounds.
Pharmacokinetics
After intravenous administration, it rapidly enters the extracellular fluid and is excreted unchanged in the urine. The half-life is 0.65 hours.
Indication
Poisoning by compounds of arsenic, mercury, lead; hydrocyanic acid and its salts; iodine, bromine and their salts.
Contraindication
Hypersensitivity to the components of the drug.
Incompatibility.
Incompatible with nitrite and nitrate solutions. Do not mix the drug in the same syringe with other drugs.
Interaction with other medicinal products and other types of interactions
Simultaneous use with drugs whose metabolism passes through the rhodanation stage leads to a weakening of the pharmacological effects of the latter.
Medicines that are iodides and bromides may not exhibit their pharmacological properties when used together with sodium thiosulfate.
Application features
Use with caution in patients with arterial hypertension, cirrhosis of the liver, congestive heart failure, renal failure, and toxemia of pregnancy, as the patient's condition may worsen.
In case of cyanide poisoning, it is initially necessary to use methemoglobin-forming agents, cyanide antimony, or amyl nitrite, and then switch to intravenous administration of sodium thiosulfate.
Before use, the contents of the ampoule should be inspected. If a precipitate is present, the drug should not be used.
Patients with renal impairment: Sodium thiosulfate is known to be primarily excreted by the kidneys, and the risk of drug toxicity may be higher in patients with impaired renal function.
Elderly patients: Elderly patients are more likely to have decreased renal function, so caution should be exercised in dose selection and renal function should be monitored.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are no clinical data, therefore, during treatment, one should refrain from driving or working with other mechanisms that require increased concentration of attention and speed of psychomotor reactions.
Use during pregnancy or breastfeeding
During pregnancy or breastfeeding, the drug can be prescribed only for vital indications.
Method of administration and doses
In case of poisoning with arsenic compounds, mercury, lead, iodine, bromine and their salts, the drug is administered intravenously as a bolus in a dose of 1.5-3 g (5-10 ml of a 30% solution). In case of poisoning with hydrocyanic acid and its salts, the drug is administered intravenously slowly in a dose of 15 g (50 ml of a 30% solution).
The drug should be administered throughout the entire toxicogenic period (from the appearance of the first clinical symptoms of poisoning until the complete elimination of the toxin from the body).
Children
The drug should not be used in children due to the lack of clinical data.
Overdose
Symptoms: arthralgia, hyperreflexia, convulsions, psychotic behavior, including agitation, hallucinations; nausea, vomiting; increased manifestations of adverse reactions.
Treatment: hemodialysis; supportive therapy.
Adverse reactions
From the respiratory system, chest organs, mediastinum: shortness of breath, difficulty breathing.
Gastrointestinal: nausea, vomiting.
From the nervous system: headache, dizziness, impaired consciousness, ringing in the ears, blurred vision.
Cardiovascular system: decrease in blood pressure up to collapse, loss of consciousness, tachycardia.
Immune system disorders: hypersensitivity reactions, including anaphylactic reactions, arthralgia, fever.
Skin and subcutaneous tissue disorders: itching, rash (including maculopapular), urticaria, flushing, feeling of heat.
General disorders and administration site conditions: injection site reactions, general weakness, increased diuresis.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ° C. Do not freeze.
Keep out of reach of children.
Packaging
5 ml in an ampoule, 5 ampoules in a contour blister pack, 2 contour blister packs in a pack.
Vacation category
According to the recipe.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the manufacturer and its business address
Ukraine, 02093, Kyiv, Boryspilska St., 13.
