Expiration date: 05/2025

The composition and form of issue:

The solution is for intramuscular and subcutaneous injection. 1 ml contains:

dimercaprol sodium monohydrate (unithiol) 50 mg

excipients: disodium edetate (Trilon B), 0.1 mg sulfuric acid 0.1 M until a pH of 3.1–4.5 water for injection to 1 ml 

in ampoules of 5 ml, complete with a knife ampulnam, in a contour acheikova package 5 ampoules, in a cardboard bundle 2 package.

Description pharmaceutical form:

Transparent colorless or pinkish colored liquid with a faint odor of hydrogen sulfide.

Feature:

Complexing agent.

Pharmacokinetics:

For parenteral administration, is rapidly absorbed into the blood. Cmax achieved through 15-30 minutes after the/m injection. T1/2 is 1-2 hours Volume of distribution — to $ 166.5 ml/kg. the Drug is distributed mainly in the aqueous phase (blood plasma). Not koumouliruet. Excreted kidneys, mainly in the form of products of incomplete and complete oxidation, partly in an unmodified form.

Description pharmacological action:

The active sulfhydryl group of unithiol, interacting with thiol poisons (arsenic compounds, heavy metal salts) and forming with them non-toxic water-soluble compounds that restore the function of enzyme systems of the body, violated by the poison. Increases down of some cations (especially copper and zinc) of metal-containing enzymes in the cells.

Dosage:

Method of application and doses

Mainly intramuscularly or subcutaneously. Intoxication with arsenic, 250-500 mg (5-10 ml of an aqueous solution of 50 mg/ml), at the rate of 0.05 g/10 kg in the first day and 3-4 times on the second day, 2-3 times followed by 1-2 times. In cases of poisoning by mercury compounds - the same pattern for 6-7 days. The treatment is carried out until the disappearance of signs of intoxication. When digitalisnaya intoxication in the first 2 days is administered 250-500 mg (5-10 ml of an aqueous solution of 50 mg/ml) 3-4 times a day, then 1-2 times a day until the termination of cardiotoxicity.

In hepatolenticular degeneration - the intramuscular injection, 250-500 mg (5-10 ml of a solution of 50 mg/ml) daily or every other day treatment course - 25-30 injection, repeated if necessary every 3-4 months.

In chronic alcoholism is prescribed 150-250 mg (3-5 ml of a solution of 50 mg/ml) 2-3 times a week. For relief of delirium - once 200-250 mg (4-5 ml solution 50 mg/ml).

Side effects

Nausea, dizziness, tachycardia, pallor. Allergic reactions are possible.

Interaction with other drugs

Not recommended simultaneous application of Unithiol with drugs, which include heavy metals and alkalis, due to a fast decomposition of Unithiol.

Special instructions

In acute poisoning, carry out additional therapeutic measures (gastric lavage, oxygen therapy, the introduction of dextrose, etc.).

Release form

The solution is for intramuscular and subcutaneous administration of 50 mg/ml In 5 ml ampoules made of neutral glass. 5 vials are placed in a contour cell package of polyvinyl chloride film.

2 contour packaging along with instructions on application and ampoule scarifier disc ceramic put in the cardboard pack. The packaging of ampoules with point or ring fracture scarifier do not invest.

Storage conditions

List B. Store in protected from light place at temperature from 0 to 25°C.

Do not freeze.

Keep out of reach of children.

Shelf life

5 years.

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

Conditions of supply of pharmacies

Released by prescription.

Manufacturer/organization that accepts claims

JSC "moschimpharmpreparaty" to them. N. A. Semashko"

B. Bricklayers str., 9, Moscow, 115172

tel/Fax (495) 912-71-61.

Zam. General Director

JSC "moschimpharmpreparaty"

them. N. A. Semashko" A. A. Trifonov

Indications:

• intoxication with arsenic, mercury, bismuth, chromium, cardiac glycosides
  
• hepatolenticular degeneration (a disease Westphal-Wilson-Konovalov)
  
• chronic alcoholism (in the complex therapy)
  
• delirium tremens.
  

Contraindications:

• hypersensitivity to the drug
  
• liver failure
  
• hypertension
  
• pregnancy
  
• lactation
  
• children up to age 18 years.
  

Side effects:

Nausea, dizziness, tachycardia, pallor.

Allergic reactions are possible.

Drug interactions:

Not recommended simultaneous application of Unithiol with drugs, which include heavy metals and alkali, since there is a rapid deactivation of Unithiol.

Method of application and dose:

Mainly in the/m or p/A. In intoxication by arsenic, 250-500 mg (5-10 ml of an aqueous solution of 50 mg/ml), at the rate of 0.05 g/10 kg in the first day and 3-4 times on the second day, 2-3 times in the next 1-2 times. In cases of poisoning by mercury compounds — the same pattern for 6-7 days. The treatment is carried out until the disappearance of signs of intoxication.

When digitalisnaya intoxication in the first 2 days is administered 250-500 mg (5-10 ml of an aqueous solution of 50 mg/ml) 3-4 times a day, then 1-2 times a day until the termination of cardiotoxicity. In hepatolenticular degeneration — /m 250-500 mg (5-10 ml of a solution of 50 mg/ml) daily or every other day treatment course — 25-30 injection, repeated if necessary every 3-4 months. In chronic alcoholism is prescribed 150-250 mg (3-5 ml of a solution of 50 mg/ml) 2-3 times a week. For relief of delirium — once 200-250 mg (4-5 ml solution 50 mg/ml).

Overdose:

Symptoms: shortness of breath, hyperkinesis, lethargy, drowsiness, stupor, intermittent seizures (occur in excess of the recommended therapeutic doses more than 10 times).

Treatment: symptomatic therapy.

Special instructions:

In acute poisoning, carry out additional therapeutic measures (gastric lavage, oxygen therapy, the introduction of dextrose, etc.).