Unitiol - instructions for use, dose, side effects, contraindications

Excipients: disodium edetate dihydrate (disodium ethylenediaminetetraacetic acid) 0.1 mg; 0.1 M sulfuric acid solution to pH 3.1-4.5; water for injection - up to 1.0 ml.

Description:A clear, colorless or pinkish solution with a faint smell of hydrogen sulphide.

Pharmacotherapeutic group:complexing agent

ATX: & nbsp

V.03.A.B Antidotes

Pharmacodynamics:

Complexing agent, has detoxification effect.Active sulfhydryl groups, reacting with thiol poisons (arsenic compounds, salts of heavy metals) and forming non-toxic water-soluble compounds with them, restore the functions of the enzyme systems of the organism affected by poison. Increases the excretion of certain cations (especially copper and zinc) from metal-containing cell enzymes.

Pharmacokinetics:

When parenteral administration is rapidly absorbed into the blood. The maximum concentration in the blood plasma (C_mOh) is achieved 15-30 minutes after intramuscular injection.

The half-life (T_1/2) 1-2 hours. The volume of distribution is 166.5 ml / kg. The drug is distributed, mainly in the aqueous phase (blood plasma). The drug is widely distributed in the tissues of the body, the highest concentrations found in the kidneys and liver. Do not cumulate.

Excreted by the kidneys, mainly in the form of incomplete and complete oxidation products, partially unchanged. Excreted also with bile. Eliminated within 4 hours after applying a single dose.

Indications:

- Intoxication with arsenic, mercury, bismuth, chromium, gold, antimony, thallium and cardiac glycosides;

- hepatocerebral dystrophy (Wilson-Westfal-Konovalov disease);

- chronic alcoholism (as part of complex therapy), alcoholic delirium (as part of complex therapy),

- diabetic polyneuropathy.

Contraindications:

Hypersensitivity to the components of the drug, liver failure, hypertension, pregnancy, the period of breastfeeding, children under 18 years.

Carefully:With the development of renal failure, the drug should be discontinued or applied with extreme caution.

Long-term use of the drug should be carried out under the constant supervision of the excretion of heavy metals by the kidneys.

Pregnancy and lactation:

The drug is contraindicated in pregnancy and during breastfeeding.

Dosing and Administration:

Intramuscularly, subcutaneously.

With intoxication with arsenic: 250-500 mg (5-10 ml of the drug), at a rate of 50 mg / 10 kg, for the first time day - 3-4 times, on the second day - 2-3 times, in the subsequent - 1-2 times.

When poisoning with mercury compounds: on the same schedule for 6-7 days. Treatment is carried out until the signs of intoxication disappear.

With digital intoxication: For the first 2 days 250-500 mg (5-10 ml of the drug) are injected 3-4 times a day, then 1-2 times a day until the cardiotoxic action stops.

In hepatocerebral dystrophy: intramuscularly 250-500 mg (5-10 ml of the drug) daily or every other day; course of treatment - 25-30 injections; if necessary, repeat after 3-4 months.

With diabetic polyneuropathy - intramuscularly 250 mg (5 ml of the drug), treatment course - 10 injections.

In chronic alcoholism prescribe 150-250 mg (3-5 ml of the drug) 2-3 times a week.

For the relief of delirium: once 200-250 mg (4-5 ml of the drug).

Side effects:

Allergic reactions are possible.

Nausea, dizziness, tachycardia, pale skin.

Increased blood pressure, vomiting, headache, burning sensation in the lips, mouth and throat, a feeling of restraint and pain in the throat, chest and hands, conjunctivitis, lacrimation, spasm of the eyelids, rhinorrhea, drooling, tingling in the hands, burning sensation in the penis , sweating of the forehead, brushes and other areas, abdominal pain, anxiety, weakness, anxiety, hemolysis, transient leukocytopenia, tremor, burning eyes, hepatotoxicity, spasms and muscle pain, jaw pain, kidney failure, hyperthermia, pain in place injections, renewal of assets th e partial thromboplastin time, reducing the concentration of zinc in the blood.

When applying high doses of the drug, a sharp increase in blood pressure with convulsions and coma may occur.

When used in a therapeutic dose, adverse reactions are almost always reversible and are rarely serious enough to stop treatment.

It is possible to reduce unwanted reactions while observing the interval of 4 hours between application of the drug, taking into account the method of application of the drug.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Symptoms: malaise, nausea, vomiting, lacrimation and salivation, a burning sensation of the lips, mouth, throat and eyes with a headache. Feeling tight in the throat and chest. Increase in blood pressure maximum after 15-20 minutes. These effects can last about four hours.

Possible treatment: subcutaneous administration of diphenhydramine 50 mg or 30 mg ephedrine.

Interaction:

It is not recommended to use simultaneously with preparations that contain heavy metals and alkalis, as the rapid decomposition of Unithiol occurs.

Special instructions:

In acute poisoning, additional therapeutic measures are carried out (gastric lavage, oxygen therapy, dextrose administration, etc.).

It is not allowed to apply simultaneously with iron preparations.

At application it is recommended alkalinization of urine, t. in an acid medium, the sodium-metal dimercaptopropanesulfonate complex is unstable.

There is insufficient evidence of the effectiveness of the drug in bismuth and antimony poisoning.

The drug is effective in acute poisoning with mercury (if therapy is started within 1-2 hours after poisoning), the drug is ineffective in chronic mercury poisoning.

It is inadmissible to use the drug for iron, cadmium, selenium poisoning, since their complexes with unithiol are more toxic, especially for the kidneys.

When using Unithiol, a transient decrease in the percentage of polymorphonuclear leukocytes is possible.

In patients with deficiency of glucose-6-phosphate dehydrogenase, when unithiol is used, hemolysis is possible (which can be very serious). In patients with a high risk of glucose-6-phosphate dehydrogenase deficiency, a preliminary examination and monitoring of possible hemolysis during drug therapy is necessary.

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

Data confirming the influence of Uniothiol on the ability to engage in potentially hazardous activities that require increased attention, no.

Form release / dosage:

Solution for intramuscular and subcutaneous administration, 50 mg / ml.

Packaging:

5 ml into neutral glass ampoules.

5 ampoules are placed in a contour cell box made of a polyvinylchloride (PVC) film or a polyethylene terephthalate (PET) film.

For 1 or 2 contour mesh packages together with the instruction for use and the ampoule scarifier are placed in a pack of cardboard.

For 5 or 10 ampoules, together with the instructions for use and the ampoule scarifier, they are placed in a pack of cardboard with a corrugated liner.

When using ampoules with a dot or a ring of fracture, the ampoule scaper is not inserted.

Packing for hospitals

For 4, 5 or 10 contour mesh packages, together with instructions for use in an amount equal to the number of contour mesh packages, are placed in a pack of cardboard.

For 50 or 100 contour mesh packages, together with instructions for use in an amount equal to the number of contour mesh packages,placed in a box of cardboard corrugated.

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-003756

Date of registration:27.07.2016

Expiration Date:27.07.2021

The owner of the registration certificate:ELLARA, LTD. ELLARA, LTD. Russia

Manufacturer: & nbsp

ELLARA, LTD. Russia

Information update date: & nbsp21.08.2016

Illustrated instructions

Instructions

Unithiol (Unithiol)