Zincazol^® (Solution) Instructions for Use

Marketing Authorization Holder

Pharmazashchita SPC, FSUE FMBA of Russia (Russia)

ATC Code

V03AB (Antidotes)

Active Substance

Zinc bisvinylimidazole diacetate (Grouping name)

Dosage Form

Zincazol®

Solution for intramuscular injection 60 mg/1 ml: amp. 1 ml 1, 2, 5, 10, or 20 pcs., syringes 1 ml 1 or 5 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular injection in the form of a colorless, transparent liquid with a characteristic odor.

Excipients : acetic acid (pH corrector) – 0.005 ml, water for injection – up to 1 ml.

1 ml – glass ampoules (1) – contour cell packaging (1) – cardboard boxes.
1 ml – glass ampoules (1) – contour cell packaging (2) – cardboard boxes.
1 ml – glass ampoules (1) – contour cell packaging (10) – cardboard boxes.
1 ml – glass ampoules (1) – contour cell packaging (20) – cardboard boxes.
1 ml – glass ampoules (5) – contour cell packaging (1) – cardboard boxes.
1 ml – glass ampoules (5) – contour cell packaging (2) – cardboard boxes.
1 ml – glass syringes (1) – contour cell packaging (1) together with 1 injection needle – cardboard boxes.
1 ml – glass syringes (5) – contour cell packaging (1) together with 5 injection needles – cardboard boxes.

Clinical-Pharmacological Group

Antidote

Pharmacotherapeutic Group

Other therapeutic products; antidotes

Pharmacological Action

It is known that under conditions of exposure to elevated concentrations of carbon monoxide (II), the so-called Haldane effect is manifested, when as a result of cooperative interaction of hemes, the 4th heme of the hemoglobin molecule loses its ability to release oxygen if the other 3 hemes have bound carbon monoxide (II).

Zinc bisvinylimidazole diacetate, being a complex zinc-organic compound, by reducing the cooperativity of hemes and the relative affinity of hemoglobin for carbon monoxide (II), inhibits the formation of carboxyhemoglobin, resulting in improved oxygen-binding and gas-transport properties of the blood in carbon monoxide (II) poisoning, and accelerated elimination of carbon monoxide (II) from the body.

The increase in hemoglobin’s affinity for oxygen (O₂) and the leftward shift of the oxyhemoglobin dissociation curve allow hemoglobin to become fully saturated with oxygen at much lower partial pressure values of O₂, thereby increasing the body’s resistance to lack of oxygen in the environment.

The difficulty in releasing O₂ to tissues leads to a relative deterioration in the supply of O₂ only to organs and tissues with a high threshold for its uptake, while vital organs with a low threshold for O₂ uptake, such as the brain, are in better conditions than in the absence of the left shift.

Zinc bisvinylimidazole diacetate, by promoting the acceleration of carbon monoxide elimination from the body, reduces the severity of intoxication in carbon monoxide (II) poisoning according to the indicators of the severity of metabolic acidosis. It replenishes the zinc deficiency in the body.

Pharmacokinetics

C_max in blood is reached 20-30 minutes after intramuscular injection of 1 ml (60 mg) of the drug and remains in the blood plasma for 4-5 hours. It is mainly metabolized by the liver. Metabolites are excreted from the body predominantly through the gastrointestinal tract. T_1/2 is 1-1.5 hours.

Indications

Treatment and prevention of carbon monoxide (II) poisoning of varying severity.

ICD codes

Dosage Regimen

Administered intramuscularly.

For prophylactic purposes when there is a threat of poisoning, 1 ml of zinc bisvinylimidazole diacetate is administered 20-30 minutes before the expected exposure – entering a smoke/gas-filled area, at high risk of carbon monoxide (II) inhalation during work to eliminate the consequences of accidents and disasters accompanied by fires, or when extinguishing the fires themselves and rescuing victims.

The protective effect of the drug lasts for 1.5-2 hours. Repeated administration is allowed 1 hour after the first injection.

As a therapeutic agent, zinc bisvinylimidazole diacetate is recommended for use in carbon monoxide (II) poisoning as early as possible, regardless of the severity of the lesion.

1 ml of zinc bisvinylimidazole diacetate is administered immediately after removing the victim from the fire/gas-filled area. A repeated injection is allowed after 1 hour. Subsequently – 1 ml 2-4 times/day.

The maximum daily dose for an adult is 240 mg (4 ml). The course of treatment averages 7-10 days.

Adverse Reactions

Moderate pain at the injection site is possible.

Contraindications

Hypersensitivity to zinc bisvinylimidazole diacetate; breastfeeding period; age under 18 years (due to insufficient data).

With caution in patients with copper deficiency.

Use in Pregnancy and Lactation

Adequate and strictly controlled studies in pregnant women to assess the effect of zinc bisvinylimidazole diacetate on pregnancy outcome have not been conducted.

It is unknown whether zinc bisvinylimidazole diacetate can pass into breast milk. If use during lactation is necessary, the issue of discontinuing breastfeeding should be decided.

Experimental studies in animals did not reveal embryotoxic or teratogenic properties of zinc bisvinylimidazole diacetate, nor any adverse effects on reproductive function.

Pediatric Use

Use in children and adolescents under 18 years of age is contraindicated (due to insufficient data).

Drug Interactions

It is not recommended to use zinc bisvinylimidazole diacetate together with sodium dimercaptopropanesulfonate. No negative effects have been observed when used concomitantly with other medicinal products.

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.