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Acyzol (Capsules, Solution) Instructions for Use

ATC Code

V03AB (Antidotes)

Active Substance

Zinc bisvinylimidazole diacetate (Grouping name)

Clinical-Pharmacological Group

Antidote

Pharmacotherapeutic Group

Antidote

Pharmacological Action

Acyzol is a highly effective antidote against acute poisoning with lethal doses of carbon monoxide, as well as an effective antihypoxant in oxygen deficiency.

The administration of Acyzol to victims in mass casualty areas increases their chances of survival in severe forms of intoxication, accelerates the elimination of carbon monoxide, and contributes to the success of subsequent medical measures.

Acyzol is an original domestic drug that has no analogues abroad in terms of structure and action. There have been no medicinal or prophylactic agents used for carbon monoxide poisoning until now.

The use of Acyzol opens a fundamentally new way to combat anoxia by changing the affinity of hemoglobin for blood gases and increasing tolerance to high concentrations of carboxyhemoglobin.

Acyzol prevents the formation of carboxyhemoglobin by influencing the cooperative interaction of hemoglobin subunits, resulting in a decrease in the relative affinity of hemoglobin for carbon monoxide and an improvement in the oxygen-binding and gas-transport properties of blood.

Acyzol reduces the severity of intoxication in carbon monoxide poisoning according to the severity of metabolic acidosis and accelerates the elimination of carbon monoxide (CO) from the body.

The protective index of Acyzol with parenteral use is 1.40-1.45. Oral administration of Acyzol enhances the prophylactic and therapeutic effect against carbon monoxide, and the protective index increases to 1.6-1.8.

Acyzol reduces the body’s oxygen demand and promotes increased resistance to hypoxia in organs most sensitive to oxygen deficiency: the brain, myocardium, and liver.

Acyzol is a complex zinc-organic compound and replenishes zinc deficiency in the body.

Pharmacokinetics

When taken orally, it is rapidly absorbed from the gastrointestinal tract. Cmax after a dose of 120 mg is reached in 1-1.5 hours. T1/2 is 1-1.5 hours; trace amounts of the drug are recorded after 8-10 hours. It is mainly metabolized in the liver.

With intramuscular administration of Acyzol, Cmax is reached 20-30 minutes after administration of a 60 mg (1 ml) dose and remains in the plasma for 4-5 hours. T1/2 is 1-1.5 hours.

Indications

  • Prophylactic agent in case of threat of poisoning;
  • Therapeutic agent for poisoning of varying severity by carbon monoxide (CO) and other products of thermal oxidative degradation;
  • For emergency medical care in emergencies when people are affected by carbon monoxide and combustion products of organic substances in the foci of large-scale disasters and chemical accidents; mine and mine rescue operations, various fires (at industrial sites, in forests), ailments caused by automobile exhausts (traffic controllers, traffic police workers) – areas of application of Acyzol.

As an antihypoxic agent, Acyzol can be used for many diseases accompanied by ischemia and hypoxia of internal organs: in therapeutic and surgical practice, in urology, gynecology, dermatology, as well as for the treatment of functional impotence.

Due to its antihypoxic and antioxidant action, Acyzol can find application in resuscitation, emergency therapy, and surgery for the correction of metabolic acidosis and protection of cell membranes from the effects of lipid peroxidation products.

Acyzol can be recommended for implementation in obstetric practice as an effective agent for fetal hypoxia.

In sports medicine, the use of Acyzol will increase performance and endurance in training processes by replenishing zinc in enzymatic systems, optimizing tissue respiration, and improving the oxygen-binding properties of blood.

Due to the presence of ionized zinc in the Acyzol dosage form, the drug can be used in the treatment of zinc-deficient conditions: Prasad’s disease, immunodeficiencies, alopecia, allergic dermatoses, prostate dysfunction, and delayed mental and physical development in children.

ICD codes

ICD-10 code Indication
D84.9 Immunodeficiency, unspecified
E87.2 Acidosis
F52.2 Insufficiency of genital response (psychogenic impotence)
F89 Unspecified disorder of psychological development
L20.8 Other atopic dermatitis (neurodermatitis, eczema)
L23 Allergic contact dermatitis
L24 Irritant contact dermatitis
L28.0 Lichen simplex chronicus (circumscribed neurodermatitis)
L63 Alopecia areata
L64 Androgenic alopecia
O36.3 Signs of fetal intrauterine hypoxia requiring the provision of medical care to the mother
T58 Toxic effect of carbon monoxide
Z73.0 Burn-out
Z73.3 Stress, not elsewhere classified (physical and mental strain)
ICD-11 code Indication
4A0Z Unspecified primary immunodeficiencies
5C73.Z Acidosis, unspecified
6A0Z Neurodevelopmental disorders, unspecified
9A06.70 Atopic eczema of the eyelids
EA80.0 Infantile atopic eczema
EA80.1 Childhood atopic eczema
EA80.2 Adult atopic eczema
EA80.Z Atopic eczema, unspecified
EA83.00 Lichen simplex of vulva
EA83.01 Lichen simplex of male genital organs
EA83.02 Lichen simplex of perianal area
EA83.0Z Lichen simplex of unspecified location
EA85.20 Atopic hand eczema
ED70.1 Female pattern hair loss
ED70.2Z Alopecia areata, unspecified
EK00.Z Allergic contact dermatitis, unspecified
EK02.Z Irritant contact dermatitis, unspecified
HA01.00 Female sexual arousal dysfunction, lifelong, generalized
HA01.01 Female sexual arousal dysfunction, lifelong, situational
HA01.02 Female sexual arousal dysfunction, acquired, generalized
HA01.03 Female sexual arousal dysfunction, acquired, situational
HA01.0Z Female sexual arousal dysfunction, unspecified
HA01.10 Male erectile dysfunction, lifelong, generalized
HA01.11 Male erectile dysfunction, lifelong, situational
HA01.12 Male erectile dysfunction, acquired, generalized
HA01.13 Male erectile dysfunction, acquired, situational
HA01.Z Sexual arousal dysfunctions, unspecified
JA86.2 Maternal care for signs of intrauterine fetal hypoxia
NE61 Toxic effect of poisonous substances, chiefly nonmedicinal, not elsewhere classified
QD85 Burn-out
QE01 Stress, 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.

Capsules

For prophylactic purposes, Acyzol is prescribed at a dose of 1 ml intramuscularly 20-30 minutes before or 1 capsule (120 mg) 30-40 minutes before entering a smoke-filled (gassed) area, when there is a high risk of CO 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 Acyzol lasts for 1.5-2 hours when using the drug solution, and repeated administration is allowed 1 hour after the 1st administration. When using capsules, the protective effect lasts for 2-2.5 hours, and repeated administration of the drug is allowed after 1.5-2 hours.

Solution

For prophylactic purposes, 1 ml of Acyzol solution is administered intramuscularly when there is a threat of poisoning 20 – 30 minutes before the expected exposure to CO and thermal degradation products. Repeated administration is allowed 1 hour after the first administration.

As a therapeutic agent, Acyzol is recommended to be used as early as possible after poisoning, regardless of the severity of the lesion. The drug is administered at a dose of 1 ml intramuscularly immediately after the victim is removed from the fire area (gassed room). Subsequently, Acyzol is administered intramuscularly at 1 ml 2 – 4 times a day.

The maximum daily dose for an adult is 240 mg (4 ml).

The course of treatment averages 7 – 10 days.

Adverse Reactions

Acyzol does not exhibit side effects; in some cases, moderate pain at the injection site is possible.

Contraindications

  • Hypersensitivity to the components of the drug Acyzol.

Special Precautions

The administration of Acyzol does not exclude the need for other therapeutic measures aimed at maintaining the vital functions of the body: oxygen therapy, infusion therapy.

Overdose

In case of an overdose of Acyzol, a metallic taste in the mouth, headache, and nausea are noted, which may occur during course treatment and disappear after discontinuation of the drug.

Storage Conditions

The drug should be stored in a place protected from light, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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

Nizhpharm JSC (Russia)

Manufactured By

Makiz-Pharma, LLC (Russia)

Dosage Form

Bottle Rx Icon Acyzol Capsules 120 mg: 1, 3, 10, 20, 30, 50, 100, 150, 500, or 1000 pcs.

Dosage Form, Packaging, and Composition

Capsules 1 caps.
Zinc bisvinylimidazole diacetate 120 mg

1 pcs. – blister packs (1) – cardboard packs.
1 pcs. – blister packs (50) – cardboard boxes.
1 pcs. – blister packs (100) – cardboard boxes.
3 pcs. – blister packs (1) – cardboard packs.
3 pcs. – blister packs (50) – cardboard boxes.
3 pcs. – blister packs (100) – cardboard boxes.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (50) – cardboard boxes.
10 pcs. – blister packs (100) – cardboard boxes.
30 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Russian Cardiological Research and Production Complex of the Ministry of Health of the Russian Federation – Branch of Experimental Production of Medical and Biological Preparations (Russia)

Dosage Form

Bottle Rx Icon Acyzol Solution for intramuscular injection 60 mg/ml: 1 ml amp. 5, 10, 250, or 500 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular injection 1 ml
Zinc bisvinylimidazole diacetate 60 mg

1 ml – ampoules (5) – blister packs (1) – cardboard packs.
1 ml – ampoules (5) – blister packs (2) – cardboard packs.
1 ml – ampoules (5) – blister packs (50) – cardboard boxes.
1 ml – ampoules (5) – blister packs (100) – cardboard boxes.

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