Atonzil

INSTRUCTION
for medical use of medicinal product

ATONZIL®

Composition:

Active ingredient: benzyl dimethyl [3-(myristoylamino)propyl] ammonium chloride monohydrate;

1 ml of solution contains benzyl dimethyl [3-(myristoylamino)propyl] ammonium chloride monohydrate (calculated as anhydrous substance) 0.1 mg;

Excipients: sodium chloride, purified water.

Pharmaceutical form. Oromucosal solution.

Main physicochemical properties: colorless, clear liquid.

Pharmacotherapeutic group.

Dermatologicals. Antiseptics and disinfectants. Quaternary ammonium compounds. ATC Code D08AJ.

Pharmacological properties.

Pharmacodynamics.

The mechanism of action of benzyl dimethyl [3-(myristoylamino)propyl] ammonium chloride monohydrate is based on direct hydrophobic interaction of the molecule with microbial membrane lipids, leading to their fragmentation and destruction. Part of the molecule penetrates into the hydrophobic region of the membrane, disrupts the supramembrane layer, loosens the membrane, increases its permeability for high-molecular-weight substances, alters enzymatic activity of the microbial cell, and inhibits enzyme systems, resulting in suppression of microbial viability and cytolysis.

Unlike other antiseptics, benzyl dimethyl [3-(myristoylamino)propyl] ammonium chloride exhibits high selectivity of action against microorganisms because it has practically no effect on human cell membranes. This effect is associated with a different structure of human cell membranes (significantly longer lipid radicals that severely limit the possibility of hydrophobic interaction between benzyl dimethyl [3-(myristoylamino)propyl] ammonium chloride and human cells).

Benzyl dimethyl [3-(myristoylamino)propyl] ammonium chloride has pronounced antimicrobial activity against Gram-positive and Gram-negative, aerobic and anaerobic, spore-forming and non-spore-forming bacteria, both as monocultures and microbial associations, including hospital strains with polyresistance to antibiotics.

It acts destructively on pathogens of sexually transmitted diseases: gonococci, Treponema pallidum, Trichomonas, Chlamydia, as well as on herpes viruses, human immunodeficiency virus, etc. It exhibits antifungal activity against Ascomycetes of the genus Aspergillus and Penicillium, yeasts (Rhodotorula rubra, Torulopsis gabrata, etc.), yeast-like fungi (Candida albicans, Candida krusei, etc.), dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, T. schoenleini, T. violaceum, Epidermophyton Kaufman-Wolf, E. floccosum, Microsporum gypseum, Microsporum canis, etc.), and other pathogenic fungi (e.g., Pityrosporum orbiculare [Malassezia furfur]). The drug is effective against both monocultures and microbial associations, including fungal microflora resistant to chemotherapeutic agents. Under the influence of benzyl dimethyl [3-(myristoylamino)propyl] ammonium chloride, microbial resistance to antibiotics decreases. The substance has anti-inflammatory and immunoadjuvant effects, enhances local defense reactions and regenerative processes, and activates non-specific defense mechanisms due to modulation of cellular and local humoral immune responses.

Pharmacokinetics.

Benzyl dimethyl [3-(myristoylamino)propyl] ammonium chloride exerts a local effect. Data on the possibility of the drug penetrating into systemic circulation are lacking.

Clinical characteristics.

Indications.

Otorhinolaryngology: in complex treatment of acute and chronic tonsillitis.

Dentistry: treatment of periodontitis and stomatitis; hygienic care of removable dentures; prevention of microbial complications after surgical interventions on the oral mucosa.

Contraindications.

Individual hypersensitivity to the components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

When used concomitantly with locally acting antibiotics, a reduction in microbial resistance to the latter is observed.

Special precautions.

To minimize the risk of infection spread, the medicinal product container should be used by only one person.

Avoid contact of the medicinal product with ocular mucous membranes. In case of accidental contact with eyes, rinse thoroughly with copious amounts of running water.

The drug does not cause local irritation and has no allergenic properties.

Use during pregnancy or breastfeeding.

Since the medicinal product is almost not absorbed, it may be used in women during pregnancy or breastfeeding; however, the decision on its use should be made by a physician.

Ability to influence reaction rate when driving or operating machinery.

The medicinal product does not affect reaction speed when driving or operating machinery.

Method of administration and dosage.

If necessary, after opening the bottle, replace the cap with a spray nozzle.

Otorhinolaryngology. For treatment of tonsillitis and laryngitis, perform repeated rinsing of the throat with the product or spray it using the spray device (3–4 actuations) 4–6 times daily.

The treatment course lasts 3–5 days.

In purulent maxillary sinusitis, during puncture, the maxillary sinus is irrigated with 10 ml of the product.

Dentistry. For treatment of stomatitis and prevention of microbial complications after surgical interventions on the oral mucosa, the product is sprayed into the oral cavity or used for rinsing 4–6 times daily. For treatment of periodontitis, the product is applied on pledgets into periodontal pockets, followed by application on the gums for 15 minutes. During exacerbations, periodontal pockets are irrigated with Atonzil® using a syringe, and pledgets soaked with the product are inserted into the abscess cavity. After surgical procedures on the oral mucosa, the product is used as mouth baths in outpatient settings. For hygienic care of removable dentures, dentures are soaked overnight in sufficient quantity of the product; before use, dentures should be thoroughly rinsed with running water.

Children.

The medicinal product can be used in children aged 3 years and older. The method of administration, duration of treatment, and frequency are determined individually by a physician.

Overdose.

Not observed.

Adverse reactions.

In some cases, transient burning sensation may occur, which resolves spontaneously within
5–10 seconds and does not require discontinuation of treatment.

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after medicinal product registration is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, and their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

Store in original packaging, in a place inaccessible to children. No special storage conditions required.

Packaging.

20 ml or 50 ml in a polymer bottle with spray nozzle, 100 ml in a polymer bottle; 1 bottle per cardboard box.

Release category.

Over-the-counter.

Manufacturer.

LLC "Slaviya 2000".

Manufacturer's address and location of its operations.

91 Varshavska St., Kropyvnytskyi, Kirovohrad Oblast, 25005, Ukraine.

Marketing Authorization Holder.

KNVMP "ISNA".

Address of the Marketing Authorization Holder.

8 Dubrovitska St., Office 160, Kyiv, 04114, Ukraine.