Gentaksan®

INSTRUCTIONS for medical use of the medicinal product GENTAXAN® (GENTAXAN)

Composition:

Active substances: gentamicin sulfate, L-tryptophan, zinc sulfate heptahydrate;

1 g of powder contains: GENTAXAN**®** substance consisting of: gentamicin sulfate (calculated as gentamicin and anhydrous substance) 0.024 g, L-tryptophan 0.014 g, zinc sulfate heptahydrate 0.010 g;

Excipient: metoxan (sufficient quantity to obtain 1 g mass).

Pharmaceutical form.

Topical powder.

Main physicochemical properties: amorphous powder of white or white with light-yellow tint color, odorless.

Pharmacotherapeutic group.

Antibiotics and chemotherapeutic agents for dermatological use. Combinations of antibiotics with chemotherapeutic agents.

ATC code D06C.

Pharmacological properties.

Pharmacodynamics.

GEN-TAXAN® is a combined prolonged-action antimicrobial medicinal product for topical use, containing the aminoglycoside gentamicin sulfate, the organosilicon sorbent polymethylsiloxane (metoxane), and a zinc-tryptophan complex. Gentamicin sulfate is a broad-spectrum antibiotic with bactericidal activity effective against pathogenic gram-positive microorganisms: Staphylococcus aureus, Streptococcus, Mycobacterium spp., and gram-negative microorganisms: Pseudomonas aeruginosa, Aerobacter aeruginosa, Escherichia coli, Proteus spp., Klebsiella spp., Serratia spp., Shigella spp., Salmonella spp., Citrobacter spp., Providencia spp., Yersinia spp. Polymethylsiloxane provides sorption and detoxifying properties and, together with zinc-tryptophan, potentiates the antibiotic's antibacterial effects and maintains the antibiotic concentration at a therapeutic level in the wound for up to 8 days. Application of GEN-TAXAN® reduces the number of microorganisms in the wound to a minimal level (10²–10³ per 1 g) by the 2nd–3rd day of treatment, accelerates the transition from the hydration phase to the dehydration phase, and prevents possible purulent-septic complications. Due to its sorption properties, the medicinal product absorbs toxic metabolic products of microorganisms and low-molecular-weight tissue metabolites (pyruvic and lactic acids, peroxide compounds, amino acid oxidation products, polypeptides, lipids, etc.), as well as products of fibrin dehydration. The mechanism of action of GEN-TAXAN® is associated not only with inhibition of microbial protein synthesis but also with disruption of the lipid layer of the cell wall due to complex formation. GEN-TAXAN® reduces manifestations of local and systemic intoxication; thanks to its antibacterial, drainage, and anti-edematous effects, it normalizes microcirculation, gas exchange, and pH in the wound environment. This promotes wound debridement from exudative and necrotic products, resolution of local inflammatory reactions, stimulation of granulation tissue growth, and improved wound healing, while preventing the formation of keloid scars. GEN-TAXAN® also cleanses burn wounds, reduces inflammatory reactions during their treatment, decreases the area of deep burns by preventing tissue destruction, accelerates granulation tissue formation in deep burns and epithelialization in superficial burns, and promotes optimal wound preparation for autodermoplasty.

Pharmacokinetics.

Not studied, as GEN-TAXAN® is a non-systemic medicinal product intended for topical use only, acting superficially without any resorptive effect.

Clinical characteristics.

Indications.

Treatment of wounds infected with microorganisms sensitive to the drug:

• infected surgical wounds (postoperative suppurations, phlegmons, abscesses);
• traumatic infected wounds of various locations and origins;
• trophic ulcers occurring against a background of chronic venous insufficiency, obliterative atherosclerosis, thrombophlebitis of superficial veins of the lower limbs;
• burns of degree II and III A – III B;
• various forms of erysipelas;
• pressure sores;
• wounds in patients with various diseases associated with impaired regenerative processes (diabetes mellitus, immunodeficiency, radiation injury).

Prevention of sepsis in extensive purulent processes.

Prevention of keloid scar formation.

Contraindications.

Hypersensitivity to gentamicin sulfate and other components of the medicinal product GENTAXAN®.

Interaction with other medicinal products and other types of interactions.

The interaction of the medicinal product GENTAXAN® with other medicinal products has not been studied.

When applied over large wound surface areas or used for prolonged periods, absorption of gentamicin may occur, potentially enhancing the ototoxicity of other aminoglycoside antibiotics, polymyxin B, colistin, cephaloridine, ethacrynic acid, and furosemide.

Special precautions for use.

GENTAXAN® may be applied to wound surfaces only after thorough surgical debridement. The medicinal product prevents dressing adherence and pain upon removal.

GENTAXAN® does not exert an irritant effect when used locally; however, contact of the powder with the eyes must be avoided.

Prolonged use of the product may lead to overgrowth of resistant microorganisms. If irritation, sensitization, or superinfection develops during treatment, therapy should be discontinued and appropriate treatment initiated.

With prolonged use (more than 14 days) over large skin areas, especially in patients with chronic renal insufficiency, the possibility of systemic absorption effects of gentamicin should be considered: ototoxicity (dizziness, nausea, tinnitus), nephrotoxicity (increased blood urea and creatinine levels, decreased diuresis), and elevated serum bilirubin and transaminase levels.

Use during pregnancy or breastfeeding.

There are no data on the use of the medicinal product GENTAXAN® during pregnancy or breastfeeding. If use of the product is necessary during pregnancy or breastfeeding, the physician should provide recommendations based on an assessment of the benefit-risk ratio.

Ability to affect reaction speed when driving or operating machinery.

Does not affect.

Method of Administration and Dosage

GEN-TAXAN® should be applied topically throughout the entire treatment period until complete wound healing. During the initial stage (days 1–5), dressings should be changed 1–2 times daily; after reduction of inflammation, wound cleansing from purulent-necrotic masses, and upon appearance of granulation and epithelialization, dressings should be changed once every 1–2 days. GEN-TAXAN® should be applied directly onto the wound surface through the dropper cap (the opening in the cap) after removing the cap, following thorough surgical debridement and irrigation of the wound with antiseptic solutions, with mandatory subsequent drying, in such a quantity that it forms a uniform layer (0.5–1 mm) covering the entire wound surface. In extensive lesions, such as burns, a single application of 8–12 g of the medicinal product may be used. After application of GEN-TAXAN®, wound drainage should be performed according to standard protocols, followed by dressing application. In cases of extensive tissue defects, loose packing with gauze pads is permissible. If partial removal of GEN-TAXAN® occurs together with wound exudate and the dressing, the wound should be dried with gauze swabs and an additional dose of the medicinal product should be applied as specified above, without any further manipulations within the wound.

For burn treatment, the medicinal product GEN-TAXAN® should be applied to the burned surface both within the first 5–6 days and during the eschar sequestration phase (up to 15 days). The medicinal product should be secured on the wound using an aseptic dressing. During dressing changes, GEN-TAXAN® should be completely removed from the surface of burn wounds using antiseptics or special wound shampoos. The medicinal product may be used on any body areas affected by burns.

If complete surgical wound debridement cannot be performed, the wound should be filled with GEN-TAXAN® in a dose of 0.5–4 g, depending on the lesion area, and a dressing applied for no longer than 24 hours.

Children.

The medicinal product can be used in children aged 2 years and older.

Overdose.

Allergic reactions may occur, requiring discontinuation of the drug and initiation of desensitizing therapy.

Prolonged use of gentamicin on large body surfaces may lead to overgrowth of insensitive microorganisms. In case of excessive growth of resistant microorganisms, treatment with the drug should be discontinued and appropriate therapy initiated.

Adverse reactions.

Allergic reactions are possible, including erythema, urticaria, contact dermatitis, and pruritus.

Reporting suspected adverse reactions.

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

Shelf life. 4 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging.

2 g, 5 g, and 8 g in a dropper bottle; 1 dropper bottle per cardboard box; 1 dropper bottle without secondary packaging.

Supply classification. Over-the-counter (without prescription).

Manufacturer.

LLC "Pharmaceutical Company "FarkoS".

Manufacturer's address and place of business.

360, Sviato-Pokrovska Street, Sviatoshyn district, Hostomel, Irpin, Kyiv region, 08290, Ukraine.