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Composition:


active ingredients: gentamicin sulfate, L-tryptophan, zinc sulfate heptahydrate;


1 g of powder contains: GENTAXAN® substance consisting of: gentamicin sulfate (in terms of gentamicin and anhydrous substance) 0.024 G, L-tryptophan 0.014 G, zinc sulfate heptahydrate 0.010 G,


auxiliary substance: methoxane (sufficient amount to obtain a mass of 1 g).


Dosage form.


Powder for skin use.


Basic physical and chemical properties: amorphous powder of white or white with a light yellow tint of color, odorless.


Pharmacotherapeutic group.


Antibiotics in combination with chemotherapeutic drugs.


ATX code D06C.


Pharmacological properties.


Pharmacodynamics.


GENTAXAN® is a combined long-acting antimicrobial drug for topical use, containing aminoglycoside gentamicin sulfate, organosilicon sorbent polymethylsiloxane (methoxane) and a zinc compound with tryptophan. Gentamicin sulfate is a broad-spectrum antibiotic with a bactericidal effect, active 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., Providenta spp., Yersinia spp. Polymethylsiloxane provides sorption-detoxification properties and, together with zinctryptophan, potentiates the antibacterial effects of the antibiotic and maintains the antimicrobial concentration of the antibiotic in the wound at a therapeutic level for 8 days. Application therapy with GENTAXAN® reduces the number of microorganisms in the wound to a minimum level (102-103 in 1 g) on the 2nd-3rd day, accelerates the transition of the hydration phase to the dehydration phase, and prevents the development of possible purulent-septic complications. Due to its sorption properties, the drug absorbs toxic waste products of microorganisms, low-molecular toxic metabolites of tissues (pyruvic and lactic acids, peroxidation compounds, amino acid oxidation products, polypeptides, lipids, etc.), fibrin dehydration products. The mechanism of action of GENTAXAN® is associated not only with inhibition of protein synthesis of microorganisms, but also with a violation of the lipid layer of the cell wall due to the formation of complexes. GENTAXAN® reduces the manifestations of local and general intoxication, due to its antibacterial properties, drainage and decongestant action, it normalizes microcirculation, gas exchange, and the pH of the medium in the wound. This helps to clear wounds of exudation and tissue breakdown products, eliminate local inflammatory reactions, stimulate the growth of granulation tissue, improve the healing process, and prevent the formation of keloid scars. GENTAXAN® also cleanses burn wounds, reduces inflammatory reactions during their treatment, reduces the area of deep burns, preventing tissue destruction, accelerates the formation of granulation cover in deep burns and epithelialization in superficial burns, promotes high-quality preparation of wounds for autodermoplasty.


Pharmacokinetics.


It has not been studied, since GENTAXAN® is a non-systemic drug, acts only superficially and has no resorptive effect.


Clinical characteristics.


Indications.


Treatment of wounds infected with pathogens sensitive to the drug:


infected surgical wounds (postoperative suppuration, phlegmons, abscesses); traumatic infected wounds of various localization and Genesis; trophic ulcers that occur against the background of chronic venous insufficiency, obliterating atherosclerosis, thrombophlebitis of the superficial veins of the lower extremities; Burns of II and III A – III B degrees; various forms of erysipelas; bedsores; wounds in patients with various diseases that reduce regenerative processes (diabetes mellitus, immunodeficiency, Radiation Damage); Prevention of sepsis with common purulent processes; prevention of the formation of keloid scars.

Contraindications.


Hypersensitivity to gentamicin sulfate and other components that are part of the drug GENTAXAN®.


Interactions with other drugs and other types of interactions.


The interaction of GENTAXAN with other drugs has not been studied, but it is possible to increase the effect when applied topically with antibiotics that have a bactericidal effect.


Application features.


GENTAXAN® can only be applied to the wound surface after careful surgical treatment. The drug prevents bandages from sticking and pain when they are removed.


When applied topically, the drug does not have a local irritant effect, but do not allow the drug GENTAXAN® to get into the eyes.


Prolonged use of the drug can lead to excessive growth of insensitive microorganisms. If irritation, sensitization or superinfection develops during the use of the drug, treatment should be discontinued and appropriate therapy should be prescribed.


Use during pregnancy or lactation.


There are no data on the use of the drug during pregnancy or lactation. If it is necessary to use GENTAXAN® during pregnancy or lactation, the doctor should provide recommendations, taking into account the benefit/risk ratio.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


It doesn't affect you.


Dosage and administration.


GENTAXAN® should be applied topically throughout the entire treatment of wounds until they are completely healed. At the initial stage (Day 1-5), dressings should be changed 1-2 times a day; after reducing inflammatory processes, cleaning the wound from purulent-necrotic masses, the appearance of granulation and epithelialization of the wound-1 time for 1-2 days. Apply GENTAXAN® to the wound surface through a dropper plug (hole in the plug), removing the lid, after careful surgical treatment, washing the wound with antiseptic solutions with mandatory subsequent drying, so that it covers the wound surface in a uniform layer (0.5-1 mm). For extensive lesions, such as Burns, a single application of 8-12 g of the drug is possible. After applying the drug GENTAXAN®, the wound is drained according to the general rules and a bandage is applied. With common wound tissue defects, loose tamponing with gauze napkins is allowed. In case of partial withdrawal of the drug GENTAXAN® together with the discharge from the wound and the dressing, dry the wound with gauze Tupperware and additionally apply the drug in the above single dose without any other manipulations in the wound.


For the treatment of burns, apply GENTAXAN® to the burn surface both in the first 5-6 days and during the sequestration of the burn scab (up to 15 days). In this case, the drug should be fixed on the wound with an aseptic dressing. During dressings, GENTAXAN® should be completely removed from the surface of burn wounds with antiseptics or special shampoos for wounds. The use of the drug is possible on any part of the body of a burn patient.


If surgical treatment of the wound cannot be performed in full, fill the wound with GENTAXAN® at a dose of 0.5–4 g, depending on the area of the lesion, and apply a bandage for a time that does not exceed 24 hours.


Children.


The drug is used in children from 2 years of age.


Overdose.


Possible allergic reactions that require discontinuation of the drug and desensitizing therapy.


Adverse reactions.


Adverse reactions may occur due to the presence of gentamicin sulfate in the drug: allergic reactions, including erythema, urticaria, contact dermatitis, pruritus.

Tags: tryptophan, Gentamicin, Zinc sulfate