Instructions Gentasept powder for external use plastic bottle 5 g No. 1
Composition
active ingredients:
1 bottle, dropper bottle of 2 g contains a substance consisting of: gentamicin sulfate in terms of gentamicin and anhydrous substance - 0.048 g (48 mg), L-tryptophan - 0.028 g (28 mg), zinc sulfate heptahydrate - 0.020 g (20 mg), methoxane - sufficient to obtain a weight of the contents of the bottle of 2 g;
1 bottle, dropper bottle of 5 g contains a substance consisting of: gentamicin sulfate in terms of gentamicin and anhydrous substance - 0.120 g (120 mg), L-tryptophan - 0.070 g (70 mg), zinc sulfate heptahydrate - 0.050 g (50 mg), methoxane - sufficient amount to obtain a mass of the contents of the bottle of 5 g.
Dosage form
Powder for external use.
Main physicochemical properties: amorphous powder of white or white with a light yellow tint, odorless.
Pharmacotherapeutic group
Antibiotics in combination with chemotherapeutic drugs. ATX code D 06 C.
Pharmacological properties
Pharmacodynamics.
Gentacept is a combined antimicrobial drug of prolonged action for topical use, containing the aminoglycoside gentamicin sulfate, an organic silicon 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 and detoxification properties and, together with zinc tryptophan, 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 Gentacept reduces the number of microorganisms in the wound to a minimum level (102-103 in 1 g) for 2-3 days, accelerates the transition from 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, peroxide compounds, amino acid oxidation products, polypeptides, lipids, etc.), and fibrin dehydration products. The mechanism of action of Gentacept is associated not only with the inhibition of protein synthesis of microorganisms, but also with the disruption of the lipid layer of the cell wall due to the formation of complexes. Gentacept reduces the manifestations of local and general intoxication, having antibacterial properties, drainage and anti-edematous effects, normalizes microcirculation, gas exchange, pH of the wound environment. This helps to cleanse wounds of exudation and tissue decay products, eliminate local inflammatory reactions, stimulate the growth of granulation tissue, improve the healing process, and prevent the formation of keloid scars. Gentacept 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, and promotes high-quality preparation of wounds for autodermoplasty.
Pharmacokinetics.
Not studied, since Gentacept is a drug for non-systemic use, acts only superficially and has no resorptive effect.
Indication
Treatment of wounds infected with pathogens sensitive to the drug:
infected surgical wounds (postoperative suppurations, 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 in which regenerative processes are reduced (diabetes mellitus, immunodeficiency, radiation injury); prevention of sepsis in widespread purulent processes; prevention of the formation of keloid scars.
Contraindication
Hypersensitivity to gentamicin sulfate and other components that make up the Gentacept preparation.
Interaction with other medicinal products and other types of interactions
The interaction of Gentacept with other drugs has not been studied, but it is possible that the effect may be enhanced when used topically with antibiotics that have a bactericidal effect.
Application features
Gentacept can be applied to the wound surface only after thorough surgical treatment. The drug prevents dressings from sticking and pain when removing them.
When applied topically, the drug does not have a local irritating effect, however, Gentacept should not be allowed to get into the eyes.
Prolonged use of the drug may lead to overgrowth of non-susceptible microorganisms. If irritation, sensitization or superinfection develops during use of the drug, treatment should be discontinued and appropriate therapy should be prescribed.
Use during pregnancy or breastfeeding
There are no data on the use of the drug during pregnancy or breastfeeding. If it is necessary to use Gentacept during pregnancy or breastfeeding, the doctor should provide recommendations, taking into account the benefit/risk ratio.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
Gentacept should be applied topically throughout the entire treatment of wounds until they are completely healed. In the initial stage (day 1-5), the dressings should be changed 1-2 times a day, after the inflammatory processes have subsided, the wound has been cleared of purulent-necrotic masses, granulation and epithelialization of the wound have appeared - once every 1-2 days. Gentacept should be applied to the wound surface through a dropper plug (hole in the plug), removing the cap, after thorough surgical treatment, washing the wound with antiseptic solutions with mandatory subsequent drying, so that it covers the wound surface with an even layer (0.5-1 mm). For large lesions, for example, burns, a single application of 8-12 g of the drug is possible. After applying Gentacept, the wound is drained according to general rules and a bandage is applied. For widespread wound tissue defects, loose tamponade with gauze napkins is allowed. If Gentacept is partially removed along with wound discharge and dressing, dry the wound with gauze pads and additionally apply the drug in the above single dose without any other manipulations in the wound.
For the treatment of burns, Gentacept should be applied to the burn surface both in the first 5-6 days and during the period of sequestration of the burn scab (up to 15 days). In this case, the drug should be fixed on the wound using an aseptic bandage. During dressings, Gentacept should be completely removed from the surface of the burn wounds using antiseptics or special wound shampoos. The drug can be used on any part of the body of a burn patient.
In cases where surgical treatment of the wound cannot be performed in full, Gentacept should be applied to the wound in a dose of 0.5-4 g, depending on the area of the lesion, and a bandage should be applied for a period not exceeding 24 hours.
Children
Gentacept can be used in the treatment of children of all age groups, since it is a drug for non-systemic use, acts only superficially and does not have a resorptive effect.
Overdose
Allergic reactions are possible, requiring discontinuation of the drug and desensitization therapy.
Adverse reactions
Adverse reactions due to the presence of gentamicin sulfate in the composition of the drug may occur: allergic reactions, including erythema, urticaria, contact dermatitis, itching.
Expiration date
4 years.
Storage conditions
In the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
2 g or 5 g in a glass dropper bottle; 2 g in a glass bottle; 2 g or 5 g in a plastic bottle.
Vacation category
Without a prescription.
Producer
Public Joint Stock Company "Research and Production Center "Borshchagov Chemical and Pharmaceutical Plant".
Location of the manufacturer and address of its place of business
Ukraine, 03134, Kyiv, Myru St., 17.
