«Gentamicin Hydrogel Plates 0.1%»
Hydrogelum Gentamycini 0.1%
Agent for topical treatment of wound and burns
100 g of gentamicin sulfate hydrogel 0.1 g, as well as excipients: povidone – 7.5 g, agar – 1.0 g, low molecular polyethylene glycol (polyethylene oxide) 400 – 1.5 g, purified water – up to 100 g.
«Gentamicin Hydrogel Plates 0.1%» are intended for topical use during the treatment of wounds, ulcers, bedsores, burns. Mentioned wound covering has high elasticity, simulates wound surfaces well, of sufficient strength, which provides protection of wound surface from mechanical injury. Has a high degree of atraumaticity, does not stick to wound surface, which precludes pain syndrome when applying a bandage, does not damage tender granulation tissue, skin transplants. «Gentamicin Hydrogel Plates 0.1%» contact well with the wound surface, which provides high adhesive properties of the surface. Application of «Gentamicin Hydrogel Plates 0.1%» creates optimal microclimate in the area of wound defect due to maintaining of humid environment, exhibits plasticising effect, softening necrotic crust, spreading under it, facilitating mechanical removing of devitalized tissues. Wound coating possesses good drainage and sorption properties, due to which it eliminates decay products, wound exudate, microbial bodies, mediators of inflammation from the wound surface. Applications of «Gentamicin hydrogel plates 0.1%» do not prevent normal gas exchange in the wound, and having sufficient barrier function they preclude permeation of microorganisms from outside, prevent re- and superinfection. When «Gentamicin hydrogel» is applied the wound surface is cooled which is very important in the treatment of burns. «Gentamicin hydrogel plates 0.1%» exhibit stimulatory effect on the wound reparative processes. Antibiotic gentamycin contained in the preparation is characterized by a wide range of antimicrobial activity, exhibits bactericidal activity. It is active against the majority of gram-negative and gram-positive microorganisms: Pseudomonas aeruginosa, Escherichia coli, Proteus spp., Klebsiella spp., Serratia spp., Salmonella spp., Shigella spp., Staphylococcus spp., including a lot of resistant strains. Is not active against anaerobe bacteria, fungi, viruses.
Gentamycin poorly penetrates through intact skin and mucosa due to this when used topically in the form of hydrogel plates the preparation virtually does not exhibit resorptive effect. The duration of the effect following a single dose is 8-12 hours. When applied on a damaged skin it is readily absorbed. Gentamycin is excreted via kidneys in unchanged form, predominantly as a result of glomerular filtration.
It was experimental proved that water extract from patch «Gentamicin hydrogel plates 0.1%» (1:1) does not have systemic toxic effects on animals, has not any negative influence on the main functional systems of the organs (CNS, cardiovascular system, hepatic and renal functions), does not have hemolytic, cytotoxic and topical irritating effects. When administered as subchronic parenteral injection they do not irritate peritoneum, do not induce adhesive process in peritoneal cavity, do not influence blood system and immunoreactivity of animals, do not produce postmortem changes of internal organs and are biological safe.
Following contact of hydrogel wound coating with wound surface, mucosa, hypoderm, serosal and epithelial tissues there are no evidence of local alternative, irritating or inflammatory tissue reactions.
Fresh traumatic wounds, granulating wounds (infected and noninfected), chronic sluggish granulating wounds, traumatic wounds with the exposure of bones and tendon tissues, wounds after skin grafting (application should be done on donor as well as host bed), phlyctenulae (exfoliation and epidermis necrosis) after complete removal of necrotizing epidermis, bed sores, trophic sluggish granulating ulcers, post-traumatic ulcers, erysipelatous inflammation, wound after autopsy of hematic abscess, abscesses, carbuncles, furuncles, phlegmons in regeneration phase, thermal burns of 2-3a degree, thermal burns of 3b-4 degree in regeneration phase.
Administration and dosing regimen
“Gentamicin Hydrogel Plates 0.1%” should be used by application directly onto a wound or burn surface. Application is performed after surgical processing,wound toilette. Hydrogel plate is thoroughly molded according to the wound surface, and fixed with a gauze bandage. The preparation should be used during 1-st and 2-nd phases of the wound process with a scant purulent discharge.
Bandages are applied once daily or every two days, if necessary. In case of the wound following autografting bandages are applied every two days. The treatment is performed till complete epithelization of the wound surface.
As a rule, hydrogel plate can be easily removed from the sound surface. After removal the wound surface is often covered with a mucoid film, consisting of a mixture of hydrogel and fibrin, which can be easily removed with the help of a gauze swab. In rare cases drying of hydrogel can occur, which complicates its removal. In such situation it is necessary to cover hydrogel with a gauze napkin, copiously moistened with a physiological solution or Ringer solution for 5-10 minutes, after this procedure hydrogel will swell and can be easily removed from the wound surface.
When «Gentamicin hydrogel plates 0.1%» are applied on traumatic wounds with soft tissues defects, bone and tendon exposure wound coating serves as temporary investing tissue, preventing their dehydration, degeneration and infection. Bandages are applied when necessary. During slight exudation in 1-2 days, during active - daily.
Application of the preparation on granulating noninfected wounds should be done after the wound surface toilette. Bandages are applied every 1-2 days.
Application of the preparation on granulating infected wounds should be done after necrectomy, the wound surface toilette. Bandages are applied daily.
During treatment of trophic sluggish granulating ulcers – Application of «Gentamicin hydrogel plates 0.1%» should be done after necrectomy and the wound surface toilette. Bandages are applied every 2 days, or daily when if required.
During autografting application is performed on donor (place of transplant origin) and host beds. Bandage is reapplied on day 5 in case of normal wound process. In the area of the donor bed hydrogel plate can be left till the end of the epithelization process.
During the treatment of phlyctena complete dissection of necrotizing epidermis and the toilette of the wound surface should be performed. «Gentamicin hydrogel plates 0.1%» should be applied on a clean wound. Usually bandages are applied in 1-2 days, or daily if required.
Bed sores: after necrectomy and toilette hydrogel is applied on the wound surface. Bandages are applied daily. After the appearance of granulation in the wound, in absence of active infectious processes bandages can be applied every 1-2 days. When it is necessary to soften and remove necrotic crust the preparation can be applied directly on it.
Thermal burns of 2-3a degree – application after complete dissection of necrotizing epidermis directly on the burn surface. Bandages are applied daily in case of marked exudation, in moderate exudation - every 1-2 days.
Thermal burns of 3b-4 degree. in regeneration phase: medicinal product «Gentamicin hydrogel plates 0.1%» are used as mentioned for granulating wounds.
Increased tissue reactions at the site of application of «Gentamicin hydrogel plates 0.1%» can occur, associated with individual hypersensitivity of patients (redness, skin, wound soft tissues edema, enhancement of exudation). The above mentioned reaction can be reduced by nonsteroidal anti-inflammatory drugs, and when necessary – a short-term treatment with glucocorticosteroids.
Besides that during prolonged usage (more than 2 week) «Gentamicin hydrogel plates 0.1%» in rare occasions can cause skin maceration.
Pyogenic-necrotic wound in phase I of the wound process with marked exudation. Hypersensitivity to the components of hydrogel, individual intolerance to gentamycin, skin diseases (eczema in exacerbation phase with oozing lesion, syphilous skin lesions, skin tuberculosis, viral and mycotic skin diseases).
When there are signs of marked exudation in the wound with copious pyogenic-necrotic sequester hydrogen plate can be melted with a loss of medical properties.
The preparation should be used with caution in patients with the history of severe allergic reactions.
Interaction of the components of the preparation «Gentamicin hydrogel plates 0.1%» with other drugs is not established, due to relative biological inactivity of hydrogel, as well as low absorption of gentamycin sulfate into systemic blood flow.
There are repots about the Overdosage with medicines on the basis of hydrogel. This is due to a relative biological inactivity of hydrogel, as well as low absorption of miramistin into systemic blood flow.
«Gentamicin hydrogel plates 0.1%» are packed into a polymer package with internal cell dimensions of 10õ12 cm, or 6õ9 cm or two forms of 4õ6 cm. The form is packed into 2 sealed polythene bags with a label between them. One carton contains 1 or 5 bags with hydrogel plates.