Included in the formulation
АТХ:D.06.B.A.03 Mafenide
D.06.B.A Sulfonamides
Pharmacodynamics:Sulfanilamide means of a wide spectrum of action. Has a bacteriostatic effect.The mechanism of action is associated with a competitive antagonism with paraaminobenzoic acid and competitive inhibition of dihydropteroate synthetase, which leads to a disruption in the synthesis of tetrahydrofolic acid necessary for the synthesis of purine and pyrimidine bases.
Effective in vitro for gram-positive and gram-negative bacteria (Citrobacter, Enterobacter, enterococci, Escherichia coli, Klebsiella, Proteus morganii, Proteus mirabilis, Proteus vulgaris, Proteus rettgeri, Pseudomonas aeruginosa, Serratia, Staphylococcus aureus, Staphylococcus epidermidis and beta-hemolytic streptococcus), pathogenic anaerobes, including the causative agent of gas gangrene (Clostridium perfringens), as well as in relation to Candida albicans. The minimum inhibitory concentration, depending on the type of microorganism, is 30-5000 μg / ml. The activity in the presence of para-aminobenzoic acid and in an acidic medium is not reduced. In a concentration of 5-10% effective in the local treatment of purulent infection
Pharmacokinetics:When applied to the wound surface, it is absorbed through the areas with disturbed blood circulation, including through the scab, into the tissue and into the systemic blood stream for 3 hours. FROMmax after local application in patients with burns of II and III degree, 35-70% of the body surface is reached after 24 hours.
Rapidly metabolized to p-carboxybenzenesulfonamide, which does not possess antibacterial activity. Mafenide and its metabolite inhibit the activity of carbonic anhydrase, which can lead to metabolic acidosis. It is excreted by the kidneys in the form of inactive metabolites.
Indications:Infected burns of II and III degree, purulent wounds, bedsores, trophic ulcers.
XII.L80-L99.L89 Decubital ulcer
XII.L80-L99.L98.4 Chronic skin ulcer, not elsewhere classified
XIX.T20-T32.T30 Thermal and chemical burns, unspecified
IX.I80-I89.I83.2 Varicose veins of the lower extremities with ulcer and inflammation
XIX.T79.T79.3 Post-traumatic wound infection, not elsewhere classified
Contraindications:Hypersensitivitytion. Metabolic acidosis or impaired lung function. Renal insufficiency, deficiency of glucose-6-phosphatedehydrogenase.
Pregnancy and lactation:Recommendations FDA category C. Studies in humans or animals have not been conducted. It is not recommended if the area of application of Mafenide exceeds 20% of the body surface. Mafenide is absorbed and can displace bilirubin from the bonds with proteins in fetal plasma, which increases the risk of developing nuclear jaundice. Do not use women who are expecting the development of labor.
There is no information about the penetration of mafenide into milk. However, with topical application mafenide absorbed and penetrates into the systemic circulation. Sulfanilamides for systemic use penetrate into breast milk and can cause nuclear jaundice in infants. Also sulfonamides can lead to the development of hemolytic anemia in the deficiency of glucose-6-phosphate dehydrogenase.
Dosing and Administration:Locally, as a 10% ointment, applied directly to the wound surface, tampons impregnated with ointment are injected into the cavity. On wounds, previously cleared of purulent necrotic masses, apply napkins, lubricated with a layer of ointment 2-3 mm thick, 30-70 g of ointment per bandage. Change of dressings are carried out daily or 2-3 times a week, depending on the amount of purulent discharge.
Duration of treatment from 1 week to 4-5 weeks. With burns of II degree, a single application of the dressing is possible.
Use in children
Use is not recommended in preterm infants or in newborns for up to 2 months, since sulfonamides can cause nuclear jaundice.
Side effects:Perhaps the development of Stevens-Johnson syndrome, Lyell syndrome, blood diseases, crystalluria.
Allergic reactions, hemorrhage, metabolic acidosis (drowsiness, nausea, rapid deep breathing, must be absorbed mafenide from the application area, stop treatment for 24-48 hours, perform infusion therapy, if necessary - introduce sodium bicarbonate or perform hardware ventilation until acid-base balance is restored).
Pain and burning in the place of application.
Interaction:Not described.
Special instructions:Analgesics are prescribed to reduce severe pain that occurs when applied to the burn surface.
Local application leads to a marked decrease in the number of bacteria, even in conditions of avascularization of tissues with second and third degree burns. The decrease in the growth of bacteria leads to spontaneous healing of deep burns, but in some patients the separation of the scab can be slowed down.
Mafenide and its metabolites inhibit the activity of carbonic anhydrase, which can lead to metabolic acidosis. Usually, hyperventilation compensates for this acidosis, but there may be problems in people with impaired ventilation, pulmonary function, and renal failure due to increased concentrations of metabolites in the blood. It is necessary to monitor the acid-base balance, especially for people with risk factors.
In the case of drying the bandage with ointment to the wound surface before removing the bandage, it is recommended to soak it with an antiseptic solution to avoid traumatization of the superficial epithelium and bleeding of the wound surface.