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Active ingredients
Bacitracin + Neomycin
Release form
Powder
Composition
Bacitracin (in the form of bacitracin zinc) 250 IU, neomycin (in the form of neomycin sulfate) 5000 IU. Auxiliary substances: sterilized powder base (corn starch, containing not more than 2% magnesium oxide).
Pharmacological effect
The combined antibacterial drug for topical administration. It contains two antibiotics that have a bactericidal effect, neomycin and bacitracin. Bacitracin is a polypeptide antibiotic that inhibits the synthesis of the cell wall of bacteria. Especially active against gram-positive (Streptococcus spp. / Including β-hemolytic streptococcus /, Staphylococcus spp.) And some gram-negative microorganisms. Bacitracin resistance is rarely developed. Neomycin is an aminoglycoside antibiotic that inhibits the synthesis of bacteria proteins. It is active against gram-positive and gram-negative bacteria. Through the use of a combination of these two antibiotics, a wide spectrum of drug action and synergism of action against a number of microorganisms, for example, staphylococci, is achieved.
Pharmacokinetics
Active ingredients are usually not absorbed (even damaged skin), however, their concentrations are high in the skin. It has excellent tissue tolerance; inactivation by biological products, blood and tissue components is not observed. When applying the drug to large areas of skin lesions, the possibility of systemic absorption of the drug should be taken into account.
Indications
Infectious and inflammatory skin diseases caused by microorganisms susceptible to the drug: - bacterial infections of the skin of limited prevalence, incl. weeping contagious impetigo, infected trophic ulcers of the lower extremities, infected eczema, bacterial diaper dermatitis, secondary bacterial infection in case of diseases caused by Herpes simplex, Varicella zoster (including infection of vesicles in chicken pox) - prevention of umbilical infection in newborns; prevention of infection after surgical (dermatological) procedures: for additional treatment in the postoperative period (after excision of tissues, cautery, episiotomy, treatment of cracks, perineal rupture) , weeping wounds and stitches).
Contraindications
- extensive skin lesions (risk of ototoxic effect, accompanied by hearing loss) - pronounced impaired renal excretory function (due to cardiac or renal failure) in patients with existing diseases of the cochleo-vestibular apparatus (if systemic absorption of the drug is possible); - infections of the external auditory canal with perforation of the eardrum; - simultaneous use of systemic aminoglycosides with antibiotics of the aminoglycoside group (risk of cumulative toxicity); - increased sensitivity for bacitracin, neomycin or other aminoglycosides and auxiliary components of the drug. Do not use powder for treating eye infections. Caution should be taken in patients with impaired liver and / or kidney function, acidosis, severe myasthenia or other neuromuscular diseases.
Precautionary measures
Use for violations of liver functionWith caution, the drug should be prescribed to patients with impaired liver function. Use for renal impairmentWith caution, the drug should be prescribed to patients with impaired renal function. Use in children If the drug is used in children, you should first consult a doctor. dose adjustment is not required
Use during pregnancy and lactation
Use of the drug Baneocin; during pregnancy and lactation is possible if the intended benefit to the mother outweighs the potential risk to the fetus or baby (only after consulting a doctor). It must be remembered that neomycin, like all antibiotics of the aminoglycoside group, can penetrate the placental barrier. With the systemic use of antibiotics of the aminoglycoside group in high doses, intrauterine hearing loss of the fetus has been described.
Dosage and administration
Adults and children from the 1st day of life apply the drug in a thin layer to the affected areas 2-4 times / day; if necessary, under the dressing. The powder application area should not exceed 1% of the body surface area (which corresponds to the size of the patient’s palm). When topically applied, the dose of neomycin for adults and children and adolescents under the age of 18 should not exceed 1 g / day (corresponds to 200 g of powder) within 7 days. For patients with impaired liver / kidney function and elderly patients, dose adjustment is not required.
Side effects
According to the WHO, undesirable effects are classified according to the frequency of development as follows: very often (≥1 / 10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1000 to <1/100) , rarely (from ≥10 000 to <1/1000), very rarely (<1/10 000), the frequency is unknown (according to the available data it was not possible to establish the frequency of occurrence). The preparation Baneotsin; usually well tolerated by external use. From the immune system: rarely - allergic reactions (in the presence of allergic reactions to neomycin in a history of 50% of cases, the development of cross-allergy to other aminoglycosides is possible); frequency unknown - increased sensitivity to various substances, including neomycin (usually observed when used in the treatment of chronic dermatosis), in some cases, allergic reactions may look like the lack of effect of the therapy. From the nervous system: frequency is unknown - damage to the vestibular nerve, violation of neuromuscular conduction. From the side of the organ of hearing: the frequency is unknown - ototoxicity. On the side of the skin and subcutaneous tissues: rarely - allergic reactions, manifesting in the form of cont active dermatitis, an allergic reaction to neomycin; frequency unknown - allergic reactions in the form of redness and dry skin, rash, pruritus (with prolonged use). From the urinary system: frequency unknown - nephrotoxicity. the patient should immediately inform the doctor.
Overdose
When used in doses substantially higher than recommended, due to the possible absorption of the active components of the drug Baneotsin; special attention should be paid to symptoms indicating nephro- and ototoxic reactions.
Interaction with other drugs
With systemic absorption of the active components of the drug, the simultaneous use of cephalosporins or antibiotics of the aminoglycoside group may increase the likelihood of nephrotoxic reactions. With the simultaneous use of the drug Baneocin; with ethacrynic acid or furosemide increases the risk of developing oto-and nephrotoxic reactions. Absorption of the active components of the drug Baneotsin; when used simultaneously with opioid analgesics, anesthetics and muscle relaxants may increase the risk of developing impaired neuromuscular conduction.
special instructions
Since the risk of toxic effects increases with a decrease in liver and / or kidney function, in patients with hepatic and / or renal insufficiency, blood and urine tests should be performed along with an audiometric study before and during therapy with Baneocin; It is necessary to monitor the possible appearance of signs of neuromuscular blockade, especially in patients with acidosis, myasthenia (myasthenia gravis) or other neuromuscular diseases. With the development of neuromuscular blockade, calcium or neostigmine preparations are indicated. With prolonged use of the drug, it is necessary to monitor possible excessive growth of resistant microorganisms. If necessary, appropriate treatment should be prescribed. In case of use of the drug in children, patients with impaired liver and kidney function, as well as with a large area of the treated surface, prolonged use and deep skin lesions, you should first consult with your doctor. cancel.The effect on the ability to drive motor vehicles and control mechanisms. No special precautions are required.