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Active ingredients
Bacitracin + Neomycin
Release form
Ointment
Composition
Ointment for external use is yellowish, homogeneous, with a weak characteristic odor.1 gbacitracin (in the form of bacitracin zinc) 250 MEneomycin (in the form of neomycin sulfate) 5000 MW adjuvants: lanolin, white paraffin soft.
Pharmacological effect
Combined antibacterial drug for external use. 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. It is 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. When applying the drug to large areas of skin lesions, the possibility of systemic absorption of the drug should be taken into account. It has good tissue tolerance; inactivation by biological products, blood and tissue components is not observed.
Indications
Treatment of infectious and inflammatory skin diseases caused by microorganisms susceptible to the drug: - focal infections of the skin, including furuncles, carbuncles (after surgical treatment), staphylococcal sycosis, periporitis, deep folliculitis, purulent hydradenitis, paronychia; - bacterial infections of the skin of limited prevalence, incl. contagious impetigo, infected ulcers of the lower extremities, secondarily infected eczema, secondary infection for dermatoses, cuts, abrasions, burns, in cosmetic surgery and for skin transplantation (also for the purpose of prevention and for impregnation of dressings). Prevention and treatment of infection after surgery (in composition of combination therapy in the postoperative period).
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, auxiliary components of the drug. Do not use the drug for the treatment of eye infections. Caution should be taken in patients with impaired liver function and / or kidney disease, 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 after consultation with the doctor and only if the intended benefit to the mother outweighs the potential risk to the fetus or infant. It should 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
The drug is used externally. For adults and children, ointment is applied with a thin layer on the affected areas - 2-3 times / day. It is possible to apply ointment under the dressing. The area of application of the ointment should not exceed 1% of the surface area of the body (which corresponds to the size of the patient’s palm). 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 ointment ) for 7 days. Patients with impaired liver / kidney function and elderly patients do not need dose adjustment. The ointment can be used as an additional treatment in the postoperative period.Applying ointment on the bandages is preferable for the local treatment of infected cavities and wounds (for example, bacterial infections of the external auditory canal without perforation of the eardrum, wounds or surgical incisions that heal by secondary tension).
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 is unknown - allergic reactions in the form of redness and dryness of the skin, rash, pruritus (with prolonged use) may also be similar to the spread of primary lesions or the lack of healing. Photosensitization and phototoxic reactions may develop (if under the sun or exposed to UV radiation). From the urinary system: frequency unknown - nephrotoxicity. If these side effects occur or any other side effects develop that are not listed in the instructions, the patient should be immediately informed about this doctor.
Overdose
When used in doses significantly higher than recommended, especially in the treatment of (neuro) trophic ulcers, due to the possible absorption of the active components of the drug Baneotsin; Nephro and ototoxic reactions may occur.
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. It is possible that photosensitization or phototoxic reactions may develop in patients who use Baneocin ointment; while in the sun or exposed to UV -radiation. Impact on the ability to drive vehicles and control mechanisms. No special precautions are required.