Baneocin^® (Ointment, Powder) Instructions for Use

ATC Code

D06AX (Other antibiotics for topical use)

Active Substances

Bacitracin (Rec.INN registered by WHO)

Neomycin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

A drug with antibacterial action for external use

Pharmacotherapeutic Group

Combined antibiotic (polypeptide antibiotic + aminoglycoside antibiotic)

Pharmacological Action

A combined antibacterial drug for external use. It contains two antibiotics that have a bactericidal effect: Neomycin and Bacitracin, and their combination results in a synergistic effect.

Bacitracin primarily inhibits the synthesis of murein in the cell wall of Gram-positive bacteria (and some Gram-negative bacteria). Bacitracin is active mainly against Gram-positive microorganisms such as Streptococcus hemolyticus, Staphylococcus spp., Clostridium spp., Corynebacterium diphtheriae, and some Gram-negative microorganisms such as Neisseria spp. and Haemophilus influenzae. Bacitracin is also active against Treponema pallidum, Actinomyces spp. and Fusobacteria spp.

Resistance to bacitracin is extremely rare.

The efficacy of neomycin is partly due to an increase in cell membrane permeability resulting from the inhibition of protein synthesis. Neomycin is active against both Gram-positive and Gram-negative pathogens, such as Staphylococcus spp., Proteus spp., Enterobacter aerogenes, Klebsiella pneumoniae, Salmonella spp., Shigella spp., Haemophilus influenzae, Pasteurella, Neisseria meningitidis, Vibrio cholerae, Bordetella pertussis, Bacillus anthracis, Corynebacterium diphtheriae, Streptococcus faecalis, Listeria monocytogenes, Escherichia coli and Mycobacterium tuberculosis. Some strains of staphylococci are resistant to neomycin.

The use of the combination of these two substances achieves a broad spectrum of action of the drug, except for action against pseudomonads, nocardia, fungi, and viruses.

The tissue tolerance of the drug Baneocin^® is considered good, and no inactivation by biological products, blood, or tissue components is observed.

If the drug is applied to extensive areas of skin lesions (in violation of the recommended dosage regimen), the possibility of drug absorption and its consequences should be taken into account (see sections “Contraindications”, “Drug Interactions”, “Special Precautions” and “Adverse Reactions”).

Baneocin^® Powder also has a drying, soothing, and cooling effect.

Pharmacokinetics

When used properly, it acts locally at the site of application. However, in case of absorption, the T_1/2 of neomycin or bacitracin from the blood serum is approximately 2-3 hours. Bacitracin is practically not absorbed through the mucous membranes and skin. However, the possibility of absorption when the drug is applied to open wounds should be taken into account.

Only a small amount of neomycin is absorbed through intact skin. Neomycin is rapidly absorbed when the keratin layer is damaged (ulcers, wounds, burns) and through inflamed or damaged skin.

Any amount of the drug absorbed through intact skin is excreted in the urine.

Indications

Baneocin^® Powder is indicated for use in infections caused by microorganisms sensitive to neomycin and/or bacitracin

• Bacterial skin infections of limited prevalence, for example: weeping contagious impetigo, infected trophic ulcers of the lower extremities, infected eczema, bacterial diaper dermatitis, bacterial complications of viral infections caused by Herpes simplex or Herpes zoster (including infection of vesicles in chickenpox);
• Prevention of umbilical infection in newborns;
• Prevention and treatment of infection after surgical (dermatological) procedures: for additional treatment in the postoperative period (after tissue excision, cauterization, episiotomy, treatment of skin fissures, perineal rupture, weeping wounds and sutures).

ICD codes

Dosage Regimen

Ointment

The drug is used externally. For adults and children, the ointment is applied in a thin layer to the affected areas 2-3 times/day. Application of the ointment under a bandage is possible.

The area of application of the ointment should not exceed 1% of the body surface area (which corresponds to the size of the patient’s palm).

The dose of neomycin for adults and children and adolescents under 18 years of age should not exceed 1 g/day (corresponding to 200 g of ointment) for 7 days.

Patients with impaired liver/kidney function and elderly patients do not require dose adjustment.

Powder

The drug is used externally. It can be applied without touching the affected surface with hands.

For adults and children, the powder is applied in a thin layer to the affected areas 2-4 times/day; if necessary – under a bandage.

The area of application of the powder should not exceed 1% of the body surface area (which corresponds to the size of the patient’s palm). The duration of treatment should not exceed 7 days.

Patients with impaired liver and/or kidney function

When using doses significantly exceeding the recommended ones, it is necessary to take into account the possibility of nephro- and/or ototoxic changes, due to the increased risk of possible absorption of active substances, especially in patients with impaired liver and/or kidney function. It is recommended to perform appropriate urine and blood tests or audiometric studies.

Elderly patients (65 years and older)

Dose adjustment in elderly patients is not required.

Adverse Reactions

According to WHO, adverse effects are classified according to frequency as follows: very common (≥1/10), common (from ≥1/100 to <1/10), uncommon (from ≥1/1000 to <1/100), rare (from ≥10,000 to <1/1000), very rare (<1/10,000), frequency unknown (cannot be estimated from the available data).

The drug Baneocin^® is usually well tolerated when applied externally.

From the immune system rare – allergic reactions (if there is a history of allergic reactions to Neomycin, cross-allergy to other aminoglycosides is possible in 50% of cases); frequency unknown – increased sensitivity to various substances, including Neomycin (usually observed when used in the therapy of chronic dermatoses), in some cases allergic reactions may appear as a lack of effect from the therapy.

From the nervous system frequency unknown – damage to the vestibular nerve, neuromuscular blockade.

From the hearing organ and labyrinthine disorders frequency unknown – ototoxicity.

From the skin and subcutaneous tissues rare – allergic reactions manifesting as contact dermatitis, allergic reaction to Neomycin; frequency unknown – allergic reactions in the form of redness and dryness of the skin, skin rashes and itching (with prolonged use).

From the kidneys and urinary tract frequency unknown – nephrotoxicity.

If any of the side effects listed in the instructions worsen or any other side effects not listed in the instructions are noted, the patient should immediately inform the doctor.

Contraindications

• Hypersensitivity to bacitracin, neomycin, antibiotics of the aminoglycoside group, to the excipients of the drug;
• Extensive skin lesions (risk of developing an ototoxic effect accompanied by hearing loss);
• Severe excretory function impairment due to cardiac or renal failure in patients with pre-existing lesions of the vestibular and cochlear systems in cases where absorption of the active components of the drug is possible;
• Infections of the external auditory canal with perforation of the eardrum;
• Use of the powder for the treatment of eye infections;
• Simultaneous use with systemic aminoglycoside antibiotics (risk of cumulative toxicity).

With caution, the drug should be prescribed to patients with impaired liver and/or kidney function, acidosis, severe myasthenia gravis or other neuromuscular diseases.

Use in Pregnancy and Lactation

The use of the drug Baneocin^® during pregnancy and breastfeeding is possible only after consultation with a doctor, 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 cross the placental barrier. With systemic use of aminoglycoside antibiotics in high doses, intrauterine hearing loss in the fetus has been described.

Use in Hepatic Impairment

With caution, the drug should be prescribed to patients with impaired liver function.

Use in Renal Impairment

With caution, the drug should be prescribed to patients with impaired kidney function.

Pediatric Use

In case of using the drug in children, a doctor should be consulted beforehand.

Geriatric Use

Elderly patients do not require dose adjustment.

Special Precautions

Since the risk of toxic effects increases with reduced liver and/or kidney function, patients with hepatic and/or renal insufficiency should undergo blood and urine tests along with an audiometric study before and during therapy with Baneocin^®.

If the active components of the drug Baneocin^® are absorbed, attention should be paid to the potential blockade of neuromuscular conduction, especially in patients with acidosis, myasthenia gravis or other neuromuscular diseases. In this case, calcium preparations or neostigmine methylsulfate may prevent the development of such blockades.

During long-term treatment, attention should be paid to the possible growth of resistant microorganisms. In such situations, appropriate treatment tactics should be chosen.

In case of using 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, a doctor should be consulted beforehand.

If allergic reactions and superinfection develop, the drug should be discontinued.

Effect on the ability to drive vehicles and mechanisms

No special precautions are required.

Overdose

When used in doses significantly exceeding the recommended ones, due to the possible absorption of the active components of the drug Baneocin^®, special attention should be paid to symptoms indicating nephro- and/or ototoxic reactions.

Drug Interactions

With systemic absorption of the active components of the drug, simultaneous use of cephalosporins or antibiotics of the aminoglycoside group may increase the likelihood of developing nephrotoxic reactions.

Simultaneous use with Baneocin^® Powder of such diuretics as ethacrynic acid or furosemide may provoke oto- and nephrotoxic effects.

Absorption of the active components of the drug Baneocin^® may enhance the phenomena of neuromuscular conduction blockade in patients receiving narcotic substances, anesthetics and/or muscle relaxants.

Storage Conditions

The drug should be stored in the original packaging in a place inaccessible to children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 2 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.