Baneocin, ointment 250 me/g+5000 me/g 5 g

A combined antibacterial drug for external use. It contains two antibiotics with bactericidal action, neomycin and bacitracin.

Bacitracin is a polypeptide antibiotic that inhibits the synthesis of the bacterial cell membrane.

It is active against Gram-positive (Streptococcus spp. /including β-hemolytic streptococcus/, Staphylococcus spp.) and some gram-negative microorganisms. Resistance to bacitracin develops rarely.

Neomycin is an aminoglycoside antibiotic that inhibits bacterial protein synthesis. It is active against Gram-positive and Gram-negative bacteria.

The use of the combination of these two antibiotics has achieved a broad spectrum of the drug and synergistic action against a number of microorganisms, such as staphylococci.

Indications

Treatment of infectious and inflammatory skin diseases caused by microorganisms sensitive to the drug:

– focal skin infections, including furuncles, carbuncles (after surgical treatment), staphylococcal sycosis, periporitis, deep folliculitis, purulent hydradenitis, paronychia;

– bacterial skin infections of limited incidence, including contagious impetigo, infected ulcers of the lower extremities, secondary infected eczema, secondary infection in dermatoses, cuts, abrasions, burns, in cosmetic surgery and skin transplants (also for prevention and for dressing impregnation).

The prevention and treatment of infection after surgical interventions (as part of combination therapy in the postoperative period).

Active ingredient

Composition

1 g of the ointment contains:

The active ingredients:

Bacitracin (in the form of bacitracin zinc) 250 IU;

neomycin (in the form of neomycin sulfate) 5000 IU.

Auxiliary substances:

Lanolin,

White soft paraffin.

How to take, the dosage

The drug is used topically. Adults and children apply the ointment in a thin layer on the affected areas – 2-3 times a day. It is possible to apply the ointment under a bandage.

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

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.

The ointment can be used as an additional treatment in the postoperative period. Application of the ointment on bandages is preferred in the local treatment of infected cavities and wounds (e.g., bacterial infections of the external auditory canal without perforation of the tympanic membrane, wounds or surgical incisions healing by secondary tension).

Interaction

In case of systemic absorption of active drug components concomitant use of cephalosporins or antibiotics of aminoglycoside group may increase the risk of nephrotoxic reactions.

In concomitant use of Baneocin® with etacrynic acid or furosemide the risk of ototoxic and nephrotoxic reactions increases.

The absorption of the active ingredients of Baneocin® when used concomitantly with opioid analgesics, anesthetics and muscle relaxants may increase the risk of neuromuscular conduction disorders.

Directions for use

The use of the drug Baneocin® in pregnancy and during lactation is possible after consultation with a physician and only if the expected benefits to the mother exceed the potential risk to the fetus or infant.

We should remember that neomycin, like all antibiotics of the aminoglycoside group, may pass through the placental barrier. Intrauterine fetal hearing loss has been described with systemic use of high-dose aminoglycoside antibiotics.

Special Instructions

Because the risk of toxic effects increases with decreased liver and/or renal function, in patients with hepatic and/or renal failure blood and urine tests should be performed together with audiometric study before and during therapy with Baneocin®.

Possible absorption of the active ingredients of Baneocin® should be watched for possible signs of neuromuscular blockade, especially in patients with acidosis, myasthenia gravis or other neuromuscular diseases. Calcium preparations or neostigmine are indicated if neuromuscular blockade develops.

In long-term use of the drug it is necessary to monitor possible overgrowth of resistant microorganisms. Appropriate treatment should be administered if necessary.

People with impaired hepatic and renal function, as well as patients with a large surface area to be treated, prolonged use and deep skin lesions should consult a physician before using the product.

The drug should be discontinued if allergic reactions and superinfections develop.

Possible photosensitization or phototoxic reactions in patients using Baneocin ointment® when exposed to sunlight or UV radiation.

Impact on the ability to drive and operate machinery

No special precautions are required.

Contraindications

– extensive skin lesions (risk of ototoxic effects accompanied by hearing loss);

– marked renal excretory dysfunction (due to cardiac or renal insufficiency) in patients with existing cochleo-vesicular diseases (if systemic absorption of the drug is possible);

p> – infections of the external auditory canal with eardrum perforation;

– concomitant use with antibiotics of the aminoglycoside group of systemic action (risk of cumulative toxicity);

– hypersensitivity to bacitracin, neomycin or other aminoglycosides, excipients of the drug.

Do not use the drug for the treatment of eye infections.

The drug should be used with caution in patients with impaired hepatic and/or renal function, acidosis, severe myasthenia gravis or other neuromuscular diseases.

Side effects

According to WHO, adverse effects are classified according to the frequency of occurrence as follows: very frequently (≥1/10), frequently (≥1/100 to < 1/10), infrequently (≥1/1000 to < 1/100), rarely (≥10 000 to < 1/1000), very rarely (< 1/10 000), frequency is unknown (according to available data it was impossible to determine the incidence).

Baneocin® is generally well tolerated when used externally.

Immune system disorders: rare – allergic reactions (if there is a history of allergic reactions to neomycin in 50% of cases cross-allergy to other aminoglycosides may develop); frequency is 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 lack of effect of the current therapy.

Nervous system disorders: frequency is unknown – damage to the vestibular nerve, impaired neuromuscular conduction.

Hearing organ: frequency unknown – ototoxicity.

Skin and subcutaneous tissue disorders: rare – allergic reactions manifesting as contact dermatitis, allergic reaction to neomycin; frequency unknown – allergic reactions in the form of red and dry skin, rash, itching (with long-term use) may also be similar to the spread of primary foci or lack of healing. Photosensitization and phototoxic reactions may develop (when exposed to sunlight or UV radiation).

Urinary system disorders: frequency unknown – nephrotoxicity.

If the above side effects occur or if any other side effects develop that are not stated in the instructions, the patient should inform the physician immediately.

Overdose