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

Composition

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of 1 g of ointment contains:

Active ingredients:  

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

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

Auxiliary substances:  

lanolin,

soft white paraffin.

Pharmacological action

Combined antibacterial drug for external use. Contains two antibiotics that have a bactericidal effect, neomycin and bacitracin.

Bacitracin is a polypeptide antibiotic that inhibits bacterial cell wall synthesis.

Active against gram-positive bacteria (Streptococcus spp. /incl. beta-hemolytic streptococcus/, Staphylococcus spp. ) and some gram-negative microorganisms. Bacitracin resistance is rare.

Neomycin is an antibiotic-an aminoglycoside that inhibits bacterial protein synthesis. Active against gram-positive and gram-negative bacteria.

Due to the use of a combination of these two antibiotics, a wide spectrum of action of the drug and synergy of action against a number of microorganisms, for example, staphylococci, are achieved.

Indications

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

— patchy skin infections, including boils, carbuncles (after surgery), staphylococcal sycosis, peripera, deep folliculitis, hidradenitis suppurative, paronychia;

bacterial infections of the skin of the limited prevalence, including contagious impetigo, infected ulcers of the lower extremities, secondarily infected eczema, secondary infection with dermatitis, cuts, abrasions, burns, cosmetic surgery and skin grafting (also in order to prevent and to impregnate bandages).

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

Recommendations for use

The use of Baneocin® during pregnancy and lactation is possible after consultation with a doctor and only if the intended benefit to the mother exceeds 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. Intrauterine hearing loss in the fetus has been described with the systemic use of high-dose aminoglycoside antibiotics.

Contraindications

— extensive skin lesions (risk of ototoxic effect, accompanied by hearing loss);

— expressed human excretory function of the kidneys (due to heart or kidney failure) in patients with existing disease cochleo-vestibular (if possible systemic absorption of the drug);

infection of the external auditory canal with perforation of the tympanic membrane;

— simultaneous use of aminoglycoside antibiotics group system actions (risk of cumulative toxicity);

— hypersensitivity to bacitracin, neomycin, or to other aminoglycosides, the auxiliary components of the drug.

Do not use the drug to treat eye infections.

Caution should be exercised when prescribing the drug to patients with impaired liver and/or kidney function, acidosis, severe myasthenia gravis, or other neuromuscular diseases.

Side effects

According to WHO, adverse events are classified according to frequency as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥10,000 to <1/1000), very rare (

Baneocin® is usually well tolerated when used externally.

From the immune system:  rarely-allergic reactions (in the presence of a history of allergic reactions to neomycin,50% of cases may develop cross-allergy to other aminoglycosides); frequency is unknown-increased sensitivity to various substances, including neomycin (usually observed when used in the treatment of chronic dermatoses), in some cases, allergic reactions may look like a lack of effect from the therapy.

Nervous system disorders:  frequency unknown-vestibular nerve damage, neuromuscular conduction disorder.

From the side of the hearing organ:  frequency unknown-ototoxicity.

Skin and subcutaneous tissue disorders:  rarely-allergic reactions that manifest in the form of contact dermatitis, an allergic reaction to neomycin; frequency unknown-allergic reactions in the form of redness and dryness of the skin, rash, itching (with prolonged use) may also be similar to the spread of primary foci or the lack of their healing. Photosensitization and phototoxic reactions may occur (when exposed to the sun or UV radiation).

From the urinary system:  frequency unknown-nephrotoxicity.

If you experience these side effects or develop any other side effects that are not specified in the instructions, the patient should immediately inform the doctor.

Interaction

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 developing nephrotoxic reactions.

Concomitant use of Baneocin with ethacric acid or furosemide increases the risk of oto – and nephrotoxic reactions.

Absorption of the active components of Baneocin® when used concomitantly with opioid analgesics, anesthetics and muscle relaxants may increase the risk of developing impaired neuromuscular conduction.

How to take, course of use and dosage

The drug is used externally. For adults and children, the ointment is applied in a thin layer on the affected areas – 2-3 times a day. It is possible to apply ointment under the dressing.

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 (corresponds to 200 g of ointment) for 7 days.

Patients with impaired liver/kidney function and elderly patients do not need to adjust the dose.

The ointment can be used as an additional treatment in the postoperative period. Applying the ointment to bandages is preferable for topical treatment of infected cavities and wounds (for example, bacterial infections of the external ear canal without perforation of the eardrum, wounds or surgical incisions that heal by secondary tension).

Overdose

When used in doses significantly higher than recommended, especially in the treatment of (neuro)trophic ulcers, due to possible absorption of the active components of Baneocin®, nephrotoxic and ototoxic reactions may occur.

Special instructions

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

If the active components of Baneocin® can be absorbed, it is necessary to monitor for possible signs of neuromuscular blockade, especially in patients with acidosis, myasthenia gravis or other neuromuscular diseases. In the development of neuromuscular blockade, calcium supplements or neostigmine are indicated.

With prolonged use of the drug, it is necessary to monitor the possible excessive growth of resistant microorganisms. If necessary, appropriate treatment should be prescribed.

If the drug is used 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 a doctor.

With the development of allergic reactions and superinfection, the drug should be discontinued.

The development of photosensitization or phototoxic reactions in patients using Baneocin® ointment, when exposed to the sun or UV radiation, is not excluded.

Influence on the ability to drive motor vehicles and manage mechanisms

No special precautions are required.

Form of production

Ointment for external use is yellowish, homogeneous, with a weak characteristic smell.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

Shelf

life is 3 years.

Active ingredient

Bacitracin, Neomycin

Dosage form

ointment

Purpose

Pregnant women as prescribed by a doctor, Children as prescribed by a doctor, For adults, Nursing mothers as prescribed by a doctor

Indications

Trophic Ulcers, Skin Infections, Minor Skin Injuries, Boils