Baneocin ointment tube 20g

Pharmacodynamics. Baneocin is a combined antibacterial drug for external use, which contains two bactericidal antibiotics with synergistic action. Bacitracin is a polypeptide antibiotic active against gram-positive microorganisms, such as hemolytic streptococcus, staphylococcus, clostridium spp., corynebacterium diphtheriae, treponema pallidum, as well as against some gram-negative pathogenic microorganisms, such as neisseria spp. and haemophilus influenzae. The spectrum of action of the drug also includes actinomycetes and fusobacteria. Bacitracin-resistant strains are rare.

Neomycin is active against gram-positive and gram-negative microorganisms, such as staphylococci, Proteus, Enterobacter aerogenes, Klebsiella pneumoniae, Salmonellae, Shigellae, Haemophilus influenzae, Pasteurella, Neisseria meningitidis, Vibrio cholerae, Bordetella pertussis, Bacillus anthracis, Corynebacterium diphtheriae, Streptococcus faecalis, Listeria monocytogenes, Escherichia coli, Mycobacterium tuberculosis, Borrelia and Leptospira interrogans (L. icterohaemorrhagiae).

The combined use of bacitracin and neomycin provides a broad antimicrobial spectrum, but the drug is inactive against Pseudomonas, Nocardia spp., fungi, and viruses.

Bacitracin and neomycin are not usually prescribed systemically. Topical application of Baneocin ointment and powder significantly reduces the risk of developing sensitization, which is typical for systemic antibiotics.

Pharmacokinetics. Baneocin is well tolerated. Since the absorption of bacitracin and neomycin through the affected skin is insignificant, C _max of the drug is achieved at the site of application. Tissue tolerance is excellent, the drug is not inactivated by tissues, blood and other biological fluids. If the drug is applied to large affected areas of the skin, one should remember about the possibility of absorption of the drug and its consequences (see Side effects, Features of use).

When used correctly, Baneocin has a local effect at the site of application. If absorption of the active substances occurs, T _½ of neomycin and bacitracin in blood serum is about 2-3 hours.

Bacitracin is poorly absorbed through mucous membranes and skin. However, absorption through the skin is possible in the presence of open wounds.

Neomycin is absorbed in minimal amounts through intact skin. Through inflamed or damaged skin and in the absence of a keratin layer (ulcers, wounds, burns), neomycin is absorbed rapidly.

Ointment. Local treatment and prevention of bacterial skin infections caused by microorganisms sensitive to the drug:

• furuncle, carbuncle (after surgery), abscess (after autopsy), sycosis, including deep, in the chin area, purulent hidradenitis, pseudofurunculosis, paronychia;
• limited bacterial skin infections, including contagious impetigo, infected varicose ulcers, secondary infections in eczema, infections in burns, after cosmetic surgery and skin grafting (also for prophylactic purposes and when using bandages);
• as an adjunctive therapy for infected wounds (e.g. otitis externa, secondary infection of surgical scars).

Powder. Bacterial infections of limited skin areas: bacterially infected herpes simplex, herpes zoster/varicella; contagious impetigo; infected varicose ulcers; infected eczema; bacterially infected diaper dermatitis.

Prevention of umbilical cord infection in newborns.

As adjunctive therapy:

• after surgical (dermatological) manipulations (including after excision and cauterization);
• with cracks in the skin;
• with perineal tears, episiotomy;
• with eroded wound surfaces (with exudate).

Ointment: Baneocin ointment should be used by adults and children usually 2-3 times a day for 7 days.

When applied topically for more than 7 days, the dose of neomycin should not exceed 1 g/day (equivalent to 200 g of ointment). When repeated courses are used, the maximum dose should be reduced by 2 times.

Apply a small amount of ointment to the affected area and rub in lightly. If necessary, a gauze bandage can be applied to the affected area after applying the drug.

Powder: Baneocin powder is usually used 2-4 times a day for adults and children from birth.

After applying the powder to the affected areas of the skin, the natural process of evaporation (sweating) is activated, so the drug has a cooling, soothing effect.

The powder should be sprinkled over the surface to be treated. If necessary, a gauze bandage can be applied to the affected area after applying the drug.

Patients with burns covering more than 20% of the body surface should not use Baneocin powder more than once a day, especially if kidney function is impaired, as absorption of the active substances of the drug is possible.

When applied topically, the dose of neomycin should not exceed 1 g/day (equivalent to 200 g of powder) for more than 7 days. When repeated courses are used, the maximum dose should be reduced by 2 times.

Hypersensitivity to the components of the drug or other aminoglycoside antibiotics.

Large and severe skin lesions (possible resorption of the drug with the development of an ototoxic effect with hearing loss).

If uncontrolled absorption of the drug is likely, it should not be used in patients with severe cardiogenic or nephrogenic excretory disorders, as well as in patients with a history of lesions of the vestibular and cochlear systems. The drug should not be administered into the external auditory canal in case of perforation of the eardrum. Do not use in the area around the eyes.

The frequency of adverse reactions is defined as follows: very common (≥1/10), common (≥1/100, 1/10), uncommon (≥1/1000, 1/100), rare (≥1/10,000, 1/1000), very rare (1/10,000), frequency unknown (cannot be estimated from the available data).

Usually, the drug is well tolerated when used externally.

On the part of the immune system: rarely – in the presence of allergic reactions to neomycin, cross-allergy to other aminoglycoside antibiotics also occurs in approximately 50% of cases; frequency unknown – hypersensitivity to neomycin and many other substances may occur when the drug is used for chronic dermatosis or chronic otitis media. Under certain circumstances, allergy may manifest as the absence of successful wound healing.

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

From the side of the organs of hearing and labyrinth: frequency unknown – ototoxicity.

Skin and subcutaneous tissue disorders: rarely – allergic reactions, mainly manifested as contact dermatitis. Allergic reactions caused by neomycin do not occur as often as is generally believed; frequency unknown – in case of prolonged use, allergic reactions such as redness, dryness and peeling of the skin, rash, itching may occur. Spreading of lesions or lack of healing may be caused by allergies. Photosensitization or phototoxic reactions when exposed to sunlight or UV radiation cannot be ruled out.

On the part of the kidneys and urinary tract: frequency unknown – nephrotoxicity.

When using the drug in patients with extensive skin lesions, the possibility of absorption of the active components of Baneocin and, as a consequence, the development of oto- and / or nephrotoxic effects should be taken into account. Since the risk of developing toxic effects is increased in patients with severe liver and / or kidney disorders, such patients should undergo urine, blood, and audiometric tests before and during intensive therapy with Baneocin. Precautions should be taken with prolonged use in patients with chronic otitis media due to the possible ototoxic effect.

The combination of systemic and topical aminoglycosides should be avoided due to the risk of cumulative toxicity.

If uncontrolled absorption of Baneocin occurs, the possibility of neuromuscular blockade should be considered, especially in patients with acidosis, a history of myasthenia gravis, or other neuromuscular disorders. Neuromuscular blockade is reversed with calcium preparations or neostigmine.

Prolonged treatment may result in overgrowth of resistant microorganisms and fungi. In this case, appropriate treatment should be prescribed.

Patients who develop an allergy or superinfection should discontinue the drug.

Phototoxic reactions or photosensitivity may occur upon exposure to sunlight or UV rays.

The ointment contains the excipient lanolin, which may cause local skin reactions (e.g. contact dermatitis).

Use during pregnancy and breastfeeding. If there is a risk of aspiration of active substances during pregnancy and breastfeeding, the drug is used only if the expected benefit to the mother outweighs the potential risk to the fetus or child.

Like other aminoglycoside antibiotics, neomycin crosses the placental barrier. There have been reports of fetal hearing impairment following systemic administration of aminoglycosides at high doses.

Before breastfeeding, it is necessary to remove the remnants of the drug from the mammary gland with boiled water and sterile cotton wool.

children

Powder: used from the first days of life as prescribed by a doctor after a careful assessment of the benefit/risk ratio.

Ointment: there is insufficient data on the safety of using the drug in this dosage form in young children, therefore the use of the drug in children is possible only on the prescription of a doctor after a careful assessment of the benefit/risk ratio.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms is unknown.

If systemic absorption is detected, the risk of nephrotoxic reactions increases with the simultaneous use of cephalosporins or aminoglycoside antibiotics.

Concomitant use of diuretics such as ethacrynic acid or furosemide may increase the severity of oto- or nephrotoxicity.

In case of systemic absorption and simultaneous use with opioid analgesics, painkillers or muscle relaxants, the risk of developing neuromuscular conduction disorders increases.

When used in doses significantly exceeding the recommended ones, due to the possible absorption of the active substances of the drug, attention should be paid to symptoms indicating nephro- and/or ototoxic reactions, especially in patients with trophic ulcers.

Treatment: therapy is symptomatic.

Powder – at a temperature not exceeding 25 °C in the original packaging; ointment – at a temperature not exceeding 25 °C. Store out of the reach of children.