Банеоцин®

General characteristics. Structure:

Active agents:  bacitracin (in the form of zinc bacitracin) 250 ME Neomycinum (in the form of sulfate Neomycinum) 5000 ME
excipients: lanolin; soft paraffin white  Powder for external use of 1 g
active agents:  bacitracin (in the form of zinc bacitracin) 250 ME Neomycinum (in the form of sulfate Neomycinum) 5000 ME
excipients: the powder basis sterilized (the corn starch containing no more than 2% of magnesium of oxide)  

Description of a dosage form

Ointment for external use: yellowish, homogeneous ointment with a slight characteristic smell.

Powder for external use: finely divided, from white till yellowish color.

Pharmacological properties:

Baneotsin — the combined antibacterial drug for external use containing two bactericidal antibiotics with synergistic action. Bacitracin — a polypeptide antibiotic, is active rather gram-positive microorganisms, such as a hemolitic streptococcus, staphylococcus, Clostridium spp., Corynebacterium diphtheriae, Treponema pallidum, and also rather some gram-negative pathogenic microorganisms, such as Neisseria spp. and Haemophilus influenzae. Actinomycetes and fuzobakteriya also treat a drug action spectrum. Strains, resistant to bacitracin, meet seldom.
Neomycinum is active rather gram-positive and gram-negative microorganisms, such as staphylococcus, 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. icterohaemorrhagicae).
The combined use of bacitracin and Neomycinum provides a wide antimicrobic range, however drug is inactive concerning Pseudomonas, Nocardia spp., mushrooms and viruses.
Usually bacitracin and Neomycinum are not appointed systemically. Topical administration of ointment and powder Baneotsin considerably reduces risk of a sensitization which is inherent for antibiotics of systemic action.
Baneotsin is well had. As absorption of bacitracin and Neomycinum through the affected skin slightly, Cmax of drug is reached in the place of use. Fabric portability excellent, drug is not inactivated by fabrics, blood and other biological liquids. If to apply drug on extensive affected areas of skin, it is necessary to remember a possibility of absorption of drug and its effects (see sections SIDE EFFECTS, SPECIAL INSTRUCTIONS).
At the correct use ointment Baneotsin shows local action on the site of use. If there is an absorption of active ingredients, serumal Т½ Neomycinum and bacitracin makes about 2-3 h.
For a form ointment:
Bacitracin is slightly soaked up through a mucous membrane and skin. However can note dermal absorption in the presence of open wounds.
Neomycinum in the minimum quantity is absorbed through intact skin. And in the absence of keratinaceous layer (ulcers, wounds, burns) Neomycinum is absorbed through the inflammatory or affected skin quickly.

Indications to use:

Powder: bacterial infection of limited sites of skin at herpes infections, including at chicken pox; the infected varicose ulcers; eczema; bacterial diaper dermatitis; prevention of an umbilical infection at newborns.
After surgical manipulations: as auxiliary therapy during the postoperative period (including treatment of ruptures of a crotch and an epiziotomiya, mastitis at drainage, posttraumatic infections); infections at burns.
Ointment: topical treatment and prevention of the bacterial infections of skin caused by microorganisms, sensitive to drug:
furuncles, anthrax (after surgical intervention), abscesses (after a section), a sycosis, including deep, on the site of a chin, a purulent hydradenitis, a pseuofurunculosis, paronychias;
the bacterial infections of skin of limited degree, including contagious impetigo infected varicose ulcers, consecutive infections at eczema, an infection at burns after cosmetic surgery and skin transplantation (also with the preventive purpose and at use of bandages);
as auxiliary therapy at treatment of postoperative contaminated wounds (for example at outside otitis, secondary infection of surgical hems).

Route of administration and doses:

At topical administration the daily dose of drug should not exceed 1 g (200 g of ointment or 200 g of powder are equivalent). A course of treatment — 7 days. At a repeated course the maximum dose has to be lowered twice.
Powder: to adults and children since the birth powder is scattered on the surface which is subject to treatment, 2–4 times a day. If necessary after putting drug apply a gauze bandage an affected area. At patients with the burns occupying more than 20% of a body surface powder Baneotsin is applied not more often than 1 time a day, especially at a renal failure as there can be an absorption of active agents of drug.
Ointment: to adults and children a small amount of ointment is applied on an affected area and slightly rubbed 2–3 times a day for 7 days. If necessary after putting drug apply a gauze bandage an affected area.

Features of use:

At drug use by patients with extensive damages of skin it is necessary to take into account a possibility of absorption of active components of Baneotsin and, as a result, development from - and/or nephrotoxic action. As the risk of development of toxic effects increases at patients with the expressed disturbances of a liver and/or kidneys, such patients should carry out analyses of urine, blood, audiometric researches to and during an intensive care by Baneotsin. At long use for patients with chronic average otitis the risk of development of ototoksichesky effect of drug increases. It is necessary to avoid a combination of aminoglycosides of systemic and local action in connection with risk of development of cumulative toxicity.
If there was an uncontrollable absorption of Baneotsin, it is necessary to consider a possibility of development of blockade of neuromuscular conductivity, especially at patients with acidosis, a heavy myasthenia in the anamnesis or other neuromuscular disturbances. Neuromuscular blockade is eliminated with drugs of calcium or a neostigmin with bromide.
At prolonged treatment the overgrowth of resistant microorganisms and mushrooms is possible. In this case it is necessary to appoint the corresponding treatment.
Patients at whom the allergy or superinfection developed should cancel drug.
At contact with a sunlight or UV rays there can be phototoxic reactions or a photosensitization.
Use during pregnancy and feeding by a breast
If there is a risk of absorption of active ingredients during pregnancy and feeding by a breast, drug is used only if the expected advantage for mother exceeds potential risk for a fruit or the child.
As well as other aminoglikozidny antibiotics, Neomycinum gets through a placental barrier. The fruit had messages on a hearing disorder owing to system use of aminoglycosides in high doses.
Before feeding by a breast it is necessary to remove the drug remains from a mammary gland with boiled water and sterile cotton wool.
Children
Powder: apply from the first days of life on doctor's orders after careful assessment of a ratio advantage/risk.
Ointment: have not enough data on safety of use of drug in this dosage form children of younger age therefore use of drug for children perhaps on doctor's orders after careful assessment of a ratio advantage/risk.
Ability to influence speed of response at control of vehicles or work with other mechanisms. It is unknown.

Side effects:

Usually drug is transferred well. At long treatment development of allergic reactions (a hyperemia, dryness and a peeling of skin, rash, an itch) is possible. If defeats extend or wounds do not heal, it can be a consequence of allergic reaction.
Very seldom allergic reactions arise in the form of contact eczema. The allergic reactions caused by Neomycinum arise seldom. Approximately in 50% of cases of development of allergic reactions to Neomycinum note a cross allergy to other aminoglikozidny antibiotics.
At treatment of chronic dermatitis the sensitization to other drugs, including Neomycinum can develop that is shown in weak reaction to treatment.
For patients with considerable damage of skin it is necessary to consider possible absorption of drug and development of such side effects as disturbance of vestibular and cochlear function, a hearing disorder, neuromuscular conductivity.

Interaction with other medicines:

If system absorption is revealed, at simultaneous use of cephalosporins or aminoglikozidny antibiotics the risk of development of nephrotoxic reactions increases.
Simultaneous use of diuretics, such as Acidum etacrynicum or furosemide, can increase expressiveness from - or nephrotoxicity.
In case of system absorption at the combined use with opioid analgetics, the anesthetizing drugs or muscle relaxants the risk of development of disturbances of neuromuscular conductivity increases.

Contraindications:

Hypersensitivity to components of drug or to other aminoglikozidny antibiotics.
Extensive and severe damages of skin (the drug resorption with development of ototoksichesky effect with a hearing loss is possible).
If uncontrollable absorption of drug is probable, it is not necessary to apply at patients with heavy cardiogenic or nephrogenic excretory disturbances, and also in the presence in the anamnesis of defeats of vestibular and cochlear systems. The drug cannot be administered in outside acoustical pass at perforation of a tympanic membrane. Not to apply on the site around eyes.

Overdose:

At use in doses which significantly exceed recommended owing to possible absorption of active agents of drug, it is necessary to pay attention to the symptoms specifying on nefro-and/or ototoksichesky reactions, especially at patients with trophic ulcers.
Treatment: therapy is symptomatic.

Storage conditions:

In the place protected from light and moisture, at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity of the drug Банеоцин® 3 of year.

Issue conditions:

Without recipe

Packaging:

Ointment for external use. On 20 g of ME/1 ointment 250 ME/5000 of in aluminum tubas; on 1 tuba in a cardboard pack.

Powder for external use. On 10 g of powder in polyethylene banks with the polyethylene doser; after 1 bank in a cardboard pack.