Composition, form of production and packaging
? Ointment for external use yellowish, homogeneous, with a weak characteristic odor.
bacitracin (in the form of zinc bacitracin) 250 IU
Neomycin (in the form of neomycin sulfate) 5000 IU
Excipients: lanolin, paraffin white soft.
20 g - aluminum tubes (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
Combined antibacterial drug for external use. Contains two antibiotics, which have a bactericidal effect, 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? -Hemolytic streptococcus /, Staphylococcus spp.) And some gram-negative microorganisms. Resistance to bacitracin is rare.
Neomycin is an antibiotic-aminoglycoside, which inhibits the synthesis of bacterial proteins. It is active against gram-positive and gram-negative bacteria.
By using a combination of these two antibiotics, a broad spectrum of action of the drug is achieved and synergism of action against a number of microorganisms, for example, staphylococci.
The active substances, as a rule, are not absorbed (even damaged by the skin), nevertheless, their skin contains high concentrations. When applying the drug to extensive areas of skin lesions, the possibility of systemic absorption of the drug should be taken into account.
Has good tissue tolerance; Inactivation by biological products, blood and tissue components is not noted.
Treatment of infectious and inflammatory skin diseases caused by microorganisms sensitive to the preparation:
- focal skin infections, incl. furuncles, carbuncles (after surgical treatment), staphylococcus sycosis, periporitis, deep folliculitis, purulent hydradenitis, paronychia;
- bacterial skin infections of limited prevalence, incl. contagious impetigo, infected ulcers of the lower extremities, secondarily infected eczema, secondary infection with dermatoses, cuts, abrasions, burns, cosmetic surgery and skin transplantation (also for prevention and for impregnation of dressings).
Preventive maintenance and treatment of an infection after surgical interventions (in structure of the combined therapy in the postoperative period).
The drug is used externally. Adults and children ointment is applied a thin layer on the affected areas - 2-3 times / day. It is possible to apply ointment under the bandage.
The application area of вЂ‹вЂ‹the ointment should not exceed 1% of the surface area of вЂ‹вЂ‹the body (which corresponds to the size of the palm of the patient).
The dose of neomycin for adults and children and adolescents under the age of 18 should not exceed 1 g / day (corresponding to 200 g of ointment) for 7 days.
Patients with impaired hepatic / renal function and elderly patients do not need dose adjustment.
Ointment can be used as an additional treatment in the postoperative period. The application of the ointment to the bandages is preferred for the local treatment of infected cavities and wounds (for example, bacterial infections of the external auditory canal without perforation of the tympanic membrane, wounds or surgical incisions healing with secondary tension).
According to WHO, unwanted effects are classified according to the frequency of development as follows: very often (? 1/10), often (from? 1/100 to <1/10), infrequently (from? 1/1000 to <1/100) , rarely (from? 10 000 to <1/1000), very rarely (<1/10 000), the frequency is unknown (according to available data, it was not possible to establish the frequency of occurrence).
The drug BaneocinВ® is usually well tolerated when applied externally.
On the part of the immune system: rarely - allergic reactions (in the presence of allergic reactions to neomycin in the anamnesis, in 50% of cases it is possible to develop a cross-allergy to other aminoglycosides); frequency unknown - increased sensitivity to various substances, including neomycin (usually seen with chronic dermatoses), in some cases, allergic reactions may look like a lack of effect from the therapy.
From the side of the nervous system: the frequency is unknown - the lesion of the vestibular nerve, the violation of neuromuscular conduction.
From the side of the hearing organ: the frequency is unknown - ototoxicity.
From the skin and subcutaneous tissues: rarely - allergic reactions that manifest in the form of contact dermatitis, an allergic reaction to neomycin; the frequency is unknown - allergic reactions in the form of redness and dryness of the skin, rash, itchy skin (with prolonged use) may also be similar to the spread of primary foci or the absence of their healing. Possible the development of photosensitization and phototoxic reactions (when staying in the sun or exposure to UV radiation).
From the side of the urinary system: the frequency is unknown - nephrotoxicity.
If these side effects occur or if any other side effects not listed in the instructions develop, the patient should immediately inform the doctor.
- extensive skin lesions (risk of ototoxic effect, accompanied by hearing loss);
- severe impairment of the excretory function of the kidneys (due to cardiac or renal insufficiency) in patients with existing diseases of the cochlear-vestibular apparatus (if systemic absorption of the drug is possible);
- infection of the external auditory canal with perforation of the tympanic membrane;
- simultaneous use with the antibiotics of the group of aminoglycosides systemic action (risk of cumulative toxicity);
- hypersensitivity to bacitracin, neomycin or other aminoglycosides, auxiliary components of the drug.
Do not use the drug to treat eye infections.
With caution should prescribe the drug to patients with impaired liver and / or kidney function, acidosis, severe myasthenia gravis or other neuromuscular diseases.
PREGNANCY AND LACTATION
The use of BaneocinВ® during pregnancy and lactation is possible after consultation with a doctor and only if the intended benefit for the mother exceeds the potential risk to the fetus or baby.
It should be remembered that neomycin, like all antibiotics of the aminoglycoside group, can penetrate the placental barrier. At systemic use of antibiotics of the aminoglycoside group in high doses, intrauterine decrease in fetal hearing was described.
APPLICATION FOR FUNCTIONS OF THE LIVER
Caution should be given to patients with impaired renal function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution should prescribe the drug to patients with impaired liver function.
APPLICATION FOR CHILDREN
If the drug is used in children, you should consult your doctor in advance.
APPLICATION IN ELDERLY PATIENTS
Older patients do not need dose adjustment
Since the risk of toxic effects increases with decreasing liver and / or kidney function, blood and urine tests should be performed with patients with hepatic and / or renal insufficiency together with an audiometric test before and during therapy with BaneocinВ®.
With the possible absorption of the active components of the Baneocin В® preparation, it is necessary to monitor the possible appearance of signs of neuromuscular blockade, especially in patients with acidosis, myasthenia gravis or other neuromuscular diseases. With the development of neuromuscular blockade, calcium preparations 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, and also with a large area of вЂ‹вЂ‹the treated surface, prolonged use and deep skin lesions, it is necessary to consult a doctor in advance.
With the development of allergic reactions and superinfection, the drug should be discarded.
It is not excluded the development of photosensitization or phototoxic reactions in patients using Baneocin В® ointment, while staying in the sun or exposure to UV radiation.
Impact on the ability to drive vehicles and manage mechanisms
No special precautions are required.
When applied at doses much higher than recommended, especially in the treatment of (neuro) trophic ulcers, nephro- and ototoxic reactions may occur as a result of the possible absorption of the active components of the BaneocinВ® preparation.
With systemic absorption of the active components of the drug, the simultaneous use of cephalosporins or antibiotics of the aminoglycoside group can increase the likelihood of developing nephrotoxic reactions.
With the simultaneous use of BaneocinВ® with ethacrylic acid or furosemide, the risk of oto and nephrotoxic reactions increases.
Absorption of the active components of the BaneocinВ® preparation with simultaneous use with opioid analgesics, anesthetics and muscle relaxants can increase the risk of developing a violation of neuromuscular conduction.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C.