Universal reference book for medicines
Product name: BANEOCIN ® (BANEOCIN ® )

Active substance: bacitracin, neomycin

Type: Antibacterial agent for external use

Manufacturer: SANDOZ (Austria) manufactured by Pharmazeutische Fabrik MONTAVIT (Austria)
Composition, form of production and packaging

?
Powder for external use is finely dispersed, from white to yellowish color.
1 g

bacitracin (in the form of zinc bacitracin) 250 IU

Neomycin (in the form of neomycin sulfate) 5000 IU

Auxiliary substances: the basis is powder sterilized (corn starch, containing not more than 2% magnesium oxide).

10 g - polyethylene cans (1) with a dispenser - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

Combined antibacterial agent for topical application.
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 especially active against Gram-positive (Streptococcus spp. / Including? -gemolytic 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.

PHARMACOKINETICS

The active substances, as a rule, are not absorbed (even damaged by the skin), nevertheless, their skin contains high concentrations.
Has excellent tissue tolerance;Inactivation by biological products, blood and tissue components is not noted.
When applying the drug to extensive areas of skin lesions, the possibility of systemic absorption of the drug should be taken into account.

INDICATIONS

Infectious-inflammatory skin diseases caused by microorganisms sensitive to the preparation:

- bacterial skin infections of limited prevalence, incl.
wetting contagious impetigo, infected trophic ulcers of the lower extremities, infected eczema, bacterial diaper dermatitis, secondary bacterial infection in diseases caused by Herpes simplex, Varicella zoster (including infection of vesicles with chicken pox);
-prophylaxis of umbilical infection in newborns;

- prevention of infection after surgical (dermatological) procedures: for additional treatment in the postoperative period (after excision of tissues, cauterization, episiotomy, treatment of cracks, rupture of perineum, wiping wounds and sutures).

DOSING MODE

Adults and children from the first day of life drug is applied a thin layer on the affected areas 2-4 times / day;
if necessary, under the bandage.
The area of ​​application of the powder should not exceed 1% of the surface area of ​​the body (which corresponds to the size of the palm of the patient).

At local application, 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 powder) for 7 days.

Patients with impaired hepatic / renal function and elderly patients do not need dose adjustment.

SIDE EFFECT

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 Baneocin® 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;
frequency unknown - allergic reactions in the form of redness and dryness of the skin, rash, itchy skin (with prolonged use).
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.

CONTRAINDICATIONS

- 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 and auxiliary components of the drug.

Do not use powder 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 Baneocin® during pregnancy and lactation is possible if the intended benefit to the mother exceeds the potential risk to the fetus or infant (only after consulting a doctor).

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


SPECIAL INSTRUCTIONS

Since the risk of toxic effects increases with a decrease in liver and / or kidney function, patients with hepatic and / or renal failure should undergo blood and urine tests together with audiometric testing before and during therapy with Baneocin®.

With the possible absorption of the active components of the Baneocin ® 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 ​​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.

Impact on the ability to drive vehicles and manage mechanisms

No special precautions are required.

OVERDOSE

When used in doses that are significantly higher than recommended, due to the possible absorption of the active components of the Baneocin ® preparation, special attention should be paid to the symptoms indicating nephro- and ototoxic reactions.

DRUG INTERACTION

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 Baneocin® with ethacrylic acid or furosemide, the risk of oto and nephrotoxic reactions increases.

Absorption of the active components of the Baneocin® 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.

RU1608519244

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, protected from light and moisture, at a te
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