bacitracin, neomycin |

Latin name

BANEOCIN

Pharmacological action

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

Bacitracin is a polypeptide antibiotic that inhibits bacterial cell wall synthesis. It is active against gram-positive (Streptococcus spp. / Including Hemolytic streptococcus /, Staphylococcus spp.) And some gram-negative microorganisms. Bacitracin resistance is rare.

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

By using a combination of these two antibiotics, a broad 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 preparation:

- focal infections of the skin, including boils, carbuncles (after surgical treatment), staphylococcal sycosis, periporitis, deep folliculitis, purulent hydradenitis, paronychia

- bacterial infections of the skin of a limited prevalence, including 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 dressing dressings).

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

Contraindications

- extensive skin lesions (risk of developing an ototoxic effect, accompanied by hearing loss)

- pronounced impaired renal excretory function (due to heart or kidney failure) in patients with existing diseases of the cochleo-vestibular apparatus (if systemic absorption of the drug is possible)

- infections of the external auditory canal with perforation of the tympanic membrane

- simultaneous use with antibiotics groups of systemic aminoglycosides (risk of cumulative toxicity)

- hypersensitivity to bacitracin, neomycin or other amines glycosides, auxiliary ingredients.

Do not use to treat eye infections.

With caution, the drug should be prescribed to patients with impaired liver and / or kidney function, acidosis, severe myasthenia gravis, or other neuromuscular diseases.

Use during pregnancy and lactation

The use of Baneocin® during pregnancy and lactation is possible after consulting a doctor and only if the intended benefit to the mother outweighs the potential risk to the fetus or baby.

It should be remembered that neomycin, like all antibiotics of the aminoglycoside group, can cross the placental barrier. With the systemic use of antibiotics of the aminoglycoside group in high doses, intrauterine hearing loss of the fetus has been described.

Special instructions

Since the risk of toxic effects increases with decreased liver and / or kidney function, blood and urine tests should be performed in patients with hepatic and / or renal failure along with an audiometric test before and during BaneocinВ® therapy.

With the possible absorption of the active components of BaneocinВ®, it is necessary to monitor the possible appearance of signs of neuromuscular blockade, especially in patients with acidosis, myasthenia gravis (myasthenia gravis) or other neuromuscular diseases. With the development of neuromuscular blockade, calcium preparations or neostigmine are indicated.zmov. If necessary, appropriate treatment should be prescribed.

In the case of the drug in children, patients with impaired liver and kidney function, as well as with a large surface area, prolonged use and deep skin lesions, you should first consult your doctor.

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

It is possible that photosensitization or phototoxic reactions may develop in patients using BaneocinВ® ointment when exposed to the sun or exposed to UV radiation.

Impact on driving ability and driving

No special precautions are required.

Composition

1 g of ointment contains:

Active substances: bacitracin (in the form of zinc bacitracin) 250 IU neomycin (in the form of neomycin sulfathat) 5000 IU.

Excipients: lanolin, white soft paraffin.

Dosage and administration

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

The area of ​​application of the ointment should not exceed 1% of the surface area of ​​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 years should not exceed 1 g / day (corresponding to 200 g of ointment) for 7 days.

Dose adjustment is not required for patients with impaired liver / kidney function and elderly patients.

Ointment can be used as an additional treatment in the postoperative period. Applying an ointment to bandages is preferred in the local treatment of infected cavities and wounds (for example, bacterial infections of the external auditory canal without perforation of the eardrum, wounds or surgical incisions healing by second intention).

Side effects

According to the WHO, unwanted effects are classified according to the frequency of development as follows: very often (? 1/10), often (? 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) .

Baneocin® is usually well tolerated for external use.

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

From the nervous system: the frequency is unknown - damage to the vestibular nerve, impaired neuromuscular conduction.

On the part of the hearing organ: frequency unknown - ototoxicity.

From the skin and subcutaneous tissues: rarely - allergic reactions manifesting in the form of contact dermatitis, an allergic reaction to neomycin is not known - the allergic reactions in the form of redness and dryness of the skin, rash, itching (with prolonged use) can also be similar to the spread of primary foci or the absence of their healing. Perhaps the development of photosensitivity and phototoxic reactions (when exposed to the sun or exposure to UV radiation).

From the urinary system: frequency unknown - nephrotoxicity.

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

Drug interaction

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

Absorption of the active components of Baneocin® while the use of opioid analgesics, anesthetics and muscle relaxants may increase the risk of neuromuscular conduction disturbance.

Overdose

Nephro- and ototoxic reactions may occur when administered at doses that are significantly higher than those recommended, especially in the treatment of (neuro) trophic ulcers, due to the possible absorption of the active components of Baneocin®.

Storage conditions

The product should be stored out of the reach of children at a temperature not exceeding 25 РC.

Shelf life

3 years.

Active ingredient

Bacitracin, Neomycin

Terms and conditions

without prescription

dosage form

ointment