Baneocin® [Bacitracin Zinc, Neomycin]

Pharmacological properties

Baneocin is a combined antibacterial drug for external use containing two bactericidal antibiotics with a synergistic effect. bacitracin is a polypeptide antibiotic that is active against gram-positive microorganisms, such as hemolytic streptococcus, staphylococcus, clostridium spp., corynebacterium diphtheriae, treponema pallidum, as well as against some gram-negative pathogens, such as neisseria spp. and haemophilus influenzae. actinomycetes and fusobacteria also belong to the spectrum of action of the drug. 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 meningiticellis periochemidaeperiella bifteriella periella straina perifolia Escherichia coli, Mycobacterium tuberculosis, Borrelia and Leptospira interrogans (L. icterohaemorrhagicae).

The combined use of bacitracin and neomycin provides a broad antimicrobial spectrum, but the drug is inactive with respect to Pseudomonas, Nocardia spp., Fungi and viruses.

Usually, bacitracin and neomycin are not prescribed systemically. Topical application of ointment and Baneocin powder significantly reduces the risk of sensitization, which is characteristic of systemic antibiotics.

Pharmacokinetics Baneocin is well tolerated. Since absorption of bacitracin and neomycin through the affected skin is negligible, C_max the drug is achieved at the place of use. The tissue tolerance is excellent, the drug is not inactivated by tissues, blood and other biological fluids. If the drug is applied to extensive affected areas of the skin, one should remember about the possibility of absorption of the drug and its consequences (see ADVERSE EFFECTS, SPECIAL INSTRUCTIONS).

When used correctly, Baneocin exerts local action at the site of application. If absorption of active substances occurs, T_½ serum neomycin and bacitracin is about 2-3 hours.

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

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

Indications

Ointment. local treatment and prevention of bacterial skin infections caused by drug-sensitive microorganisms:

• furuncle, carbuncle (after surgery), abscess (after opening), sycosis, including deep, in the chin area, purulent hydradenitis, pseudofurunculosis, paronychia;
• bacterial skin infections of a limited degree, including contagious impetigo, infected varicose ulcers, secondary infections with eczema, infections with burns, after cosmetic surgery and skin grafting (also for preventive purposes and when applying dressings);
• as adjunctive therapy for infected wounds (for example, with external otitis media, secondary infection of surgical scars).

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

Prevention of umbilical infection in newborns.

As an adjunct therapy:

• after surgical (dermatological) manipulations (including after excision and cauterization);
• with cracked skin;
• with ruptures of the perineum, episiotomy;
• with wound erosive surfaces (with exudate).

Application

Ointment: adults and children, Baneocin ointment should be used 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). With a repeated course, the maximum dose should be reduced by 2 times.

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

Powder: For adults and children from birth, Baneocin powder is usually used 2–4 times a day.

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

Powder should be scattered over the surface to be treated. If necessary, after applying the drug to the affected area, a gauze dressing can be applied.

For patients with burns occupying more than 20% of the body surface, Baneocin powder should be used no more than 1 time per day, especially in case of impaired renal function, since 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. With a repeated course, the maximum dose should be reduced by 2 times.

Contraindications

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

Extensive and severe skin lesions (possible resorption of the drug with the development of the 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 the presence of a history of lesions of the vestibular and cochlear systems. The drug can not be entered into the external auditory meatus during perforation of the eardrum. Do not use in the area around the eyes.

Side effects

The frequency of adverse reactions is determined as follows: very often (≥1 / 10), often (≥1 / 100, 1/10), infrequently (≥1 / 1000, 1/100), rarely (≥1 / 10,000, 1 / 1000), very rarely (1/10 000), the frequency is unknown (cannot be calculated from the available data).

Usually, when applied topically, the drug is well tolerated.

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

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

From the side of the organ of hearing and the labyrinth: the frequency is unknown - ototoxicity.

On the part of the skin and subcutaneous tissue: rarely - allergic reactions, manifested mainly as contact dermatitis. Allergic reactions caused by neomycin do not occur as often as generally believed; the frequency is unknown - in case of prolonged use, allergic reactions such as redness, dryness and peeling of the skin, rash, itching can occur. The spread of lesions or lack of healing can be caused by allergies. Photosensitization or phototoxic reactions due to exposure to sunlight or UV radiation cannot be ruled out.

From the kidneys and urinary tract: frequency unknown - nephrotoxicity.

special instructions

When using the drug in patients with extensive skin lesions, the possibility of absorption of the active components of baneocin should be taken into account and, as a consequence, the development of oto- and / or nephrotoxicity. since the risk of developing toxic effects increases in patients with severe hepatic and / or renal impairment, such patients should undergo urinalysis, blood tests, audiometric studies before and during intensive therapy with baneocin. it is necessary to observe precautions for prolonged use in patients with chronic otitis media due to the possible ototoxic effect.

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

If uncontrolled absorption of Baneocin has occurred, it is necessary to consider the possibility of developing a blockade of neuromuscular conduction, especially in patients with acidosis, severe myasthenia gravis (Myasthenia gravis) or with other neuromuscular disorders. Neuromuscular blockade is eliminated with calcium preparations or neostigmine.

With prolonged treatment, excessive growth of resistant microorganisms and fungi is possible. In this case, appropriate treatment should be prescribed.

Patients who have developed an allergy or superinfection, the drug must be discontinued.

In contact with sunlight or UV rays, phototoxic reactions or photosensitivity may occur.

The ointment contains an auxiliary substance lanolin, which can cause local skin reactions (for example, contact dermatitis).

Use during pregnancy and lactation. If there is a risk of absorption of the active substances during pregnancy and lactation, 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 impaired hearing in the fetus due to systemic use of aminoglycosides in high doses.

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

Children

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

Ointment: data on the safety of using the drug in the indicated dosage form in young children is not enough, therefore, the use of the drug in children is possible according to the doctor’s prescription after a careful assessment of the benefit / risk ratio.

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

Interactions

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

The simultaneous use of diuretics, such as ethacrylic acid or furosemide, can increase the severity of oto- or nephrotoxicity.

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

Overdose

When used in doses significantly higher than recommended, 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: symptomatic therapy.

Storage conditions

Powder - at a temperature not exceeding 25 ° c in the original packaging; ointment - at a temperature not exceeding 25 ° c. Keep out of the reach of children.