Baneocin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BANEOCIN® (BANEOCIN®)

Composition:

Active substances: 1 g of powder contains bacitracin zinc 250 IU, neomycin sulfate 5000 IU;

Excipients: corn starch, magnesium oxide.

Pharmaceutical form. Topical powder.

Main physicochemical properties: fine powder, white to yellowish.

Pharmacotherapeutic group.
Antibiotics for topical use. ATC code D06AX.

Pharmacological properties.

Pharmacodynamics.

Baneocin is a combined antibacterial medicinal product for topical use, containing two bactericidal antibiotics with synergistic action. Bacitracin is a polypeptide antibiotic active primarily against gram-positive microorganisms such as hemolytic streptococcus, staphylococcus, Clostridium spp., Corynebacterium diphtheriae, Treponema pallidum, as well as against some gram-negative pathogenic microorganisms such as Neisseria spp. and Haemophilus influenzae. The spectrum of activity of the drug also includes actinomycetes and fusobacteria. Bacitracin-resistant strains are rarely encountered.

Neomycin is active against gram-positive and gram-negative microorganisms, including staphylococci, 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 icterohaemorrhagiae.

The combined use of bacitracin and neomycin provides a broad antimicrobial spectrum, although the drug is inactive against Pseudomonas, Nocardia spp., fungi, and viruses.

Bacitracin and neomycin are generally not administered systemically. Topical application of the powder significantly reduces the risk of sensitization associated with systemic administration of antibiotics.

Pharmacokinetics.

Baneocin is well tolerated. Since absorption of bacitracin and neomycin through damaged skin is negligible, the maximum concentration of the drug is achieved at the site of application. Tissue tolerance is considered excellent, and inactivation by biological products, blood, and tissue components is not observed. However, when applying the drug to large areas of damaged skin, potential absorption of the drug and its consequences should be taken into account (see sections "Side Effects", "Special Warnings").

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

Bacitracin is minimally absorbed through mucous membranes and skin. However, absorption through the skin may occur in the presence of open wounds.

Neomycin is absorbed in minimal amounts through intact skin. However, through inflamed or damaged skin and in the absence of a keratinized layer (ulcers, wounds, burns), neomycin is rapidly absorbed.

Clinical characteristics.

Indications.

Bacterial infections of localized areas of the skin: bacterially infected simple herpes, herpes zoster / chickenpox; impetigo contagiosa; infected varicose ulcers; infected eczema; bacterially infected diaper dermatitis.

Prevention of umbilical infection in newborns.

As adjunctive therapy:

• following surgical (dermatological) procedures (including after excision and cauterization);
• in skin fissures;
• in perineal tears, episiotomy;
• in the treatment of eroded wound surfaces (with exudate).

Contraindications.

Hypersensitivity to the components of the medicinal product or to other aminoglycoside antibiotics. Extensive and severe skin lesions (possible resorption of the drug with development of ototoxic effects leading to hearing loss). Do not use in patients with severe cardiogenic or nephrogenic excretory disorders when uncontrolled absorption of the drug is possible, as well as in patients with a history of vestibular or cochlear system disorders. Do not apply into the external auditory canal in cases of perforated eardrum, or near the eye area.

Interaction with other medicinal products and other forms of interactions.

If systemic absorption occurs, concomitant use of cephalosporins or aminoglycoside antibiotics increases the risk of nephrotoxic reactions.

Concomitant use of diuretics such as ethacrynic acid or furosemide may enhance signs of ototoxicity or nephrotoxicity.

In case of systemic absorption, concomitant use with opioid analgesics, analgesic agents, or muscle relaxants increases the risk of neuromuscular conduction disturbances.

Special precautions for use.

Baneocin, topical powder, must not be used in the oral cavity, especially in children.

When treating patients with extensive skin lesions, one should consider the possibility of absorption of the active components of Baneocin and, consequently, the development of ototoxic and/or nephrotoxic effects. Since the risk of toxic effects increases in patients with pronounced liver and/or kidney impairment, such patients should undergo monitoring of urine and blood parameters and audiometric testing before and during intensive Baneocin therapy.

Precautionary measures should be observed when using the drug long-term in patients with chronic otitis media due to the potential ototoxic effect.

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

If uncontrolled absorption of Baneocin occurs, the possibility of neuromuscular blockade should be considered, especially in patients with acidosis, a history of myasthenia gravis (Myasthenia gravis), or other neuromuscular disorders. Neuromuscular blockade can be reversed with calcium salts or proserine (neostigmine).

With prolonged treatment, overgrowth of resistant microorganisms and fungi may occur. In such cases, appropriate therapy should be initiated.

The drug should be discontinued in patients who develop allergy or superinfection.

Phototoxic reactions or photosensitization may occur following exposure to sunlight or UV radiation.

Use during pregnancy or breastfeeding.

If there is a risk of absorption of active substances, the powder may be used during pregnancy or breastfeeding only when the expected benefit to the mother outweighs the potential risk to the fetus or infant. Like other aminoglycoside antibiotics, neomycin crosses the placental barrier. There have been reports of fetal hearing impairment following systemic administration of high doses of aminoglycosides.

Before breastfeeding, any residual drug should be removed from the mammary gland using boiled water and sterile cotton.

Ability to affect reaction rate while driving or operating machinery.

Unknown.

Method of Administration and Dosage

For adults and children from birth, Baneocin powder is usually applied 2–4 times daily.

During treatment, it is recommended to apply the powder to an area of skin not exceeding 1% of the body surface (corresponding to the size of the palm).

After application of the powder to the affected skin areas, the natural evaporation process (sweating) is activated; therefore, the medicinal product exerts a cooling and soothing effect.

The powder should be evenly sprinkled over the area to be treated. If necessary, after applying the medication to the affected area, a gauze dressing may be applied.

Patients with burns covering more than 20% of the body surface should use Baneocin powder no more frequently than once daily, especially if renal function is impaired, as absorption of the active ingredients of the drug may occur.

With topical use, the dose of neomycin should not exceed 1 g per day (equivalent to 200 g of powder) for longer than 7 days. For repeated courses, the maximum dose should be halved.

Elderly patients (aged 65 years and older): Dose adjustment is not required in elderly patients.

Children:

Can be used in children from the first days of life, as prescribed by a physician, after careful assessment of the benefit/risk ratio.

Overdose.

When doses significantly exceeding the recommended ones are used, absorption of the active ingredients of the drug may occur. Symptoms indicating nephro- and/or ototoxic reactions should be considered, especially in patients with trophic ulcers.

Treatment: symptomatic therapy.

Adverse Reactions

The frequency of adverse reactions is defined as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10,000, < 1/1000), very rare (< 1/10,000), frequency not known (cannot be estimated from the available data).

The product is generally well tolerated when applied topically.

Immune system disorders:
Rare – in cases of allergic reactions to neomycin, cross-allergy to other aminoglycoside antibiotics occurs in approximately 50% of cases; frequency not known – hypersensitivity to neomycin and many other substances may occur when the product is used in chronic dermatoses or chronic otitis media. Under certain circumstances, allergy may manifest as failure of wound healing.

Nervous system disorders:
Frequency not known – vestibular nerve damage, neuromuscular blockade.

Ear and labyrinth disorders:
Frequency not known – ototoxicity.

Skin and subcutaneous tissue disorders:
Rare – allergic reactions, mainly manifesting as contact dermatitis. Allergic reactions caused by neomycin occur less frequently than generally assumed; frequency not known – prolonged use may lead to allergic reactions such as redness, dryness and desquamation of the skin, rash, and pruritus. Extension of lesions or failure to heal may be due to allergy. Photosensitization or phototoxic reactions cannot be ruled out upon exposure to sunlight or ultraviolet radiation.

Renal and urinary disorders:
Frequency not known – nephrotoxicity.

Shelf life. 2 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in the original packaging.

Keep out of reach of children.

Packaging.

10 g of powder in a container; 1 container in a cardboard box.

Supply category. Over-the-counter (without prescription).

Manufacturer.

Lek Pharmaceuticals d.d. (responsible for batch release).

Manufacturer's address and place of business.

Verovškova 57, 1526 Ljubljana, Slovenia.