Neomycin plus

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NEOMYCIN PLUS

Composition:

Active substances: zinc bacitracin; neomycin sulfate;

1 g of the preparation contains zinc bacitracin 250 IU; neomycin sulfate 5000 IU;

Excipients: lanolin, mineral oil, white soft paraffin.

Pharmaceutical form. Ointment.

Main physicochemical properties: white homogeneous ointment with a yellowish tint. A slight specific odor is permissible.

Pharmacotherapeutic group.

Antibiotics for topical use. ATC code D06AX.

Pharmacological Properties.

Pharmacodynamics.

Neomycin Plus 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 streptococci, staphylococci, Clostridium spp., Corynebacterium diphtheriae, Treponema pallidum, as well as against some Gram-negative pathogenic microorganisms such as Neisseria spp. and Haemophilus influenzae. The antimicrobial spectrum also includes actinomycetes and fusobacteria. Bacitracin-resistant strains are rare.

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; however, the medicinal product is inactive against Pseudomonas, Nocardia spp., fungi, and viruses.

Bacitracin and neomycin should generally not be administered systemically. Topical application of the ointment significantly reduces the risk of sensitization associated with systemic antibiotic use.

Pharmacokinetics.

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

When Neomycin Plus ointment is used correctly, it exerts local action at the site of application. If absorption of 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 when open wounds are present.

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

Clinical characteristics.

Indications.

Local treatment and prevention of bacterial skin infections caused by microorganisms sensitive to the drug:

• furuncles, carbuncles (after surgical intervention), abscesses (after incision), pseudofolliculitis barbae, deep folliculitis, suppurative hidradenitis, pseudofurunculosis, paronychia;
• limited bacterial skin infections, including contagious impetigo, infected varicose ulcers, secondary infections in eczema, infections in burns, after cosmetic surgery and skin grafting (also for prophylactic purposes and when dressings are used);
• as adjunctive therapy in the treatment of infected wounds (e.g., in external otitis, secondary infection of surgical scars) and slowly healing wounds.

Contraindications.

Hypersensitivity to the components of the medicinal product or to other aminoglycoside antibiotics.

Extensive and severe skin lesions (possible resorption of the drug leading to ototoxic effects with hearing loss).

The drug should not be used in patients with severe cardiogenic or nephrogenic excretory disorders, or with a history of vestibular or cochlear system disorders, if uncontrolled absorption of the drug is possible. Do not use in the external auditory canal in case of perforation of the tympanic membrane.

Do not apply to areas around the eyes.

Interaction with other medicinal products and other forms of interaction.

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, analgesics, or muscle relaxants increases the risk of neuromuscular conduction disturbances.

Special precautions for use.

The medicinal product must not be used in the oral cavity, especially in children.

When treating patients with large areas of skin affected, one should consider the possibility of absorption of the active components of the medicinal product 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 have urine and blood parameters monitored, and undergo audiometric testing before and during intensive treatment with the medicinal product.

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

Avoid combining aminoglycosides with systemic and local action due to the risk of cumulative toxicity.

If uncontrolled absorption of the medicinal product Neomycin Plus occurs, the possibility of neuromuscular blockade should be considered, especially in patients with acidosis, a history of myasthenia gravis, or other neuromuscular disorders. Neuromuscular blockade can be reversed by calcium preparations or proserin (neostigmine).

Prolonged treatment may lead to overgrowth of resistant microorganisms and fungi. In such cases, appropriate therapy should be initiated.

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

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

The ointment contains lanolin as an excipient, which may cause local skin reactions (e.g., contact dermatitis).

Use during pregnancy or breastfeeding.

The ointment may be used during pregnancy or breastfeeding only if, in the opinion of the physician, the expected benefit to the mother outweighs the potential risk to the fetus or infant, and if there is a risk of absorption of active substances. Like other aminoglycoside antibiotics, neomycin crosses the placental barrier. Cases of fetal hearing impairment have been reported following systemic administration of high doses of aminoglycosides.

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

Ability to affect reaction speed when driving or operating machinery.

Unknown.

Dosage and Administration.

Neomycin Plus ointment should usually be applied 2–3 times daily for 7 days in adults and children.

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

When used locally for longer than 7 days, the dose of neomycin should not exceed 1 g per day (equivalent to 200 g of ointment). For repeated courses, the maximum dose should be halved.

Apply a small amount of ointment to the affected area and gently rub in. If necessary, a gauze dressing may be applied after ointment application.

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

Children:

Safety data regarding the use of this medicinal product in pediatric formulations for young children are insufficient. Therefore, use in children is possible only upon a physician's prescription following careful assessment of the benefit-risk ratio.

Overdose.

With doses significantly exceeding the recommended ones, due to possible absorption of active substances, symptoms indicating nephro- and/or ototoxic reactions should be considered, especially in patients with trophic ulcers.

Treatment: symptomatic therapy.

Side effects.

The frequency of side effects is defined as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000), very rare (< 1/10000), frequency not known (cannot be calculated from available data).

Generally, the drug is well tolerated when applied topically.

Immune system disorders: rare – in cases of allergic reactions to neomycin, cross-allergy to other aminoglycoside antibiotics may occur in approximately 50% of cases; frequency not known – increased sensitivity to neomycin and to many other substances may develop when the drug 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 presenting as contact dermatitis. Allergic reactions caused by neomycin occur less frequently than generally believed; frequency not known – prolonged use may lead to allergic reactions such as redness, dryness and peeling of the skin, rash, itching. Worsening of lesions or lack of healing may be due to allergy. Photosensitization or phototoxic reactions upon exposure to sunlight or ultraviolet radiation cannot be excluded.

Renal and urinary disorders: frequency not known – nephrotoxicity.

Reporting of side effects.

Reporting of adverse reactions after drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the drug. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of drug efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions.

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

Keep out of reach and sight of children.

Packaging.

10 g or 20 g in a tube; 1 tube per cardboard box.

Prescription status. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's address and location of business activity.

22, Shevchenka Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.