Neomycin (Aerosol) Instructions for Use

Marketing Authorization Holder

Tarchomin Pharmaceutical Works Polfa, S.A. (Poland)

ATC Code

D06AX04 (Neomycin)

Active Substance

Neomycin (Rec.INN registered by WHO)

Dosage Form

Neomycin

External use aerosol 1.172 %: 16 or 32 g canisters

Dosage Form, Packaging, and Composition

Aerosol for external use in the form of a homogeneous suspension of white or almost white color with a characteristic odor.

Excipients: sorbitan trioleate – 10.3 mg, lecithin – 0.2 mg, isopropyl myristate – 134 mg, propellant (propane/butane/isobutane) – 843.8 mg.

16 g – aerosol cans (1) with a valve and spray device – cardboard packs.
32 g – aerosol cans (1) with a valve and spray device – cardboard packs.

Clinical-Pharmacological Group

Antibiotic for external use

Pharmacotherapeutic Group

Glucocorticosteroid + aminoglycoside antibiotic + antifungal agent

Pharmacological Action

Aminoglycoside antibiotic. It disrupts protein synthesis by inhibiting the formation of the transport and matrix RNA complex. In low concentrations, it has a bacteriostatic effect (due to disruption of protein synthesis in microbial cells), in high concentrations – a bactericidal effect (damages the cytoplasmic membranes of the microbial cell).

It penetrates the microbial cell, binds to specific receptor proteins on the 30S ribosomal subunit. It disrupts the formation of the transport and matrix RNA complex (by the 30S ribosomal subunit) and stops protein synthesis.

It is active against a number of gram-positive and gram-negative aerobic microorganisms: Staphylococcus spp., Streptococcus spp.; moderately active against aerobic bacteria – Corynebacterium diphtheriae, Listeria monocytogenes; enterobacteria – Escherichia coli, Salmonella spp., Shigella spp., Proteus spp., Enterobacter aerogenes, Klebsiella pneumonia, Vibrio cholerae; Mycobacterium tuberculosis, Haemophilus influenzae.

It does not act on Pseudomonas aeruginosa, anaerobic bacteria.

Microbial resistance to neomycin develops slowly and to a small extent.

The drug Neomycin, aerosol for external use, suppresses the development of bacterial flora in the foci of skin inflammation. It also has a drying and cooling effect.

Pharmacokinetics

Neomycin, applied to intact skin surface, acts locally and is practically not absorbed into the blood. When applied to damaged skin, Neomycin can be absorbed into the blood and cause systemic action.

Indications

• Infectious and inflammatory skin diseases caused by microorganisms sensitive to neomycin (including furunculosis, contagious impetigo);
• Infected burns and frostbite of I and II degree.

ICD codes

Dosage Regimen

Use externally only. Shake the canister vigorously several times immediately before each application.

Hold the canister in a vertical position at a distance of 15-20 cm from the affected skin surface.

Spray the aerosol onto the treatment area for a duration of three seconds.

Apply the drug one to three times per day, maintaining approximately equal intervals between applications.

The standard treatment course is seven to ten days. Do not exceed the recommended duration of therapy.

Avoid contact with eyes and other mucous membranes. Do not inhale the spray.

Do not apply to large areas of damaged skin or under occlusive dressings due to the risk of systemic absorption.

Discontinue use if skin irritation, rash, itching, or swelling occurs.

Adverse Reactions

Allergic reactions: itching, rash, hyperemia, swelling. Long-term use of neomycin can lead to contact allergy.

If the above symptoms worsen or other side effects not listed in the instructions appear, it is necessary to consult a doctor.

Contraindications

• Hypersensitivity to neomycin or other components of the drug;
• Impaired skin integrity, extensive lesion area, weeping at the application site, trophic ulcers;
• Simultaneous use with other oto- and nephrotoxic drugs;
• Childhood.

Use in Pregnancy and Lactation

During pregnancy, the drug can be prescribed only in cases where the potential benefit to the mother outweighs the possible risk to the fetus.

If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Pediatric Use

Contraindicated in children

Special Precautions

It is necessary to avoid contact of the drug with mucous membranes and protect the eyes from the aerosol. If the drug gets into the eyes or on mucous membranes, rinse them thoroughly with cool water.

Do not inhale the sprayed drug.

It is not recommended to apply the drug to a large skin surface, especially damaged skin, or under an occlusive dressing due to the possibility of the drug being absorbed into the blood and the occurrence of adverse reactions characteristic of the systemic action of neomycin (ototoxicity, nephrotoxicity). If the above adverse events occur, the drug should be discontinued immediately.

If skin irritation occurs at the application site, it is necessary to stop using the drug.

Long-term use of the drug may lead to the growth of resistant strains of bacteria and fungi.

The contents of the can are under pressure. Do not strike, heat, or open the can. The empty can must be discarded. The drug is flammable. Do not spray near an open flame. Store away from open flames and operating heating appliances.

Effect on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions.

Overdose

Symptoms: itching, rash, hyperemia, swelling, nephrotoxicity, ototoxicity.

Treatment: discontinuation of the drug, rapid elimination of the drug from the body, symptomatic therapy.

Drug Interactions

To avoid possible drug interactions with neomycin, it is recommended to use other drugs only after consultation with a doctor.

Long-term use of the drug simultaneously with oto- and nephrotoxic drugs (including gentamicin, ethacrynic acid, colistin) may enhance the toxicity of neomycin.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years. Do not use the drug after the expiration date printed on the packaging.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.