Neomycin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Neomycin (Neomycin)

Composition:

Active substance: neomycin sulfate;

1 g of suspension contains 11.72 mg of neomycin in the form of neomycin sulfate;

Excipients: sorbitan trioleate, lecithin, isopropyl myristate, propellant (isobutane, butane, and propane).

Pharmaceutical form. Cutaneous aerosol, suspension.

Main physicochemical properties: homogeneous white or almost white suspension.

Pharmacotherapeutic group. Antibiotics and chemotherapeutic agents for dermatological use. Topically applied antibiotics.

ATC code D06AX04.

Pharmacological properties.

Pharmacodynamics.

Neomycin is an aminoglycoside antibiotic with a broad spectrum of antibacterial activity. It acts against many Gram-positive and Gram-negative bacteria. Its bactericidal mechanism involves binding to the bacterial 30S ribosomal subunit, causing errors in reading the information contained in mRNA, as well as termination of protein synthesis initiation, resulting in bacterial cell death.

Pharmacokinetics.

Neomycin applied to intact skin exerts a local effect and is practically not absorbed into the bloodstream. When the medicinal product is applied to damaged skin, neomycin may penetrate into the blood and cause systemic effects.

Clinical characteristics.

Indications.

• Skin infections, particularly those caused by staphylococci (e.g., furunculosis, streptoderma).
• Suppurative complications of allergic skin diseases (in combination with corticosteroids).
• Minor infected burns and frostbite.

Contraindications.

Hypersensitivity to neomycin or to any excipient.

Do not apply to damaged skin areas, large skin surfaces, areas with exudative pathological changes, or varicose ulcers.

Do not use concomitantly with other ototoxic and nephrotoxic medicinal products.

Interaction with other medicinal products and other forms of interaction.

No interactions have been reported with topical application of the medicinal product when used according to recommended indications and mode of administration.

Simultaneous topical use of two or more medicinal products is not recommended, as this may affect the concentration of active substances at the site of application or cause skin hyperemia.

Prolonged concomitant use with nephrotoxic and ototoxic medicinal products (such as gentamicin, ethacrynic acid, colistin) may enhance the toxicity of neomycin.

Special precautions for use

The medicinal product is intended for topical application to the skin only.

Care should be taken to avoid exposure of the eyes to the sprayed substance.

If the suspension comes into contact with the eyes, they should be thoroughly rinsed with water at room temperature.

Do not inhale the sprayed substance.

Avoid contact of the medicinal product with mucous membranes.

If skin irritation occurs at the site of application, discontinue use of the medicinal product.

Do not bandage the areas of skin to which the product has been applied, and do not use under occlusive dressings. Application under occlusive dressings increases the penetration of neomycin through the skin into the bloodstream.

The medicinal product should not be applied to large areas of skin, especially if the skin is damaged, due to the possibility of systemic absorption of neomycin and the occurrence of adverse reactions (ototoxicity, nephrotoxicity) characteristic of systemic effects. If any of the aforementioned adverse effects occur, use of the medicinal product should be discontinued immediately.

Prolonged use of the medicinal product may lead to the growth of neomycin-resistant bacterial strains and to the development of neomycin allergy.

In case of infections caused by bacteria resistant to neomycin or by fungi, appropriate antibacterial or antifungal treatment should be administered.

Use during pregnancy or breastfeeding

The safety of using the medicinal product during pregnancy has not been established.

During pregnancy, the medicinal product should be used only if the benefit to the woman outweighs the potential risk to the fetus.

Pregnant women and women who are breastfeeding should strictly follow the recommendations provided in the sections of this instruction titled "Method of administration and dosage", "Contraindications", and "Special precautions for use", due to the potential risk of systemic effects of neomycin.

Ability to affect reaction speed when driving or operating machinery

There are no data regarding the influence of the medicinal product on the ability to drive vehicles or operate machinery.

Dosage and Administration

This medicinal product is intended for topical use (on the skin).

For use in adults.

Affected skin areas should be sprayed with the suspension for 1 to 3 seconds from a distance of 15–20 cm, holding the can upright with the spray head pointing upwards.

The product should be applied 2 or 3 times daily at equal intervals.

Caution! Avoid contact with eyes to prevent exposure to the sprayed substance.

Do not inhale the sprayed substance.

Before each use, the can should be shaken vigorously several times.

After each application, hands must be thoroughly washed with soap and water.

Children

The safety of this medicinal product in children has not been established.

Overdose

Application of the medicinal product over large areas of skin, in high doses, under occlusive dressings, or on damaged skin may result in systemic absorption of neomycin and lead to systemic effects (see section "Special Warnings and Precautions for Use").

Symptoms of overdose may include pronounced local adverse reactions as well as systemic side effects typical of neomycin (ototoxicity, nephrotoxicity). In such cases, the use of the medicinal product should be discontinued immediately, and measures should be taken to eliminate neomycin from the body as quickly as possible. Treatment is symptomatic.

Side effects.

Immune system:

Frequency unknown: contact allergy (more common with prolonged use of the medicinal product), possibly delayed in time.

Skin and subcutaneous tissue:

Frequency unknown: skin irritation: itching, rash, erythema, swelling (may occur at the site of application of the medicinal product).

General disorders and administration site reactions:

Frequency unknown: with prolonged application of neomycin over large areas of skin, especially if the skin is damaged, absorption into the bloodstream may occur and cause adverse reactions characteristic of systemic neomycin effects (nephrotoxicity, ototoxicity).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions via the national pharmacovigilance system.

Shelf life.

3 years.

Storage conditions.

Store out of reach and sight of children, at a temperature not exceeding 25 °C.

Extremely flammable aerosol.

Pressurized container. Heating may cause an explosion.

Store away from heat sources, hot surfaces, sparks, open flames, and other sources of ignition. Smoking is prohibited.

Do not spray near open flames or other sources of ignition.

Pressurized container. Do not pierce or burn, even after use.

Protect from sunlight. Do not expose to temperatures exceeding 50 °C / 122 °F.

Flammable preparation; keep the container away from flames.

Packaging.

16 g or 32 g of suspension in an aerosol can with valve and spray head with polypropylene cap; 1 can per cardboard box.

Prescription status.

Prescription only.

Manufacturer.

Tarchomin Pharmaceutical Plant "Polfa" S.A.

Manufacturer's address and location of operations.

2 A. Fleming Street, 03-176 Warsaw, Poland.