FURACILIN

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT FURACILIN (FURACILIN)

Composition:

Active substance: furacilin;

1 ml of solution contains 0.66 mg of furacilin;

Excipient: ethanol 70%.

Pharmaceutical form.

Ear drops, solution.

Main physicochemical properties: clear yellow liquid with a characteristic odor of alcohol.

Pharmacotherapeutic group.

Antiseptics and disinfectants. Nitrofuran derivatives. ATC code D08AF01.

Pharmacological properties.

Pharmacodynamics.

Nitrofurazone is an antibacterial agent. It disrupts the formation of acetyl-CoA from pyruvic acid, thereby interfering with energy metabolism and synthetic processes in bacterial cells. It inhibits the growth and reproduction of staphylococci, streptococci, Shigella, Escherichia coli, Salmonella paratyphi, Clostridium perfringens, and other Gram-positive and Gram-negative bacteria.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Chronic suppurative otitis, furuncles of the external auditory canal.

Contraindications.

Increased individual sensitivity to nitrofurazone or to other nitrofuran derivatives, allergic dermatoses.

Special precautions.

None.

Interaction with other medicinal products and other forms of interactions.

Not detected.

Special precautions for use.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, the decision on the appropriateness of using the drug is made by a physician.

Ability to affect reaction speed when driving or operating machinery. Not observed.

Administration and Dosage.

Apply nitrofurazone externally. Instill 8 – 10 drops of the solution onto a cotton swab or a pledget, and insert into the external auditory canal twice daily. Prior to use, the solution should be warmed to body temperature. The duration of treatment is determined individually by a physician.

Children.

The appropriateness of using the drug in children under 12 years of age is determined individually by a physician.

Overdose.

When large doses of the drug are used, the manifestations of the described adverse reactions may be intensified. In such cases, administration of the drug should be discontinued.

Side effects.

Allergic reactions (including dermatitis) may occur in individuals hypersensitive to the drug, requiring discontinuation of the drug.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

20 ml in glass bottles stoppered with a plug and cap or dropper plug and cap; 1 bottle per carton or without carton. 20 ml in polymer bottles stoppered with dropper plugs and caps; 1 bottle per carton or without carton.

Supply category. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.

69063, Ukraine, Zaporizhzhia, Akademika Amosova St., 75.

Marketing authorization holder. JSC Pharmaceutical Factory "Viola".

Address of the marketing authorization holder.

69063, Ukraine, Zaporizhzhia, Akademika Amosova St., 75.