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

Composition:

Active substance: 1 tablet contains nitrofurazone (nitrofural), calculated as 100% substance – 20 mg;

Excipients: sodium chloride, sodium croscarmellose, povidone, stearic acid.

Pharmaceutical form. Tablets for preparation of a solution for external use.

Main physicochemical characteristics: tablets are yellow or yellowish-green in color, with slightly uneven surface coloring, flat cylindrical in shape, with beveled edges and a score line.

Pharmacotherapeutic group. Antiseptics and disinfectants. ATC code D08AF01.

Pharmacological properties.

Pharmacodynamics.

Nitrofurale belongs to antibacterial agents. It is a potent antiseptic active against staphylococci, streptococci, Shigella, Escherichia coli, Salmonella, and causative agents of gas gangrene. It promotes granulation and wound healing processes. The mechanism of action of the drug is associated with its ability to reduce the nitro group to an amino group, disrupt DNA function, and inhibit cellular respiration of microorganisms.

Clinical characteristics.

Indications.

Mouth and throat rinsing, purulent wounds, pressure sores, ulcerative lesions, second- and third-degree burns, osteomyelitis, pleural empyema, chronic suppurative otitis, anaerobic infections.

Contraindications.

Hypersensitivity to the drug and to other nitrofuran derivatives, allergic dermatoses.

Special safety precautions.

The drug is intended for topical use only!

Interaction with other medicinal products and other types of interactions.

Not studied.

Special precautions.

Use during pregnancy or breastfeeding. There is no experience with the use of the drug during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery. Not studied.

Method of Administration and Dosage

Nitrofurazone® is intended for topical use as an aqueous 0.02% (1:5000) solution. To prepare the aqueous solution, dissolve 1 tablet in 100 mL of isotonic sodium chloride solution or distilled water (use hot water for faster dissolution). After preparation, cool the solution to room temperature and store for prolonged periods (sterilization by heating for 30 minutes at 100 °C).

Mouth and throat rinsing: dissolve 20 mg (1 tablet) in 100 mL of hot water.
Repeat rinsing as directed by a physician. The duration of treatment depends on the form and severity of the disease, concomitant therapy, and the therapeutic effect achieved, and is determined individually by the physician, but should not exceed 10 days.

For purulent wounds, pressure ulcers, ulcerative lesions, second- and third-degree burns, and for preparing granulating surfaces for skin grafting or secondary suture, irrigate the wound with Nitrofurazone aqueous solution and apply wet dressings.

After surgery for osteomyelitis, irrigate the cavity with Nitrofurazone aqueous solution, then apply a wet dressing.

In pleural empyema, aspirate pus and irrigate the pleural cavity using standard techniques. Then introduce 20–100 mL of the drug's aqueous solution into the pleural cavity.

In anaerobic infections, after standard surgical intervention, treat the wound with Nitrofurazone as well.

For chronic suppurative otitis, apply 8–10 drops of Nitrofurazone aqueous solution onto a cotton swab or a wick, and insert into the external auditory canal twice daily. Prior to use, warm the solution to body temperature.

Children
There is no experience with the use of this drug in children (under 18 years of age); therefore, it should not be administered to patients in this age group.

Overdose
When large doses of the drug are used, adverse reactions may be intensified.

Side effects.

When applied topically, Furacilin® is generally well tolerated. Occasionally, dermatitis may occur; when used for mouth or throat rinsing – irritation of the oral mucosa, which requires temporary discontinuation of the drug.

In individual cases, the following may occur:

Immune system side effects: allergic reactions, including itching, hyperemia, skin rashes; very rarely – angioneurotic edema.

Shelf life. 5 years.

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

Keep out of reach of children.

Packaging. Tablets: 10 in a blister; 10 in a blister, 2 blisters in a carton.

Availability. Over-the-counter (without prescription).

Manufacturer. JSC "Kyivmedpreparat" or JSC "Halychpharm".

Manufacturer's address.

139 Saksahanskoho Street, Kyiv, 01032, Ukraine, or

6/8 Opryshkovska Street, Lviv, 79024, Ukraine.