Nitrofungin

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

Composition:

Active substance: chloronitrophenol;

1 ml of solution contains 10 mg of chloronitrophenol;

Excipients: triethylene glycol, ethanol 96%, purified water.

Pharmaceutical form. Solution for external use.

Main physicochemical properties: clear solution of yellow to green-yellow color with a slight alcoholic odor.

Pharmacotherapeutic group.
Antifungal agents for topical use. ATC code D01AE.

Pharmacological Properties.

Pharmacodynamics.

Nitrofungin is an antifungal agent for topical use. The medicinal product exhibits antiseptic and disinfectant activity against gram-positive and gram-negative bacteria, mycobacteria, and some fungi. It is active against the causative agents of dermatomycoses. It exerts a fungistatic effect.

Pharmacokinetics.

Phenol is absorbed from the gastrointestinal tract, skin, and mucous membranes. It is metabolized to phenylglucuronide and phenylsulfate. A small portion of phenol is oxidized to catecholamines and quinol. Metabolites are excreted in urine, which may become light green in color.

Clinical characteristics.

Indications.

Dermatomycoses, particularly epidermophytoses, trichophytoses, candidiasis, fungal eczema, external auditory canal mycoses.

Contraindications.

Hypersensitivity to chloronitrophenol and to other components of the drug.

Interaction with other medicinal products and other forms of interaction.

The antimicrobial action of phenol may be reduced by elevated pH or upon interaction with blood substances or other organic materials.

Special precautions for use

If there is no therapeutic effect or if symptoms worsen during three days of using the medicinal product, the treatment strategy should be reconsidered.

Areas where the product is applied should be protected from direct sunlight exposure.

The solution contains 42.4% (by volume) ethanol.

Use during pregnancy or breastfeeding

The medicinal product may be used during pregnancy or breastfeeding only as prescribed by a physician who has evaluated the benefit-risk ratio.

Breastfeeding women should avoid any contact of the infant with the medicinal product.

Ability to affect reaction speed when driving vehicles or operating machinery

This medicinal product does not impair the ability to drive vehicles or operate machinery.

Dosage and Administration

For use in adults and children aged 15 years and older. Apply the solution dropwise or rub into affected skin areas 2–3 times daily until complete disappearance of disease symptoms. The therapeutic outcome is significantly improved by continuing the use of the medication even after symptoms have resolved. For prevention of relapses, it is recommended to use the product 1–2 times per week, 2–3 times daily, for 4 weeks.

The undiluted solution should generally be used. Only in cases of pronounced inflammatory skin reactions or if skin irritation develops during treatment, dilute the preparation with water in a 1:1 ratio.

Children

Do not use in children under 15 years of age.

Overdose

Symptoms of overdose may occur following absorption of phenol through damaged or intact skin, particularly after prolonged exposure over a large skin surface area. In case of accidental skin contact with phenol, remove contaminated clothing and thoroughly rinse the skin with large amounts of water, followed by application of vegetable oil. Macrogol 300 or eucalyptus oil may also be used.

Accidental ingestion of phenol causes local burns, pain, nausea, vomiting, excessive sweating, and diarrhea. Initial excitation may occur, followed by loss of consciousness. Central nervous system depression and subsequent cardiovascular and respiratory failure may lead to fatal outcomes. Metabolic acidosis may develop; hemolysis and methemoglobinemia with cyanosis are rare. Urine may turn greenish. Pulmonary edema, myocardial damage, and subsequent renal and hepatic injury may occur, potentially leading to organ failure.

In case of phenol ingestion, gastric lavage should be performed using a solution containing olive oil or another vegetable oil, which dilutes phenol and prevents further absorption. Activated charcoal may also be administered. Artificially induced vomiting is contraindicated. Gastric lavage should be carried out with warm water. Forced diuresis is also effective. In cases of hemolysis, blood transfusion may be required.

Adverse reactions.

Allergic reactions are possible. In individual cases, skin irritation at the site of application or increased skin sensitivity to direct sunlight may occur. If these adverse reactions occur, consult a physician regarding further use of the product.

Shelf life. 5 years.

Storage conditions. Store at a temperature not exceeding 25 °C in the original packaging, protected from light and out of reach of children.

Packaging. 25 ml in a bottle; 1 bottle per box.

Supply category. Over-the-counter (without prescription).

Manufacturer. Teva Czech Industries s.r.o.

Manufacturer's address and location of business operations.

Ostravska 305/29, Komarov, 747 70 Opava, Czech Republic.