Instructions Nitrofungin solution for external use 10 mg/ml bottle 25 ml No. 1
Composition
active ingredient: chloronitrophenol;
1 ml of solution contains 10 mg of chloronitrophenol;
Excipients: triethylene glycol, ethanol 96%, purified water.
Dosage form
Solution for external use.
Main physicochemical properties: transparent solution from yellow to greenish-yellow color with a slight odor of alcohol.
Pharmacotherapeutic group
Antifungal agents for topical use. ATX code D01A E.
Pharmacological properties
Pharmacodynamics
Nitrofungin is an antifungal agent for topical use. The drug is characterized by antiseptic and disinfectant effects on gram-positive and gram-negative bacteria, mycobacteria, and some fungi. It is active against the causative agent of dermatomycoses. It has a fungistatic effect.
Pharmacokinetics
Phenol is absorbed from the gastrointestinal tract, skin, mucous membranes. It is metabolized to phenylglucuronide and phenylsulfate. A small part of phenol is oxidized to catecholamines and quinol. Metabolites are excreted in the urine, which may be light green in color.
Indication
Dermatomycoses, in particular epidermophytosis, trichophytosis, candidiasis, mycotic eczema, mycoses of the external auditory canal.
Contraindication
Hypersensitivity to chlornitrophenol and other components of the drug.
Interaction with other medicinal products and other types of interactions
The antifungal effect of phenol may be reduced by elevated pH or by interaction with blood substances or other organic substances.
Application features
If no therapeutic effect is observed within three days of using the drug or the manifestations of the disease worsen, it is necessary to review the treatment tactics.
The antimicrobial effect of phenol may decrease with increasing pH or in combination with blood derivatives or other organic substances.
The areas where the drug is applied should be protected from direct sunlight.
The solution contains 42.4% (by volume) ethanol.
Use during pregnancy or breastfeeding
During pregnancy or breastfeeding, the drug can be used only as prescribed by a doctor, who will determine the benefit/risk ratio.
Breastfeeding women should prevent any contact of the child with the drug.
Ability to influence reaction speed when driving vehicles or other mechanisms
This drug does not impair the ability to drive a car or operate other mechanisms.
Method of administration and doses
Apply to adults and children over 15 years of age. Apply the solution to the affected areas of the skin with drops or rub 2-3 times a day until the signs of the disease disappear completely. The use of the drug also has a very significant effect on the results of treatment after the signs of the disease disappear. To prevent relapses, it is recommended to use the drug 1-2 times a week, 2-3 times a day for 4 weeks.
Usually, an undiluted solution should be used. Only in cases of acute inflammatory manifestations on the skin or if skin irritation occurs during treatment, the drug should be diluted with water in a ratio of 1:1.
Children
The drug should not be used in children under 15 years of age.
Overdose
Signs of overdose may occur when absorbed through damaged and intact skin in the event of prolonged exposure to a large area of skin. In case of accidental contact with phenol, the skin should be washed with plenty of water and then with vegetable oil. Macrogol 300 or eucalyptus oil can also be used.
Accidental ingestion of phenol causes nausea, vomiting, increased sweating, and diarrhea. First, excitement may occur, after which the patient may faint. Central nervous system depression and subsequent failure of the cardiovascular and respiratory systems can even cause death. Sometimes acidosis develops, rarely hemolysis and methemoglobinemia with cyanosis. Urine becomes green. Sometimes pulmonary edema, myocardial damage, and as a result, kidney and liver damage develop, which can lead to failure of these organs.
If phenol enters the stomach, gastric lavage should be performed with a solution containing olive or other vegetable oil, which dilutes phenol and prevents its further absorption. Activated charcoal can also be taken. Do not induce vomiting artificially. Gastric lavage should be performed with warm water. Forced diuresis is also effective. In case of hemolysis, blood exchange transfusion should be performed.
Adverse reactions
Allergic reactions are possible. In some cases, skin irritation at the site of application or increased skin sensitivity to direct sunlight may occur. In the event of these undesirable reactions, it is necessary to consult a doctor regarding further use of the drug.
Expiration date
5 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging to protect from light and out of the reach of children.
Packaging
25 ml in a bottle, 1 bottle in a box.
Vacation category
Without a prescription.
Producer
Teva Czech Industries s.r.o.
Location of the manufacturer and its business address
Ostravska Street 29, 747 70 Opava-Komarov, Czech Republic.
