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Composition:


active ingredient: naftifine;


1 ml of the drug contains naftifin hydrochloride 10 mg;


excipients: 96% ethanol, propylene glycol, purified water.


Dosage form. The solution is cutaneous.


Basic physical and chemical properties: clear solution of colorless to light yellow color with the smell of ethanol.


Pharmacotherapeutic group. Antifungal agents for use in dermatology.


ATX code D01A E22.


Pharmacological properties.


Pharmacodynamics. Antifungal agent of the allylamine class. Its active ingredient is naftifin hydrochloride, the mechanism of action of which is associated with inhibition of the action of ergosterol.


Naftifin is active against dermatophytes such as Trichophyton, epidermophyton and Microsporum, yeast (Candida), mold (Aspergillus) and other fungi (for example, Sporothrix Schenckii). For dermatophytes and Aspergillus, naftifin in vitro has a fungicidal effect, for yeast fungi – shows fungicidal or fungistatic activity, depending on the strain of the microorganism.


The drug also exhibits antibacterial activity against Gram-positive and Gram-negative microorganisms that can cause secondary bacterial infections along with mycotic lesions.


In addition, the drug has powerful anti-inflammatory properties.


Pharmacokinetics. Naftifin Hydrochloride is rapidly absorbed and forms persistent antifungal concentrations in various layers of the skin. Approximately 4% of the dose applied to the skin is absorbed, so the systemic effect of the active substance is very low. Only trace amounts of naftifin are detected in blood plasma and urine. The active substance is almost completely metabolized; the metabolites do not have antifungal activity and are excreted in the feces and urine. The elimination Half-Life is 2-4 days.


Clinical characteristics.


Indications. Topical treatment of fungal infections caused by naftifin-sensitive pathogens:


- fungal infections of the skin and skin folds;


- InterDigital Mycoses;


- fungal nail infections (onychomycosis);


- skin candidiasis;


- pityriasis versicolor;


- inflammatory dermatomycosis with or without itching.


Contraindications. Hypersensitivity to naftifin, propylene glycol or other components of the drug. The drug should not be applied to the wound surface. Do not use for eye treatment.


Interactions with other drugs and other types of interactions. Interaction studies have not been conducted.


Application features. The drug should be used for diseases of the nails and skin only externally.


The drug contains ethanol, so you should avoid getting the solution in the eyes and on open wounds.


The drug contains propylene glycol, which can cause skin irritation.


Use during pregnancy or lactation. Data on the use of naftifin in pregnant women are limited. The results of animal studies do not indicate the existence of a direct or indirect harmful effect of the drug on reproductive function. The drug can be used during pregnancy or lactation only if absolutely necessary after a careful assessment of the benefit/risk ratio, which is determined by the doctor.


Ability to influence the reaction rate when driving vehicles or other mechanisms. It doesn't affect you.


Dosage and administration. The drug should be applied to the affected surface of the skin and adjacent areas 1 time a day after its thorough cleaning and drying, capturing approximately 1 cm of healthy skin along the edges of the affected area.


Duration of treatment: for dermatomycosis – 2-4 weeks (if necessary – up to 8 weeks); for candidiasis – 4 weeks; for nail infections – up to 6 months.


For fungal diseases of the nails, the drug is recommended to be used 2 times a day. Before the first application, it is necessary to remove the affected part of the nail as much as possible with scissors or a nail file (to facilitate this procedure, on the recommendation of a doctor, the nails can be treated with a special softening agent).


To prevent relapses, treatment with the drug should be continued for at least 2 weeks after the main symptoms of the disease disappear.


Children. There are insufficient data on the efficacy and safety of the drug in children, so it is not recommended to prescribe the drug to patients of this age category.


Overdose. Acute overdose with topical application of naftifin was not observed. Systemic intoxication with external use of the drug is unlikely due to the fact that a small amount of the active substance is absorbed through the skin.


In case of accidental ingestion of the drug, symptomatic treatment should be initiated.


Adverse reactions. In isolated cases, local reactions may occur: dry skin, redness and burning sensation, erythema, itching, local irritation.


Expiration date. 2 years.


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


Keep out of reach of children.

Tags: Naftifin