Instructions for use Exoderil cutaneous solution 1% bottle 10 ml
Composition
active ingredient: naftifine hydrochloride;
1 ml of solution contains 10 mg of naftifine hydrochloride;
excipients: propylene glycol, ethanol (96%), purified water.
Dosage form
The solution is topical.
Main physicochemical properties: transparent, colorless to light yellow, with the smell of ethanol.
Pharmacotherapeutic group
Antifungal agents for use in dermatology. ATX code D01A E22.
Pharmacological properties
Pharmacodynamics
Exoderil® is an antifungal agent of the allylamine class. Its active ingredient is naftifine hydrochloride, the mechanism of action of which is associated with the inhibition of the action of ergosterol.
Naftifine is active against dermatophytes such as Trichophyton, Epidermophyton and Microsporum, yeasts (Candida), molds (Aspergillus) and other fungi (e.g. Sporothrix schenckii). Naftifine has fungicidal activity against dermatophytes and Aspergillus in vitro, and fungicidal or fungistatic activity against yeasts, depending on the strain of the microorganism.
Exoderil® also exhibits antibacterial activity against gram-positive and gram-negative microorganisms, which can cause secondary bacterial infections along with mycotic lesions.
In addition, Exoderil® has powerful anti-inflammatory properties.
Pharmacokinetics
Naftifine hydrochloride is rapidly absorbed and forms stable antifungal concentrations in different layers of the skin. Approximately 4% of the dose applied to the skin is absorbed, so the systemic exposure of the active substance is very low. Only trace amounts of naftifine are found in blood plasma and urine. The active substance is almost completely metabolized; the metabolites have no antifungal activity and are excreted in feces and urine. The half-life is 2–4 days.
Indication
Topical treatment of fungal infections caused by pathogens sensitive to naftifine:
fungal infections of the skin and skin folds;
interdigital mycoses;
fungal nail infections;
cutaneous candidiasis;
lichen planus;
inflammatory dermatomycoses, accompanied by itching or without it.
Contraindication
Hypersensitivity to naftifine, propylene glycol or other components of the drug. The drug should not be applied to the wound surface. Do not use for eye treatment.
Interaction with other medicinal products and other types of interactions
Interaction studies have not been conducted.
Application features
The drug should be used externally only for nail and skin diseases!
The medicine contains ethanol, so avoid getting the solution in the eyes and on open wounds.
The solution contains propylene glycol, which may cause skin irritation.
Use during pregnancy or breastfeeding
There are no or limited data on the use of naftifine in pregnant women. Animal studies do not indicate direct or indirect harmful effects of the drug on reproductive function. The drug can be used during pregnancy or breastfeeding only if absolutely necessary after a careful benefit/risk assessment by a physician.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
Exoderil® solution should be applied to the affected skin surface and adjacent areas once a day after it has been thoroughly cleaned and dried, capturing approximately 1 cm of healthy skin around the edges of the affected area.
Duration of treatment: for dermatomycoses – 2–4 weeks (if necessary – up to 8 weeks); for candidiasis – 4 weeks; for nail infections – up to 6 months.
For fungal nail diseases, the drug is recommended to be used 2 times a day. Before the first use, it is necessary to remove as much of the affected part of the nail 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 softener).
To prevent relapse, treatment with the drug should be continued for at least 2 weeks after the main symptoms of the disease have disappeared.
Children
Data on the efficacy and safety of the drug in children are insufficient, therefore it is not recommended to prescribe Exoderil® to patients in this age category.
Overdose
Acute overdose with topical application of naftifine has not been 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.
Side effects
The frequency of adverse reactions is defined as follows: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), rare (≥ 1/10000, <1/1000), very rare (<1/10000), frequency unknown (cannot be estimated from the available data).
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 30 °C.
After opening the bottle, the solution should be stored for 6 months at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 ml or 20 ml of solution in a bottle; 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
Lek Pharmaceutical Company Ltd., Slovenia (responsible for the batch release).
Address
Verovškova 57, Ljubljana 1526, Slovenia.
