Fungoderil® (Naftifine) 10 mg/ml, 10 ml of solution for external use in vial

Composition

10 ml of the drug contains the active ingredient - Naftifine hydrochloride - 100.0 mg,

Excipients - ethanol (in the form of ethyl alcohol 96%), propylene glycol, purified water.

 

Pharmacological properties

Pharmacokinetics

Fungoderil, solution is an antifungal allylamine drug intended for external use. Its active ingredient is naftifine. Naftifine is absorbed into the skin through the stratum corneum (transdermal route) and penetrates well into all layers of the nail, being present for a long time in various layers of the skin and in the nail plates in antimycotic concentrations. In clinical use, the anti-inflammatory effect of naftifine was noted, due to which signs of inflammation, especially itching, quickly disappear. The drug does not enter the systemic circulation. When applied to the skin, only 4% of the dose is absorbed. Therefore, the systemic exposure is very low. In plasma and urine, naftifine is found in trace amounts.

Pharmacodynamics

Naftifine has a fungicidal effect against the following organisms: Trichophyton spp., Microsporon spp., Epidermophyton floccosum.

Naftifine is moderately active against yeast (Candida species), mold (Aspergillus species) and other fungi (e.g. Sporothrix schenkii).

It also exhibits antibacterial activity against gram-positive and gram-negative microorganisms, which often accompany mycoses.

Mechanism of action: naftifine, by inhibiting the enzyme squalene epoxidase, inhibits the synthesis of ergosterol, which is necessary for the growth of fungal cells, resulting in a fungistatic effect. In addition, the suppression of squalene epoxidase leads to the accumulation of squalene in the fungal cell membranes and damage to its wall, resulting in a fungicidal effect.

In addition to antifungal activity, naftifine has antibacterial activity against a number of gram-positive and gram-negative pathogenic microorganisms, which are often found in combination with fungal infections: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus.

 

Indications for use

- fungal infections of the skin and skin folds caused by pathogens Tinea corporis, Tinea inguinalis;

- interdigital mycoses of the hands and feet caused by pathogens Tinea manum, Tinea pedum;

- fungal infections of the nails on the hands and feet (onychomycosis);

- skin candidiasis caused by Candida;

- pityriasis versicolor caused by the pathogen Pityriasis versicolor.

 

Dosage and administration

Apply 2-3 drops of the solution using a dropper insert on the vial or with a cotton swab. The solution must be applied not only to the affected areas of the skin / nail, but also to the adjacent areas to prevent the spread of infection.

Fungal infections of the skin

The solution is applied once a day to the affected areas of the skin, which must first be cleaned and thoroughly dried.

Duration of treatment:

- fungal infections of the skin and skin folds - up to 4 weeks;

- interdigital mycosis of the hands and feet - from 4 to 8 weeks;

- skin candidiasis - 4 weeks;

- pityriasis versicolor - up to 2 weeks.

After the manifestation of the clinical effect, namely the disappearance of itching and burning, to prevent recurrent infection, treatment should be continued for at least 2 weeks.

Fungal infections of the fingernails and toenails (onychomycosis)

The solution is applied 2 times a day to the affected surface of the nail plates, which must first be cleaned, thoroughly dried and trimmed as much as possible. The duration of treatment is determined by the rate of growth of the nail plates and can be from 3 to 6 months until the new nail is fully grown.

Fungoderil is recommended to be used under a breathable dressing (plaster, bandage, etc.), but should not be used under an occlusive dressing.

Patients with renal or hepatic insufficiency: dose adjustment is not required.

Elderly patients: dose adjustment is not required.

Application duration

To prevent recurrence of infection, treatment is continued for at least two more weeks after clinical recovery.

Patients should be informed about the necessary hygiene measures to prevent re-infection.

 

Side effects

The frequency of occurrence of adverse reactions is indicated as: very often (≥1/10); often (from ≥1/100 to <1/10); infrequently (from ≥1/1000 to <1/100); rarely (from ≥1/10000 to <1/1000); very rarely (<1/10000).

General disorders and disorders at the injection site

Frequency unknown: dry skin, redness and burning, erythema, itching, local irritation.

Adverse reactions are reversible and do not require discontinuation of treatment.

 

Contraindications

- hypersensitivity to naftifine or excipients

- open wound surface

 

Drug Interactions

Not installed

 

Special instructions

Fungoderyl is for external use only. It can not be used in ophthalmic practice, as well as applied to open wounds.

To eliminate a fungal infection (mycosis),

you should take the following precautions:

1. Fungi can get on clothes and/or socks that come into contact with the affected skin/nail area, so clothes and/or socks should be changed every day.

2. Keeping the affected skin/nail surface dry provides good protection against the spread of fungal infection. It is not recommended to cover the affected area with a dense cloth or accessories that limit or prevent ventilation (for example, stockings made from synthetic fibers, tight shoes). The affected area of ​​the skin/nail should be thoroughly dried after washing. Towels, clothing and/or socks in contact with the affected surface should also be changed daily.

3. In the case of foot fungus, you should not walk barefoot at home or in public places to prevent re-infection or the spread of pathogens.

4. Saunas or steam baths can be visited only after complete disposal of the fungal infection.

If no clinical improvement is observed within 4 weeks after the use of the drug Fungoderil, you should consult your doctor. The therapeutic approach needs to be revised.

Children and teenagers:

The safety and efficacy of naftifine in children and adolescents under 18 years of age has not been proven (experience is insufficient).

Pregnancy and lactation

As a precautionary measure, the use of Fungoderyl should be avoided during pregnancy and lactation.

Features of the effect of the drug on the ability to drive vehicles and potentially dangerous mechanisms

To date, no impact has been reported.

 

Overdose

Acute overdose and systemic intoxication with external use of naftifine are unlikely. In case of accidental ingestion, appropriate symptomatic treatment is recommended.

 

Storage conditions

Store in a place protected from light at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
Shelf life 18 months. Do not use after the expiry date stated on the package.