Exoderil
Active material: Naftifin
When ATH: D01AE22
CCF: Antifungal agents for external use
ICD-10 codes (testimony): B35.0, B35.1, B35.2, B35.3, B35.4, B35.6, B36.0, B37.2, H62.2
When CSF: 08.02.02
Manufacturer: Sandoz GmbH (Austria)
Pharmaceutical form, composition and packaging
◊ The solution for outdoor applications 1% clear, a colorless or slightly yellow, with the smell of ethanol.
| 1 ml | |
| naftifine hydrochloride | 10 mg |
Excipients: propylene glycol, ethanol, Purified water.
10 ml – vials of dark glass (1) – packs cardboard.
◊ Cream for external application white, uniform or slightly curdled, brilliant, with a faint characteristic odor.
| 1 g | |
| naftifine hydrochloride | 10 mg |
Excipients: Sodium hydroxide, benzyl alcohol, sorbitan stearate, tsetyla palmitat, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropylmyristate, Purified water.
15 g – aluminum tuba (1) – packs cardboard.
30 g – aluminum tuba (1) – packs cardboard.
Pharmacological action
Antifungal agent for external use of allylamine. The mechanism of action is associated with inhibition of the synthesis of ergosterol, wherein naftifine affects squalene epoxidase, without affecting the cytochrome P450 system.
Preparation active against dermatophyte Trichophyton, Epidermophyton, Microsporum, yeast and yeast-like fungi (Candida), molds (Aspergillus) and other fungi (Sporotrix schenckii). In the context of in vitro against dermatophytes and Aspergillus naftifine acts fungicidally. Regarding yeasts and yeasts exhibits fungicidal and fungistatic activity, depending on the strain of microorganism. The drug has antibacterial activity against Gram-positive and Gram-negative microorganisms.
In the clinical setting has been established, that the drug has anti-inflammatory effect, which contributes to the rapid disappearance of the symptoms of inflammation, especially pruritus.
Since Exoderil® penetrates quickly into the skin, creating a stable concentration of antifungal in its different layers, maybe its local application 1 time / day.
Pharmacokinetics
Absorption and distribution
For external use naftifine well into the different layers of the skin, achieving sufficient for the concentrations of the antifungal action.
After application to the skin cream systemic absorption is subject to a 6% active ingredient.
Metabolism and excretion
It sucks the number of partially metabolized and excreted in the urine and the bile. T1/2 is 2-3 day.
Testimony
- Fungal infections of the skin and skin folds;
- Interdigital mycosis (Brushes, stop);
- Onychomycosis;
- Candidiasis of the skin;
- Chromophytosis;
- Inflammatory ringworm (pruritus accompanying with or without);
- Mycosis external auditory canal (for a solution).
Dosage regimen
Exoderil® should be applied to the affected surface of the skin and its neighboring areas 1 time / day, after thorough cleaning and drying, capturing about 1 see healthy area of skin on the edges of the affected area.
At onychomycosis before the first application of the solution should be possible to remove the affected part of the nail scissors and nail file.
At mycosis external auditory canal Treatment should be carried out not less than 14 days. Treatment is carried out by inserting into the ear cotton turundas, moistened with a solution of the drug, on 5-8 m 1-2 times / day.
The duration of treatment with the dermatomykozah – 2-4 of the week (if necessary – to 8 weeks), at kandidozax – 4 of the week, In onihomikozah drug should be used 2 times / day for 6 Months.
To relapse prevention of infection therapy should be performed for at least 2 weeks after clinical cure.
Side effect
Local reactions: in some cases – xerosis, hyperemia, burning.
Side effects are reversible and do not require discontinuation of therapy.
Contraindications
- Hypersensitivity to naftifine and benzyl alcohol (ointment) or propylene glycol (for a solution).
The drug should not be applied to the wound surface.
Pregnancy and lactation
Caution should be used Exoderil® Pregnancy and lactation (breast-feeding).
Cautions
Avoid contact with the eyes and open wounds.
Use in Pediatrics
Precautions should use the drug in children.
Overdose
No data on overdose.
Drug Interactions
There was no drug interactions drug Exoderil® with other drugs.
Conditions of supply of pharmacies
The drug is resolved to application as an agent Valium holidays.
Conditions and terms
The drug should be stored out of reach of children at or above 30 ° C. Shelf life - 5 years.
