Exoderil cream d / nar. approx. 1% 15g # 1
Category
Antifungal
Scope of the drug
General
Release form
Cream
Manufacturer country
Austria
Way of introduction
On the skin
Release form, composition and packaging
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Cream for external use is white, homogeneous or slightly grainy, shiny, with a weak characteristic odor.
1 g
naftifine hydrochloride 10.0 mg
sodium hydroxide - 1.2 mg, benzyl alcohol - 10.0 mg, sorbitan stearate - 19.0 mg, cetyl palmitate - 20.0 mg, cetyl alcohol - 40.0 mg, stearyl alcohol - 40.0 mg, polysorbate 60 - 61.0 mg, isopropyl myristate - 80.0 mg, purified water - 718.8 mg.
15 g - aluminum tubes (1) - cardboard packs.
30 g - aluminum tubes (1) - cardboard packs.
pharmachologic effect
Antifungal drug for external use from the group of allylamines. The mechanism of action is associated with inhibition of the synthesis of squalene-2,3-epoxidase, which leads to a decrease in the formation of ergosterol, which is part of the cell wall of the fungus. The drug is active against dermatophytes Trichophyton, Epidermophyton, Microsporum, yeasts (Candida spp., Pityrosporum), molds (Aspergillus spp.) And other fungi (Sporotrix schenckii). In relation to dermatophytes and aspergillus, naftifine has a fungicidal effect. In relation to yeast fungi, it shows fungicidal or fungistatic activity, depending on the strain of the microorganism. The drug has an antibacterial effect against gram-positive and gram-negative microorganisms, which can cause secondary bacterial infections. The drug has an anti-inflammatory effect,which contributes to the rapid disappearance of symptoms of inflammation, especially itching.
Pharmacokinetics
Absorption and distribution When applied externally, naftifine penetrates well into various layers of the skin, reaching concentrations sufficient for the implementation of the antifungal effect.
After application of the cream to the skin, less than 6% of the active substance is systemically absorbed.
Metabolism and excretion The absorbed amount is partially metabolized and excreted by the kidneys and through the intestines.
T1 / 2 is 2-3 days.
Indications for use
- fungal infections of the skin and skin folds (tinea corporis, tinea inguinalis), incl.
interdigital mycoses (tinea manum, tinea pedum)
- fungal infections of the nails (onychomycosis)
- candidiasis of the skin
- pityriasis versicolor
- dermatomycosis (with or without accompanying itching).
Contraindications for use
- pregnancy (safety and effectiveness not determined)
- lactation period (safety and effectiveness have not been determined)
- hypersensitivity to naftifine, benzyl alcohol or other components of the drug.
With caution: childhood (clinical experience is limited).
Dosage regimen
ExoderilВ® should be applied to the affected skin surface and adjacent areas 1 time / day, after thorough cleaning and drying, capturing approximately 1 cm of healthy skin along the edges of the affected area.
The duration of treatment for dermatomycosis is 2-4 weeks (if necessary - up to 8 weeks), with candidiasis - 4 weeks.
In case of onychomycosis, before the first application of the cream, it is necessary to remove the affected part of the nail as much as possible with scissors and a nail file.
The drug should be used 2 times / day, the duration of treatment is up to 6 months.
To prevent recurrence of infection, therapy should be carried out for at least 2 weeks after the disappearance of clinical symptoms.
Overdose
No cases of overdose have been reported.
Side effect
Local reactions: in some cases - dry skin, flushing, burning.
Side effects are reversible and do not require discontinuation of therapy.
Drug interactions
There was no drug interaction of the drug ExoderilВ® with other drugs.
Application during pregnancy and lactation
The use of ExoderilВ® during pregnancy and lactation is contraindicated (safety and efficacy have not been determined).
Special instructions The drug is not intended for use in ophthalmology.
Should be avoided
Name ENG
EXODERIL
Clinical and pharmacological group
Antifungal drug for external use
ATX code
Naftifine
Structure
1 g of cream contains: active substance: naftifine hydrochloride - 10.0 mg.
Excipients: sodium hydroxide - 1.2 mg, benzyl alcohol - 10.0 mg, sorbitan stearate - 19.0 mg, cetyl palmitate - 20.0 mg, cetyl alcohol - 40.0 mg, stearyl alcohol - 40.0 mg, polysorbate 60 - 61.0 mg, isopropyl myristate - 80.0 mg, purified water - 718.8 mg.
Indications
fungal infections of the skin and skin folds (tinea corporis, tinea inguinalis), incl.
interdigital mycoses (tinea manum, tinea pedum)
- fungal infections of the nails (onychomycosis)
- candidiasis of the skin
- pityriasis versicolor
- dermatomycosis (with or without accompanying itching).
Storage conditions and periods
The drug should be stored out of the reach of children at a temperature not exceeding 3C.
The shelf life is 3 years.
Contraindications
Hypersensitivity to naftifine, benzyl alcohol or other components of the drug
pregnancy and lactation (safety and efficacy have not been determined).
Carefully
Children's age (clinical experience is limited).
INN / Active ingredient
naftifine hydrochloride
Specifications
Category
Antifungal
Scope of the drug
General
Release form
Cream
Manufacturer country
Austria
Way of introduction
On the skin
Vacation conditions
Without recipe
Brand name
Sandoz
The amount of the dosage form in the primary package
15 g
Primary packaging type
Tuba
Type of consumer packaging
Pack of cardboard
Pharmaco-therapeutic group
Antifungal agent
Anatomical and therapeutic characteristics
D01AE22 Naftifine
Dosage form
Cream for external use
Expiration date in days
1093
Package weight, g
25
Mode of application
:
In case of skin lesions, Exoderil is applied once a day to the affected skin surface and adjacent areas (approximately 1 cm of healthy skin along the edges of the affected area) after thorough cleaning and drying.
The duration of therapy for dermatomycosis is 2-4 weeks (if necessary - up to 8 weeks), with candidiasis - 4 weeks.
< br> In case of nail damage Exoderil is applied 2 times a day to the affected nail.
Before the first use of the drug, the affected part of the nail is removed as much as possible with scissors or a nail file.
The duration of therapy for onychomycosis is up to 6 months.
To prevent relapse, treatment should be continued for at least 2 weeks after the disappearance of clinical symptoms.
Information on technical characteristics, delivery set, country of manufacture