Mikoderil cream for external use, 1%, tube 15 g, No. 1
Category
Antifungal
Scope of the drug
Leather
Release form
Cream
Manufacturer country
Russia
Package quantity, pcs
one
Release form
Cream
Packaging
Tube 15 g
pharmachologic effect
Mikoderil - antifungal agents for external use, belonging to the class of allylamines.
Their active ingredient is naftifine.
The mechanism of action is associated with inhibition 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.
Naftifine, affecting squale epoxidase, does not affect the cytochrome P-450 system.
Naftifine is active against dermatophytes such as Trichophyton, Epidermophyton, Microsporum, yeast and yeast-like fungi (Candida spp., Pityrosporum), molds (Aspergillus) and other fungi (such as Sporothrix schenckii).
In relation to dermatophytes and aspergillus, naftifine acts fungicidal.
In relation to yeast fungi, the drug exhibits fungicidal or fungistatic activity, depending on the strain of the microorganism.
Naftifine has antibacterial activity against gram-positive and gram-negative microorganisms that cause secondary bacterial infections.
Naftifine has an anti-inflammatory effect that promotes the rapid disappearance of symptoms of inflammation, especially itching.
Pharmacokinetics
When applied externally, it penetrates well into various layers of the skin, creating stable antifungal concentrations in its various layers.
After application to the skin, less than 6% of naftifine is absorbed systemically.
The absorbed amount is partially metabolized and excreted by the kidneys and through the intestines.
T1 / 2 of the drug is 2-3 days.
Indications
fungal infections of smooth skin and skin folds (tinea corporis, tinea inquinalis)
interdigital mycoses (tinea manum, tinea pedum)
fungal infections of the nails (onychomycosis)
candidiasis of the skin
pityriasis versicolor
dermatomycosis (with or without itching).
Contraindications
Hypersensitivity to naftifine, benzyl alcohol or other components of the drug
pregnancy and lactation (the safety and efficacy of the drug in this category of patients has not been studied).
Application during pregnancy and lactation
The use of the drug during pregnancy and lactation is not recommended (the safety and efficacy of the drug in this category of patients has not been studied).
special instructions
Course treatment is required.
The drug Mikoderil is not intended for use in ophthalmology.
Avoid contact with the eyes and open wounds.
Use in pediatrics: the drug should be used with caution in children under 18 years of age (the effectiveness and safety of the drug has not been proven).
Structure
1 g of cream contains:
Active ingredient: naftifine hydrochloride 10 mg
Excipients: sodium hydroxide - 1.2 mg
benzyl alcohol - 10 mg
sorbitan stearate - 19 mg
cetyl palmitate - 20 mg
polysorbate 60 - 61 mg
cetostearyl alcohol - 80 mg
isopropyl myristate - 80 mg
purified water - up to 1000 mg
Method of administration and dosage
Outwardly.
In case of skin lesions, Mikoderil is applied once a day to the affected skin surface and adjacent areas, after thorough cleaning and drying (capturing approximately 1 cm of healthy skin along the edges of the affected area).
3 Duration of therapy for dermatomycosis - 2-4 weeks (if necessary - up to 8 weeks), with candidiasis - 4 weeks.
In case of nail damage, Mikoderil 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.
Side effects
In some cases, local reactions can be observed: dry skin, skin flushing and burning.
Side effects are reversible and do not require treatment withdrawal.
If any of the side effects indicated in the instructions are aggravated, or are noted
Name ENG
MYCODERIL
Clinical and pharmacological group
Antifungal drug for external use
ATX code
Naftifine
Dosage
1% x 15g
Structure
1 g of cream contains: Active ingredient: naftifine hydrochloride 10 mg
Excipients: sodium hydroxide - 1.2 mg
benzyl alcohol - 10 mg
sorbitan stearate - 19 mg
cetyl palmitate - 20 mg
polysorbate 60 - 61 mg
cetostearyl alcohol - 80 mg
isopropyl myristate - 80 mg
purified water - up to 1000 mg
Indications
fungal infections of smooth skin and skin folds (tinea corporis, tinea inquinalis)
interdigital mycoses (tinea manum, tinea pedum)
fungal infections of the nails (onychomycosis)
candidiasis of the skin
pityriasis versicolor
dermatomycosis (with or without itching).
INN / Active ingredient
naftifine
Contraindications
hypersensitivity to naftifine, benzyl alcohol or other components of the drug
pregnancy and lactation (the safety and efficacy of the drug in this category of patients has not been studied).
With caution: childhood (clinical experience is limited).
Storage conditions and periods
At a temperature not exceeding 25 ° C.
Specifications
Category
Antifungal
Scope of the drug
Leather
Release form
Cream
Manufacturer country
Russia
Package quantity, pcs
one
Way of introduction
On the skin
Vacation conditions
Without recipe
Brand name
OTCPharm
The amount of the dosage form in the primary package
15 g
Primary packaging type
Tuba
Type of consumer packaging
Pack of cardboard
Dosage form
Cream for external use
Dosage (volume) of the substance in the preparation
10 mg
Expiration date in days
730
Package weight, g
twenty
Mode of application
:
Outwardly.
In case of skin lesions, Mikoderil is applied once a day to the affected skin surface and adjacent areas, after thorough cleaning and drying (capturing approximately 1 cm of healthy skin along the edges of the affected area).
3 Duration of therapy for dermatomycosis - 2-4 weeks (if necessary - up to 8 weeks), with candidiasis - 4 weeks. < br> < br> In case of nail damage, Mikoderil 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