Composition
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1 ml of the solution contains:
Active ingredient: Â Naftifine hydrochloride – 10 mg.
Auxiliary substances: Â propylene glycol-50 mg, ethanol (ethyl alcohol) 95% – 400 mg, purified water – up to 1.0 ml
Pharmacological action
Pharmacotherapy group
Antifungal agent
ATX code
D01AE22
Pharmacodynamics :
Naftifine is an antifungal agent for external use belonging to the class of allylamines. The mechanism of action is associated with the inhibition of squalene-23-epoxidase, which leads to a decrease in the formation of ergosterol, which is part of the cell wall of the fungus.
Active against dermatophytes such as Trichophyton Epidermophyton Microsporum mold fungi (Aspergillus spp. ) yeast fungi (Candida spp. Pityrosporum) and other fungi (e. g. Sporothrix schenckii).
Naftifine acts as a fungicide against dermatophytes and aspergillus.
With respect to yeast fungi, Naftifine exhibits fungicidal or fungistatic activity, depending on the strain of the microorganism.
It has antibacterial activity against gram-positive and gram-negative microorganisms that can cause secondary bacterial infections.
It has an anti-inflammatory effect that contributes to the rapid disappearance of symptoms of inflammation, especially itching.
Pharmacokinetics:
When applied externally, Naftifine penetrates well into the skin, creating stable antifungal concentrations in its various layers, which makes it possible to use it once a day.
Indications
-Fungal infections of the skin and skin folds (tinea corporis tinea inquinalis);
– interdigital mycoses (tinea manum tinea pedum);
– fungal infections of the nails (onychomycosis);
– candidiasis of the skin;
– multi – colored (pityriasis) lichen;
– dermatomycosis (with or without concomitant itching).
The drug Naphtoderil is effective in the treatment of mycoses affecting areas of the skin with hyperkeratosis as well as in areas of hair growth.
Use during pregnancy and lactation
The use of the drug during pregnancy and lactation is contraindicated (the safety and efficacy of Naftifine in this category of patients has not been studied).
Contraindications
-Hypersensitivity to Naftifine or other components of the drug;
– pregnancy and lactation (safety and effectiveness of use have not been established).
– application on the wound surface.
With caution:
Children’s age (limited clinical experience).
Side effects
In some cases, local reactions may occur: dry skin, skin hyperemia (redness) and burning. Side effects are reversible and do not require discontinuation of treatment.
If any of the side effects listed in the instructions are aggravated or any other side effects not listed in the instructions are noted, you should immediately inform your doctor.
Interaction
Interactions with other drugs have not been studied.
How to take, course of use and dosage
Externally.
If the skin is affected
Naphthoderyl 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.
Duration of therapy for dermatomycosis – 2-4 weeks (if necessary up to 8 weeks) for candidiasis-4 weeks.
If the nails are affected
The drug Naphthoderyl is applied 2 times a day to the affected nail. Before the first application 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 clinical symptoms disappear.
If there is no improvement after treatment, or if the symptoms worsen or new symptoms appear, you should consult your doctor. Use the drug only according to the method of use and in the doses indicated in the instructions. If necessary, please consult your doctor before using the drug.
Overdose
When using the drug in accordance with the instructions for use, overdose is unlikely.
In case of accidental ingestion, gastric lavage and symptomatic therapy are indicated.
Special instructions
Naphthoderyl is not intended for use in ophthalmology. Do not allow the drug to get into the eyes.
To achieve a therapeutic effect, a course of treatment is required.
Propylene glycol, which is part of the solution, can cause skin irritation; if side effects occur, stop using the drug and consult a doctor.
Influence on the ability to drive vehicles and mechanisms:
The drug Naphthoderyl does not adversely affect the ability to drive vehicles and perform other activities that require concentration of attention and speed of psychomotor reactions.
Form of production
Solution for external use 1%.
Storage conditions
At a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf
life is 3 years.
Do not use after the expiration date.
Active ingredient
Naftifine
Dosage form
solution for external use
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Side effects of Naftoderil solution for external use 1%, 10ml
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