Naftoderil solution for external use 1%, 20ml

Composition

Composition per 100 g:

Active ingredient:

naphthifine hydrochloride – 1.00 g.

Auxiliary substances:

cetostearyl alcohol-8.00 g;

isopropyl myristate-8.00 g;

polysorbate-60-6.10 g;

cetyl palmitate-2.00 g;

sorbitan stearate-1.90 g;

benzyl alcohol-1.00 g;

sodium hydroxide-0.12 g;

purified water-up to 100.00 g.

Pharmacological action

Pharmacotherapeutic group: Antifungal MEDIATX: D. 01. A. E. 22 Naftifine 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-2,3-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 (for example, 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, which contributes to the rapid disappearance of inflammatory symptoms, especially itching.

Pharmacokinetics

When applied externally, Naftifine penetrates well into the skin, creating stable antifungal concentrations in its various layers. After application to the skin, less than 6% of Naftifine is absorbed by the system. The absorbed amount is partially metabolized and excreted by the kidneys and through the intestines. The half-life of Naftifine is 2-3 days.

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 Naphthoderyl is effective in the treatment of mycoses affecting areas of the skin with hyperkeratosis, as well as in areas of hair growth.

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, hyperemia of the skin (redness) and burning. Side effects are reversible and do not require discontinuation of treatment.

If any of the side effects listed in the instructions get worse, or any other side effects that are 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.

The duration of therapy for dermatomycosis is 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.

Description

Homogeneous cream of white or almost white color with a faint characteristic smell.

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

Cream for external use 1%.15,30 g in aluminum tubes. One tube together with the instructions for use is placed in a cardboard package (pack). It is allowed to complete 2 or 3 cardboard packages (bundles) in a group package (transport container).

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