Naftifin, cream 1% 15 g

Pharmacodynamics

Naftifin is an antifungal agent for external use, belonging to the class of allilamines. The mechanism of action is associated with inhibition of squalene-2,3-epoxidase, which leads to reduction of formation of ergosterol which is a part of the cell wall of the fungus.

It is active against dermatophytes such as Trichophyton, Epidermophyton, Microsporum, molds {Aspergillus spp.), yeast fungi {Candida spp., Pityrosporum) and other fungi (such as Sporothrix schenckii). Against dermatophytes and aspergillus naphthifin acts fungicidal.

In yeast fungi the drug has fungicidal or fungistatic activity depending on the strain of the microorganism. It has antibacterial activity against Gram-positive and Gram-negative microorganisms which may cause secondary bacterial infections. It has anti-inflammatory action, which contributes to the rapid disappearance of symptoms of inflammation, especially itching.

Pharmacokinetics

When applied externally, it penetrates the skin well, creating sustained antifungal concentrations in its various layers. After application on the skin less than 6% of naphthifin is absorbed systemically. Absorbed amount is partially metabolized and excreted by kidneys and intestine. Half-life of naphthifin is 2-3 days.

Indications

Fungal infections of the skin and skin folds (tinea corporis, tinea inquinalis);
interdigital mycoses (tinea manum, tinea pedum);
fungal nail infections (onychomycosis);
skin candidiasis;
versicolor (pityriasis versicolor);
ringworm (with or without accompanying itching).

Pharmacological effect

Pharmacodynamics

Naftifine is an antifungal agent for external use, belonging to the class of allylamines. 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.

Active against dermatophytes such as Trichophyton, Epidermophyton, Microsporum, molds {Aspergillus spp.), yeasts {Candida spp., Pityrosporum) and other fungi (for example, Sporothrix schenckii). Naftifine has a fungicidal effect against dermatophytes and aspergillus.

Against yeast fungi, the drug 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 symptoms of inflammation, especially itching.

Pharmacokinetics

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

Special instructions

The drug Naftifin is not intended for use in ophthalmology. The drug should not come into contact with the eyes.

To achieve a therapeutic effect, a course of treatment is required.

The effect of the drug on the ability to drive vehicles and machinery

The drug Naftifin does not have a negative effect on the ability to drive vehicles and perform other activities that require concentration and speed of psychomotor reactions.

Active ingredient

Naftifin

Composition

Active ingredient:

naftifine hydrochloride – 10 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,

stearic alcohol – 40.0 mg,

polysorbate 60-61.0 mg,

isopropyl myristate – 80.0 mg,

purified water – up to 1000 mg.

Contraindications

Hypersensitivity to naftifine, benzyl alcohol or other components of the drug. Pregnancy and breastfeeding (safety and effectiveness have not been established).

With caution

Children’s age (experience of clinical use is limited).
Use during pregnancy and breastfeeding
The use of the drug during pregnancy and breastfeeding is contraindicated (the safety and effectiveness of naftifine in this category of patients has not been studied).

Side Effects

In some cases, local reactions may be observed: dry skin, skin hyperemia (redness) and burning. Side effects are reversible and do not require discontinuation of treatment. If any of the side effects indicated in the instructions worsen, or any other side effects not listed in the instructions are noted, you should immediately inform your doctor.

Interaction

Interaction with other drugs has not been studied.

Overdose

When using the drug in accordance with the instructions for use, an overdose is unlikely. In case of accidental ingestion, gastric lavage and symptomatic therapy are indicated.

Storage conditions

At a temperature not exceeding 30 °C. Keep out of the reach of children.

Shelf life

5 years.

Manufacturer

Tula pharmaceutical factory, Russia