Naftifine cream for external use 1%, 15g

Composition

Active ingredient:  

Naftifine hydrochloride – 10 mg.

Auxiliary substances:  

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

Pharmacological action

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, molds {Aspergillus spp. ), yeast fungi {Candida spp., Pityrosporum) and other fungi (for example, Sporothrix schenckii). Naftifine acts as a fungicide against dermatophytes and aspergillus.

In relation to 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 inflammatory symptoms, especially itching.

Pharmacokinetics

When applied 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 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).

Contraindications

Hypersensitivity to naphthifine, benzyl alcohol or other components of the drug. Pregnancy and lactation (safety and efficacy have not been established).

With caution

• Children’s age (limited clinical experience).
• 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).

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

The drug Naftifine is applied 1 time a day to the affected skin surface and adjacent areas (approximately 1 cm of a healthy skin area along the edges of the affected area) after thorough cleaning and drying.

The duration of therapy for dermatitis and goats is 2-4 weeks (up to 8 weeks if necessary), for candidiasis – 4 weeks.

If the nails are affected

The drug Naftifine 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 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 medicine.

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

Naftifine 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.

Effect of the drug on the ability to drive vehicles, mechanisms

The drug Naftifine does not adversely affect the ability to drive vehicles and perform other activities that require concentration of attention and speed of psychomotor reactions.

Storage conditions

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

Shelf

life is 5 years.

Active ingredient

Naftifine

Dosage form

cream