Naphthyne

Pharmacological properties

exic is an antimycotic agent of the class of allylamines. the active component of the drug is naftifine hydrochloride. the mechanism of action of naftifin hydrochloride is the inhibition of the effect of ergosterol.

Naphthyphine is active against dermatophytes, such as trichophyton, epidermophyton and microsporum, yeast (Candida), mold (Aspergillus) and other fungi (e.g. Sporothrix schenckii). Naftifin has a fungicidal effect against dermatophytes and ampergillus, relative to yeast fungi - it exhibits a fungicidal or fungistatic effect depending on the microorganism strain.

Also, the Exik drug is characterized by antibacterial activity against gram-positive and gram-negative microorganisms that can cause secondary bacterial infections along with mycotic lesions.

In addition, the drug has powerful anti-inflammatory properties.

Pharmacokinetics Naftifine hydrochloride is rapidly absorbed and forms stable antifungal concentrations in different layers of the skin. About 4% of the dose applied to the skin is absorbed, so the systemic effect of the active substance is extremely low. Only trace amounts of naftifin are detected in blood plasma and urine. The active substance is almost completely metabolized; metabolites do not have antifungal activity and are excreted in feces and urine. T_½ - 2-4 days.

Indications

Topical treatment of fungal infections caused by naphthyphine-sensitive pathogens:

• fungal infections of the skin and skin folds;
• interdigital mycoses;
• fungal infections of the nails;
• pityriasis versicolor;
• inflammatory dermatomycosis, with or without itching.

Application

A cream or solution of cutaneous exic should be applied to the affected surface of the skin and its adjacent areas 1 r / day after thorough cleaning and drying, capturing about 1 cm of a healthy area of ​​skin from the edge of the affected area.

The duration of therapy with dermatomycosis is 2–4 weeks (if necessary, up to 8 weeks) with candidiasis - 4 weeks, with infectious lesions of the nails - up to 6 months.

In case of mycotic lesions of the nails, the drug is recommended to use 2 r / day. Before the first use, you should perform the maximum removal of the affected part of the nail with scissors or a nail file (to facilitate this procedure, on the recommendation of a doctor, the nails can be treated with a special emollient).

In order to prevent relapse, therapy should be continued for at least 2 weeks after the disappearance of the main symptoms of the disease.

Children. Data on the efficacy and safety of the drug in children are insufficient, therefore, it is not recommended to prescribe Exik to patients of this age category.

Contraindications

Hypersensitivity to naftifine or other components of the drug. the drug should not be applied to the wound surface. do not use to treat eye diseases.

Side effects

The frequency of adverse reactions is determined in accordance with the medical dictionary for meddra regulatory activity as follows: very often (≥1 / 10), often (from ≥1 / 100 to 1/10), infrequently (from ≥1 / 1000 to 1/100) , rarely (≥1 / 10,000 to 1/1000), very rarely (1/10 000), the frequency is unknown (cannot be calculated from the available data).

General disorders: the frequency is unknown - local reactions can rarely occur: dry skin, redness and burning sensation, erythema, itching, local irritation.

special instructions

The drug is used for diseases of nails and skin only externally!

The cream contains cetyl alcohol and stearyl alcohol, which can cause local skin reactions (e.g. contact dermatitis).

The cutaneous solution contains ethanol, so avoid contact with the solution in the eyes and open wounds.

The solution contains propylene glycol, which can cause skin irritation.

Use during pregnancy or lactation.Data on the use of naftifine in pregnant women are absent or limited. The results of animal studies do not indicate the presence of a direct or indirect harmful effect of the drug on reproductive function. It is possible to use the drug during pregnancy or lactation only if absolutely necessary after a thorough assessment of the benefit / risk ratio, which is determined by the doctor.

Mothers who are breastfeeding should avoid getting the cream on the skin and in the digestive tract of the baby.

The ability to influence the reaction rate when driving or working with other mechanisms. Does not affect.

Interactions

No studies of drug interactions have been performed.

Overdose

Acute overdose with topical use of naftifine was not observed.

Systemic intoxication with external use of the drug is unlikely due to the fact that a small amount of the active substance is absorbed through the skin.

If the drug is accidentally swallowed, symptomatic treatment should be initiated.

Storage conditions

Cream: at a temperature not exceeding 30 ° C. do not freeze.

cutaneous solution: at a temperature not exceeding 30 ° C. After opening the vial, store for 6 months at a temperature not exceeding 25 ° C.

Keep out of the reach of children.