Exik

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INSTRUCTIONS FOR USE

Ingredients: active substance: naftifine hydrochloride; 1 g of cream contains naftifine hydrochloride (in terms of 100% dry matter) 10 mg; Excipients: benzyl alcohol, sorbitan stearate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, cetyl palmitate, sodium hydroxide, purified water.

Dosage form: Cream.

Main physical and chemical properties: white cream with a faint specific odor.

Pharmacotherapeutic group: Antifungal agents for use in dermatology. ATX code D01A E22.

Pharmacological properties

Pharmacodynamics: Exic is an antifungal agent of the allylamine class. Its active ingredient is naftifine hydrochloride, the mechanism of action of which is related to the inhibition of ergosterol. Naftifine is active against dermatophytes such as trichophyton, epidermophyton and microsporum, yeast (Candida), mold (Aspergillus) and other fungi (eg Sporothrix schenckii). For dermatophytes and aspergillus, naftifine has a fungicidal effect in vitro, and for yeast fungi, it has fungicidal or fungistatic activity, depending on the strain of the microorganism. Exik also has antibacterial activity against gram-positive and gram-negative microorganisms, which can cause secondary bacterial infections along with fungal infections. In addition, the drug has powerful anti-inflammatory properties. Pharmacokinetics. Naftifine hydrochloride is rapidly absorbed and forms stable antifungal concentrations in various layers of the skin. Approximately 4% of the dose applied to the skin is absorbed, so the systemic effect of the active substance is very low. Only trace amounts of naftifine are found in blood and urine plasma. The active substance is almost completely metabolized; metabolites have no antifungal activity and are excreted in the feces and urine. The half-life is 2-4 days.

Clinical characteristics.

Indication: Local treatment of fungal infections caused by naftifine-sensitive pathogens:

  • fungal infections of the skin and skin folds;
  • interdigital mycoses;
  • fungal nail infections;
  • skin candidiasis;
  • herpes zoster;
  • inflammatory dermatomycoses with or without itching.

Contraindications: Hypersensitivity to naftifine or to other components of the drug. The drug should not be applied to the wound surface. Do not use for eye treatment.

Interaction with other medicinal products and other forms of interaction: Interaction studies have not been performed.

Features of application: The drug should be used for nail and skin diseases only externally! It contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (eg contact dermatitis).

Use during pregnancy or breast-feeding: There are no or limited data from the use of naftifine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive function. The drug can be used during pregnancy or breastfeeding only if absolutely necessary after careful evaluation of the benefit / risk ratio determined by your doctor. Breastfeeding mothers should prevent the drug from getting on the skin and digestive tract of the baby.

Ability to influence the speed of reaction when driving a car or other machinery: Does not affect.

Dosing and Administration: Exic Cream should be applied to the affected area of ??skin and adjacent areas once a day after thorough cleansing and drying, capturing approximately 1 cm of healthy skin at the edges of the affected area. Duration of treatment: for dermatomycoses - 2-4 weeks (if necessary - up to 8 weeks); with candidiasis - 4 weeks; for nail infections - up to 6 months. At fungal diseases of nails the drug is recommended to be applied 2 times a day. Before the first application, the affected part of the nail should be removed as much as possible with scissors or a nail file (to facilitate this procedure, the nails can be treated with a special emollient on the advice of a doctor). To prevent recurrence, treatment with the drug should be continued for at least 2 weeks after the disappearance of the main symptoms of the disease.

Children: There are insufficient data on the efficacy and safety of the drug in children, so it is not recommended to prescribe Exic to patients in this age group.

Overdose: Acute overdose with topical application of naftifine was not observed. Systemic intoxication with external use of the drug is unlikely due to the fact that a small amount of active substance is absorbed through the skin. In case of accidental ingestion of the drug should begin symptomatic treatment.

Adverse reactions: Frequency of adverse reactions is defined as follows: very common (1/10), common (1/100, <1/10), uncommon (1/1000, <1/100), rare (1 / 10000, <1/1000), very rare (<1/10000), frequency unknown (cannot be estimated from the available data). General disorders: frequency not known - in isolated cases, local reactions may occur: dry skin, redness and burning sensation, erythema, itching, local irritation.

Shelf life: 3 years.

torage conditions: Store at a temperature not exceeding 30 C. Do not freeze. Keep out of reach of children.

Packing: 15 g in a tube; 1 tube per pack.

Vacation category: Without a prescription.