Termicon, spray 1% 15 ml

Pharmacotherapeutic group.

Antifungal agent

ATC code D01AE15.

Pharmacological properties.

A topical antifungal agent with a broad spectrum of antifungal activity. At low concentrations terbinafine has fungicidal effect against dermatophytes (Trychophyton rubrum, T. mentagrophytes, T. verrucosum, T. violaceum, T. tonsurans, Microsporum canis, Epidermophyton floccosum), molds, certain dimorphs (Pityrosporum orbiculare) and yeasts (mainly Сandida albicans). Activity against yeast fungi, depending on their species, can be fungicidal or fungistatic.

Terbinafine specifically alters the early stage of sterol biosynthesis that occurs in fungi. This leads to ergosterol deficiency and intracellular accumulation of squalene, which causes cell death of the fungus. The action of terbinafine is carried out by inhibiting the enzyme squaleneepoxidase located on the cell membrane of the fungus.

Terbinafine has no effect on the cytochrome P450 system in humans and therefore on the metabolism of hormones or other drugs.

Pharmacokinetics. When applied topically, absorption is less than 5%, has little systemic effect.

Indications

Prevention and treatment of fungal skin infections, including:

– mycoses of the feet (“fungus” of the foot),

– inguinal epidermophytosis,

– fungal lesions of smooth skin of the body caused by dermatophytes (trichophytosis, microsporia, epidermophytosis, rubrophytosis).

The variegated shingles caused by dimorphic fungi.

Heel rash caused by mold fungi.

Active ingredient

Terbinafine

Composition

Composition per cylinder (vial).

The active ingredient:

• terbinafine hydrochloride – 0.15 g or 0.30 g;

Excipients:

• ethanol (rectified ethyl alcohol) – 5.625 g or 11.25 g,
• propylene glycol – 0,30 g or 0,60 g,
• poloxamer – 0,15 g or 0,30 g,
• purified water – 8,775 g or 17,55 g.

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How to take, the dosage

Externally.

Termicon Spray for adults can be used 1 or 2 times a day, depending on the indication.

Before using the drug, thoroughly clean and dry the affected areas of the skin.
During use the bottle (bottle) should be held vertically.
Several short presses on the spray nozzle prior to use to ensure even dispersion of the content.

The product is applied to the affected areas of skin and adjacent healthy skin in sufficient amounts to hydrate them.

Treatment duration and number of applications:

• dermatomycosis of the trunk, tibia: 1 week, 1 time per day;
• dermatomycosis of the feet: 1 week, once a day;
• pain and lichen: 1 week, 2 times a day;
• dandruff epidermophytosis, diaper rash caused by mold fungi: 1 week, once a day.

The dosing regimen of Termicon Spray in the elderly is the same as described above.

The use of Termicon Spray in children under 12 years of age is limited, and therefore the use in children is not recommended.

Special Instructions

A reduction in clinical manifestations is usually seen in the first days of treatment. If treatment is irregular or discontinued prematurely, there is a risk of recurrence of the infection. If there is no sign of improvement after a week of treatment, the diagnosis must be verified.

Please use caution when applying Termicon Spray^® to damaged skin, as the alcohol may cause irritation.

Termicon^® Spray is for external use only. Contact with the eyes should be avoided as it may cause irritation. If the drug accidentally gets into the eyes, they should be rinsed immediately with running water, and if persistent irritation develops, a doctor should be consulted.

If the drug was accidentally injected into the respiratory tract through inhalation, a physician should be consulted if any symptoms occur, and especially if they persist.

If allergic reactions develop, the drug should be discontinued.

Influence on ability to drive vehicles, operating machinery

There are no data on the effect of the drug on the ability to drive vehicles or operate other mechanisms.

Contraindications

Hypersensitivity to terbinafine or to the excipients included in the drug, children under 18 years of age.

With caution: hepatic and/or renal failure, alcoholism, suppression of medullary hematopoiesis, tumors, metabolic diseases, vascular occlusive disease of the extremities.

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Side effects

Redness, itching or burning sensation may occur where the drug is applied. Allergic reactions.

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Overdose

No cases of overdose of the drug have been reported. If Termicon^® Spray is accidentally taken orally, the same side effects as in case of overdose of Termicon^® tablets can be expected (headache, nausea, epigastric pain and dizziness). The content of ethyl alcohol in the drug should also be taken into account.

Treatment: activated charcoal, if necessary – symptomatic supportive therapy.

Pregnancy use

Terbinafine has not been shown to have teratogenic properties in experimental studies. To date, no malformations have been reported with Termicon^®. However, since clinical experience with Termicon^® in pregnant women is very limited, it should only be used when strictly indicated.

Terbinafine is excreted with the breast milk. However, when a nursing mother uses Termicon^® spray, a small amount of the active substance is absorbed through the skin, so adverse effects on the baby are unlikely.

Similarities

Terbinafin-Teva, Exifin, Lamisil, Fungoterbin, Lamisil Dermgel, Terbisil, Binafin, Termicon, Exiter, Terbinafin, Terbix