Termicon, spray 1%, 15ml

Composition

Composition for one cylinder (bottle).

Active ingredient:  

• terbinafine hydrochloride – 0.15 g or 0.30 g;

Auxiliary substances:

• 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

Pharmacological action

Pharmacotherapy group.

Antifungal agent

ATX code D01AE15.

Pharmacological properties.

Antifungal drug for topical application, which has a wide spectrum of antifungal activity. In low concentrations, terbinafine has a fungicidal effect against dermatophytes (Trychophyton rubrum, T. mentagrophytes, T. verrucosum, T. violaceum, T. tonsurans, Microsporum canis, Epidermophyton floccosum), molds, certain dimorphic (Pityrosporum orbiculare) and yeast fungi (mainly Candida albicans). Activity against yeast fungi, depending on their type, 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 squalene accumulation, which causes fungal cell death. The action of terbinafine is carried out by inhibiting the squalene oxidase enzyme located on the cell membrane of the fungus.

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

Pharmacokinetics. When applied locally, absorption is less than 5%, has a slight systemic effect.

Indications

Prevention and treatment of fungal skin infections, including:

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

– inguinal epidermophytosis,

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

Multicolored lichen caused by dimorphic fungi.

Diaper rash caused by molds.

Use during pregnancy and lactation

No teratogenic properties of terbinafine were found in experimental studies. To date, no malformations have been reported with the use of Thermicon®. However, since the clinical experience of using Thermicon® in pregnant women is very limited, it should only be used for strict indications.

Terbinafine is excreted in breast milk. However, if a nursing mother uses Thermicon® spray, a small amount of the Active ingredient is absorbed through the skin, so adverse effects on the baby are unlikely.

Contraindications

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

With caution: hepatic and / or renal insufficiency, alcoholism, suppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive vascular diseases of the extremities.

Side effects

Redness, itching or burning sensation may appear in the areas where the drug is applied. Allergic reactions.

How to take, course of use and dosage

Externally.

Thermicon spray for adults can be used 1 or 2 times a day, depending on the indications.

Before using the product, thoroughly clean and dry the affected areas of the skin. During use, the balloon (bottle) should be held vertically. To ensure uniform atomization of the contents, first make several short-term taps on the spray nozzle.

The drug is applied to the affected areas of the skin and adjacent areas of healthy skin in sufficient quantities to moisturize them.

Duration of treatment and frequency of use of the drug:  

• dermatomycosis of the trunk, legs: 1 week,1 time a day;
• dermatomycosis of the feet: 1 week,1 time a day;
• multicolored lichen: 1 week,2 times a day;
• inguinal epidermophytosis, diaper rash caused by mold fungi: 1 week,1 time a day.

The dosage regimen of Thermicon spray in the elderly does not differ from the one described above.

Experience of using Thermicon spray in children under 12 years of age is limited, and therefore the use of the drug in children is not recommended.

Overdose

No overdose cases have been reported. If Termicon® spray is accidentally taken orally, you can expect to develop the same side effects as with an overdose of Termicon®tablets(headache, nausea, epigastric pain and dizziness). You should also take into account the content of ethyl alcohol in the preparation.

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

Special instructions

A decrease in the severity of clinical manifestations is usually noted in the first days of treatment. In case of irregular treatment or its premature termination, there is a risk of recurrence of infection. If there are no signs of improvement after a week of treatment, the diagnosis should be verified.

Caution should be exercised when applying Thermicon® spray to damaged areas of the skin, as alcohol can cause irritation.

Thermicon® spray is intended for external use only. Avoid getting it in your eyes, as it can cause irritation. If the drug accidentally gets into the eyes, they should be immediately rinsed with running water, and in case of persistent irritation, consult a doctor.

If the drug was accidentally introduced into the respiratory tract during inhalation, then, in case of any symptoms and especially if they persist, it is necessary to consult a doctor.

If allergic reactions develop, the drug should be discontinued.

Influence on the ability to drive vehicles and mechanisms

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

Form of production

Spray for external use

Storage conditions

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

Shelf

life is 3 years.

Active ingredient

Terbinafine

Dosage form

spray for external use