TERMYKON (Spray for external use)

Active material: Terʙinafin
When ATH: D01AE15
CCF: Antifungal agents for external use
ICD-10 codes (testimony): B35.0, B35.2, B35.3, B35.4, B35.6, B36.0, B37.2
When CSF: 08.02.02
Manufacturer: OAO Pharmstandard-Leksredstva (Russia)

Pharmaceutical form, composition and packaging

◊ Spray for external use 1% in the form of a transparent, a colorless or pale yellow liquid with a characteristic odor of ethyl alcohol.

Excipients: ethanol rectified, propylene glycol, poloxamer (proksanol 268), Purified water.

30 g – vials made of polypropylene (1) with a metering pump, nozzle and protective cap – packs cardboard.

Pharmacological action

Antifungal agent, allilamin. It has a wide range of antifungal activity.

It is active against dermatofitov: Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Trichophyton verrucosum, Trichophyton violet, Microspores dog, Epidermophyton floccosum. At low concentrations it has a fungicidal effect on dermatophyte, molds (incl. Aspergillus, Cladosporium, Scopulariopsis brevicaulis) and certain dimorphic fungi. In yeast fungi of the genus Candida (especially Candida albicans) and filamentous forms, depending on the type of, the drug has fungicidal or fungistatic.

Termykon^® violates the early stage of the biosynthesis of the main component of the fungus cell membrane ergosterol by inhibiting the enzyme squalene epoxidase. This leads to a deficiency of ergosterol and to an intracellular accumulation of squalene, causing cell death fungus. Step terbinafine accomplished by inhibition of the enzyme squalene epoxidase, located on the cell membrane of the fungus.

Pharmacokinetics

When applied topically absorbed less spray 5% dose, therefore the systemic exposure of the drug minimal.

Testimony

- Prevention and treatment of fungal infections of the skin, incl. foot mycoses, jock itch (moth leg), fungal infections of the skin smooth body (moth body), caused by dermatophytes such as the Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Trichophyton verrucosum, Trichophyton violet, Microsporum canis и Epidermophyton floccosum;

- Multi-colored shingles, caused by Pityrosporum orbiculare (Malassezia furfur).

Dosage regimen

The duration of treatment and dosage regimen is established individually and depends on the location and severity of the disease.

Topically administered drug adult 1-2 times / day, depending on the evidence. Before applying the medication should be clean and dry affected areas. The drug is sprayed onto the affected skin and surrounding areas in the amount of, sufficient for their moisturizing, and, Besides, is applied to the adjacent intact skin.

The dosage regimen for elderly patients same, for younger adults.

Side effect

Local reactions: perhaps – redness, itching or burning.

There are allergic reactions.

Contraindications

- Hypersensitivity to the drug.

FROM caution use in patients with renal and / or hepatic insufficiency, alcoholism, suppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive vascular diseases of extremities, children under the age of 12 years.

Pregnancy and lactation

Termykon^® It should be used under strict indications and in case, if the expected benefit to the mother outweighs the potential risk to the fetus.

In the case of nursing mother Termikona^® in spray form for external application through the skin is absorbed a small quantity of active substance, so the adverse effects on the baby are unlikely.

IN experimental studies teratogenic effects of terbinafine is not revealed. So far no reports of any malformations in the application of terbinafine.

Cautions

It should be taken into account, that the irregular use or early termination of the treatment increases the risk of relapse.

Duration of treatment may be determined by the presence of comorbidities, the state of the nails in the beginning of treatment.

If after 1 week treatment Termikonom^® no improvement in the state, must re-determine the causative agent and its sensitivity to the drug.

Special care should be prescribed to patients with psoriasis, because in very rare cases can cause psoriasis terbinafine flash.

When drug treatment should follow the general rules of hygiene to prevent the possibility of re-infection through underwear and footwear. During (through 2 Sun.) and at the end of treatment should be performed antifungal treatment of footwear, socks and stockings.

Termykon^® in the form of a spray for topical use intended for external use only. Avoid contact with the eyes, because it can cause irritation. In case of accidental contact with the eye should be rinsed with running water, and in the case of persistent irritation of the patient should consult a doctor. In case of accidental contact with the drug in the airways in case of any symptoms, especially when they are stored, the patient should also consult a doctor. Caution must be exercised when applying Termikona^® on damaged skin, because alcohol, included in its composition, may irritate.

With the development of allergic reactions the drug should be discontinued.

Use in Pediatrics

Previous applications Termikona^® in spray form at children aged 12 years limited.

Effects on ability to drive vehicles and management mechanisms

Terbinafine does not influence the ability to drive vehicles and work performance, require high concentration and speed of psychomotor reactions.

Overdose

No cases of overdose Termikona^® in spray form for external application is not reported. If you accidentally taking the drug orally, We should expect the same side effects, as well as at the reception Termikona^® in the form of tablets (nausea, vomiting, Pain in the lower abdomen and epigastric, dizziness). It should also take into account the content of ethanol in the formulation.

Treatment: Activated carbon, in case of need – Symptomatic supportive therapy.

Drug Interactions

Currently, drug interactions Termikona^® in spray form for external application is not known.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug should be stored out of reach of children at or above 30 ° C; Do not freeze. Shelf life – 2 year.