TERMYKON (Cream for external application)

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: Pharmstandard-Phytopharm-NN LLC (Russia)

Pharmaceutical form, composition and packaging

Cream for external application 1% white, uniform, with low specific smell.

1 g
terbinafine hydrochloride10 mg

Excipients: benzyl alcohol, tsetylpalmytat, Sodium hydroxide, sorbitan stearate, stearyl alcohol, cetyl alcohol, polysorbate 60, isopropyl myristate, Purified water.

15 g – aluminum tuba (1) – packs cardboard.

 

Pharmacological action

Antifungal drug for topical use. 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. In small concentrations, in addition to dermatophytes, terbinafine has fungicidal action against mold, yeast (mostly Candida albicans) and certain dimorphic fungi (Pityrospomm orbiculare). Activity against yeast, depending on the species, It may be fungicidal or fungistatic.

Terbinafine specific changes the early stage of the biosynthesis of sterols, what is happening in mushrooms. This leads to a deficiency of ergosterol and 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.

Termykon® no effect on cytochrome P450 isoenzymes of human and, respectively, metabolism of hormones or other drugs.

 

Pharmacokinetics

When applied topically absorption – less 5%, It has little systemic effects.

 

Testimony

- Prevention and treatment of fungal infections of the skin, in t. no. foot mycoses (foot moth), jock itch (moth leg), fungal infections of the skin smooth body (moth body), caused by dermatophytes;

- Yeast infections of the skin (mainly caused by Candida albicans), in particular, chafing;

- Multi-colored shingles (Pityriasis versicolor), caused by Pityrosporum orbiculare.

 

Dosage regimen

Termykon® appointed cream topically adults and children over 12 years.

Before applying the cream should be clean and dry affected areas. The cream is applied 1-2 times / day a thin layer to the affected skin and surrounding areas, gently rub.

When infections, accompanied intertrigo (under the breasts, interdigital spaces, between the buttocks, groin), place applying the cream you can cover the gauze, especially at night.

The average duration of treatment in ringworm of the body, goleneй, stop – 1 times / day for 1 of the week; at candidiasis skin – 1-2 times / day for 1-2 weeks; at pityriasis versicolor – 1-2 times / day for 2 weeks.

Reducing the severity of the clinical manifestations are usually noted in the first days of treatment. If irregular or premature treatment termination there is a risk of renewed infection. When, if in 1-2 weeks of treatment were observed signs of improvement, should conduct a verification of the diagnosis.

The dosage regimen for the drug elderly patients such as for patients in other age groups.

 

Side effect

Local reactions: the site of application may be redness cream, itching or burning, allergic reactions.

 

Contraindications

- Hypersensitivity to the drug.

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

 

Pregnancy and lactation

So far, no reports of any malformation when applying Termikona®. But, as clinical experience with Termikona® during pregnancy is very limited, it should be used only on strict conditions.

Terbinafine is excreted in breast milk. In the case of nursing mother Termikona® cream is absorbed through the skin a small amount of active substance, so the adverse effects on the baby are unlikely.

IN experimental studies teratogenic properties of terbinafine have been identified.

 

Cautions

Reducing the severity of the clinical manifestations are usually noted in the first days of treatment. If irregular or premature treatment termination there is a risk of recurrence of infection.

Termykon® Cream is for external use only.

Avoid getting it in your eyes, because it can cause irritation. In case of contact with the eyes, they should immediately wash with running water, and in the case of persistent phenomena of irritation consult a doctor.

With the development of allergic reactions need to stop the drug.

 

Overdose

No cases of overdose were reported. If Termikon® Cream is accidentally ingested, You can expect the same symptoms, as tablets overdose: headache, nausea, epigastric pain and dizziness.

Treatment: Activated carbon, if necessary – Symptomatic supportive therapy.

 

Drug Interactions

Data on drug interactions Termikona® cream is not available.

 

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. Shelf life – 2 year. Do not use after the expiry date.

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