Termicon, cream 1% 15 g

Antifungal drug for external use, which has a broad spectrum of antifungal activity. In low concentrations terbinafine has fungicidal effect against dermatophytes (Trychophyton rubrum, T.mentagrophytes, T.verrucosum, T.violaceum, T.tonsurans, Microsporum canis, Epidermophyton floccosum), molds (e.g. Aspergillus, Cladosporium, Scorpulariopsis brevicalius), certain dimorphs (Pityrosporum orbiculare) and yeasts (mainly Сandida albicans).

Activity against the remaining yeast fungi Candida spp., depending on their species, may 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 performed 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, accordingly, on the metabolism of hormones or other drugs.

Pharmacokinetics.

In topical application absorption is less than 5%, has little systemic effect.

Indications

Prevention and treatment of fungal skin infections, including:

foot mycoses (“fungus” of the foot);

inguinal epidermophytosis;

fungal lesions of smooth skin of the body;

Infections caused by Candida yeast-like fungi (candida), particularly diaper rash;

Tuberculous (peptic ulcer).

Active ingredient

Composition

1 g of the cream contains:

The active ingredient: terbinafine hydrochloride – 10.0 mg

Auxiliary substances: cetyl alcohol and stearyl alcohol or cetostearyl alcohol – 80.

Holypropyl alcohol – 10.0 mg, benzyl alcohol – 10.0 mg, cetyl palmitate – 20.0 mg, polysorbate 60 – 61.0 mg, isopropyl myristate – 80.0 mg, sorbitan stearate – 19.0 mg, sodium hydroxide – 1.2 mg, purified water – to 1000, 0 mg.

How to take, the dosage

Termicon® is used topically in adults and children over 12 years of age.

The affected areas should be cleaned and dried before applying the cream. The cream is applied 1-2 times a day in a thin layer to the affected skin and adjacent areas and rubbed in gently.

Infections accompanied by diaper rash (under the breasts, between the fingers, between the buttocks, in the groin area), the spots where the cream is applied can be covered with gauze, especially at night.

The average duration of treatment in dermatomycosis of the trunk, shins, feet – 1 time / day for 1 week; in candidiasis of the skin – 1-2 times / day for 1-2 weeks; in lichen planus – 1-2 times / day for 2 weeks.

Development of clinical manifestations is usually observed in the first days of treatment. If treatment is irregular or if it is discontinued prematurely, there is a risk of a recurrence of the infection. If no signs of improvement are noted after 1-2 weeks of treatment, the diagnosis must be verified.

The dosing regimen for elderly patients is the same as for patients in other age groups.

Interaction

Termicon has no data on drug interactions.

Special Instructions

A reduction in clinical manifestations is usually seen in the first days of treatment.

If treatment is not given regularly or is stopped prematurely, there is a risk of a recurrence of the infection.

Termicon® is for external use only.

Contacting it in the eyes should be avoided because it can cause irritation.

If the drug accidentally gets in the eyes, rinse them immediately with running water, and if persistent irritation develops, consult a physician.

If allergic reactions develop, the drug should be discontinued.

Synopsis

The cream for external use 1% is white, homogeneous, with a slight specific smell.

Contraindications

Hypersensitivity to terbinafine or to any component of the drug; period of breast-feeding; children under 12 years of age (for this dosage form).

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

Side effects

Local reactions: redness, itching or burning sensation, allergic reactions may occur where the cream is applied.

Overdose

No cases of drug overdose have been reported. If Termicon® is accidentally ingested, the same symptoms as in case of overdose of tablets can be expected: headache, nausea, epigastric pain and dizziness.

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 terbinafine cream.

However, because clinical experience with the use of terbinafine cream in pregnant women is very limited, it should not be used unless absolutely necessary. In pregnancy, it should only be used if the expected benefit to the mother outweighs the potential risk to the fetus. A doctor should be consulted.

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