Exiter, cream 1% 15 g

Antifungal drug for external use with a broad spectrum of antifungal activity. In low concentrations terbinafine has fungicidal effect against dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum, Trichophyton tonsurans, Microsporum canis, Epidermophyton floccusom).

Moderately sensitive: molds (mainly Candida albicans) and dimorphic fungi (Pityrosporum orbiculare (also known as Malassezia furfur)). Activity against yeast fungi, depending on their species, can be fungicidal or fungistatic.

Terbinafine specifically alters the early stage of sterol biosynthesis in fungi, by inhibiting the squalene epoxidase enzyme located on the cell membrane of the fungus. This leads to ergosterol deficiency and to intracellular accumulation of squalene, which causes cell death of the fungus.

Terbinafine has no effect on the metabolism of hormones or other drugs.

Pharmacokinetics

On external use, absorption is less than 5% and has little systemic effect.

Indications

Fungal infections of the skin caused by pathogens sensitive to terbinafine: trichophytosis, microsporia, epidermophytosis, rubrophytosis, cutaneous candidiasis, lichen versicolor.

Pharmacological effect

An antifungal drug for external use with a wide spectrum of antifungal activity. In small concentrations, terbinafine has a fungicidal effect against dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum, Trichophyton tonsurans, Microsporum canis, Epidermophyton floccusom).

Moderately sensitive: molds (mainly Candida albicans) and dimorphic fungi (Pityrosporum orbiculare (also known as Malassezia furfur)). Activity against yeast fungi, depending on their type, can be fungicidal or fungistatic.

Terbinafine specifically modifies the early stage of sterol biosynthesis in fungi by inhibiting the enzyme squalene epoxidase located on the cell membrane of the fungus. This leads to ergosterol deficiency and intracellular accumulation of squalene, which causes the death of the fungal cell.

Terbinafine does not affect the metabolism of hormones or other drugs.

Pharmacokinetics

When applied externally, absorption is less than 5% and has a slight systemic effect.

Special instructions

If you have any questions about the use of this drug, consult your doctor.
The drug is intended for external use only. Avoid contact with the mucous membrane of the eyes, nose, and mouth, 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, you should consult a doctor.

If allergic reactions develop, the drug must be discontinued.

During the treatment process, it is necessary to follow general hygiene rules to prevent re-infection (through underwear, shoes).

To increase the effectiveness of treatment, it is recommended to avoid contact with possible external sources of fungal infection.

Irregular use or premature cessation of treatment increases the risk of disease relapse.

Impact on the ability to drive vehicles and operate machinery

Active ingredient

Terbinafine

Composition

100 g of cream contains:

Active substance:
terbinafine hydrochloride – 1.0 g.
Excipients:
benzyl alcohol – 1.0 g;
polysorbate-60 – 5.0 g;
sorbitan stearate – 2.4 g;
cetyl alcohol – 6.0 g;
isopropyl myristate – 6.0 g;
cetyl palmitate – 3.0 g;
sodium hydroxide – 0.122 g;
water – 75.478 g.

Pregnancy

There are no data on the safety of terbinafine during pregnancy. Therefore, terbinafine should be used during pregnancy only if the expected benefit to the mother outweighs the possible risk to the fetus.

Terbinafine is excreted in breast milk, so the drug should not be used by nursing mothers.

Contraindications

Hypersensitivity to terbinafine and other components of the drug; children’s age (up to 12 years), lactation period.

With caution

Kidney/liver failure, alcoholism, suppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive vascular diseases of the extremities.

If you have one of the diseases listed in this section, you should consult your doctor before starting to use the drug.

Side Effects

From the senses: eye irritation.

From the skin: peeling of the skin, pigmentation disorders, erythema, burning sensation of the skin, dry skin, contact dermatitis, eczema.

Individual messages: rash.

Local reactions: pain at the site of application, irritation at the site of application of the drug.

Symptoms may worsen.

Allergic reactions: redness, papules, blisters, itching.

If any side effects occur, including those not listed in the instructions for use, you should consult a doctor.

Interaction

Drug interactions of terbinafine in the cream dosage form have not been described.

Overdose

Overdose for external use is unlikely. If the drug is accidentally ingested, systemic side effects from the digestive tract may occur (nausea, gastralgia, lack of appetite, diarrhea), as well as headache, dizziness, frequent urination, rash.

If the above symptoms occur, you should stop using the drug and consult a doctor.
Treatment: activated carbon, symptomatic maintenance therapy.

Storage conditions

In a place protected from light at a temperature not exceeding 25 °C.
Keep out of the reach of children.

Shelf life

3 years.

Manufacturer

Ozon, Russia