Terbix, spray 1% 30 g

Antifungal drug for external use with a broad spectrum of antifungal activity. In low concentrations, terbinafine has fungicidal activity against dermatophytes (Trychophyton rubrum Trychophyton mentagrophytes Trychophyton verrucosum Trychophyton violaceum Trychophyton tonsurans Microsporum canis Epidermophyton floccosum) molds (mainly Candida albicans) and certain dimorphs (Pityrosporum orbiculare). Activity against yeast fungi depending on their species can be fungicidal or fungistatic.

Terbinafine specifically alters the early stage of sterol biosynthesis occurring in fungi. This leads to ergosterol deficiency and to intracellular accumulation of squalene which causes cell death of the fungus. The action of terbinafine is carried out 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 therefore on the metabolism of hormones or other drugs.

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

Indications

Prevention and treatment of fungal skin infections including foot mycosis (“fungus” of the foot) inguinal epidermophytosis (tinea cruris) fungal lesions of smooth body skin (tinea corporis) caused by dermatophytes such as Trichophyton (including Trichophyton rubrum Trichophyton mentagrophytes Trichophyton verrucosum Trichophyton violaceum) Microsporum canis and Epidermophyton floccosum.

The yeast infections of the skin are mainly those caused by the genus Candida (e.g. Candida albicans), particularly diaper rash.

Pityriasis versicolor is caused by Pityrosporum orbiculare (also known as Malassezia furfur).

Active ingredient

Terbinafine

Composition

Active ingredients: terbinafine hydrochloride – 0.30 g.

Auxiliary substances: isopropanol (isopropyl alcohol), 1,2-propylene glycol, polysorbate 60, macrogol-400 (polyethylene oxide-400), purified water.

How to take, the dosage

Externally.

Adults. Terbix® Spray can be used 1 or 2 times a day depending on the indication. The affected areas should be thoroughly cleaned and dried before using the product. The product is sprayed on the affected areas in an amount sufficient to thoroughly moisten them and is also applied to adjacent areas of both affected and intact skin.

Duration of treatment and number of applications:

Dermatomycosis of the trunk of the shins: 1 week; once daily

Dermatomycosis of the feet: 1 week; once daily

Multiple lichen: 1 week; 2 times daily

The dosing regimen of Terbix® Spray in the elderly is the same as described above.

Children.

The experience with Terbix® Spray in children is limited; therefore, the use of the drug is not recommended.

Interaction

No drug interactions are known for Terbix® Spray.

Special Instructions

A reduction in clinical manifestations is usually seen in the first days of treatment. If treatment is irregular or is stopped prematurely, there is a risk of a recurrence of the infection. If there is no sign of improvement after a week of treatment, the diagnosis must be confirmed.

Perhaps caution should be exercised when applying Terbix® to damaged skin, as the alcohol may cause irritation.

Terbix® Spray is for external use only. Eye contact should be avoided as it may cause irritation. If the drug accidentally gets into the eyes, rinse immediately with running water, and consult a physician if persistent irritation develops.

If the drug was accidentally injected into the respiratory tract through inhalation, a physician should be consulted if any symptoms occur, and especially if they persist.

If allergic reactions develop, the drug should be discontinued.

Contraindications

Hypersensitivity to terbinafine or to any of the excipients included in the preparation. Cautions:

Hepatic and/or renal insufficiency alcoholism suppression of medullary hematopoiesis tumors metabolic diseases occlusive diseases of limb vessels childhood age (lack of sufficient clinical experience).

Side effects

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

Overdose

No cases of drug overdose have been reported. If by chance Terbix® Spray is taken orally, side effects 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 Terbix®. However, since clinical experience with Terbix® in pregnant women is very limited, it should only be used when strictly indicated.

Terbinafine is excreted with the breast milk.

When a nursing mother uses Terbix® Spray, however, only a small amount of the active ingredient is absorbed through the skin, so adverse effects on the baby are unlikely.

Similarities

Terbinafin-Teva, Exifin, Lamisil, Fungoterbin, Lamisil Dermgel, Terbisil, Binafin, Termicon, Exiter, Terbinafin