Terbinafine Cream 1% 30g

Mechanism of action

Antifungal drug for local use, with a wide range of antifungal activity. Even in low concentrations, terbinafine has a fungicidal effect against dermatophytes (Trychophyton rubrum, T.mentagrophytes, T.verrucosum, T.violaceum, T.tonsurans, Microsporum canis, Epidermophyton floccosum), mold (mainly C.albicans) and certain dymorphic fungi. (Pityrosporum orbiculare). Activity against yeast fungi, depending on their species, can be fungicidal or fungistatic.

Terbinafine in a specific way changes the early stage of sterol biosynthesis occurring in fungi. This leads to a deficiency of ergosterol and intracellular accumulation of squalene, which causes the death of the fungal cell. The action of terbinafine is carried out by inhibiting the enzyme squalene epoxidase, located on the cell membrane of the fungus.

Terbinafine does not affect the cytochrome P450 system in humans and, accordingly, the metabolism of hormones or other drugs.

Pharmacokinetics

When applied topically, absorption - 5%, has a slight systemic effect.

Indications

- prevention and treatment of fungus, fungal infections of the skin, including foot mycoses ("fungus" of the foot), inguinal athlete (tinea cruris), fungal lesions of smooth skin of the body (tinea corporis) caused by dermatophytes such as Trichophyton (including T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum;

- yeast infections of the skin, mainly those caused by the Candida genus (for example, Candida albicans), in particular diaper rash;

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

Dosage and administration

Outwardly.

Adults and children from 12 years

Before applying the cream must be cleaned and dried the affected areas. The cream is applied once or twice a day with a thin layer on the affected skin and surrounding areas and lightly rubbed. For infections accompanied by diaper rash (under the mammary glands, in the interdigital spaces, between the buttocks, in the groin area), the places of application of the cream can be covered with gauze, especially at night. For extensive fungal infections of the body, it is recommended to apply cream in tubes of 30 g each.

The average duration of treatment: dermatomycosis of the trunk, legs - 1 week 1 time per day; dermatomycosis of the feet - 1 week 1 time per day; skin candidiasis - 1-2 weeks 1 or 2 times a day; pityriasis versicolor: 2 weeks 1 or 2 times a day.

Reducing the severity of clinical manifestations is usually observed in the first days of treatment. In the case of irregular treatment or its premature termination, there is a risk of re-infection. If after one or two weeks of treatment there are no signs of improvement, the diagnosis should be verified.

Dosing regimen of the drug elderly people does not differ from the above.

It is not recommended to use this drug in children under 12.

Side effect

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

Contraindications

- Hypersensitivity to terbinafine or to any of the inactive ingredients that make up the drug.

WITH caution: hepatic and / or renal failure, alcoholism, inhibition of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive vascular diseases of the extremities, children under 12 years old (lack of sufficient clinical experience).

Use during pregnancy and lactation

AT experimental studies no teratogenic properties of terbinafine have been identified. To date, no malformations have been reported with Terbinafine. However, since the clinical experience of using Terbinafine in pregnant women is very limited, it should be used only under strict indications.

Terbinafine is excreted in breast milk. However, when Terbinafine cream is used by the nursing mother, a small amount of the active substance is absorbed through the skin, therefore an adverse effect on the infant is unlikely.

Use in children

It is not recommended to use this drug in children under 12.

Use in elderly patients

Dosing regimen of the drug elderly people does not differ from the above.

Special notes

Reducing the severity of clinical manifestations is usually observed in the first days of treatment. In the case of irregular treatment or its premature termination, there is a risk of recurrence of the infection.

Terbinafine Cream is for external use only. Avoid contact with eyes, as it may cause irritation. In case of accidental ingestion of the drug in the eyes, they should be immediately washed with running water, and in the case of persistent irritation, you should consult with your doctor.

With the development of allergic reactions necessary to cancel the drug.

Overdosage

No cases of drug overdose have been reported. If terbinafine cream is accidentally ingested, you can expect the development of the same side effects as overdose of pills (headache, nausea, epigastric pain and dizziness).

Treatment: Activated carbon, if necessary - symptomatic supportive therapy.

Drug interaction

No drug interactions for Terbinafine Cream are known.

Terms and conditions of storage

In a dry, protected from light, out of reach of children, at a temperature not higher than 25 ° C.