Description
Termicon Pharmacodynamics
Terbinafin belongs to the group of allilamines, has a broad spectrum of antifungal action. At low concentrations it has fungicidal effect on dermatophytes Trychophyton (T. rubrum, T. mentagrophytes, T. tonsurans, T. verrucosum, T. violaceum), Microsporum canis, Epidermophyton floccosum, mold fungi (e.g. Aspergillus, Cladosporium, Scopulariopsis brevicalius), yeast fungi, mainly Candida albicans, and some dimorphic fungi. On Candida fungi and its mycelial forms has fungicidal or fungistatic effect depending on the fungus species.
Terbinafine disrupts the early stage of biosynthesis of the main component of the cell membrane of the fungus ergosterol by inhibiting the enzyme squalene epoxidase.
When administered orally, it is not effective in treating variegated lichen caused by Malassezia furfur.
Indications
Mycoses of the scalp (trichophytosis, microsporia).
Mycoses of skin and nails caused by Trychophyton (T. rubrum, mentagrophytes, verrucosum, violaceum), Microsporum (M. canis, M. gypseum) and Epidermophyton floccosum.
Onychomycoses.
Severe, widespread dermatomycoses of smooth skin of the trunk and extremities, requiring systemic treatment.
Candidiasis of the skin and mucous membranes.
Contraindications
Hypersensitivity to terbinafine or to any other component of the drug; children under 3 years of age and body weight less than 20 kg (for this dosage form).
Severe, chronic or active liver disease.
It is not recommended to use terbinafine in patients with impaired renal function (creatinine clearance less than 50 ml/min or creatinine concentration in serum more than 300 µmol/l), because the drug administration in this category of patients has not been studied enough.
Dosage and administration regimen
- Duration of treatment course and dosage regimen are determined individually and depend on localization of the process and severity of the disease.
- The drug is used orally, regardless of the meal, with water. It is desirable to apply the drug at the same time.
- Adults:
- Normal dose: 250 mg (1 tablet) once daily.
- Onychomycosis: duration of therapy about 6-12 weeks.
- In onychomycosis of hands in most cases 6 weeks of treatment is enough.
- With onychomycosis of the feet, 12 weeks of treatment is enough in most cases.
- Some patients who have a reduced nail growth rate may require longer treatment. The optimal clinical effect is seen several months after mycological cure and discontinuation of therapy. This is determined by the period of time it takes for the healthy nail to grow back.
- Fungal skin infections: duration of treatment in interfinger, plantar or “toe” type localization of infection is 2-6 weeks, in mycoses of other body areas: shins – 2-4 weeks, torso – 4 weeks, in mycoses caused by Candida – 2-4 weeks, in mycoses of the head caused by Micisporum canis – more than 4 weeks.
- Children:
- The single dose depends on body weight and is: for children with body weight from 20 to 40 kg – 125 mg (1/2 tablet 250 mg); with body weight over 40 kg – 250 mg.
- The drug is prescribed once a day.
- Duration of treatment of mycoses of the scalp is about 4 weeks, in case of infection with Micisporum canis – may be longer.
- Elderly people are prescribed the drug in the same doses as adults. If the drug is used in this age group in tablets, the possibility of concomitant liver or kidney dysfunction should be taken into account.
