LAMITEL

Active material: Terʙinafin
When ATH: D01AE15
CCF: Antifungal agents for external use
When CSF: 08.02.02
M: S.C. ROMPHARM Company S.R.L. (Romania)

Pharmaceutical form, composition and packaging

◊ Spray for external use 1% a transparent or slightly opalescent, colorless or yellowish liquid.

[Ring] propylene glycol, macrogol 300 (polyethylene glycol 300), ethanol 96%, Purified water.

20 мл – флаконы полимерные с пульверизатором (1) – пачки картонные.

DESCRIPTION OF ACTIVE SUBSTANCES

PHARMACOLOGICAL ACTION

Antifungal allylamine. It has an effect by suppressing the squalene epoxidase in the fungal cell membrane. This leads to a deficiency of ergosterol and to an intracellular accumulation of squalene, causing cell death of agent.

It has a fungicidal effect on dermatophytes, molds and certain dimorphic fungi, yeast and yeast-like fungi. On some types of yeasts can act fungistatically.

It is active against pathogens dermatomycoses (Trichophyton / incl. Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Trichophyton verrucosum, Trichophyton violet /, and Microsporum canis and Epidermophyton floccosum); yeast fungi of the genus Candida (mostly Candida albicans); pathogen multi-colored lichen (Malassezia furfur).

Pharmacokinetics

After ingestion well absorbed from the gastrointestinal tract. Plasma protein binding - 99%. Terbinafine diffuses through the dermal layer of the skin and accumulate in the lipophilic stratum corneum, secreted sebum, as a result, are high concentrations in the hair follicles, nails. During the first few weeks after you start taking terbinafine accumulates in the skin and the nail plate concentrations, providing fungicidal action. It is metabolized in the liver with the formation of active metabolites. Excreted in the urine, mainly as metabolites. T_1/2 – 17 no.

Testimony

Orally: fungal skin lesions, caused by dermatophytes, – трихофития, athlete, microsporia, fungal nail infections (onychomycosis), candidiasis.

For outdoor use: fungal skin lesions, caused by dermatophytes, candidiasis; pityriasis versicolor.

Dosage regimen

Внутрь взрослым – 250 mg / day 1 or 2 admission. The duration of treatment depends on the indication and the severity of infection: при кожных поражениях – 2-4 Sun., при поражении ногтей – от 6 Sun. to 4 months or more. Children weighing more 40 kg- 250 mg / day, 20-40 kg- 125 mg / day, to 20 kg- 62.5 mg / day.

External used 1-2 times / day for 1-2 Sun.

Side effect

From the digestive system: nausea, anorexia, mild stomach pain, diarrhea, infringement or loss of taste, cholestasis, jaundice, hepatitis.

Allergic reactions: skin rash; a rare - arthralgia, myalgia, erythema multiforme, Stevens-Johnson syndrome.

CNS: headache.

Co hemopoiesis system: neutropenia, thrombocytopenia.

Local reactions: hyperemia, itch, burning sensation.

Contraindications

Hypersensitivity to terbinafine.

Pregnancy and lactation

Experience in the use of terbinafine in pregnancy is limited. If necessary, the appointment during lactation should decide the issue of termination of breastfeeding.

Cautions

It should be used with caution for oral terbinafine in patients with impaired liver and / or kidney, as well as in the elderly.

Drug Interactions

Preparations, causing induction of hepatic microsomal enzymes, increase the clearance of terbinafine; preparations, ингибирующие микросомальные ферменты печени – уменьшают клиренс тербинафина.