Exiter, pills 250mg, 14pcs

Composition

Active ingredient:

terbinafine hydrochloride 281 mg, based on terbinafine 250 mg;

Auxiliary substances:

microcrystalline cellulose,

sodium starch glycolate,

pregelatinized starch,

magnesium stearate,

colloidal anhydrous silicon.

Pharmacological action

Terbinafine belongs to the group of allylamines, has a wide spectrum of antifungal action. In low concentrations, it has a fungicidal effect on dermatophytes Trychophyton spp. (T. rubrum, T. mentagrophytes, T. tonsurans, T. verrucosum, T. violaceum), Microsporum canis, Epidermophyton floccosum, yeast fungi, mainly Candida albicans. For fungi Candida spp. and their mycelial forms have a fungicidal or fungistatic effect, depending on the type of fungus.

Terbinafine disrupts the early stage of biosynthesis of the main component of the fungal cell membrane (ergosterol) by inhibiting the squalene oxidase enzyme.

When administered orally, it is not effective in the treatment of multicolored lichen caused by Pityrosporum ovale, Pityrosporum orbiculare (Malassezia furfur).

Pharmacokinetics

When taken orally, more than 70% is well absorbed; absolute bioavailability due to the “first pass” effect is reduced by 40%. After a single oral dose of 250 mg, the time to reach the maximum concentration (TStax) is about 2 hours; the maximum concentration (Ctax) is approximately 1 mcg / ml. The area under the concentration — time curve (AUC) is 4.5 mcg * h / ml, and when taken simultaneously with food, the AUC increases by 20%. With prolonged use, the Cmax increases by 25%, the AUC-by 2.5 times. The effective half — life (T 1/2) is about 36 hours, the terminal half-life is 200-400 hours (indicates prolonged elimination from the skin and adipose tissue). The equilibrium concentration (Css) is independent of age. The concentration of terbinafine in plasma does not depend on gender.

Binding to plasma proteins is more than 99%. Quickly distributed in the tissues, penetrates the dermal layer of the skin and nail plates. Penetrates the secret of the sebaceous glands and accumulates in high concentrations in the hair follicles, hair, skin and subcutaneous tissue.

Undergoes significant biotransformation, the resulting metabolites do not have antifungal activity. 70% are excreted by the kidneys. It does not accumulate in the body. The age of patients does not affect the pharmacokinetics of terbinafine, but elimination may decrease with kidney or liver damage, leading to high concentrations of terbinafine in the blood. It is excreted in breast milk.

Indications

Fungal lesions of the skin and mucous membranes.

Contraindications

Hypersensitivity to Exeter.

Side effects

From the digestive system: nausea, anorexia, mild abdominal pain, diarrhea, impaired or lost taste, cholestasis, jaundice, hepatitis.

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

From the central nervous system:  headache.

From the hematopoietic system:  neutropenia, thrombocytopenia.

Local reactions:  hyperemia, itching, burning sensation.

Interaction

Drugs that induce microsomal liver enzymes increase the clearance of terbinafine; drugs that inhibit microsomal liver enzymes decrease the clearance of terbinafine.

How to take, course of use and dosage

Inside adults-250 mg / day in 1 or 2 doses.

The duration of treatment depends on the indications and severity of the infection: for skin lesions-2-4 weeks, for nail lesions – from 6 weeks to 4 months or more. Children with a body weight of more than 40 kg – 250 mg / day,20-40 kg-125 mg/day, up to 20 kg-62.5 mg / day.

Topically applied 1-2 times a day for 1-2 weeks.

Form of production

Tablets

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Terbinafine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

Children over 3 years of age, For adults, Children as directed by a doctor, For adults as directed by a doctor

Indications

Nail Fungus, Mildew, Thrush, Scalp Fungus, Skin Fungus, Prevention of Fungal diseases, Diaper rash