Terbinafine tablets 250mg, No. 28
Expiration Date: 05/2027
Russian Pharmacy name:
Тербинафин таблетки 250мг, №28
Inside for adults - 250 mg / day in 1 or 2 admission. The duration of treatment depends on the indications and the severity of the infection: with skin lesions - 2-4 weeks, with nail damage - from 6 weeks. up to 4 months or more. Children weighing more than 40 kg - 250 mg / day, 20-40 kg - 125 mg / day, up to 20 kg - 62.5 mg / day.
Tablets white or white with a yellowish tinge, flat-cylindrical shape with a beveled and scored.
1 tab.
terbinafine hydrochloride 281.5 mg,
which corresponds to the content of terbinafine 250 mg
Excipients: lactose monohydrate (milk sugar) - 86 mg, hydroxypropyl cellulose - 3.6 mg, potato starch - 28.4 mg, croscarmellose sodium - 8.4 mg, talc - 8.4 mg, magnesium stearate - 4.2 mg.
Hypersensitivity to terbinafine.
pharmachologic effect
Antifungal agent of the allylamine group. It acts by inhibiting squalene epoxidase in the cell membrane of the fungus. This leads to a deficiency of ergosterol and intracellular accumulation of squalene, which causes cell death of the pathogen. Has a fungicidal effect on dermatophytes, molds and some dimorphic fungi, yeast and yeast-like fungi. It can act fungistatically on some types of yeast. Active against pathogens of dermatomycosis (Trichophyton / including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Trichophyton verrucosum, Trichophyton violaceum /, also Microsporum canis and Epidermophyton floccosum); yeast-like fungi of the genus Candida (mainly Candida albicans); the causative agent of multi-colored lichen (Malassezia furfur).
Pharmacokinetics
After oral administration, it is well absorbed from the gastrointestinal tract. Plasma protein binding - 99%. Terbinafine diffuses through the dermal layer of the skin and accumulates in the lipophilic stratum corneum, secreted into sebum, resulting in high concentrations in hair follicles and nails. During the first few weeks after the start of administration, terbinafine accumulates in the skin and nail plates in concentrations that provide a fungicidal effect. It is metabolized in the liver with the formation of inactive metabolites. It is excreted in the urine, mainly in the form of metabolites. T1 / 2 - 17 hours
Side effect
From the digestive system: nausea, anorexia, moderate abdominal pain, diarrhea, disturbance or loss of taste, cholestasis, jaundice, hepatitis. Allergic reactions: skin rash; rarely - arthralgia, myalgia, erythema multiforme, Stevens-Johnson syndrome. From the side of the central nervous system: headache. From the side of the hematopoietic system: neutropenia, thrombocytopenia. Local reactions: hyperemia, itching, burning sensation.
Application during pregnancy and lactation
Experience with terbinafine in pregnancy is limited. If necessary, the appointment during lactation should decide on the termination of breastfeeding.
Application for violations of liver function
Terbinafine should be used with caution for oral administration in patients with impaired liver function.
Application for impaired renal function
Terbinafine should be used with caution for oral administration in patients with impaired renal function.
Application in children
Application is possible according to the dosage regimen.
Use in elderly patients
Terbinafine should be used with caution in the elderly.
special instructions
Terbinafine should be used with caution for oral administration in patients with impaired liver and / or kidney function, as well as in the elderly.
Drug interactions
Drugs that induce the induction of liver microsomal enzymes increase terbinafine clearance; drugs that inhibit liver microsomal enzymes - reduce the clearance of terbinafine.