Treatment of fungal infections of the skin sensitive to Terbinafine, such as: trunk tinea, inguinal toenail, foot tinea (caused by dermatophytes), when this treatment is justified due to the location or extent of the infection. Treatment of fungal nail infections (terbinafine-sensitive) caused by dermatophytes. Note: Terbinafine in the form of oral tablets is not effective in the treatment of Miscanthus dandruff. Official local guidelines should be taken into account, eg national recommendations on the correct use and prescription of antimicrobials.
Composition:
1 tabl contains 250 mg of terbinafine hydrochloride.
Action:
Antifungal medicine from the group of allylamines. It exerts fungicidal or fungistatic activity, consisting in inhibiting ergosterol biosynthesis in fungal cells. It works on dermatophytes (Trichophyton rubrum, T. mentagrophytes, T. verrucosum, T. violaceum, Microsporum canis, Epidermophyton floccosum), molds and some dimorphic fungi. It has a weak effect on most yeastsCandida spp. Terbinafine given orally does not work onPityrosporum versicolor. It is well absorbed from the digestive tract. It penetrates quickly into the stratum corneum, dermis and tissues and is deposited in the nail plate. Plasma proteins are 99% bound. Terbinafine is rapidly and extensively metabolised in the liver; its inactive metabolites are mainly excreted in the urine. T0,5 in the absorption phase is 0.8 h; in the distribution phase - 4.6 h; in the elimination phase - 17 h.
Contraindications:
Hypersensitivity to terbinafine or any of the excipients. Severe liver or kidney problems.
Precautions:
Use in children and adolescents under 18 years of age and in patients with liver disease is not recommended. Use with caution in patients with psoriasis (risk of exacerbation) and in combination with other medicines metabolised by CYP 2D6.
Pregnancy and lactation:
Use only in case of extreme necessity. Do not use during breast-feeding.
Side effects:
Very often: decreased appetite; indigestion, feeling of fullness, nausea, abdominal pain, diarrhea; allergic skin reactions (rash, urticaria); muscle and joint pain. Headache was often observed. Uncommon: loss of taste, reduced sensation of taste stimuli, taste disorder. Rare: paraesthesia, hypoesthesia, dizziness, liver failure, increase in liver enzymes, hepatitis, jaundice, cholestasis; severe skin reactions (eg Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity and angioneurotic edema); bad mood, tiredness. Very rare: haematological abnormalities such as neutropenia, agranulocytosis and thrombocytopenia, pancytopenia; Anaphylactoid reactions, angioneurotic edema, cutaneous lupus erythematosus and systemic lupus erythematosus; depression, anxiety; erythema multiforme, acute generalized pustular exanthema, psoriasis skin eruptions or exacerbation of psoriasis, hair loss. Frequency unknown: anemia; anaphylactic reactions, a reaction similar to serum sickness; loss of smell; hearing loss, impaired hearing, tinnitus; vasculitis; inflammation of the pancreas; photosensitivity, photodermatitis, hypersensitivity reactions to light and multiform dermal exudates; rhabdomyolysis; fever, flu-like symptoms; increase in creatine kinase in the blood, weight loss.
Dosage:
Oral adults: 250 mg once a day. Patients with renal insufficiency (creatinine clearance <50 ml / min) are given half the dose. Duration of treatment: 2-4 weeks in tinea, groin, and foot (for interdigital and plantar-moccasal tinea up to 6 weeks); 6-12 weeks in onychomycosis (in the onychomycosis of the hands usually 6 weeks; in onychomycosis of the feet - usually 12 weeks, however, treatment may be necessary up to 6 months).
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