Fungal infections of the skin (including tinea, groin, foot) and fungal nail infections caused by dermatophytes (incl.Trichophyton rubrum, T. mentagrophytes, T. verrucosum, T. tonsurans, T. violaceum, Microsporum canis, Epidermophyton floccosum) when oral treatment is indicated due to the location or extent of the infection.
Composition:
1 tabl contains 250 mg of Terbinafine hydrochloride.
Action:
The drug is an allylamine group with a wide range of antifungal activity. It disrupts the selectively early phase of ergosterol biosynthesis in a fungal cell, leading to cell death. In small concentrations, it fungicides fungicides against dermatophytes, molds and some dimorphic fungi; for yeasts - depending on the species - fungicidal or fungistatic. Terbinafine is well absorbed from the gastrointestinal tract; food does not affect its absorption. It quickly achieves fungicidal concentrations in the skin, nails and hair, which last for 15-20 days after treatment. Plasma proteins are 99% bound. T0,5 distribution is 4.6 h; T0,5 elimination - 17 h. It is rapidly metabolized in the liver with the participation of cytochrome P-450 enzymes; inactive metabolites are mainly excreted in the urine and partly in the faeces.
Contraindications:
Hypersensitivity to terbinafine or any of the other ingredients. It is not recommended for patients with chronic or acute liver disease. In patients with renal insufficiency (creatinine clearance <50 ml / min), terbinafine is not recommended because no studies have been performed in this patient group. Terbinafine used orally is not effective in the treatment of Miscanthus dandruff. Not recommended for children.
Precautions:
Before prescribing Terbinafine, liver function should be investigated. Hepatotoxicity may occur in patients with or without pre-existing liver disease, therefore it is recommended to perform periodic (after 4-6 weeks of treatment) liver function tests and for increased results discontinuation of treatment. Use with caution in patients with previous psoriasis or Lupus erythematosus.
Pregnancy and lactation:
Use only in case of extreme necessity. Do not use during breast-feeding.
Side effects:
Very common: decreased appetite, abdominal distension, abdominal pain, diarrhea, indigestion, nausea; rash, urticaria; pain in the joints and muscles. Common: headache. Uncommon: taste disorders, no taste sensation. Rare: liver failure, increased liver enzymes. Very rare: neutropenia, agranulocytosis, thrombocytopenia, pancytopenia; anaphylactoid reactions, angioneurotic edema, occurrence or worsening of cutaneous or systemic lupus erythematosus; dizziness, paresthesia, hypoesthesia; erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized pustular exanthema (AGEP), psoriasis-like rash or exacerbation of psoriasis, alopecia; fatigue. Frequency unknown: anemia; anaphylactic reactions, reactions resembling serum sickness; loss of smell; anxiety, depression; hearing loss, impaired hearing, tinnitus; vasculitis; pancreatitis, hepatitis, jaundice, cholestasis; hypersensitivity to light, photodermatosis, allergic reactions associated with photosensitivity and slight polymorphic rash; flu-like symptoms, fever; increase in blood creatinine phosphokinase, weight loss. The drug should be discontinued in the event of liver dysfunction, hypersensitivity reactions or neutropenia, which symptoms include fever, tonsillitis or other infections.
Dosage:
Adults orally: 250 mg once a day. Patients with renal insufficiency (creatinine clearance <50 ml / min) are given half the dose. Time of treatment: 2-6 weeks in tinea pedis (interdigital, plantar / moccasin type); 2-4 weeks in the inguinal tinea; 4 weeks in tinea mycosis; 6 weeks-3 months (sometimes up to 6 months or more) in onychomycosis of the hands and feet.In some cases, complete resolution of lesions may appear only a few weeks after mycological cure.
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