Fungal infections of the skin, such as: athlete's tinea, inguinal toenail, tinea pedis, mycosis of the scalp, tinea caused by dermatophytes. In the case of athlete's torso, groin, or foot, oral treatment with Terbinafine depends on the location, severity and extent of the infection. In contrast to topical terbinafine preparations on the skin, the tablets are not effective in the treatment of wild dandruff and yeast infections.
Composition:
1 tabl contains 250 mg of terbinafine hydrochloride.
Action:
Antifungal medicine from the group of allylamines. It has a wide range of activity against pathogenic fungi of the skin, hair and nails, including type dermatophytesTrichophyton(Eg.T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum(Eg.M. canis) andEpidermophyton floccosum. Terbinafine interferes selectively with the early phase of fungal sterol biosynthesis. This leads to a deficiency of ergosterol and to the intracellular accumulation of squalene, which causes the death of fungal cells. Terbinafine works by inhibiting squalene epoxidase in the fungal cell membrane. When administered orally, it quickly penetrates the skin, accumulating in the stratum corneum. It also separates from sebum, thus reaching high concentrations in hair follicles, hair and skin, in places where the most sebum is released. Terbinafine is deposited in the nail plate within the first weeks of starting treatment. Plasma proteins are 99% bound. It is rapidly metabolised in the liver to inactive metabolites excreted mainly in the urine. T0,5 in the elimination phase is 17 hours.
Contraindications:
Hypersensitivity to terbinafine or any of the excipients.
Precautions:
Terbinafine is not recommended in patients with chronic or active liver disease. Before starting treatment, liver function tests should be performed. Hepatotoxicity may occur in patients with previously diagnosed liver disease, as well as in patients who did not have it - periodic liver function tests are recommended (after 4-6 weeks of treatment). Terbinafine should be discontinued immediately in the event of elevated liver function tests. In patients receiving oral Terbinafine, cases of liver failure (some with fatal outcome or requiring liver transplantation) have been reported very rarely. In most cases of liver failure, patients had severe systemic diseases and a causal relationship with terbinafine. Patients should be warned to immediately report any symptoms of persistent nausea, unexplained origins, reduced appetite, tiredness, vomiting, upper right abdominal pain, jaundice, dark colored urine, or brightly colored stools. In patients with the above-mentioned symptoms, oral terbinafine should be discontinued. In the event of a progressive skin rash, treatment with terbinafine should be discontinued. If a blood disorder occurs, their etiology should be determined and consideration should be given to changing the dosage and even discontinuing terbinafine. The use of terbinafine has not been adequately tested in patients with renal impairment (creatinine clearance <50 ml / min or creatinine concentration> 300 μmol / l), therefore use of terbinafine is not recommended. In patients with pre-existing psoriasis or lupus erythematosus, terbinafine should be used with caution due to the very rare reports of lupus erythematosus.
Pregnancy and lactation:
Terbinafine tablets should not be used during pregnancy unless the clinical condition of the woman requires oral terbinafine and the potential benefits of treatment outweigh the risks to the fetus. Terbinafine is excreted in human milk, therefore mothers taking orally terbinafine should not breast-feed.
Side effects:
Very common: decreased appetite, indigestion, feeling of fullness in the stomach, nausea, abdominal pain, diarrhea, rash, urticaria, pain in the joints and muscles. Common: headache.Uncommon: temporary weakness in taste sensation, including loss. Rarely: hepatic failure, elevated liver enzymes. Very rare: neutropenia, thrombocytopenia, agranulocytosis, pancytopenia, anaphylactoid reactions, angioneurotic edema, cutaneous and systemic lupus erythematosus, dizziness, paresthesia, hypoesthesia, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized pustular exanthema, eruptions psoriasis-like or exacerbation of psoriasis, alopecia, fatigue. Frequency unknown: anemia, anaphylactic reactions, serum sickness, anxiety, depression, loss of sense of smell, hearing loss, hearing disorders, tinnitus, vasculitis, pancreatitis, hepatitis, jaundice, cholestasis, photosensitivity, photodermatitis, allergic reactions photosensitivity, multiform light eruption, rhabdomyolysis, flu-like illness, fever, increase in creatine kinase in the blood, weight loss.
Dosage:
Orally. Adults: 250 mg once a day. Children> 5 years old. 20-40 kg: 125 mg once a day; children about the month of above 40 kg: 250 mg once a day. It is not recommended for patients with chronic or active liver disease and patients with impaired renal function. Time of treatment: 2-6 weeks in tinea pedis (interdigital, type of plantar / moccasin); 2-4 weeks in inguinal tinea; 4 weeks in tinea fungal disease (in these cases it may happen that the complete disappearance of the signs and symptoms of the infection will occur only after a few weeks after the mycological cure); 4 weeks in onychomycosis of the scalp; 6 weeks in onychomycosis of the hands; 12 weeks in onychomycosis of feet (some patients with slow nail growth may require longer treatment).
(C)
