AMIKONUM (LAMICON) Terbinafin of 0.25 g
Other ingredients: corn starch, cellulose microcrystalline, aerosil, sodium krakhmalglikolit, a hydroksipropilmetiltsellyuloza, magnesium stearate.
cream for external use of 1% of a tube of 15 g
Terbinafin of 1%
Other ingredients: phenylethyl alcohol, a macrogoal the 20th cetostearyl ether, cetostearyl alcohol, half-oxameasures 407, liquid paraffin (liquid paraffin), paraffin white soft (vaseline white), propylene glycol, sodium hydroxide, water purified.
spray for external use 1% (bottle) with a spray of 25 g
Terbinafin of 1%
Other ingredients: benzoic acid, propylene glycol, a macrogoal the 20th cetostearyl ether, half-oxameasures 407, dinatrium edetat, water for injections.
PHARMACOLOGICAL PROPERTIES: terbinafin ((E) – N-(6.6-dimethyl-2-heptene-4-инил)-N-methyl-1-naftalenmetanamin) antifungal means of group of allylamines of a broad spectrum of activity. Specifically suppresses an early stage of biosynthesis of sterols in a mushroom cell by skvalenepoksidaza enzyme inhibition in a cellular membrane. It results in deficiency of ergosterol, intracellular accumulation of squalene and death of a cell of a mushroom. Does not influence the system of P450 cytochrome, metabolism of hormones or other medicines.
It is active concerning causative agents of dermatomycoses (Trichophyton, including T. mentagrophytes, T. tonsurans, T. verrucosum, T. violaceum and also Microsporum canis and Epidermophyton floccosum), of yeast-like mushrooms of the sort Candida (in the main Candida albicans), the activator multi-colored depriving (Pityrosporum orbiculare or Malasseria furfur). On dermatophytes, mold and some dimorphous mushrooms the fungistatic or fungicide action depending on their look has fungicide effect, on barmy mushrooms. Shows maximum efficiency concerning a red trikhofiton and a pathogenic fungi mold, a pitiriazis and filamentous forms of the sort Candida.
Tablets: Lamikon is quickly soaked up in a digestive tract. After single dose in a dose of 250 mg the maximum concentration in blood plasma is reached in 2 h and makes 1 mkg/ml. The period of semi-absorption is 0.8 h, the period of semi-distribution of 4.6 h. Dose adjustment of drug at a concomitant use with food is not required. Almost completely contacts proteins of blood plasma (99%). Possesses expressed epidermo- and an onikhotropnost. For the 2nd day after reception of 250 mg the concentration of a terbinafin in a corneal layer of skin increases by 10 times, for the 12th day by 70 times. Speed of diffusion exceeds nail growth rate. Elimination half-life in a terminal phase makes 200400 h. Is exposed to biotransformation in a liver with formation of inactive metabolites. About 70% of the accepted dose are removed by kidneys.
Cream, spray: at topical administration in the form of spray or Lamikon cream it is slightly soaked up in a system blood stream through skin (less than 5% of the applied dose), that is systemic action of drug is minimum.
INDICATIONS: tablets: onychomycosis, mycoses of a hairy part of the head, fungal infections of skin (dermatomycoses of a trunk, shins, feet, brushes, skin candidiasis).
Cream, spray: treatment of dermatomycoses of smooth skin and a hairy part of the head (including feet, brushes, large skin folds and interdigital intervals), multi-colored depriving, seborrheal dermatitis, dandruff, the fungal infections of skin caused by dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum, Microsporum canis and Epidermophyton floccosum) and also a pathogenic mushroom of Pityrosporum orbiculare (Malassezia furfur).
USE: tablets: accept in 1 times a day after a meal. To adults and children with body weight more than 40 kg terbinafin appoint in a dose 250 mg, to children with body weight less than 20 kg 62.5 mg, 2040 kg 125 mg. The average duration of a course of treatment in an onychomycosis of 612 weeks, a dermatomycosis of feet of 26 weeks, a dermatomycosis of a trunk, shins, brushes of 24 weeks, candidiasis of skin of 24 weeks, a dermatomycosis of a hairy part of the head of 4 weeks.
Cream, spray: apply outwardly, applying to skin or a hairy part of the head. Before putting drug it is necessary to clean and dry affected areas carefully. Drug is applied (spray) on the affected skin and the sites adjoining to it in the quantity sufficient for their careful moistening, and slightly rubbed. In the infections which are followed by an intertrigo of folds of skin (under mammary glands, between fingers, between buttocks, in inguinal area), sites with the applied drug can be covered with a gauze, especially for the night. Duration of treatment depends on character and weight of a course of the disease.
The dosage for adults and children at the age of 12 years is also more senior: spray or cream put 12th once a day. The average duration of treatment is:
a dermatomycosis of a trunk, shins of 1 week (12th once a day),
a dermatomycosis of feet of 1 week (12th once a day),
multi-colored deprive of 12 weeks (2 times a day),
seborrheal dermatitis, dandruff and other fungus diseases of a hairy part of the head of 23 weeks (1 time a day).
Reduction of expressiveness of clinical manifestations is usually noted in the first days of treatment. In case of irregular treatment or its premature termination the risk of a recurrence of an infection is increased. If in 1 week of treatment signs of improvement are not noted, it is necessary to specify the diagnosis.
To patients of advanced age Lamikon appoint in the same dose, as the adult. Depending on character and disease severity the individual mode of dosing and a route of administration of drug can be appointed, and the course of treatment is prolonged up to 24 weeks and more. As experience of topical administration of drug at children is limited, aged up to 12 years the use of a terbinafin is not recommended.
CONTRAINDICATIONS: tablets: hypersensitivity to a terbinafin, the profound liver and renal failure, diseases of blood, a tumor, disbolism, pathology of vessels of extremities, the period of pregnancy and feeding of a breast, age up to 2 years.
Cream, spray: hypersensitivity to a terbinafin or other component of drug.
SIDE EFFECTS: tablets: heavy feeling and pains in epigastric area, disturbance of taste, a loss of appetite, nausea, diarrhea, a cholestasia, a neutropenia, skin allergic reactions.
Cream, spray: in places of applique of drug there can sometimes be erubescence, feeling of an itching or burning, however these phenomena seldom result in need to stop treatment. These side effects should be distinguished from allergic reactions which arise infrequently and which development demands the treatment termination.
SPECIAL INSTRUCTIONS: tablets: patients with a renal failure (clearance of creatinine less than 50 ml/min. and level of creatinine of blood serum more than 300 µmol/l) have to receive a half of a usual dose of drug.
It is necessary to observe constantly the patients receiving along with terbinafiny treatment by the drugs which are mainly metabolized with cytochrome 2D6 enzyme participation (tricyclic antidepressants, blockers – adrenoceptors, selective serotonin reuptake inhibitors and MAO inhibitors of V type) if the used drug has the small range of therapeutic concentration.
Cream, spray: clinical experience of use of cream or spray with terbinafiny during pregnancy is very limited therefore it is necessary to appoint this drug during this period only according to strict indications. When performing topical treatment it is improbable that that insignificant quantity of a terbinafin which is soaked up through skin will have adverse impact on a fruit. According to help data, terbinafin gets into breast milk. However any negative influence on the child at cream use by mother during feeding by a breast is improbable as system absorption of drug through skin is insignificant.
When spraying spray or putting cream it is necessary to avoid hit of drug in eyes and airways. At accidental hit of drug in their eyes it is necessary to wash with flowing water immediately.
In multi-colored herpes the reception of a terbinafin is inside inefficient, unlike topical administration. System use in an onychomycosis is justified in case of total damage of the majority of nails, presence of the profound hyponychial hyperkeratosis, inefficiency of the previous local therapy. In the course of treatment (in 2 weeks and at the end of treatment) it is necessary to make antifungal processing of footwear, socks and stockings.
INTERACTIONS: tablets: H2 blockers – receptors increase concentration of a terbinafin in blood plasma due to suppression of its biotransformation. P450 cytochrome inhibitors (terfenadin, Cimetidinum) reduce, and rifampicin increases clearance of a terbinafin twice.
Cream, spray: at topical administration of drug its interaction with other medicines is not revealed.
OVERDOSE: tablets: there can be dizziness, a headache, nausea, pain in epigastric area. Carry out gastric lavage, activated carbon, if necessary symptomatic and maintenance therapy inside appoint.
Cream, spray: about cases of overdose of drug at its use in the form of cream or spray it was not reported.
STORAGE CONDITIONS: tablets: in the dry, protected from light place at a temperature of 15 25C.
Cream, spray: at a temperature up to 25 Pages. To protect from freezing!