Lamikon

Lamikon – antifungal drug for topical and system administration.

Form of release and structure

Lamikon release in the following dosage forms:

• Tablets (on 7 pieces in blisters, on 2 blisters in a cardboard pack);
• Cream (on 15 g in tubas, on 1 tuba in a cardboard pack);
• Spray cutaneous (on 25 g in bottles with the pump doser, on 1 bottle in a cardboard pack).

Is a part of 1 tablet:

• Active agent: a hydrochloride of a terbinafin – 250 mg (in terms of тербинафин 100% anhydrous substance);
• Auxiliary components: microcrystallic cellulose, corn starch, anhydrous colloid silicon dioxide, krakhmalglikolit sodium (type A), a gidroksipropilmetiltsellyuloz, magnesium stearate.

Is a part of 100 mg of cream:

• Active agent: a hydrochloride of a terbinafin – 1 mg (in terms of тербинафин 100% anhydrous substance);
• Auxiliary components: phenylethyl alcohol, soft white paraffin, mineral oil, cetostearyl alcohol, polyethyleneglycol (macrogoal) the 20th cetostearyl ether, propylene glycol, half-oxameasures 407, sodium hydroxide, the purified water.

Cutaneous is a part of 100 mg of spray:

• Active agent: a hydrochloride of a terbinafin – 1 mg (in terms of тербинафин 100% anhydrous substance);
• Auxiliary components: the benzoic acid (Е 210), polyethyleneglycol (macrogoal) the 20th cetostearyl ether, propylene glycol, half-oxameasures 407, эдетат dinatrium, water for injections.

Indications to use

Lamikon in the form of tablets appoint for treatment of the following diseases:

• Onychomycoses (fungal infections of nails) caused by mushrooms dermatophytes;
• Mycoses of a pilar part of the head;
• Fungal infections of skin (trichophytosis of a crotch, smooth skin, the dermatomycoses and barmy infections of skin caused by sort Candida mushrooms), in cases when localization of defeats, prevalence or expressiveness of an infection cause expediency of oral administration of drug.

Outwardly Lamikon appoint in the presence of the following indications:

• The fungal skin infections caused by such dermatophytes as Trichophyton (for example, T. mentagrophytes, T. rubrum, T. Violaceum, T. verrucosum), Epidermophytonfloccosum and Microsporum canis (for example, dermatofitiya of feet);
• Dermatofitiya of a trunk ("cutting deprive");
• Inguinal dermatofitiya ("itch of the jockey");
• The skin candidiasis caused by sort Candida fungi, usually Candida albicans;
• Multi-colored deprive (Pityriasis versicolor), the caused Pityrosporum orbiculare.

Contraindications

Lamikon in all dosage forms it is contraindicated to apply with hypersensitivity to drug components.

To children drug is appointed:

• Tablets: since 6 years at body weight not less than 20 kg;
• Cream: since 12 years.

Spray cutaneous is applied from 18 years (safety and efficiency of use of drug in this form at patients are younger than 18 years are not established).

To pregnant women it is possible to apply any of Lamikon's forms only after consultation with the doctor who will estimate a ratio advantage/risk for health of mother and a fruit. The feeding women are not recommended to use drug.

Route of administration and dosage

Lamikon in the form of tablets accept inside.

Duration of therapy is defined by character and weight of a course of a disease.

As a rule, apply the following modes of dosing:

• Children of 6 years with the body weight of 20-40 kg: 125 mg once a day;
• Adults and children with body weight from 40 kg: 250 mg once a day.

The recommended duration of treatment of skin infections:

• Dermatomycoses of feet: 2-6 weeks;
• Skin candidiasis: 2-4 weeks;
• Trichophytosis of a crotch, smooth skin: 2-4 weeks.

Total disappearance of symptoms of an infection and the complaints connected with it usually comes only in several weeks after mycologic recovery.

At fungal infections of a pilar part of the head Lamikon is recommended to apply for 4 weeks (the disease is observed preferential at children).

At onychomycoses the following duration of use of drug is recommended:

• Onychomycosis on hands – 6 weeks;
• Onychomycosis standing – 12 weeks.

More long treatment can be required by some patients with the reduced growth rate of nails.

The optimum clinical effect at fungal infections of nails is observed in several months after mycologic recovery and phase-out of drug that corresponds to the span necessary for growth of a healthy nail.

Depending on a disease Lamikon in the form of cream and spray cutaneous apply 1-2 times a day on the affected areas of skin which are previously carefully cleared and dried and also on adjacent sites. Cream after drawing needs to be rubbed slightly.

At the infections which are followed by an intertrigo (in an interdigital zone, under mammary glands, between buttocks and in a groin) cream sites of application Lamikon, especially for the night, it is possible to cover with a gauze.

The scheme of use of drug is defined by indications:

• Inguinal dermatofitiya, interdigital dermatofitiya of feet, trunk dermatofitiya: once a day, a course – 1 week;
• Skin candidiasis: 1-2 times a day, a course – 1 week;
• Squamous гиперкератотическая dermatofitiya of feet ("mokasinovy foot"): 2 times a day, a course – 2 weeks;
• Multi-colored deprive: 1-2 times a day, a course – 2 weeks (cream); 2 times a day, a course – 1 week (spray cutaneous).

Elderly patients should not adjust the dosing mode.

As a rule, relief of symptoms happens over several days. Irregular use of Lamikon or the premature termination of therapy can lead to development of a recurrence.

If within 2 weeks of treatment there are no signs of improvement of a state, it is necessary to see a doctor.

Side effects

As a rule, Lamikon is had well.

At administration of drug inside side effects usually moderately or are poorly expressed and have short-term character. During therapy the following disturbances can develop (≥10% – very often; from ≥1% to 10% – it is frequent; from ≥0,1% to <1% – infrequently; from ≥0,01% to <0,1% – are rare; from <0,01%, including single messages – are very rare):

• Nervous system: often – a headache; seldom – taste disturbance (passes independently, as a rule, after the termination of treatment within several weeks); very seldom – dizziness, a hypesthesia, paresthesia;
• Gepatobiliarny system: seldom – increase in level of liver enzymes, gepatobiliarny dysfunction (mainly a cholestatic origin); there are separate messages on development of heavy functional disturbances of a liver, including jaundice, hepatitis, a cholestasia;
• Immune system: very seldom – anaphylactoid reactions (including a Quincke's disease), system and skin manifestations of a lupus erythematosus, Stephens-Johnson's syndrome, a photosensitization, a toxic epidermal necrolysis (Lyell's disease);
• Digestive tract: very often – dyspepsia, feeling of overflow of a stomach, appetite loss, diarrhea, nausea, small pains in a stomach;
• Musculoskeletal system: very often – a mialgiya, an arthralgia;
• Skin and hypodermic cellulose: very often – not heavy skin reactions (an urtikariya, rash); very seldom – acute generalized exanthematous пустулез, an exacerbation of psoriasis or psoriazopodobny rashes, loss of hair (relationship of cause and effect is not proved);
• Blood and lymphatic system: very seldom – an agranulocytosis, a neutropenia, a pancytopenia, thrombocytopenia;
• General frustration: very seldom – fatigue.

At topical administration of Lamikon in a site of application such disturbances as burning or a peeling of skin, an itch, an erythema, pigmentation disturbance, crusting and others can develop. These insignificant side effects need to be distinguished from hypersensitivity reactions, including rash about which there are single messages. In these cases the therapy termination is required.

The accidental contact of drug with eyes can lead to irritation. The exacerbation of the masked fungal infection is in rare instances possible.

At external use of Lamikon the following side effects can develop:

• Immune system: hypersensitivity reactions, including a small tortoiseshell;
• Skin and connecting fabrics: eczema, injury of skin, itch, contact dermatitis, feeling of a xeroderma, rash;
• Organ of sight: irritation of eyes;
• The general disturbances and reactions in a site of application: pain and irritation in a site of application, an aggravation of symptoms of a disease.

Special instructions

Lamikon in the form of tablets is not recommended to accept sick with active or chronic damage of a liver. Before therapy it is necessary to estimate a condition of the patient and already existing liver diseases.

At emergence of such symptoms as constant nausea of not clear etiology, anorexia, fatigue, vomiting, pains in the right upper part of an abdominal cavity, jaundice, dark urine or light excrements it is necessary to see a doctor. Assessment of a functional condition of a liver and, perhaps, the treatment termination can be required.

At development of the progressing skin rash Lamikon's reception needs to be interrupted.

At development of any pathological changes of a picture of blood it is necessary to revise the applied scheme of therapy.

Patients with reduced function of kidneys (at clearance of creatinine it is less than 50 ml in a minute or blood serum creatinine higher than 300 µmol/l) are not recommended to apply Lamikon (due to the lack of sufficient data).

It is necessary to avoid cream contact Lamikon with eyes, at their accidental hit it is necessary to wash out carefully flowing water.

The cetostearyl alcohol which is a part of drug can cause local skin irritation (for example, contact dermatitis).

To prevent a reinfitsirovaniye mycoses of skin it is necessary to change daily linen, to avoid wearing badly passing air or too close clothes, to carefully dry up the struck skin sites after washing, to daily use an individual pure towel. At mycosis of feet it is impossible to go barefoot.

In addition to use of cream it is recommended to process footwear or socks spray Lamikon inside.

It is necessary to avoid spray inhalation. At its accidental inhalation it is necessary to consult with the doctor in case of development, preservation or strengthening of any side effects.

It is impossible to put spray on a face. It is also necessary to avoid hit of means in eyes. At accidental hit of Lamikon in eyes or on the person, they should be washed out immediately flowing water.

Propylene glycol and the benzoic acid which can cause irritation of skin, an eye and mucous membranes is a part of spray cutaneous.

Medicinal interaction

In a blood plasma medicines which induce metabolism can increase clearance of a terbinafin, decrease is observed at simultaneous use with drugs which inhibit _{P450 cytochrome}. In need of the accompanying therapy by such medicines dose adjustment of Lamikon can be required.

At simultaneous use of Lamikon in the form of tablets with some medicines there can be following effects:

• Rifampicin: significant increase in clearance of a terbinafin;
• Oral contraceptives: disturbance of a regularity of a menstrual cycle;
• Caffeine (at intravenous administration): decrease in its clearance;
• Drugs which are metabolized by CYP2D6 enzyme (β-blockers, tricyclic antidepressants, selective serotonin reuptake inhibitors, antiarrhytmic drugs, monoamine oxidase inhibitors of type B): oppression of the mediated metabolism CYP2D6;
• Desipramine: reduction of its clearance;
• Cyclosporine: increase in its clearance.

At external use of Lamikon interaction with other medicines was not studied.

Terms and storage conditions

To store in protected from light, the place, unavailable to children, at a temperature up to 25 °C. Freezing is not allowed.

Period of validity:

• Tablets – 2 years;
• Cream and spray cutaneous – 3 years.