Lamizil

Lamizil – antifungal means with fungistatic and fungicidal action.

Form of release and structure

Dosage forms:

• Tablets: from white with a yellowish shade till white color, a round biconvex form, with a facet, a smooth or rough surface, on the party from dividing risky there is a text around of the tablet "LAMISIL 250" (in blisters: on 7 pieces, in a cardboard pack 1 blister; on 14 pieces, in a cardboard pack 1 or 2 blisters);
External
• use cream: homogeneous white structure with a characteristic slight smell (on 15 or 30 g in aluminum tubas, in a cardboard pack 1 tuba);
• Spray for external use: colourless or light yellow transparent liquid with a specific smell (15 ml or 30 ml in polyethylene bottles of high density with a tip sprayer, in a cardboard pack 1 bottle).

Active ingredient of Lamizil – a terbinafin a hydrochloride:

• 1 tablet – 250 mg;
• 1 g of cream – 10 mg;
• 1 g of spray – 10 mg.

Auxiliary components:

• Tablets: silicon dioxide colloid anhydrous, magnesium stearate, methylhydroxypropyl cellulose, microcrystallic cellulose, sodium glycollate starch;
• Cream: sodium hydroxide, benzyl alcohol, sorbitan stearate, stearyl alcohol, tsetit palmitate, cetyl alcohol, an isopropyl myristate, polysorbate 60, the water purified;
• Spray: ethanol of 96%, macrogoal цетостеарат, propylene glycol, water.

Indications to use

Use of all forms of Lamizil is shown for treatment and prevention of the skin diseases caused by fungal infections:

• The dermatomycosis of smooth skin of a body (tinea corporis) caused by dermatophytes like Trichophyton including T. rubrum, T. verrucosum, T. mentagrophytes, T. violaceum, Epidermophyton floccosum, Microsporum canis;
• Mycosis of feet (tinea pedis), peeling of skin and itch, cracks, orogovelost (because of a foot fungus);
• Inguinal epidermophitia (tinea craris);
• The barmy infections of skin generally caused by sort Candida mushrooms (including Candida albicans), including an intertrigo.

Besides, drug is appointed:

• Tablets: at treatment of the onychomycosis caused by mushrooms dermatophytes and mycosis of a pilar part of the head;
• Cream and spray: for therapy multi-colored depriving (Pityriasis versicolor), caused by dimorphous mushrooms (Malassezia furfur).

Contraindications

Use of all forms of Lamizil is contraindicated at hypersensitivity to a terbinafin or to auxiliary components of drug.

It is impossible to take a pill:

• The pregnancy period (except for special cases when the expected clinical effect exceeds potential threat for a fruit);
• Breastfeeding period.

With care it is necessary to appoint drug:

• Tablets: at a renal failure (clearance of creatinine less than 50 ml/min.), chronic or active diseases of a liver;
• Cream and spray: at a liver and/or renal failure, an alcoholism, tumors, oppression of a marrowy hemopoiesis, metabolism diseases, occlusal pathologies of vessels of extremities, during pregnancy.

Age restrictions of use of drug:

• Tablets: children up to 2 years;
• Cream: children up to 12 years;
• Spray: children up to 2 years.

Route of administration and dosage

Tablets:
Accept in 1 times a day. The dose and duration of therapy are appointed by the doctor on the basis of clinical testimonies and a condition of the patient. The recommended daily dosing: for adult patients – on 1 tablet; for children with a weight: to 20 kg – on ¼ tablets, from 20 to 40 kg – on ½ tablets, is higher than 40 kg – on 1 tablet. At children good tolerance of drug is noted. The recommended duration of reception of tablets: mycosis of a pilar part of the head (it is more often observed at children) – 4 weeks; a dermatomycosis of feet (bottom, interdigital or as socks) – from 2 to 6 weeks; a dermatomycosis of a trunk and shins, skin candidiasis – 2-4 weeks; an onychomycosis – from 6 to 12 weeks (on brushes – 6 weeks, on feet – 12 weeks) or the period of growth of a new healthy nail (at the reduced growth rate of nails more prolonged treatment can be required). In the absence of the accompanying abnormal liver functions and/or kidneys dose adjustment is not required to patients of advanced age;

External use cream:
It is necessary to apply with a thin layer on previously cleared and dry-through struck area of a body and the easy movements to rub in skin, occupying adjacent sites. At treatment of an intertrigo in interdigital intervals, under mammary glands, between buttocks and in inguinal area use of gauze bandages is shown, especially when putting cream for the night. Frequency rate of procedures and the period of treatment depends on clinical indications: a dermatomycosis of a trunk, shins, feet – 1 times a day within 1 week, at the dermatomycosis of feet burdened by orogovelost, cracks, a peeling and an itch of skin – 1-2 times a day for 2 weeks; skin candidiasis – 1-2 times a day 1-2 weeks; at multi-colored herpes – 1-2 times a day 2 weeks. In the absence of effect signs after 1-2 weeks of therapy it is necessary to see a doctor for verification of the diagnosis;

Spray for external use:
Apply by spraying on previously cleared and the dry-through struck and adjacent body parts to a stage of careful moistening of skin. Period of treatment and frequency rate of sprayings: at a dermatomycosis of feet, shins and trunks – 1 week on 1 time a day; at multi-colored herpes – 1 week on 2 times a day; at an inguinal epidermophitia, an intertrigo – 1 week on 1 time a day.

Side effects

In spite of the fact that tablets in general are well transferred by patients, their use can cause side effects:

• Alimentary system: very often – nausea, appetite loss, feeling of overflow of a stomach, dyspepsia, a mild pain in a stomach, diarrhea;
• System of a hemopoiesis: very seldom – a neutropenia, an agranulocytosis, a pancytopenia, thrombocytopenia;
• Gepatobiliarny system: seldom – gepatobiliarny dysfunction (is more often than the cholestatic nature), including cases of development of a heavy liver failure (including with a lethal outcome or the demanding transplantation of a liver), as a rule, at patients with the serious accompanying system pathologies;
• Immune system: very seldom – anaphylactoid reactions (including a Quincke's disease), a lupus erythematosus (skin and system);
• Skeletal and muscular system: very often – a mialgiya, an arthralgia;
• Nervous system: often – a headache; sometimes – disturbance or loss of flavoring feelings (after treatment cancellation recovery of flavoring receptors occurs in several weeks); very seldom – paresthesias, dizziness, hypesthesias; in some cases – weight reduction against the background of reduction of the consumed food;
• From hypodermic cellulose and skin: very often – insignificant skin reactions in the form of rash and urticaria; very seldom – a toxic epidermal necrolysis, Stephens-Johnson's syndrome and other heavy skin reactions, an exacerbation of psoriasis or skin psoriazopodobny rashes; very seldom – a hair loss;
• Others: very seldom – feeling of fatigue.

Lamizil's use in the form of cream and spray can cause the following undesirable actions:

• Local reactions: burning sensation or itch, reddening;
• Others: development of allergic reactions.

Special instructions

Terbinafin suppresses metabolism of tricyclic antidepressants, selective serotonin reuptake inhibitors, beta adrenoblockers, monoamine oxidase inhibitors like B, antiarrhythmic means 1C of a class which is mediated by CYP2D6 enzyme. If the concomitant use of these drugs with Lamizil in the form of tablets has the small range of therapeutic concentration, it should be accompanied with constant observation.

If use of tablets causes qualitative or quantitative changes of uniform elements of blood it is necessary to define the reason of disturbances and to lower a drug dose, in case of need to consider a question of its cancellation.

When progressing skin rash against the background of reception of tablets, it is necessary to stop therapy.

If action of tablets causes dizziness, then during their reception patients are recommended to refuse control of vehicles and mechanisms temporarily.

Use of cream and spray reduces expressiveness of clinical manifestations after several days of treatment. The premature termination and their irregular use can cause an infection recurrence.

Cream and spray are intended only for external use. It is impossible to allow their hits in eyes, it can cause irritation. In case of unintentional hit of drug, an eye it is necessary to wash out flowing water at once, and at development of steady irritation – to address the specialist.

If against the background of use of cream or spray there was a development of allergic reactions – drugs need to be cancelled.

In the absence of therapeutic effect after 1 week of use of spray it is necessary to specify the diagnosis.

As availability of alcohol in spray can cause irritation, it is necessary to be careful at its spraying on affected areas of skin.

Not to allow hit of spray in respiratory tracts.

At treatment of extensive sites of fungal infections of a body it is necessary to use tubas on 30 g of cream or bottles of spray of 30 ml.

Spray does not exert impact on ability of the patient to control of vehicles and mechanisms.

Medicinal interaction

Cimetidinum can increase concentration of a terbinafin in a blood plasma or strengthen its action.

Rifampicin is capable to weaken action of a terbinafin or to reduce its content in plasma due to possible increase in clearance of a terbinafin up to 100%.

In case of need a concomitant use of inductors of metabolism and inhibitors of P450 cytochrome with Lamizil's tablets it is necessary to consider a question of dose adjustment of a terbinafin.

It is necessary to consider influence of a terbinafin at a concomitant use of Lamizil in the form of tablets with medicines which metabolism is implemented with the participation of system of P450 cytochrome. Is among such drugs терфенадин, to triazoles, Tolbutamidum, oral contraceptives. The exception is made by the means which are metabolized with participation of CYP2D6.

Tablets at a combination to digoxin or antipyrine do not influence their clearance, with caffeine – strengthen its action.

If the concomitant use of tricyclic antidepressants, selective serotonin reuptake inhibitors, beta adrenoblockers, monoamine oxidase inhibitors B of type and antiarrhythmic drugs of a class 1A, 1B and 1S is limited to the small range of their therapeutic concentration, then тербинафин can suppress their metabolism.

Lamizil reduces clearance of desipramine, weakens effect of cyclosporine, reducing its concentration in a blood plasma.

Interaction of cream and Lamizil's spray with other medicines is unknown.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature up to 30 °C.

To protect tablets from direct sunshine.

Spray – not to freeze.

Period of validity: tablets and cream – 5 years, spray – 3 years.