Lamikon (spray)

Compound

1 gram of cream, spray and dermgel (gel) of Lamikon includes 10 mg of terbinafine as an active ingredient.
Additional ingredients of the cream: soft white paraffin, phenylethyl and cetostearyl alcohol, sodium hydroxide, mineral oil, macrogol 20 cetostearyl ether, poloxamer 407, propylene glycol, purified water.

Additional ingredients of the spray: propylene glycol, benzoic acid, macrogol 20 cetostearyl ester, disodium edetate, poloxamer 407, water for injection.

Additional ingredients of dermgel: gasoline alcohol, butylated hydroxytoluene, sorbitan laurate, isopropyl myristate, polysorbate 20, ethanol 96%, sodium hydroxide, carbomer 974P, purified water.

1 tablet of Lamikon contains 250 mg of terbinafine as an active ingredient.

Additional tablet ingredients: sodium starch glycolate, microcrystalline cellulose, anhydrous colloidal silicon dioxide, corn starch, magnesium stearate, hydroxypropyl methylcellulose.

Pharmacodynamics and pharmacokinetics

The antifungal substance terbinafine is an allylamine that is active against a fairly large number of fungal strains . The fungicidal effect of terbinafine, in adequate concentrations, extends to molds, dermatophytes, and some dimorphic fungi. Regarding yeast fungi, depending on their type, terbinafine exhibits fungicidal or fungistatic effectiveness.

The mechanism of action of Lamikon is a specific inhibition, in the membrane of fungal cells, of the early stage of sterol biosynthesis . The consequence of this effect is the intracellular accumulation of squalene and ergosterol deficiency , which leads to the destruction of fungal cells.

The effect of terbinafine is manifested through the process of inhibition, in the membranes of fungal cells, of the enzyme squalene epoxidase , which belongs to the cytochrome P450 . Lamikon has no effect on the effects of other drugs, as well as on the metabolism of hormones. When applied externally (locally), the absorption of terbinafine is less than 5% of the applied dose, and therefore its systemic exposure is negligible.

When applied externally, Lamikon is absorbed in a very small amount, begins its action almost immediately and remains effective for a short time, about 7-14 days. The fungicidal effect of terbinafine, due to the preservation of its required concentration in the stratum corneum of the epidermis obtained during treatment, continues for 7 days after discontinuation of the external agent.

When taking Lamikon tablets internally, terbinafine accumulates in nails, hair, and skin, in concentrations that provide its fungicidal effects. Absorption of the drug in tablet form is about 70%, with absolute bioavailability of approximately 50%.

After taking one 250 mg tablet, after 90 minutes a Cmax in the blood of 1.3 mcg/ml is observed. Compared with a single dose, at steady state, the Cmax of terbinafine is approximately 25% higher, with a 2.3-fold increase in blood AUC. Effective T½ approximately 30 hours. Food intake has little effect on the bioavailability of Lamikon and does not require dose adjustment.

Terbinafine is 99% bound to plasma proteins. The drug quickly penetrates the dermis and accumulates in the stratum corneum. It is also secreted by the sebaceous glands and is found in high concentrations in hair, hair follicles and skin . In the first weeks of treatment it penetrates into the nail plates .

The metabolism of terbinafine occurs quite quickly, with the participation of cytochrome P450 . After the biotransformation , inactive metabolites of Lamikon are excreted mainly by the kidneys.

With pathologies of the kidneys and/or liver, the rate of elimination of terbinafine slows down, which makes its concentration in the blood higher.

Pharmacological properties of the drug Lamikon

Terbinafine ((E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine) is a broad-spectrum allylamine antifungal agent. Specifically inhibits the early stage of sterol biosynthesis in the fungal cell by inhibiting the enzyme squalene epoxidase in the cell membrane. This leads to ergosterol deficiency, intracellular accumulation of squalene and death of the fungal cell. Does not affect the cytochrome P450 system, the metabolism of hormones or other drugs. Active against pathogens of dermatomycosis ( Trichophyton , including T. mentagrophytes, T. tonsurans, T. verrucosum, T. violaceum ; as well as Microsporum canis and Epidermophyton floccosum ), yeast-like fungi of the genus Candida (mainly Candida albicans ), the causative agent of pityriasis versicolor ( Pityrosporum orbiculare or Malasseria furfur ). It has a fungicidal effect on dermatophytes, molds and some dimorphic fungi; on yeast fungi - fungistatic or fungicidal effect depending on their type. It exhibits maximum effectiveness against red trichophyton and pathogenic fungi - molds, pityriasis and mycelial forms of the genus Candida . Tablets: Lamikon is quickly absorbed from the digestive tract. After a single dose of 250 mg, the maximum concentration in the blood plasma is reached after 2 hours and is 1 mcg/ml. The half-absorption period is 0.8 hours, the half-distribution period is 4.6 hours. No dose adjustment is required when taken simultaneously with food. Almost completely binds to blood plasma proteins (99%). It has pronounced epidermo- and onychotropism. On the 2nd day after taking 250 mg, the concentration of terbinafine in the stratum corneum of the skin increases 10 times, on the 12th day - 70 times. The rate of diffusion exceeds the rate of nail growth. The half-life in the terminal phase is 200–400 hours. It undergoes biotransformation in the liver with the formation of inactive metabolites. About 70% of the dose taken is excreted by the kidneys. Cream, spray: when applied topically in the form of a spray or cream, Lamikon is slightly absorbed into the systemic circulation through the skin (less than 5% of the applied dose), that is, the systemic effect of the drug is minimal.

Indications for use

All local dosage forms of Lamikon (cream, spray, gel) are intended for the treatment of:

• fungal infections of the skin caused by fungi of the genus Microsporum , Trichophyton , Epidermophyton ( dermotophytosis of the groin, feet, trunk, etc.);
• pityriasis versicolor (pityriasis versicolor) caused by exposure to Malassezia (Pityrosporum) fungi ;
• candidiasis of the skin, caused by fungi of the genus Candida .

The oral form of the drug Lamikon - tablets is used for therapy:

• fungal infections of the skin , in cases where the concentration of lesions, their prevalence or severity are a sufficient reason for oral treatment;
• mycoses of the scalp and onychomycosis (damage to the nails).

Tablets are not prescribed for the treatment of versicolor (pityriasis versicolor) .

Indications for use of the drug Lamikon

Tablets: onychomycosis; mycoses of the scalp; fungal infections of the skin (dermatomycosis of the trunk, legs, feet, hands; candidiasis of the skin). Cream, spray: treatment of dermatomycosis of smooth skin and scalp (including feet, hands, large skin folds and interdigital spaces), lichen versicolor, seborrheic dermatitis, dandruff; fungal skin infections caused by dermatophytes ( Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum , Microsporum canis and Epidermophyton floccosum ), as well as the pathogenic fungus Pityrosporum orbiculare (Malassezia furfur).

Side effects

When using external forms of the drug, local reactions may occur, such as: burning or peeling of the skin , itching , irritation and pain , pigmentation disorders , crust formation, erythema in the treated area, and others. These reactions rarely lead to cessation of therapy and generally resolve spontaneously.

It is necessary to distinguish the above reactions from some possible similar allergic manifestations : skin itching , urticaria , rash (including bullous ), which are observed quite rarely, but often require discontinuation of treatment. In this regard, if any side effects are detected, you should inform your doctor.

Eye irritation has also been observed following accidental exposure to terbinafine.

latent fungal infection may worsen .

Therapy using Lamikon tablets is usually tolerated without serious side complications, although in some cases the following manifestations are possible:

Blood system:

• agranulocytosis;
• neutropenia;
• pancytopenia;
• thrombocytopenia.

The immune system:

• Lyell's syndrome;
• anaphylactoid reactions (including angioedema );
• Stevens-Johnson syndrome;
• systemic and cutaneous symptoms of lupus erythematosus ;
• photosensitivity.

Nervous system:

• taste disorders;
• headache;
• hypoesthesia;
• dizziness;
• paresthesia.

Gastrointestinal organs:

• feeling of a full stomach;
• dyspepsia;
• loss of appetite;
• nausea;
• diarrhea;
• stomach ache.

Skin and subcutaneous tissues:

• mild skin reactions ( urticaria , rash );
• exacerbation of psoriasis or psoriasis-like rashes;
• acute exanthematous generalized pustulosis (very rare);
• hair loss (with unproven cause-and-effect relationship).

Musculoskeletal system:

• myalgia;
• arthralgia.

Hepatobiliary system:

• increased levels of liver enzymes;
• hepatobiliary dysfunction (mainly cholestatic );
• Isolated cases severe liver pathologies jaundice , cholestasis , hepatitis ) have been described.

Are common:

• feeling tired (very rare).

Side effects of the drug Lamikon

Tablets: feeling of heaviness and pain in the epigastric region, taste disturbance, loss of appetite, nausea, diarrhea, cholestasis, neutropenia, skin allergic reactions. Cream, spray: skin redness, itching or burning sensation may sometimes occur at the sites where the drug is applied, but these phenomena rarely lead to the need to stop treatment. These side effects should be distinguished from allergic reactions, which occur infrequently and the development of which requires discontinuation of treatment. Special instructions for the use of the drug Lamikon: tablets: patients with impaired renal function (creatinine clearance less than 50 ml/min and serum creatinine level more than 300 µmol/l) should receive half the usual dose of the drug. It is necessary to constantly monitor patients receiving concomitant treatment with terbinafine with drugs that are predominantly metabolized with the participation of the cytochrome 2D6 enzyme (tricyclic antidepressants, β-adrenergic receptor blockers, selective serotonin reuptake inhibitors and MAO type B inhibitors), if the drug used has a small range of therapeutic concentrations. Cream, spray: clinical experience with the use of terbinafine cream or spray during pregnancy is very limited, so this drug should be prescribed during this period only for strict indications. When carrying out local treatment, it is unlikely that the small amount of terbinafine that is absorbed through the skin will have an adverse effect on the fetus. According to reference data, terbinafine passes into breast milk. However, any negative effect on the child when the cream is used by the mother during breastfeeding is unlikely, since systemic absorption of the drug through the skin is negligible. When spraying a spray or applying a cream, avoid getting the drug into the eyes and respiratory tract. If the drug accidentally gets into your eyes, rinse them immediately with running water. For lichen versicolor, oral terbinafine is ineffective, unlike topical application. Systemic use for onychomycosis is justified in the case of total damage to most nails, the presence of severe subungual hyperkeratosis, and the ineffectiveness of previous local therapy. During treatment (after 2 weeks and at the end of treatment), it is necessary to carry out antifungal treatment of shoes, socks and stockings.

Instructions for use

The instructions for Lamikon spray, cream and gel suggest the use of these dosage forms only externally. Before using external products, you should first clean and dry the affected areas of the skin.

Depending on the pathogen and severity of the lesion, Lamikon cream, instructions for use, recommend applying 1-2 times throughout the day. Lamikon spray is also applied 1 to 2 times, while Lamikon dermgel is applied once a day.

The cream and gel are applied to the affected skin and adjacent areas of the skin in a thin layer and lightly rubbed in. If infections are accompanied by diaper rash, for example in the groin area, between the fingers, under the mammary glands, between the buttocks, etc., the treated areas can be covered with gauze, especially at night.

The spray, in an amount sufficient for visible moisturizing, is sprayed onto areas of the skin affected by fungi , as well as onto healthy adjacent skin.

The duration of treatment with the use of local agents, depending on its severity, usually takes from 7 to 14 days.

Relief from the symptoms of the disease is usually observed after a few days. For therapy to be effective, it is necessary to strictly adhere to the drug application regimen, not skip the next application and not stop treatment earlier than the recommended period, as this can lead to relapses.

Elderly patients do not require dose adjustments of topical medications.

Lamikon tablets are prescribed to adults and children over 6 years of age, weighing more than 20 kilograms. Taking the pills is continued for a period of time sufficient for the complete disappearance of the symptom of the disease , depending on its severity and nature.

The recommended dose of Lamicon in the form of tablets for adults is 250 mg, for children weighing from 20 to 40 kilograms - 125 mg, over 40 kilograms - 250 mg.

The duration of treatment for skin candidiasis , trichophytosis of the skin and perineum is generally from 2 weeks to 1 month, for dermatomycosis of the feet from 2 weeks to 1.5 months.

Fungal diseases of the scalp , most often found in children, can be treated in recommended doses for 4 weeks.

Therapy for onychomycosis usually takes 1.5 months for fingernails and 3 months for toenails. In case of reduced growth of nail plates , the course of treatment may require a longer time.

Use of the drug Lamikon

Tablets: taken orally 1 time per day after meals. For adults and children weighing more than 40 kg, terbinafine is prescribed at a dose of 250 mg, for children weighing less than 20 kg - 62.5 mg, 20-40 kg - 125 mg. The average duration of treatment for onychomycosis is 6-12 weeks, dermatomycosis of the feet - 2-6 weeks, dermatomycosis of the trunk, legs, hands - 2-4 weeks, candidiasis of the skin - 2-4 weeks, dermatomycosis of the scalp - 4 weeks. Cream, spray: used externally, applied to the skin or scalp. Before applying the drug, it is necessary to thoroughly clean and dry the affected areas. The drug is applied (sprayed) onto the affected skin and adjacent areas in an amount sufficient to thoroughly moisturize them, and lightly rubbed in. For infections accompanied by diaper rash in the folds of the skin (under the mammary glands, between the fingers, between the buttocks, in the groin area), the areas with the applied drug can be covered with gauze, especially at night. The duration of treatment depends on the nature and severity of the disease. Dosage for adults and children aged 12 years and older: spray or cream applied 1-2 times a day. The average duration of treatment is:

• dermatomycosis of the trunk, legs - 1 week (1-2 times a day);
• dermatomycosis of the feet - 1 week (1-2 times a day);
• lichen versicolor - 1–2 weeks (2 times a day);
• seborrheic dermatitis, dandruff and other fungal diseases of the scalp - 2-3 weeks (once a day).

A decrease in the severity of clinical manifestations is usually observed in the first days of treatment. In case of irregular treatment or its premature cessation, the risk of recurrence of infection is increased. If after 1 week of treatment there are no signs of improvement, the diagnosis should be clarified. Elderly patients are prescribed Lamikon in the same dose as adults. Depending on the nature and severity of the disease, an individual dosage regimen and method of administration of the drug may be prescribed, and the course of treatment may be extended to 2–4 weeks or more. Since experience with topical use of the drug in children is limited, the use of terbinafine is not recommended for children under 12 years of age.

Interaction

No interactions of Lamikon cream, gel and spray with other medications have been identified.

When taking tablets, it is possible to increase the clearance of terbinafine with the parallel use of inducers of its metabolism and decrease the clearance with the use of cytochrome P450 inhibitors . This combination of drugs requires adjustment of the dose of Lamikon.

Terbinafine has no effect on the clearance of Digoxin or Antipyrine of Desipramine by 82% and reduces the clearance of Cyclosporine .

Rifampin doubles the clearance of terbinafine .

Lamicon has little effect on the change (in one direction or the other) in the clearance of drugs metabolism occurs with the participation of cytochrome P450 , such as: Terfenadine , Tolbutamide , Triazolam or oral contraceptives .

Taking Lamikon tablets reduces the clearance of intravenously administered caffeine by 19%.

Terbinafine is able to suppress CYP 2D6-mediated metabolism, which may have clinical significance for drugs metabolized by this enzyme: β-adrenergic receptor blockers , tricyclic antidepressants , SSRIs, antiarrhythmic drugs, MAO inhibitors .

special instructions

Lamikon cream, gel and spray are intended exclusively for external use.

Avoid contact of external products with the eyes, and in case of unintentional contact, rinse with sufficient amount of running water.

In order to prevent mycosis reinfection, it is necessary to regularly change underwear, do not wear poorly breathable or too tight clothes, dry problem areas thoroughly after washing, and always use a clean individual towel. Do not walk barefoot if you have mycosis of the feet. Spray socks, tights, etc., as well as the inside of shoes.

Lamicon tablets are not recommended for use in patients with active or chronic liver damage .

Since the drug has some hepatotoxicity , liver condition should be assessed even in healthy patients.

If nausea of ​​unknown etiology, fatigue , anorexia , vomiting , right-sided abdominal pain, jaundice , light-colored stool or dark urine are detected, the patient must inform his doctor and stop taking the pills. Then the condition of the liver is assessed.

If skin rashes , therapy is canceled until the cause of these phenomena is determined.

For any pathological change in the blood while taking Lamikon, you need to consider changing treatment.

When creatinine clearance is less than 50 ml/min, oral terbinafine .

Lamikon (spray)

Features of application

Preparation for external use.
Avoid inhalation. In case of accidental inhalation, consult a physician if any adverse symptoms worsen or persist. Avoid contact of the drug with the eyes. Do not apply the spray to the face. If the spray accidentally gets into your eyes or face, rinse them immediately with running water.

Since fungal infections can be transmitted to other people, you should only use individual towels and linens that should not be shared with others.

To prevent reinfection with skin mycoses, you must adhere to the following rules: change your underwear daily, since there may be fungi on clothing that has been in contact with infected skin surfaces; avoid wearing clothes that are too tight or poorly breathable; thoroughly dry the affected areas of the skin after washing it; Use a clean personal towel every day. If you have mycosis of the feet, you should not walk barefoot. In addition to external treatment, it is recommended to treat the inside of socks or shoes with Lamikon spray once a day.

Lamikon skin spray contains propylene glycol, which may cause skin irritation. Lamikon skin spray contains benzoic acid, which may be moderately irritating to the skin, eyes and mucous membranes.

In animal studies, there was no effect of terbinafine on fertility.

Use during pregnancy or breastfeeding.

Pregnancy.

Animal studies have not revealed teratogenic or embryotoxic effects of terbinafine. To date, there have been no reported cases of malformations in humans. Clinical experience with pregnant women is limited. Fetal toxicity studies in animals indicate no side effects. During pregnancy, Lamikon, a skin spray, can be used only if the expected benefit to the mother outweighs the potential risk to the fetus.

Lactation.

Terbinafine passes into breast milk in small quantities, so the drug should not be used by women who are breastfeeding.

Contact of infants with any area of ​​skin to which the drug has been applied should be avoided.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

Does not affect.

Reviews about Lamikon

Reviews about the effectiveness of external forms of the drug Lamikon (cream, spray, dermgel), when used against fungi sensitive to terbinafine , are mostly positive. The drug begins to act within a few days and leads to the complete disappearance of the manifestations of the fungal disease by the end of the course of therapy, which most often lasts 7-14 days.

In case of severe damage, for more effective and faster treatment, it is preferable to use a combination of dosage forms of the drug, for example, parallel taking of tablets and application of a cream, spray or gel. to treat the inside of shoes to prevent reinfection . Reviews about the tablets of this drug, subject to all doctor’s recommendations and taking into account indications and contraindications, are also positive and indicate the high effectiveness of this drug.

Negative reviews about Lamicon found on user forums may be associated with the use of the drug to treat fungi that are insensitive to it or the incorrect use of its dosage forms. If therapy is interrupted earlier than the recommended time, even with visible improvement, relapses of the disease are possible, and if the rules of personal hygiene associated with fungal infections are not followed, the fungi can spread to other parts of the body.

Therefore, if you suspect the presence of a fungal infection, it is necessary to accurately determine its causative agent in order to prescribe adequate and effective, in this case, treatment, which can only be recommended by a dermatologist.

It is worth paying attention to the fact that on the Internet you can often find instructions for Lamikon ointment, a description of its action, reviews of the ointment, recommendations for its use, etc., which do not correspond to reality. At this time, Lamikon produces the drug only in the form of cream, spray, dermgel and tablets. All other dosage forms of the drug described are erroneous and most likely are the result of a lack of understanding of the differences between the bases of ointment, cream and gel.

Lamikon price, where to buy

The cost of the drug Lamikon in Ukraine varies depending on its dosage form. On average, the cream can be purchased for 60 hryvnia, dermgel for 65 hryvnia and Lamikon spray for 75 hryvnia. The price of tablets of the drug varies from 130 to 160 hryvnia for 14 pieces.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine
• Online pharmacies in KazakhstanKazakhstan

LuxPharma* special offer

• Lamikon 1% 25g spray
  RUB 1,870 order
• Lamicon tablet 0.25g No. 14

  1690 rub. order

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Pharmacy24

• Lamikon 15 g cream PAT "Farmak", Ukraine
  80 UAH. order
• Lamikon 1% 25 g spray PAT "Farmak", Ukraine

  105 UAH order

• Lamicon Dermgel 1% 15 g gel PAT "Farmak", Ukraine

  81 UAH order

• Lamikon 0.25 g No. 14 tablets PAT "Farmak", Ukraine

  130 UAH order

PaniPharmacy

• Lamikon cream Lamikon cream 1% 15g Ukraine, Farmak OJSC

  86 UAH order

• Lamicon dermgel gel Lamicon Dermgel gel 1% tube 15g Ukraine, Farmak OJSC

  96 UAH order

• Lamikon liquid Lamikon spray 1% 25g Ukraine, Farmak OJSC

  118 UAH order

• Lamicon tablets Lamicon tablets. 250 mg No. 14 Ukraine, Farmak OJSC

  148 UAH order

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