Pharmacological properties
Pharmacodynamics. Terbinafine is an allylamine and has a broad spectrum of antifungal activity against skin infections caused by dermatophytes such as Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. Terbinafine at low concentrations has fungicidal activity against dermatophytes, mold fungi. Activity against yeast fungi is fungicidal (e.g. Pityrosporum orbiculare or Malassezia furfur) or fungistatic, depending on the species.
Terbinafine specifically inhibits the early stage of sterol biosynthesis in the fungal cell membrane. This leads to ergosterol deficiency and intracellular accumulation of squalene, which leads to fungal cell death. Terbinafine acts by inhibiting the enzyme squalene epoxidase in the fungal cell membrane. This enzyme does not belong to the cytochrome P450 system. Terbinafine does not affect the metabolism of hormones or other drugs.
Pharmacokinetics. When applied topically, 5% of the prescribed dose is absorbed, so the systemic exposure to terbinafine is insignificant. The fungicidal concentration of terbinafine in the stratum corneum of the skin after 7 days of use of the drug persists for up to 7 days after discontinuation of treatment.
In animal studies, no effect of terbinafine on fertility was observed.
Indication
Fungal skin infections caused by dermatophytes such as Trichophyton (e.g. T. Rubrum, T. Mentagrophytes, T. Verrucosum, T. Violaceum), Microsporum canis and Epidermophyton floccosum, e.g. tinea pedis; inguinal dermatophytosis ("jock itch"); dermatophytosis of the trunk ("ringworm"); cutaneous candidiasis caused by fungi of the genus Candida, usually Candida albicans; pityriasis versicolor caused by Pityrosporum orbiculare (also known as Malassezia furfur).
Application
Lamikon cream: adults and children over 12 years of age. Apply Lamikon cream to the skin 1 or 2 times a day, depending on the disease. Before applying the cream, the affected areas must be thoroughly cleaned and dried. Apply a thin layer of the cream to the affected skin and adjacent areas, rubbing in lightly. In infections accompanied by diaper rash (under the mammary glands, in the interdigital area, in the groin area and between the buttocks), the application sites can be covered with gauze, especially at night.
Duration and frequency of treatment
The duration of treatment depends on the severity of the disease:
Interdigital tinea pedis, inguinal tinea pedis and tinea pedis of the trunk - 1 time per day for 1 week; squamous-hyperkeratotic tinea pedis ("moccasin foot") - 2 times per day for 2 weeks; candidiasis of the skin - 1-2 times per day for 1 week; lichen variegated - 1-2 times per day for 2 weeks.
No dosage adjustment is required for elderly patients.
Symptoms usually improve within a few days. Irregular use or premature discontinuation of treatment may lead to relapse.
If there are no signs of improvement after 2 weeks of treatment, you should consult a doctor.
Lamikon cutaneous spray: Lamikon cutaneous spray is intended for external use only.
Before using the drug, it is necessary to thoroughly clean and dry the affected areas of the skin. The drug should be sprayed onto the affected areas of the skin in an amount sufficient to thoroughly moisturize them, and, in addition, applied to the adjacent areas of healthy skin.
Duration and frequency of treatment
The duration of treatment and frequency of application should be determined depending on the indications:
athlete's foot and trichophytosis of smooth skin - once a day for a week; lichen planus - twice a day for a week.
No dose adjustment is necessary for elderly patients.
A reduction in symptoms is usually expected within a few days.
Irregular use or premature discontinuation of treatment may lead to relapses of the disease. If there are no signs of improvement after a week of treatment, you should consult a doctor.
Lamikon Dermgel: Apply Lamikon Dermgel to the skin once a day. Before applying the gel, the affected areas must be thoroughly cleaned and dried. Apply a thin layer of the gel to the affected skin and adjacent areas and rub in lightly. In infections accompanied by diaper rash in skin folds (under the mammary glands, in the interdigital areas, between the buttocks, in the groin area), the areas with the applied gel can be covered with gauze, especially at night.
Duration and frequency of treatment
Dermatophytosis of the feet (interdigital) - 1 time per day for 1 week.
Inguinal ringworm and trunk ringworm - once a day for 1 week.
Tinea versicolor - once a day for 1 week.
No dosage adjustment is required for elderly patients.
A reduction in symptoms is usually noted within a few days. Irregular use of the drug or premature discontinuation of treatment may lead to relapse.
Contraindication
Hypersensitivity to terbinafine or to other components of the drug.
Lamikon cream, Lamikon spray for skin application: local symptoms such as itching, peeling or burning of the skin, pain and irritation at the application site, pigmentation disorders, erythema, crusting and others may be noted at the application site. These minor symptoms should be distinguished from hypersensitivity reactions, including rashes, which have been reported in isolated cases and require discontinuation of treatment. In case of accidental contact with the eyes, terbinafine hydrochloride may cause eye irritation. In rare cases, latent fungal infections may be aggravated.
Possible side effects:
Immune system disorders: hypersensitivity reactions, including urticaria;
From the organ of vision: eye irritation;
Skin and connective tissue disorders: skin peeling, itching, skin damage, crusting, skin lesions, pigmentation disorders, erythema, burning sensation of the skin, feeling of dry skin, contact dermatitis, eczema, rash;
General disorders and administration site conditions: pain, application site pain, application site irritation, worsening of symptoms.
Lamikon Dermgel: local manifestations such as itching, peeling or burning of the skin, pain and irritation at the application site, pigmentation disorders, erythema, crusting may occur at the application site. These minor manifestations should be distinguished from hypersensitivity reactions, including rash, which have been reported in isolated cases and require discontinuation of treatment. In case of accidental contact with the eyes, terbinafine may cause eye irritation. The presence of butylhydroxytoluene may cause irritation of the mucous membranes.
In rare cases, a latent fungal infection may become more severe.
Possible side effects:
from the immune system: frequency unknown (cannot be estimated from the available data) - hypersensitivity reactions *;
From the organ of vision: rarely (≥1/10,000, 1/1000) - eye irritation;
Skin and connective tissue disorders: common (≥1/100, 1/10) - skin peeling, itching; uncommon (≥1/1000, 1/100) - skin damage, crusting, skin lesions, pigmentation disorders, erythema, burning sensation of the skin; rare (≥1/10,000, 1/1000) - dry skin, contact dermatitis, eczema; frequency unknown (cannot be estimated from the available data) - rash *;
General disorders and administration site conditions: uncommon (≥1/1000, 1/100) - pain, application site pain, application site irritation; rare (≥1/10,000, 1/1000) - worsening of symptoms.
* Data obtained from post-marketing surveillance.
Special instructions
Lamikon cream: the cream is intended for external use only. Avoid contact of the cream with the eyes. If the cream accidentally gets into the eyes, rinse them thoroughly with running water.
Lamikon cream contains cetostearyl alcohol, which may cause skin irritation (e.g. contact dermatitis).
To prevent reinfection with skin mycoses, the following rules must be followed: change underwear daily, as there may be fungus on clothes that have been in contact with infected skin surfaces; avoid wearing clothes that are too tight or poorly permeable to air; thoroughly dry the affected areas of the skin after washing; use a clean individual towel daily. With mycosis of the feet, you cannot walk barefoot.
In addition to external treatment, it is recommended to treat the inside of socks or shoes with Lamikon spray once a day.
Use during pregnancy and breastfeeding. Animal studies have not shown any embryotoxic effects of terbinafine. Since clinical experience of the drug in women during pregnancy is limited, Lamikon cream should not be used by pregnant women, except in cases where, in the opinion of the doctor, the expected positive effect for the mother outweighs the potential risk to the fetus.
Terbinafine passes into breast milk, so the drug should not be used during breastfeeding. Infants should be avoided from contact with the skin on which the cream has been applied.
Children: Experience with the drug in children under 12 years of age is limited, so the drug should not be used in this age group of patients.
The ability to influence the reaction rate when driving vehicles or working with other mechanisms is not affected.
Lamikon cutaneous spray: a preparation for external use. Avoid inhalation. In case of accidental inhalation, consult a doctor if any adverse symptoms worsen or persist.
Avoid contact with eyes. Do not spray on face. If spray accidentally gets into eyes or face, rinse immediately with running water.
To prevent reinfection with skin mycoses, it is necessary to adhere to the following rules: change underwear daily, as there may be fungi on clothes that have 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; use a clean individual towel daily. With foot mycoses, you cannot 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 cutaneous spray contains propylene glycol, which may cause skin irritation.
In animal studies, no effect of terbinafine on fertility was observed.
Use during pregnancy and breastfeeding. Animal studies have not revealed any embryotoxic effects of terbinafine. Clinical experience in pregnant women is limited, therefore, during pregnancy, Lamikon cutaneous spray can be used only if the expected benefit to the mother outweighs the potential risk to the fetus.
Terbinafine passes into breast milk in small amounts, so the drug should not be used in women who are breastfeeding.
Children: Safety and efficacy in children have not been established, therefore, use in children is not recommended.
Infants should be avoided from coming into contact with any area of skin to which the drug has been applied.
The ability to influence the reaction speed when driving vehicles or working with other mechanisms. Does not affect.
Lamikon Dermgel: Lamikon Dermgel should be used with caution in lesions where alcohol may cause irritation during treatment.
The drug is intended for external use only. May cause irritation if in contact with eyes. If the gel accidentally gets into the eyes, rinse them thoroughly with running water; if irritation persists, consult a doctor. Do not apply to the face.
To prevent reinfection with skin mycoses, the following rules must be followed: change underwear daily, as there may be fungus on clothes that have been in contact with infected skin surfaces; avoid wearing clothes that are too tight or poorly permeable to air; thoroughly dry the affected areas of the skin after washing; use a clean individual towel daily. With foot mycoses, you cannot 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 Dermgel contains butylhydroxytoluene, which may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
Use during pregnancy and breastfeeding. Animal studies have not shown any embryotoxic effects of terbinafine. Since clinical experience with the use of terbinafine gel in women during pregnancy is limited, Lamikon Dermgel should not be used in pregnant women, except in cases where, in the opinion of the physician, the expected benefit of the drug for the mother outweighs the potential risk to the fetus.
Terbinafine passes into breast milk in small amounts, so the drug should not be used during breastfeeding. Direct contact of newborns with any area of skin to which the drug has been applied should be avoided.
Children. Due to insufficient experience, the use of Lamikon Dermgel in children is not recommended.
The ability to influence the reaction speed when driving vehicles or working with other mechanisms. Does not affect.
Interactions
Interactions are unknown, but as a precaution, other medications should not be used on treated areas.
Overdose
Lamikon cream: the low systemic absorption of terbinafine when applied topically makes overdose extremely unlikely. Accidental ingestion of the contents of two 30 g tubes (containing 300 mg of terbinafine hydrochloride) is comparable to ingestion of 1 Lamikon 250 mg tablet (oral dosage form). In case of accidental ingestion of a large amount of cream, side effects should be similar to those seen with an overdose of Lamikon tablets (headache, nausea, epigastric pain and dizziness).
Treatment of overdose in case of accidental ingestion consists of removing the active substance, primarily by taking activated charcoal, and providing symptomatic therapy if necessary.
Lamikon cutaneous spray: The low systemic absorption of terbinafine when applied topically makes overdose extremely unlikely. Accidental ingestion of the contents of one bottle of Lamikon cutaneous spray 25 g (containing 250 mg of terbinafine hydrochloride) is comparable to ingestion of one Lamikon 250 mg tablet (oral dosage form). In case of accidental ingestion of a larger amount of Lamikon cutaneous spray, side effects should be similar to those of an overdose of Lamikon tablets (headache, nausea, epigastric pain and dizziness).
Treatment of overdose in case of accidental ingestion consists of removing the active substance, primarily by taking activated charcoal, and providing symptomatic therapy if necessary.
Treatment of overdose by accidental ingestion consists of removing the active substance, primarily by administering activated charcoal, and providing symptomatic therapy if necessary.
Storage conditions
In the original packaging at a temperature not exceeding 25 °C. Freezing is not allowed.
