Instructions for use Lamikon cutaneous spray 1% bottle 25 g
Composition
active ingredient: terbinafine;
1 g of solution contains terbinafine hydrochloride, calculated as 100% anhydrous substance, 10 mg;
Excipients: benzoic acid (E 210), polyethylene glycol (macrogol) 20 cetostearyl ether, propylene glycol, poloxamer 407, disodium edetate, water for injections.
Dosage form
Skin spray.
Main physicochemical properties: the drug at the exit from the bottle is sprayed in the form of an aerosol jet, which is liquid particles dispersed in the air.
Pharmacotherapeutic group
Antifungal drugs for topical use. Terbinafine. ATX code D01A E15.
Pharmacological properties
Pharmacodynamics
Terbinafine is an allylamine with a broad spectrum of antifungal activity. Terbinafine, at appropriate concentrations, has fungicidal activity against dermatophytes, molds, and some dimorphic fungi. Its activity against yeasts, depending on the species, can be fungicidal or fungistatic.
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 causes 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, the drug is almost not absorbed, begins to act quickly, and is effective with short-term treatment (7 days).
When applied topically, less than 5% of the applied dose is absorbed, so systemic exposure to terbinafine is negligible.
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. interdigital tinea pedis ("athlete's foot"), inguinal tinea ("jock itch"), truncal tinea ("ringworm"). Tinea versicolor caused by Pityrosporum orbiculare (also known as Malassezia furfur).
Contraindication
Hypersensitivity to terbinafine and other components of the drug.
Interaction with other medicinal products and other types of interactions
Unknown.
Application features
For external use only. 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 follow 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 personal 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.
LamikonÒ, cutaneous spray contains propylene glycol, which may cause skin irritation.
LamikonÒ, cutaneous spray contains benzoic acid, which may be moderately irritating to the skin, eyes, and mucous membranes.
Animal studies have not shown any effect of terbinafine on fertility.
Use during pregnancy or breastfeeding
Animal studies have not revealed any embryotoxic effects of terbinafine. Clinical experience in pregnant women is limited, therefore, during pregnancy, LamikonÒ, cutaneous spray, can be used only if the expected benefit to the woman outweighs the potential risk to the fetus.
Terbinafine passes into breast milk in small amounts, so the drug should not be used by women who are breastfeeding.
Infants should be avoided from coming into contact with any area of skin to which the drug has been applied.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
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.
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;
- multi-colored lichen - 2 times a day for a week.
No dose adjustment is necessary for elderly patients.
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.
Children
Safety and effectiveness in children have not been established, therefore the drug is not recommended for use in children.
Overdose
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 formulation). In the event of accidental ingestion of larger amounts of Lamikon® cutaneous spray, adverse 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.
Adverse reactions
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 occur at the application site. These minor symptoms 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 hydrochloride may cause eye irritation. In rare cases, latent fungal infections may be exacerbated.
Possible side effects:
Immune system disorders: hypersensitivity reactions, including urticaria;
From the organs 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.
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in original packaging at a temperature not exceeding 25 °C. Do not freeze. Keep out of the reach of children.
Packaging
25 g in a bottle with a pump dispenser. 1 bottle in a pack.
Vacation category
Without a prescription.
Producer
PJSC "Farmak".
Location of the manufacturer and its business address
Ukraine, 04080, Kyiv, Frunze St., 74.
