Instructions for Lamikon cream 1% tube 15 g
Composition
active ingredient: terbinafine;
1 g of cream contains terbinafine hydrochloride calculated as 100% anhydrous substance – 0.01 g;
Excipients: phenylethyl alcohol, white soft paraffin, mineral oil, cetostearyl alcohol, polyethylene glycol (macrogol) 20 cetostearyl ether, propylene glycol, poloxamer 407, sodium hydroxide, purified water.
Dosage form
Cream.
Main physicochemical properties: white or almost white cream with a specific odor.
Pharmacotherapeutic group
Antifungal drugs for topical use.
ATX code D01A E15.
Pharmacological properties
Pharmacodynamics
Terbinafine is an allylamine and has a broad spectrum of antifungal activity. Terbinafine in low concentrations has a fungicidal effect on dermatophytes, molds and some dimorphic fungi. The activity against yeast fungi, depending on their species, can be fungicidal or fungistatic. The drug has a long-lasting effect, which allows you to achieve an effect in a short period of treatment.
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 hormonal agents or other drugs.
Pharmacokinetics
When applied topically, less than 5% of the dose is absorbed, so the absorption of terbinafine into the systemic bloodstream is insignificant.
Terbinafine has a rapid onset of action and is effective for short-term treatment (7 days). After 7 days of treatment with Lamikon® cream, terbinafine concentrations exceeding those required for fungicidal activity are present in the stratum corneum of the epidermis for at least 7 days after discontinuation of treatment.
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; tinea versicolor (pityriasis versicolor) caused by Pityrosporum orbiculare (also known as Malassezia furfur).
Contraindication
Hypersensitivity to terbinafine or to any of the components of the drug.
Interaction with other medicinal products and other types of interactions
Unknown.
Application features
The cream is for external use only. Avoid contact with the eyes as the medicine may cause eye irritation. If the cream accidentally gets into the eyes, rinse them thoroughly with running water. Lamikon® cream contains cetostearyl alcohol, which may cause local skin irritation (e.g. contact dermatitis).
Lamikon®, cream, contains propylene glycol, which may cause skin irritation.
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 personal 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.
In animal studies, no effect of terbinafine on fertility was observed.
Use during pregnancy or breastfeeding
In animal studies, no embryotoxic effects of terbinafine were observed. Since clinical experience of the drug in women during pregnancy is limited, Lamikon® cream should not be used in pregnant women, except in cases where, in the opinion of the physician, 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 by women during breastfeeding. Infants should be avoided from contact with the skin on which the cream has been applied, including the mammary glands.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
The cream is intended for external use only.
Adults and children aged 12 and over.
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.
Interdigital tinea versicolor, inguinal tinea versicolor and tinea versicolor of the trunk: once a day for 1 week;
squamous-hyperkeratotic dermatophytosis of the feet ("moccasin foot"): 2 times a day for 2 weeks;
skin candidiasis: 1-2 times a day for 1 week;
lichen planus: 1-2 times a day for 2 weeks.
No dose adjustment is necessary for elderly patients.
Relief of symptoms usually occurs 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.
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.
Overdose
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 tablet of Lamikon® 250 mg (oral dosage form). In case of overdose due to accidental ingestion of a large amount of cream, side effects should be similar to those of Lamikon® tablets (headache, nausea, epigastric pain and dizziness).
Treatment of overdose by accidental ingestion consists of removing the active substance, primarily by taking activated charcoal, and providing symptomatic therapy if necessary.
Side effects
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 hydrochloride may cause eye irritation. In rare cases, latent fungal infections may be exacerbated.
Possible side effects:
On the part of the immune system
Frequency not known (cannot be estimated from the available data): hypersensitivity reactions, including urticaria*. In isolated cases, angioedema and anaphylactic shock.
From the organs of vision
Uncommon (≥ 1/10,000, < 1/1,000): eye irritation.
Skin and connective tissue disorders
Common (≥ 1/100, < 1/10): skin peeling, itching.
Uncommon (≥ 1/1000, < 1/100): skin damage, crusting, skin lesion, pigmentation disorder, erythema, burning sensation of the skin.
Rare (≥ 1/10,000, < 1/1,000): dry skin, contact dermatitis (including bullous dermatitis), eczema.
Frequency not known (cannot be estimated from the available data): rash* or blistering.
General disorders and administration site conditions
Uncommon (≥ 1/1000, < 1/100): pain, application site pain, application site irritation.
Rare (≥ 1/10,000, < 1/1,000): worsening of symptoms.
* Data obtained through post-marketing surveillance.
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ° C. Do not freeze the drug. Keep out of the reach of children.
Packaging
15 g in a tube. 1 tube in a pack.
Vacation category
Without a prescription.
Producer
JSC "Farmak".
Address
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
