Description
Briefly about the product
Lamisil cream is used to prevent and treat fungal infections of the skin, including foot fungus. The active substance of the cream Lamisil terbinafine has a fungicidal effect by which it fights against an infection that causes foot fungus (mycosis). *
Suitable for use in adults and children from 12 years old. *
* Medical instruction, RU No Рџ N008851 dated 10.06 .2010
Description
Cream for external use is white, uniform or almost uniform, smooth, with a faint characteristic odor.
Latin name
Lamisil
release form
Cream for external use
Pharmacological action
Antifungal drug for external use with a wide spectrum of antifungal activity. In small concentrations, terbinafine has a fungicidal effect against dermatophytes (Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violaceum, Trychophyton tonsurans, Microsporum canis, Epidermophyton floccosum), mold (mainly Candida albicoricum fungi) and fungi.
Activity against yeast fungi, depending on their type, can be fungicidal or fungistatic.
Terbinafine specifically modifies the early stage of sterol biosynthesis in fungi. This leads to a deficiency of ergosterol and to intracellular accumulation of squalene, which causes the death of the fungal cell. The action of terbinafine is carried out by inhibiting the enzyme squalene epoxidase located on the cell membrane of the fungus.
Terbinafine does not affect the human cytochrome P450 system and, accordingly, the metabolism of hormones or other drugs.
Indications
Prevention and treatment of fungal infections of the skin: foot mycoses (tinea pedis) keratinization, cracks, itching and peeling of the skin caused by foot fungus inguinal epidermophytosis (tinea craris), fungal infections of smooth skin of the body (tinea corporis) caused by such dermatitis like Trichophyton (including T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum yeast infections of the skin, mainly those caused by Candida fungi (e.g. Candida albicans), in particular, diaper rash, versicolor (Pityriasis versicolor), called Pityrosporum orbiculare (Malassezia furfur).
Contraindications
Hypersensitivity to terbinafine or to any of the inactive ingredients in the preparation, breast-feeding period, children up to 12 years.
Recommendations for the use of
With caution, the drug is prescribed for patients with hepatic and / or renal failure, patients with chronic alcoholism, with suppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive vascular disease of the limbs.
Use during pregnancy and lactation
Since the clinical experience with Lamisil® cream in pregnant women is very limited, it should not be used, unless absolutely necessary. During pregnancy, the drug is used only if the intended benefit to the mother outweighs the potential risk to the fetus. It is necessary to consult a doctor.
In experimental studies of teratogenic properties of terbinafine have not been identified. To date, no malformations have been reported with the use of Lamisil®.
Terbinafine is excreted in breast milk, therefore, the drug should not be prescribed to nursing mothers. The baby should not be allowed to come into contact with any skin surface treated with Lamisil®.
Special instructions
A decrease in the severity of clinical manifestations is usually observed in the first days of treatment. In the case of irregular use or premature termination, there is a risk of recurrence of infection.
The drug is intended for external use only.
Avoid contact with eyes. it can cause irritation. In case of accidental contact with eyes, rinse immediately with running water, and if persistent irritation develops, consult a doctor.
With the development of allergic reactions, it is necessary to cancel the drug.
Lamisil® Cream for external use contains cetyl and stearyl alcohols, which can cause local allergic reactions in the places of application (contact dermatitis).
Caution should be exercised when applying Lamisil® Spray to damaged skin, as ethanol, which is part of it, can cause irritation. Lamisil® Spray is for external use only. Do not use Lamisil® Spray for application to the face. If Lamisil® spray was accidentally introduced into the respiratory tract during inhalation, then in case of any symptoms and especially with their persistence, it is necessary to consult a doctor. Lamisil® Spray contains propylene glycol, which in some cases can cause skin irritation. It should also be borne in mind that the drug contains 96% ethanol.
Impact on ability to drive vehicles and mechanisms
Not affected.
Composition
1 g of cream contains:
Active substance:
terbinafine hydrochloride 10 mg
Excipients:
benzyl alcohol
sodium hydroxide
sorbitan stearate
cetyl palmitate
stearyl alcohol
cetyl alcohol
polysorbate 60
isopropyl myristate
purified water.
Dosage and administration
In adults and children 12 years and older, Lamizil® cream can be applied 1 or 2 times / day, depending on the indication. Before using the drug, it is necessary to thoroughly clean and dry the affected areas. The cream is applied with a thin layer on the affected skin and adjacent areas and slightly rubbed. In the case of infections accompanied by diaper rash (under the mammary glands, in the interdigital spaces, between the buttocks, in the inguinal region), the place of application of the cream can be covered with gauze, especially at night.
It is recommended to apply cream in tubes of 30 g for extensive fungal lesions of the body.
The average duration of treatment and the multiplicity of use of the drug in dermatomycosis of the trunk, shins is 1 week 1 time / day for dermatomycosis of the feet – 1 week 1 time / day for keratinization, cracks, itching and peeling of the skin caused by foot fungus – 2 weeks 1-2 times / day for skin candidiasis – 1-2 weeks 1-2 times / day for multi-colored deprivation – 2 weeks 1-2 times / day.
Decrease in clinical manifestations is usually observed in the first days of treatment. With irregular use or premature discontinuation of treatment, there is a risk of recurrence of infection. In the absence of signs of improvement after 1-2 weeks of therapy, the diagnosis should be verified.
Lamizil® cream dosage adjustment is not required in elderly patients.
Side effects
Determination of the incidence of adverse effects (WHO): very common ( 1/10), often ( 1/100 and <1/10), infrequent ( 1/1000 and <1/100), rare ( 1/10 000 and <1/1000), very rare (<1/10 000), including individual messages. From the immune system: separate reports – hypersensitivity reactions (rash). From the eye: Rare – eye irritation. From the skin: often – skin peeling, itching infrequently – skin damage, crust formation, skin damage, pigmentation disorder, erythema, skin burning sensation rarely – skin dryness, contact dermatitis, eczema separate messages – rash. Local reactions: infrequently – pain, pain at application site, irritation at application site rarely – exacerbation of disease symptoms. In places of application of the drug itching can be observed, peeling of the skin, pain, irritation, change of skin pigmentation, burning, erythema, crust. These minor symptoms should be distinguished from hypersensitivity reactions such as a rash that occur in rare cases and require treatment discontinuation. In rare cases, the course of the fungal infection can be exacerbated. If any of these side effects are exacerbated, or if the patient has noticed any other side effects, tell your doctor. Drug Interactions Currently, the drug interaction of Lamisil® is unknown. Overdose No cases of overdose of Lamizil® have been reported. Symptoms: Accidental ingestion of 30 ml of Lamizil® spray containing 300 mg of terbinafine hydrochloride is comparable to taking 1 tablet of the drug Lamizil® with a dosage of 250 mg (single dose for an adult). If you accidentally take more Lamizil® spray inside, you can expect the development of the same side effects as you overdose on Lamizil® tablets (headache, nausea, epigastric pain and dizziness). It should also be noted that the spray contains ethyl alcohol (28.87% (v / v). Treatment: activated charcoal, if necessary, conduct symptomatic therapy. active substance active substance Terbinafine
