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. *
* Instructions for medical use, RU No Ñ N008851 dated 06/10/2010
Description
Cream for external use is white, uniform or almost uniform, smooth, with a faint characteristic odor.
Latin name
Lamisil
Product form
Cream for external use
Packaging
tube 15 g
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 ergosterol deficiency 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 dermatophytes such as Trichophyton (including T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum yeast infections of the skin, mainly those caused by fungi of the genus Candida (for example, Candida albicans), in particular, diaper rash, multicolored lichen (Pityriasis versicolor), caused by Pityrosporum orbiculare (Malassezia furfur).
Contraindications
Hypersensitivity to terbinafine or to any of the inactive ingredients that make up the drug during breast-feeding for children under 12 years of age.
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 diseases of limb vessels.
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 early 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 (contact dermatitis) at the application sites.
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 Containing :
Act vnoe substances:
terbinafine hydrochloride 10 mg
Vspomohateln e substance:
benzyl alcohol
sodium hydroxide
sorbitan stearate
cetyl palmitate
stearyl alcohol
cetyl alcohol
polysorbate 60
isopropyl myristate
water purified
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 rubbed lightly. 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.
In case of extensive fungal lesions of the body, it is recommended to apply the cream in tubes of 30 g. itching and peeling of the skin caused by the fungus of the foot – 2 weeks 1-2 times / day for skin candidiasis – 1-2 weeks 1-2 times / day for multicolored 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.
Dosage interaction
Currently drug interaction of the drug Lamizil ® 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 Lamizil ® 250 mg dose (single dose for an adult).
If you accidentally take more Lamizil ® spray inside, you can expect the development of the same side effects as with the overdose of 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.
Storage conditions
At a temperature not exceeding 30 ° C (do not freeze).
Expiration
Expiration
3 years
