LAMIZIL UNO

Active material: Terʙinafin
When ATH: D01AE15
CCF: Antifungal agents for external use
ICD-10 codes (testimony): B35.3
When CSF: 08.02.02
Manufacturer: NOVARTIS CONSUMER HEALTH S.A. (Switzerland)

Pharmaceutical form, composition and packaging

◊ The solution is for external use film-forming 1% Transparent or slightly matte, Coupling, colorless to pale yellow, with the smell of ethanol.

Excipients: acrylic acid copolymer and octylacrylamide (Dermakril 79), medium-chain triglycerides, giproloza, ethanol 96%.

4 g – Laminated tubes (1) control system of the first opening – packings Valium planimetric (1) – packs cardboard with “window”.

Pharmacological action

Antifungal agents for external use, allylamine derivative. It has a wide range of antifungal activity. At low concentrations terbinafine It has fungicidal action against dermatophytes Trichophyton (incl. Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violet, Trichophyton tonsurans), Microsporum canis и Epidermophyton floccosum, mold (mostly Candida albicans) and certain dimorphic fungi (Flea-circular или Malassezia bran). Activity against yeast, depending on the species, It may be fungicidal or fungistatic.

Terbinafine specific changes the early stage of the biosynthesis of sterols, what is happening in mushrooms. This leads to a deficiency of ergosterol and to an intracellular accumulation of squalene, causing cell death fungus. Step terbinafine accomplished by inhibition of the enzyme squalene epoxidase, located on the cell membrane of the fungus. Squalene epoxidase is not associated with the cytochrome P450. Terbinafine does not affect the metabolism of hormones or other drugs.

Pharmacokinetics

After applying the drug Lamisil^® Uno skin forms a transparent solution imperceptible film, which remains on the skin for 72 no. From the film terbinafine quickly penetrates the stratum corneum: through 60 minutes after treatment 16-18% applied dose is found in the stratum corneum. The release of terbinafine is progressive in nature, the active substance is present in the stratum corneum through 13 days in a concentration, higher than the minimum inhibitory concentration of terbinafine in vitro against dermatophytes.

Systemic bioavailability is extremely low. For external use less absorption of the drug 5%. Lamizil^® Uno has little systemic effects.

The level of recurrence after 3 months of the drug is low (not higher 12.5%).

Testimony

- Mycosis (tinea) stop (foot moth).

Dosage regimen

The drug is used topically, single.

Adults and adolescents over the age of 15 years coating solution Lamisil^® Uno is applied 1 times on both feet, even if the fungal infection is observed only on one foot. This ensures the destruction of fungi (dermatofitov), that may be present in areas of the foot, where defeat is not visually noticeable.

Before applying the drug should wash and dry your feet and hands. First, treated one foot, then another. Since the procedure in the interdigital areas, should apply a thin layer evenly between the fingers and around the whole of their surface, as well as on the sole and sides of the foot up to a height 1.5 cm. Use a sufficient amount of the drug, necessary to cover the surface of the skin, usually 1/2 tubes for processing each foot.

Likewise, it should be processed and the other foot, even if the skin looks healthy on it. Dry the solution over a period 1-2 min to form a film. After processing the stop should wash their hands.

Do not apply the drug repeatedly treated skin. Lamizil^® Uno should not be rubbed into the skin.

Side effect

Side effects are very rare, mild and are short-lived.

Systemic reactions: rarely (< 1/10 000) – allergic reactions (rash, redness, bullous dermatitis and urticaria).

Local reactions: rarely (>1/1 000, < 1/100) – dryness, skin irritation or burning sensation in the treated area of ​​skin preparation.

Contraindications

- Hypersensitivity to terbinafine or any of the inactive ingredients, members of the drug.

FROM caution should be prescribed the drug for liver and / or kidney failure, alcoholism, suppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive vascular diseases of extremities, as well as children under the age of 15 years (due to the lack of sufficient clinical experience).

Pregnancy and lactation

Clinical experience with Lamisil^® Uno in pregnancy is very limited, so the product can be used only on strict conditions.

Known, that terbinafine is excreted in breast milk, so the drug should not be administered during breastfeeding.

IN experimental studies teratogenic properties of terbinafine is not revealed. So far, no reports of any malformation when using Lamisil^® Uno.

Cautions

Lamizil^® Uno is not recommended in the case of chronic plantar hyperkeratosis, caused by Tinea pedis (mokassinovogo type).

Lamizil^® Uno is designed for external use only. The drug should not be applied on the skin, it can cause eye irritation. In case of accidental contact with eyes, they should be rinsed thoroughly under running water. The drug can not be taken orally!

In the case of an allergic reaction to the drug film must be removed with an organic solvent (eg, denaturirovannыy alcohol) and then rinsed with water and soap foot.

With the development of allergic reactions need to stop the drug.

For best results, the treated area should not be washed for 24 hours after treatment. Therefore, Lamisil^® Uno is recommended to apply after taking a shower or bath, and again the next day to wash his feet at the same time.

Use an amount of drug, it will take for the application of the film on both feet, performing the procedure to the above procedure. The unutilized balance of the drug should be destroyed.

Improvement of clinical symptoms usually occurs within a few days. If a week is no sign of improvement, should verify the diagnosis.

There is no evidence, that the treatment of elderly patients require different dosages or other side effects occur, than in younger patients.

Use in Pediatrics

Effect of the drug Lamisil^® Uno in pediatric patients has not been studied. Therefore it is not recommended to use the drug in children under the age of 15 years.

Effects on ability to drive vehicles and management mechanisms

For external use Lamisil^® Uno does not affect the ability to drive or perform work arrangements.

Overdose

No cases of overdose were reported. Overdose is unlikely, because the drug is produced in quantity, necessary for single use and is designed for outdoor use.

Symptoms: Accidental admission into possible drug headache, nausea, epigastric pain and dizziness.

Treatment: appointment of activated carbon, if necessary spend symptomatic therapy in hospital.

Drug Interactions

Currently, drug interactions Lamisil^® Uno not known.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug should be stored at a temperature no higher than 30 ° C in the original packaging of the reach of children. Shelf life – 3 year.