Lamisil UNO for the treatment of foot fungus, solution, 1% 4g

Product description

Lamisil Uno is designed to treat foot fungus in just one application. * The unique Lamizil Uno formula ensures that terbinafine stays in the stratum corneum of the skin for up to 13 days after application. During this time, terbinafine fights the infection that causes foot fungus (mycosis). ** Instructions for medical use, RU No LSR-003583/07 from 06.11.2007

Composition

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of 1 g of the solution contains:

Active ingredient:

terbinafine hydrochloride 10 mg;

Auxiliary substances:

macrogol cetostearyl ether,

ethanol,

purified water, propylene glycol, nitrogen.

Pharmacological action

Antifungal drug for external use, which has 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 albicans) and some dimorphic fungi (Pityrosporum orbiculare). Activity against yeast fungi, depending on their type, can be fungicidal or fungistatic. Terbinafine specifically alters the early stage of sterol biosynthesis occurring in fungi. This leads to ergosterol deficiency and intracellular squalene accumulation, which causes fungal cell death. The action of terbinafine is carried out by inhibiting the squalene oxidase enzyme located on the cell membrane of the fungus. Squalene oxidase is not associated with the cytochrome P450 system. Terbinafine does not affect the metabolism of hormones or other medications.

Clinical pharmacology

After applying Lamizil® When applied to the skin, the solution forms a transparent, imperceptible film that remains on the skin for 72 hours. From the film, terbinafine quickly penetrates the stratum corneum of the skin: 60 minutes after the procedure,16-18% of the applied dose is detected in the stratum corneum. The release of terbinafine is progressive, the Active ingredient is present in the stratum corneum after 13 days in a concentration exceeding the minimum inhibitory concentration of terbinafine in vitro in relation to dermatophytes. Systemic bioavailability is extremely low. When applied topically, the absorption of the drug is less than 5%. Lamisil® Uno has a minor systemic effect. The rate of relapses after 3 months of using the drug is low (not higher than 12.5%).

Indications

Mycoses (dermatophytosis) of the feet (tinea pedis).

Use during pregnancy and lactation

Clinical experience with Lamizil® Uno for external use during pregnancy is very limited, the drug should be used only for strict indications. Terbinafine is excreted in breast milk, so the drug should not be prescribed to nursing mothers. No teratogenic properties of terbinafine were found in experimental studies. To date, no malformations have been reported with Lamizil® Uno.

Contraindications

Hypersensitivity to the components of the drug.

With caution: Hepatic and / or renal insufficiency, alcoholism, suppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive vascular diseases of the extremities, children under 15 years of age (lack of sufficient clinical experience).

Side effects

Side effects are extremely rare, mild and short-term in nature. Systemic reactions: very rare (Local reactions: rare (>1/1000, >

Interaction

Currently, the drug interaction of Lamizil® Uno is not known.

How to take, course of use and dosage

The drug is used externally, once. Lamizil®film-forming solution for adults and adolescents over 15 years of age Uno is applied 1 time to both feet, even if the fungal lesion is observed only on one foot. This ensures the destruction of fungi (dermatophytes), which can be located on the areas of the foot where the lesions are not visually noticeable. Before applying the drug, wash and dry your feet and hands. First, one stop is processed, then the other. Starting the procedure on the interdigital areas, apply a thin layer evenly between the fingers and around their entire surface, as well as on the sole and sides of the foot to a height of 1.5 cm. Use a sufficient amount of the drug to cover the required surface of the skin, usually 1/2 tube for each foot treatment. The other foot should also be treated in the same way, even if the skin on it looks healthy. Dry the solution for 1-2 minutes until a film is formed. After finishing the treatment of the feet, wash your hands. Do not apply the product again on the treated skin. Lamisil® Uno should not be rubbed into the skin.

Overdose

No overdose cases have been reported. Overdose is unlikely, since the drug is available in the amount required for a single application and is intended for external use. Symptoms: if the drug is accidentally taken orally, headache, nausea, epigastric pain and dizziness may occur. Treatment: use of activated charcoal, if necessary, conduct symptomatic therapy in a hospital setting.

Description

Solution for external use film-forming 1% transparent or slightly opaque, viscous, from colorless to light yellow, with an ethanol smell.

Special instructions

Lamisil® Uno is not recommended for use in cases of chronic plantar hyperkeratosis caused by Tinea pedis (moccasin type). Lamisil® Uno is intended for external use only. The drug should not be applied to the skin of the face, it can cause irritation of the mucous membrane of the eyes. In case of accidental contact with the eyes, they should be thoroughly rinsed with running water. The drug should not be taken orally!If you develop an allergic reaction to the drug, remove the film with an organic solvent (for example, denatured alcohol) and then wash the feet with soap and water. If allergic reactions develop, the drug should be discontinued. For best results, the treated area should not be washed for 24 hours after the procedure. Therefore, Lamisil® Uno is recommended to be applied after taking a shower or bath and wash your feet again at the same time the next day. You should use the amount of the drug that is required to apply the film on both feet, performing the procedure described above. The unused remainder of the drug should be destroyed. Improvement in clinical symptoms is usually observed within a few days. If there are no signs of improvement after a week, the diagnosis should be verified. There is no evidence that the dosage regimen needs to be adjusted in the treatment of elderly patients, and other side effects occur than in younger patients. Use in pediatricsaction of Lamizil® Uno has not been studied in pediatric practice. Therefore, it is not recommended to use the drug in children under the age of 15 years. Effect on the ability to drive vehicles and mechanisms when applied externally with Lamisil® Uno does not affect the ability to drive vehicles or work with mechanisms.

Form of production

Solution for external use

Storage conditions

At temperatures below 30°C

Shelf life

3 years

Active ingredient

Terbinafine

Dosage form

solution for external use