Lamisil Uno solution for external use 4 g
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Active ingredients
Terbinafin
Release form
Solution
Composition
Sterile isotonic saline without preservatives (saline). Contains sodium chloride 0.74%, also sodium hydrogen phosphate, sodium phosphate, macrogol glyceryl ricinoleate (cremophor RH40) and purified water.
Pharmacological effect
Terbinafine (an allylamine derivative) is an antifungal drug for topical use, which has a wide spectrum of antifungal activity. In low concentrations, terbinafine has a fungicidal effect against dermatophytes (Trychophyton rubrum, T.mentagrophytes, T.verrucosum, T.violaceum, T. tonsurans, Microsporum canis, Epidermophyton floccosum), mold (mainly C. albicans) and certain dymorphic fungi ( Pityrosporum orbiculare or Malassezia furfur). Activity against yeast fungi, depending on their species, can be fungicidal or fungistatic. Terbinafine in a specific way changes the early stage of sterol biosynthesis occurring in fungi. This leads to a deficiency of ergosterol and to the 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. Squalene epoxidase is not associated with the cytochrome P450 system. Terbinafine does not affect the metabolism of hormones or other drugs.
Pharmacokinetics
After applying the Lamisil Uno solution to the skin, the drug forms a transparent, imperceptible film that remains on the skin for 72 hours. From the film, terbinafine quickly penetrates the horny layer of the skin: 60 minutes after the procedure, 16-18% of the applied dose is found in the stratum corneum. The release of terbinafine is progressive, the active substance is present in the stratum corneum after 13 days at a concentration greater than the minimum inhibitory concentration of terbinafine in vitro with respect 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 recurrence rate after 3 months of the drug is low (not higher than 12.5%).
Indications
Mycoses (dermatophytes) of the feet (“fungus” of the foot, Tinea pedis).
Contraindications
Hypersensitivity to terbinafine or to any of the inactive ingredients that make up the drug.
Precautionary measures
With caution: hepatic and / or renal failure, alcoholism, inhibition of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive vascular diseases of the extremities, children under 15 years of age (lack of sufficient clinical experience).
Use during pregnancy and lactation
In experimental studies, the teratogenic properties of terbinafine have not been identified. To date, no developmental disabilities have been reported with Lamisil Uno. However, since the clinical experience with Lamisil Uno in pregnant women is very limited, it should be used only under strict indications. Terbinafine is excreted in breast milk, so the drug should not be prescribed to nursing mothers.
Dosage and administration
Outwardly. Adults and teenagers from 15 years: The drug is intended for the treatment of foot fungus in a single application. Lamisil Uno film-forming solution is applied once on both feet, even if the fungal infection is observed only on one foot. This ensures the destruction of fungi (dermatophytes), which may be located in areas of the foot, where the lesions are not visually noticeable. Before applying the product, wash and dry the feet and hands. First one foot is processed, then the other. Starting the procedure on the interdigital areas, a thin layer should be applied evenly between the fingers and around the 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 preparation to cover the required skin surface, usually 1 / 2 tubes for each foot. In the same way, the other foot should be treated, even if the skin on it looks healthy. Dry the solution for 1-2 minutes before film formation. After the end of the treatment, stop the hands. Do not reapply the treated skin. Lamisil Uno should not be rubbed into the skin.
Side effects
With the use of Lamisil gel, systemic and local adverse reactions rarely develop. Local symptoms include redness, itching and burning on the treated area. Systemic side effects include rash and redness, urticaria, angioedema. With the development of systemic side effects, it is necessary to stop the course of treatment.
Overdose
No cases of drug overdose have been reported. If you take Lamisil Uno by accident, you can expect the development of the same side effects as with an overdose of Lamisil pills (headache, nausea, epigastric pain and dizziness). Overdose is unlikely, since the drug is produced in the quantity required for a single use and is intended for outdoor use. First aid: activated carbon, if necessary - symptomatic therapy in the hospital.
Interaction with other drugs
Drug interactions for Lamisil Uno are not known.
special instructions
Lamisil Uno is not recommended for chronic plantar hyperkeratosis caused by Tinea pedis (moccasin type / moccasin type). Lamisil Uno is 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 eyes, rinse thoroughly with running water. The drug can not be taken orally! If an allergic reaction to the drug develops, the film should be removed with an organic solvent (for example, denatured alcohol) and then washed with soap and water on the feet. With the development of allergic reactions necessary to cancel the drug. For best results, the treated area should not be washed within 24 hours after the procedure. Therefore, Lamisil Uno is recommended to apply after taking a shower or bath and the next day wash your feet again at the same time. You should use the amount of the drug, which is required for applying the film on both feet, performing the procedure according to the method described above (see the section "Method of application"). Unused residue should be destroyed. Improvement in clinical symptoms is usually observed within a few days. If after a week there are no signs of improvement, you should consult a doctor.