pharmachologic effect
The use of terbinafine in small concentrations provides a fungicidal effect against dermatophytes, molds and some dimorphic fungi. It also demonstrates activity relative to yeast fungi, depending on their type; the effect can be fungicidal or fungistatic.
Terbinafine biosynthesis process that occurs in fungi. As a result, there is a lack of ergosterol and accumulation of squalene inside the cells. As a result, the fungal cell dies. Terbinafine acts by inhibiting the enzyme squalene epoxidase, which is located on the fungal cell membrane. This enzyme is not related to the cytochrome P450 system. The active substance of Lamisil Uno does not affect the metabolism of hormones or other drugs .
Note!
Description of the drug Lamisil Uno solution for skin. 1% tube 4g on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.
Pharmacokinetics and pharmacodynamics
After the solution is applied to the skin, a transparent film is formed that remains on the skin for 72 hours. Terbinafine, which is in the film, is quickly absorbed into the stratum corneum of the dermis. Approximately 16–18% of the dose applied to the skin is detected in the stratum corneum of the skin after 60 minutes. The process of release of the active substance is progressive.
Systemic bioavailability is negligible; when applied topically, it is less than 5%. After three months of using the drug, there is a low rate of relapses - no more than 12.5%.
Lamisil UNO for the treatment of foot fungus, solution 1% 4g
A country
Switzerland
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.
Active substance
Terbinafine
Description
Lamisil Uno is designed to treat foot fungus in just one application.* The unique formula of Lamisil Uno ensures that terbinafine remains in the stratum corneum of the skin for up to 13 days after application. During this time, terbinafine fights the infection that causes fungus (mycosis) of the foot.* * Instructions for medical use, RU No. LSR-003583/07 dated 06.11.2007
Compound
Composition per 1 g of solution: Active ingredient mg/g: Terbinafine hydrochloride (corresponds to terbinafine base) 11.25 (10.00) Excipients: Acrylic acid and octylacrylamide copolymer (Dermacryl 79) 50.00 Medium chain triglycerides 50.00 Hyprolose 25 .00 Ethanol 96% vol. 863.75
Product description
A clear or slightly matte viscous solution from colorless to light yellow with an ethanol odor.
pharmachologic effect
Terbinafine (allylamine derivative) is an antifungal drug for external use with a wide spectrum of antifungal activity. In small concentrations, terbinafine has a fungicidal effect against dermatophytes (Trychophyton rubrum, T.mentagrophytes, T.verrucosum, T.violaceum, T.tonsurans, Microsporum canis, Epidermophyton floccosum), yeast (mainly Candida albicans) and certain dimorphic fungi (Pityrosporum orbiculare or Malassezia furfur). 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 accumulation of squalene, which causes the death of the fungal cell. Terbinafine acts 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. Absorption: With a single application of the film-forming solution on the back, over an area 3 times the area of both feet, terbinafine exposure was less than 0.5% of the exposure after oral administration of a terbinafine 250 mg tablet, thus systemic bioavailability is very low. The relapse rate after 3 months of using the drug is low (not higher than 12.5%). Distribution After applying the film-forming solution to the skin, a transparent, imperceptible film is formed, which remains on the skin for 72 hours. From the film, terbinafine quickly penetrates into the stratum corneum of the skin: 60 minutes after application, 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 in a concentration exceeding the minimum inhibitory concentration of terbinafine in vitro against dermatophytes. Special Patient Populations The pharmacokinetics of terbinafine in the stratum corneum is unlikely to vary in special patient populations. Any effect of special patient populations on systemic pharmacokinetics is also unlikely to be clinically significant due to the very low concentrations of terbinafine that are detected after topical administration.
Indications for use
Mycoses (dermatophytosis) of the feet (“fungus” of the foot, Tinea pedis
Contraindications
The drug Lamisil Uno is not recommended for patients: - with hypersensitivity to terbinafine or to any of the components of the drug; - during breastfeeding; - children under 15 years of age due to insufficient data on effectiveness and safety.
Carefully
If you have one of the following diseases/conditions/risk factors, be sure to consult your doctor before taking the drug: - liver and/or kidney failure; - alcoholism; - inhibition of bone marrow hematopoiesis; - tumors; - metabolic diseases; - occlusive vascular diseases of the extremities; - pregnancy.
Use during pregnancy and lactation
Pregnancy In experimental studies, teratogenic properties of terbinafine were not identified. To date, no malformations have been reported with the use of Lamisil Uno. However, since clinical experience with the use of Lamisil Uno in pregnant women is very limited, it should be used only for strict indications. Breastfeeding period Terbinafine is excreted in breast milk, so the drug should not be prescribed to nursing mothers.
Directions for use and doses
Externally. Adults and adolescents over 15 years of age: The drug is intended for the treatment of foot fungus with a one-time use. The film-forming solution Lamisil Uno is applied once to both feet, even if the fungal infection is observed on only one foot. This ensures the destruction of fungi (dermatophytes) that may be located in areas of the foot where the lesions are not visually noticeable. Before applying the drug, wash and dry your feet and hands. First one foot is processed, then the other. Starting the procedure on the interdigital areas, apply a thin layer evenly between the toes and around their entire surface, as well as on the sole and sides of the foot to a height of up to 1.5 cm. Use a sufficient amount of the drug to cover the required surface of the skin, usually ½ tube to treat each foot. The other foot should be treated in the same way, even if the skin on it looks healthy. Dry the solution for 1-2 minutes until a film forms. After finishing foot treatment, you must wash your hands. The drug should not be reapplied to treated skin. Lamisil Uno should not be rubbed into the skin. A decrease in the severity of clinical symptoms is usually observed in the first days of treatment. If after 1 week of treatment there are no signs of improvement, patients should consult a doctor to verify the diagnosis. There are no data on repeated treatment with this drug, so repeated therapy cannot be recommended for a specific manifestation of tinea pedis. For best results, the treated area should not be washed for 24 hours after application. In this regard, it is recommended to apply Lamisil Uno after a shower or bath and refrain from washing your feet again for the next 24 hours. Patients should use the amount needed to cover both feet as directed above. Any unused amount of the drug should be discarded. Elderly There is no evidence that elderly patients require different dosages or experience side effects that differ from those in younger patients.
Side effect
Adverse reactions are listed below according to organ system classes and frequency of occurrence. The frequency of occurrence is determined as follows: very often (≥ 1/10); often (≥ 1/100 - Overdose No cases of drug overdose have been reported. Overdose is unlikely, since the drug is produced in the amount necessary for a single use and is intended for external use. Accidental ingestion of the contents of one 4 g tube containing 40 mg of terbinafine is comparable to taking significantly lower dose than contained in one terbinafine 250 mg tablet (single oral dose for adults).In case of accidental ingestion, the alcohol content of the film-forming solution (81.05% (m/m)) must be taken into account.Symptoms: In case of accidental ingestion, taking the drug Lamisil Uno orally, you can expect the same side effects as with an overdose of Lamisil tablets (headache, nausea, epigastric pain and dizziness). Treatment: First aid: activated charcoal, if necessary - symptomatic therapy in a hospital setting. Treatment should be in accordance with clinical indications or recommendations of national poison control centers, if available.
Interaction with other drugs
Not studied.
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 used on the face. May cause eye irritation. If you accidentally get the drug into your eyes, rinse your eyes thoroughly with running water. Caution should be exercised during use, since the ethyl alcohol contained in Lamisil Uno may cause irritation in patients with damaged skin (for example, after exposure to the sun or with severe peeling of the skin). Contact of infants with treated skin, including breasts, should be avoided. If an allergic reaction to the drug develops, the film should be removed using an organic solvent (for example, denatured alcohol) and then wash the feet with soap and water. If allergic reactions develop, the drug must be discontinued. For best results, the treated area should not be washed for 24 hours after the procedure. In this regard, it is recommended to apply Lamisil Uno after a shower or bath and refrain from washing your feet again for the next 24 hours. You should use the amount of the drug that is required to apply the film on both feet, following the procedure described above (see section “Method of application”). The unused remainder of the drug should be destroyed. Keep away from fire
Release form
Film-forming solution for external use 1%. 4 g in laminated tubes (polyethylene/aluminum/polyethylene) with a polyethylene screw cap, equipped with a first-opening control system. 1 tube in a plastic blister pack along with instructions for use in a cardboard box with a “window”. Secondary packaging is allowed to have a first-opening control.
Storage conditions
At a temperature not exceeding 30 C in the original packaging. Store out of the reach of children.
Best before date
3 years. Do not use after the expiration date stated on the packaging.
Contraindications
Lamisil Uno should not be used to treat those patients who have a high sensitivity to both terbinafine and other components of this medicine.
The drug is prescribed with caution to people suffering from renal failure , liver failure, and alcoholism . Lamisil Uno is also prescribed with caution to people with tumors, metabolic diseases, suppression of bone marrow hematopoiesis , and occlusive vascular diseases of the extremities.
Unless absolutely necessary, the drug is not prescribed to pregnant women, nursing mothers and children under 15 years of age.
Side effects
Negative manifestations when using this medicine develop only in rare cases, if they are mild and appear over a short time.
The following manifestations are possible:
- systemic reactions: redness , rash , urticaria , dermatitis ;
- local manifestations: a burning sensation in the place where the drug was applied, as well as dryness and irritation of the skin.
Instructions for Lamisil Uno (Method and dosage)
The drug should be used externally only. The ointment can be applied to adult patients and adolescents over 15 years of age. The instructions for using the ointment stipulate that in order to treat foot fungus, the product is applied once to both feet, and it does not matter if only one foot is affected by the infection. This must be done to ensure that even those mushrooms that are on the foot are destroyed, but the lesions are not visually noticeable.
Before applying the medicine, you need to wash and dry your feet and hands thoroughly. The feet are treated with the solution one by one. You need to start from the areas between the toes, then gradually apply the solution to the entire surface - on the sole and on the sides by about 1.5 cm. As a rule, you need to spend half a tube of product on treating one foot. You need to wait for 1-2 minutes for the solution to dry and a film to form. After finishing the treatment, you should wash your hands. The product does not need to be rubbed into the skin. Lamisil Uno should not be reapplied to skin treated with the solution.
Lamisil uno overdose, symptoms and treatment
It is unlikely, since the drug is produced in the form of a monodose, intended for external use, and 1 tube contains the required amount of medication only for 1 procedure. If the contents of the tube (40 mg terbinafine) are accidentally ingested, the effect may be much less than that of taking a 250 mg tablet of Lamisil (oral dose). However, if you swallow the contents of several tubes, you can expect to develop the same side effects that are observed when taking an excessive dose of Lamisil tablets (including headache, nausea, epigastric pain and dizziness).
special instructions
Lamisil Uno should not be used for chronic plantar hyperkeratosis caused by Tinea pedis.
Do not apply the product to the skin of the face, as it may cause irritation to the mucous membranes of the eyes. If the solution gets into your eyes by accident, you should immediately rinse them with water.
If the patient has an allergic reaction after applying the solution, the film must be removed immediately using an organic solvent ( denatured alcohol ). After this, wash your feet with soap and water. If you have allergies, the drug should not be used.
To make the effect more pronounced, after treating the feet, do not wash them for 24 hours. Therefore, it is advisable to apply Lamisil Uno after hygiene procedures.
If after applying the drug there is a little product left in the tube, it must be destroyed immediately.
If there is no improvement in the condition, you should consult a doctor after a few days.
The use of the drug does not affect the severity of the reaction.
Special instructions for the use of Lamisil uno
Lamisil Uno should not be used if the patient has experienced hypersensitivity to any of the components of the drug (see list of ingredients). Lamisil Uno is for external use only. It is necessary to avoid contact with the skin and eyes or other damaged areas other than those being treated, in such cases the drug may cause irritation. In case of accidental contact with eyes, rinse thoroughly with running water. If discomfort does not disappear, you should consult a doctor. It is also necessary to avoid getting the drug into the mouth (do not swallow!). If allergic reactions to the drug occur, the film should be removed using an organic solvent such as denatured alcohol, the skin of the feet should be washed with warm soapy water and then rinsed off. Next, you need to lubricate your feet with a softening cream. If symptoms do not go away, you should consult a doctor. It is not recommended to use Lamisil Uno for chronic squamous hyperkeratotic athlete's foot. If a patient has a fungal infection on their toenails (inside or under the nail) that is accompanied by discoloration or changes in the structure of the nail (thickening or splitting), Lamisil Uno should not be used. It may be necessary to treat a nail infection. Use in elderly patients . There is no evidence that when treating elderly patients it is necessary to use the drug in other doses. There were no cases of other side effects in this category of patients. During pregnancy and breastfeeding . In studies conducted on animals, teratogenic and embryotoxic properties of terbinafine were not revealed. There is no data on the effect of terbinafine on fetal development. However, since clinical experience with Lamisil Uno in pregnant women is limited, it should only be used if the benefit outweighs the potential risk to the fetus. Terbinafine is excreted in breast milk, so the drug should not be prescribed to women who are breastfeeding. Impact on the ability to drive vehicles and operate machinery. External use of Lamisil Uno does not affect the ability to drive vehicles or operate machinery. Use in children . The effect of Lamisil Uno in pediatric practice has not been studied. Therefore, it is not recommended to use the drug to treat children over 15 years of age.
Analogues of Lamisil Uno
Level 4 ATX code matches:
Mikonorm
Undecin
Gentian violet
Zinkundan
Exoderil
Exiter
Batrafen
Lotseril
Lamisil Dermgel
Lamisil
Salicylic acid
Salicylic ointment
Keto Plus
Exifin
Fungoterbin
Mycoseptin
Thermikon
Nitrofungin
Sulsena
Baziron AS
Analogues of Lamisil Uno are the drugs Lamitel , Lamican , Atifin , Terbinox , Mycoterbin , Exiter , Binafin , Terbinafine, Ungusan , Exifin , etc. Any of the drugs can be used only after consultation with a doctor.
Lamisil Uno price, where to buy
The price of Lamisil Uno averages 750 – 850 rubles per tube. How much the cream costs depends on the place of sale - its cost may vary. You can buy Lamisil Uno in Ukraine (Kyiv, Kharkov, etc.) for an average of 240 hryvnia.
- Online pharmacies in RussiaRussia
- Online pharmacies in UkraineUkraine
Pharmacy Dialogue
- Lamisil UNO for the treatment of foot fungus, solution 1% 4gNovartis
RUB 974 order
show more
Pharmacy24
- Lamisil Uno 1% 4 g solution Novartis Consumer Health S.A., Switzerland
160 UAH order
