Composition, form of production and packaging
? Solution for external application film-forming 1% transparent or slightly matt, viscous, colorless to light yellow, with the smell of ethanol.
1 g
terbinafine hydrochloride 11.25 mg,
which corresponds to the content of terbinafine 10 mg
Excipients: copolymer of acrylic acid and octylacrylamide (Dermakryl 79) - 50 mg, medium chain triglycerides - 50 mg, giprolose - 25 mg, ethanol 96% - 863.75 mg.
4 g - laminated tubes (1) with the first opening tampering system - packings of cellular outline (1) - cardboard packs with a "window".
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
Antifungal drug for external use, which has a wide range 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), moldy (mainly Candida albicans) and some dimorphic fungi (Pityrosporum orbiculare). Activity with respect to yeast fungi, depending on their type, may be fungicidal or fungistatic.
Terbinafine specifically changes the early stage of biosynthesis of sterols occurring in fungi. This leads to a deficit of ergosterol and to intracellular accumulation of squalene, which causes 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 medications.
PHARMACOKINETICS
After applying the drug Lamizil В® Uno to the skin, the solution forms a transparent imperceptible film that remains on the skin for 72 hours. From the film, terbinafine rapidly penetrates the stratum corneum: 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 in excess of the minimum inhibitory concentration of terbinafine in vitro with respect to dermatophytes.
Systemic bioavailability is extremely low. With external application, the absorption of the drug is less than 5%. Lamisil В® Uno has an insignificant systemic effect.
The level of relapses after 3 months of use of the drug is low (not higher than 12.5%).
INDICATIONS
- Mycosis (dermatophytosis) of the feet (tinea pedis) .
DOSING MODE
The drug is applied externally, once.
Adults and adolescents over the age of 15 years of film-forming solution of Lamisil В® Uno are applied 1 time on 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 foot areas where lesions are visually invisible.
Before applying the product, you should wash and dry your feet and hands. First, one stop is processed, then the other. When starting the procedure on the interdigital areas, a thin layer should be applied evenly between the fingers and around all over their 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 necessary surface of the skin, usually 1/2 tubes for processing each foot.
In the same way, you should treat the other foot, even if the skin on it looks healthy. Dry the solution for 1-2 minutes before film formation. After finishing stop treatment, you should wash your hands.
Do not apply the product again to the treated skin.
Lamisil В® Uno should not be rubbed into the skin.
SIDE EFFECT
Side effects are extremely rare, mild, and short-term.
Systemic reactions: very rarely (<1/10 000) - allergic reactions (rash, redness, bullous dermatitis and urticaria).
Local reactions: rarely (> 1/1000, <1/100) - dryness, skin irritation or burning sensation on the skin treated area.
CONTRAINDICATIONS
- Hypersensitivity to the components of the drug.
With caution: hepatic and / or renal failure, alcoholism, oppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive diseases of the extremities, children under 15 years of age (lack of sufficient clinical experience).
PREGNANCY AND LACTATION
The clinical experience of using the drug Lamizil В® Uno for external use during pregnancy is very limited, the drug should be used only on strict indications.
Terbinafine is excreted in breast milk, so the drug should not be given to nursing mothers.
In experimental studies teratogenic properties of terbinafine have not been revealed. Until now, there have been no reports of any developmental defects when using Lamisil В® Uno.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution: kidney failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution: liver failure.
APPLICATION FOR CHILDREN
The effect of the drug Lamisil В® Uno in pediatric practice has not been studied. Therefore, it is not recommended to use the drug in children under the age of 15 years .
APPLICATION IN ELDERLY PATIENTS
There is no evidence that other doses or other side effects are required in the treatment of elderly patients than in younger patients.
SPECIAL INSTRUCTIONS
Lamisil В® Uno is not recommended for chronic plantar hyperkeratosis caused by Tinea pedis (moccasin type).
Lamisil В® 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 should not be taken inside!
If the allergic reaction to the drug develops, the film should be removed with an organic solvent (eg denatured alcohol) and then rinsed with soap and water.
When developing allergic reactions, it is necessary to cancel the drug.
For best results, the treated area should not be washed within 24 hours after the procedure. Therefore, Lamisil В® Uno is recommended to be applied after taking a shower or bath and the next day again to wash your feet at the same time.
Use the amount of preparation that will be required to apply the film on both feet by following the procedure described above. Unused residue should be disposed of.
Improvement of clinical symptoms is usually observed within a few days. If there are no signs of improvement in a week, the diagnosis should be verified.
There is no evidence that correction of the dosing regimen is required in the treatment of elderly patients, other side effects occur than in younger patients.
Use in Pediatrics
The effect of the drug Lamisil В® Uno in pediatric practice has not been studied. Therefore, it is not recommended to use the drug in children under the age of 15 years .
Impact on the ability to drive vehicles and manage mechanisms
When applied externally, Lamisil В® Uno does not affect the ability to drive vehicles or work with machinery.
OVERDOSE
No cases of drug overdose have been reported. Overdose is unlikely, because the drug is available in quantities that are necessary for a single use and is intended for external use.
Symptoms: with a random intake of the drug inside may be a headache, nausea, epigastric pain and dizziness.
Treatment: the appointment of activated carbon, if necessary, conduct symptomatic therapy in a hospital
DRUG INTERACTION
Currently, the drug interaction of the drug Lamisil В® Uno is not known.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children, in the original package, at a temperature of no higher than 30 В° C. Shelf life - 3 years.
