Ламизил®Уно

General characteristics. Structure:

Active agent - a terbinafina a hydrochloride of 11,25 mg (there correspond 10 mg of a terbinafin of the basis)
Excipients: acrylic acid and octylacrylamide copolymer (Dermakril 79), triglycerides of an average chain, hypro rod, ethanol of 96%.

Description: Transparent or slightly opaque viscous solution from colourless till light yellow color with an ethanol smell.

Pharmacological properties:

Terbinafin (derivative allylamine) - the antifungal drug for topical administration possessing a wide range of antifungal activity. In small concentration тербинафин has fungicidal effect concerning dermatophytes (Trychophyton rubrum, T.mentagrophytes, T.verrucosum, T.violaceum, T. tonsurans, Microsporum canis, Epidermophyton floccosum), mold (in the main S. albicans) and certain dimorphous mushrooms (Pityrosporum orbiculare or Malassezia furfur). Activity concerning barmy mushrooms, depending on their look, can be fungicidal or fungistatic.
Terbinafin in unusual way changes an early stage of the biosynthesis of sterol happening in mushrooms. It leads to deficit of ergosterol and to intracellular accumulation of squalene that causes death of a cell of a mushroom. Action of a terbinafin is carried out by inhibition of the enzyme of a skvalenepoksidaza located on a cellular membrane of a mushroom. Skvalenepoksidaza is not connected with system of P450 cytochrome. Terbinafin does not influence metabolism of hormones or other medicines.

Pharmacokinetics. After putting Lamizil® solution of Uno on skin drug forms a transparent imperceptible film which remains on skin during 72 h. From a film тербинафин quickly gets into a corneous layer of skin: in 60 min. after the procedure of 16-18% of the put dose it is found in a corneous layer. Release of a terbinafin has the progressing character, active ingredient is present at a corneous layer in 13 days in the concentration exceeding the minimum inhibiting concentration of a terbinafin of in vitro in relation to dermatophytes.

System bioavailability is extremely insignificant. At topical administration drug absorption less than 5%. Ламизил® Uno has insignificant systemic action. Level of a recurrence after 3 months of use of drug is low (not higher than 12,5%).

Indications to use:

Mycoses (dermatofitiya) of feet ("fungus" of foot, Tinea pedis).

Route of administration and doses:

Outwardly.
Adults and teenagers since 15 years:
Drug is intended for treatment of a fungus of foot at single application.
Film-forming Lamizil® solution of Uno is applied once on both feet even if the fungal infection is observed only on one foot. It guarantees destruction of mushrooms (dermatophytes) which can be on sites of foot where defeats are visually not noticeable.
Before putting drug it is necessary to wash up and dry up feet and hands. At first one foot, then another is processed. Beginning the procedure on interdigital sites, it is necessary to apply a thin film evenly between fingers and around on all their surface, and also on a sole and side parts of foot on height to 1,5 cm.
Use enough drug to cover the necessary surface of skin, usually 1/2 tubas for processing of each foot. In the same way it is necessary to process also other foot even if skin on it looks healthy. Dry up solution within 1-2 min. before formation of a film. After the end of processing of feet it is necessary to wash up hands.
It is not necessary to apply drug repeatedly on the processed leather.
Ламизил® Uno it is not necessary to rub in skin.

Features of use:

Ламизил® Uno is not recommended to be applied in case of the chronic bottom hyperkeratosis caused by Tinea pedis (mokassinovy type / moccasin type). Ламизил® Uno is intended only for external use. Drug should not be applied on face skin, it can cause irritation of a mucous membrane of eyes. At accidental hit in their eyes it is necessary to wash out carefully flowing water. Drug cannot be accepted inside!
In case of development of allergic reaction to drug the film should be removed by means of organic solvent (for example, denatured alcohol) and then to wash out feet water with soap.

At development of allergic reactions it is necessary to cancel drug. For achievement of the best results the processed site should not be washed during 24 h after the procedure. Therefore Uno's Lamizil® is recommended to be put after acceptance of a shower or a bathtub and next day to wash up legs again at the same time. It is necessary to use such amount of drug which will be required for drawing a film on both feet, performing a procedure for the above described technique (see the section "Route of administration"). The unused rest of drug should be destroyed. Improvement of clinical symptomatology is usually observed within several days. If in a week there are no improvement signs, it is necessary to see a doctor.

Children:
Action of Lamizil® of Uno in pediatric practice was not studied. Therefore it is not recommended to use drug at children 15 years are younger.

Elderly:
There are no data that at treatment of elderly patients other doses are required or there are other side effects, than at younger patients.

Influence on ability to drive the car or mechanisms:
At external use of Lamizil® of Uno does not influence ability to drive the car or work with mechanisms.

Side effects:

Undesirable effects are observed extremely seldom, are poorly expressed and have short-term character.

System reactions:
Very seldom (<1/10 000) - allergic reactions, such, as сьшь, reddening, violent dermatitis and a small tortoiseshell.

Local reactions:
In rare instances (> 1/1 000, <1/100) - dryness, irritation of skin or a burning sensation on the site of skin processed by drug.

Interaction with other medicines:

Medicinal interactions for Uno's Lamizil® are not known.

Contraindications:

Hypersensitivity to a terbinafin or to any of the inactive ingredients which are a part of drug.
With care: a liver and/or renal failure, alcoholism, oppression of a marrowy hemopoiesis, a tumor, a metabolism disease, occlusal diseases of vessels of extremities, children's age up to 15 years (lack of sufficient clinical experience).

Pregnancy and lactation:
In pilot studies of teratogenic properties of a terbinafin it was not revealed. So far it was not reported about any malformations at use of Lamizil® of Uno. However, as clinical experience of use of Lamizil® of Uno for pregnant women is very limited, it should be applied only according to strict indications.
Terbinafin is allocated with breast milk therefore nursing mothers should not appoint drug.

Overdose:

About cases of overdose of drug it was not reported. At accidental reception of Lamizil® of Uno inside it is possible to expect development of the same by-effects, as well as at overdose of the tablets Lamizil® (a headache, nausea, pains in epigastriums and dizziness).
The overdose is improbable as drug is produced in the quantity necessary for single use and is intended for outside use.
First aid: absorbent carbon, if necessary - symptomatic therapy in the conditions of a hospital.

Storage conditions:

Period of validity - 3 years. Not to use after the expiry date specified on packaging. At a temperature not above 30 °C in original packaging, in the place, unavailable to children.

Issue conditions:

Without recipe

Packaging:

Solution for external use film-forming 1%.
On 4 g in the tubas laminated (polyethylene/aluminium/polyethylene) with a cover polyethylene the screw-on, supplied control system of the first opening.
On 1 tuba in a plastic blister strip packaging together with the application instruction in a cardboard pack with "window".