Lotseril
Producer: Laboratoires Galderma (Galderm's Laboratories) France
Code of automatic telephone exchange: D01AE16
Release form: Nail varnish.
General characteristics. Structure:
Active ingredient: an amorolfina a hydrochloride - 64,0 mg that there corresponds the amorolfina to the basis - 57,4 mg.
Excipients: methylmethacrylate, trimetilammonioetilmetakrilat of chloride and ethyl acrylate copolymer [1:2:0.2], triacetin, butyl acetic ether, ethyl acetate, absolute ethanol.
Pharmacological properties:
Antifungal drug for external use. Has the fungistatic and fungicidal effect caused by damage of a cytoplasmic membrane of a mushroom by disturbance of biosynthesis of sterol.
Possesses a broad spectrum of activity. It is highly active in the relation as most
widespread, and rare activators of fungal infections of nails:
Dermatofitov: Trichophyton, Microsporum, Epidermophyton
Barmy mushrooms: Candida, Cryptococcus, Malassezia (Pityrosporum)
Mold mushrooms: Alternaria, Scopulariopsis, Hendersonula
Mushrooms from the Dematiaceae family: Cladopsorium, Fonsecaea, Wangiella
Dimorphous mushrooms: Coccidioides, Histoplasma, Sporothri.
Pharmacokinetics. When drawing on nails gets into a nail plate and further into a nail bed (almost completely within the first 24 hours). Effective concentration remains in the struck nail plate within 7-10 days after the first application. System absorption is insignificant: concentration is in plasma below a limit of sensitivity of methods of definition (less than 0,5 ng/ml).
Indications to use:
- treatment of the fungal infections of nails caused by dermatophytes, barmy and mold mushrooms;
- prevention of fungal infections of nails.
Route of administration and doses:
Outwardly. To apply on the affected nails of fingers of hands or legs 1-2 times a week as follows:
1. Before use of drug to remove whenever possible affected areas of a nail (especially on its surface) by means of the enclosed file for nails.
2. Then the surface of a nail to clear and degrease the enclosed tampon moistened with alcohol.
Processing of nails a file and a tampon with alcohol needs to be carried out before each use of drug.
3. To dunk a rake into a varnish. The rake should be taken out from a bottle, without concerning its neck, it is not necessary to erase excesses of a varnish about a bottle neck.
4. To apply a varnish on all surface of the affected nail by means of a rake.
To repeat the above described procedure for each affected nail.
5. To densely close a bottle at once after use.
6. To allow a varnish to dry approximately within 3 minutes.
7. To wipe a rake with the used tampon. To avoid contact of the processed nails and a tampon. To throw out the used tampon.
Treatment should be continued before regeneration of a nail and full treatment of an affected area.
The average duration of treatment makes 6 months for nails on hands and 9-12 months for nails standing.
Features of use:
The files used for processing of the affected nails should not be used for processing of healthy nails; - the persons working with organic solvents have to put on impenetrable gloves for protection of the nails varnished;
during treatment it is necessary to avoid use of false artificial nails and not to use cosmetic nail varnish the tampon contains easily flammable substance.
Side effects:
Seldom (in 0,01% - 0,1% of cases) it is possible injury of a nail (discoloration, the increased fragility of a nail plate) which can be a consequence of a fungal infection of a nail. Very seldom (less than 0,01% of cases) - easy short-term burning in a nail after drug application, contact dermatitis.
Interaction with other medicines:
It is not established.
Contraindications:
Hypersensitivity to drug.
PREGNANCY AND LACTATION
Use of drug is not recommended during pregnancy and a lactation.
USE IN PEDIATRICS
Clinical data on use of drug for children are absent therefore children should not appoint it.
Overdose:
There are no data.
Storage conditions:
At a temperature not above 30 °C. To store in the place, unavailable to children!
Issue conditions:
Without recipe
Packaging:
On 2,5 ml and 5 ml in a bottle from dark glass with the insert from polymeric material protecting drug from drying. Each bottle together with the application instructions, 10 plastic rakes laid in a row and fixed in a frame, 30 tampons moistened with isopropyl alcohol (in hermetically soldered envelopes from the laminated aluminum foil) and 30 files is placed in a cardboard box.