Universal reference book for medicines
Product name: LOTSERYL (LOCERYL)

Active substance: amorolfine

Type: Antifungal medication for external use

Manufacturer: GALDERMA (Switzerland) manufactured by Laboratoires GALDERMA (France)
Composition, form of production and packaging
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Solution for external use 5% 1 g
amorolfine (in the form of hydrochloride) 57.4 mg

Excipients: methyl methacrylate copolymer, trimethylammonioethyl methacrylate chloride and ethacrylate [1: 2: 0.2] 143 mg, triacetin 12 mg, butyl acetate 57 mg, ethyl acetate 172 mg, ethanol 552 mg.

2.5 ml - bottles of dark glass (1) complete with tampons for cleaning N16, spatulas N10 and disposable nail files N30 - packs cardboard.

5 ml - bottles of dark glass (1) complete with tampons for cleaning N16, spatulas N10 and disposable nail files N30 - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Antifungal drug for external use.
It has a fungistatic and fungicidal effect caused by damage to the cytoplasmic membrane of the fungus by disrupting the sterol biosynthesis. The content of ergosterol decreases, and the content of atypical steric non-planar sterols accumulates. Has a wide range of action. Highly active against both the most common and rare pathogens of fungal nail lesions:
Dermatophytes: Trichophyton spp., Microsporum spp., Epidermophyton spp.

Yeast fungi: Candida spp., Cryptococcus spp., Malassezia spp.
(Pityrosporum spp.)
Mold fungi: Alternaria spp., Scopulariopsis spp., Hendersonula spp.

Fungi from the family Dematiaceae: Cladopsorium spp., Fonsecaea spp., Wangiella spp.

Dimorphic fungi: Coccidioides spp., Histoplasma spp., Sporothrix spp.

PHARMACOKINETICS

When applied to the nails penetrates into the nail plate and then into the nail bed (almost completely within the first 24 hours).
Effective concentration is maintained in the affected nail plate for 7-10 days after the first application.
Systemic absorption is negligible: C max in the plasma is below the sensitivity limit of the detection methods (less than 0.5 ng / ml).

INDICATIONS

- treatment of fungal nail lesions caused by dermatophytes, yeast and mold fungi;

- prevention of fungal nail lesions.

DOSING MODE

Outwardly.
Apply on the injured nails of fingers or toes 1-2 times a week as follows:
1. Before using the drug, remove the affected areas of the nail (especially on its surface) with the help of the supplied nail file.

2. Then clean the surface of the nail and degrease with the attached tampon moistened with alcohol.
Nail treatment with a saw blade and a swab with alcohol should be performed before each use of the drug.
3. Dip the spatula into the varnish.
The scapula should be removed from the vial, without touching its neck, do not erase excess lacquer on the neck of the vial.
4. Apply the varnish to the entire surface of the affected nail with a spatula.
Repeat the above procedure for each affected nail.
5. Close the vial tightly after use.

6. Allow the varnish to dry for about 3 minutes.

7. Sponge wipe with used swab.
Avoid contact of processed nails and a tampon. Dispose of the used tampon.
Treatment should continue until the regeneration of the nail and complete cure of the affected area.

The average duration of treatment is 6 months for the nails on the hands and 9-12 months for the nails on the legs.

SIDE EFFECT

Rarely (in 0.01% -0.1% of cases) it is possible to damage the nail (discoloration, increased fragility of the nail plate), which may be the result of fungal nail injury.Very rarely (less than 0.01% of cases) - slight short-term burning in the nail area after application of the drug, contact dermatitis.

CONTRAINDICATIONS

Hypersensitivity to the drug.

PREGNANCY AND LACTATION

It is not recommended to use the drug during pregnancy and lactation.

APPLICATION FOR CHILDREN

Clinical data on the use of the drug in children are absent, so it should not be prescribed to children.

SPECIAL INSTRUCTIONS

- Files used for the treatment of damaged nails should not be used for the treatment of healthy nails;

- persons working with organic solvents should wear impermeable gloves to protect nails covered with varnish;

- during the treatment should avoid the use of false artificial nails and do not use cosmetic nail polish;

- the tampon contains a highly flammable substance.

Avoid contact with eyes, ears and mucous membranes.

Patients with conditions predisposing to the development of fungal nail lesions (violation of peripheral blood circulation, diabetes mellitus, immunodeficiencies), as well as patients with nail dystrophy or a destroyed nail plate should consult a doctor.

Clinical data on the use of the drug in children are absent, so it should not be prescribed to children.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

The preparation should be stored at a temperature not exceeding 30 ° C.
Keep out of the reach of children!
Shelf life - 3 years.
Do not use after expiry date.
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