Zuellig Pharma
Full Prescribing Info
Amorolfine HCl.
Loceryl contains amorolfine HCl 5% w/v in an ethanol-based nail lacquer containing methacrylic acid copolymer 150,000, triacetin, butyl acetate, ethyl acetate and ethanol absolute.
Each pack also contains 16 cleaning pads saturated with 70% isopropyl alcohol in foil packets, 10 spatulas and 15 disposable nail files.
Topical antifungal.
Pharmacology: Amorolfine belongs to a new chemical class of antifungal substances. Its fungicidal and fungistatic effect is based on an alteration of the fungal cell membrane targeted primarily on sterol biosynthesis. The ergosterol content is reduced, and at the same time unusual, sterically nonplanar sterols accumulate.
Microbiology: Amorolfine has a broad antifungal spectrum in vitro. It is effective against:
Dermatophytes: Trichophyton, Microsporum, Epidermophyton.
Yeasts: Candida.
Moulds: Alternaria, Scopulariopsis, Hendersonula.
With the exception of Actinomyces, bacteria are not sensitive to amorolfine.
Pharmacokinetics: Amorolfine penetrates into and diffuses through the nail plate and is thus able to eradicate poorly accessible fungi in the nail bed. Systemic absorption of amorolfine is very low with this type of application, since the drug plasma concentration remains below the sensitivity limit of the analytical assay even after 1 year of use.
Topical treatment of onychomycosis caused by dermatophytes, yeasts and moulds.
Dosage/Direction for Use
Apply Loceryl to the affected nails at a dosage of 1-2 applications weekly. When applying the varnish, carefully comply with the following recommendations:
1. Before first applying Loceryl, carefully clean the nails using a nail file, file the affected area of the nail (particularly at the surface of the nail) as completely as possible. Be careful not to file the periungual skin.
Caution: Nail files used on an infected nails must not be used on healthy nails.
2. Clean the surface of the infected nail with a cleaning pad.
3. Dip one of the reusable spatulas into the lacquer. Do not wipe the edge of the bottle.
Note: The spatula provides a measured dose of Loceryl.
4. Using the spatula, paint Loceryl over the entire surface of the infected nail.
5. Close the bottle tightly immediately after painting the infected nail to prevent Loceryl from evaporating.
6. Repeat steps 1, 2, 3 and 4 for each affected nail.
7. Allow time for the nails to dry (3-5 min).
8. When the patient has finished treating all the infected nails, clean the spatula and the neck of the bottle with the same cleaning pad used for nail cleansing.
Note: Follow previously mentioned steps each time Loceryl is used.
When working with organic solvents (thinners, white spirit, etc), wear impermeable gloves in order to protect Loceryl on the nails.
Treatment should be continued without interruption until the nail is regenerated and the affected areas are finally cured. The required duration of treatment depends essentially on intensity and localization of the infection and on the growth rate of nails. In general, it is 6 months for fingernails and 9-12 months for toenails.
Overdosage is not expected to result in any clinical problem.
Loceryl must not be reused by patients who have shown hypersensitivity to any ingredient of the product.
Special Precautions
General: Nail files for affected nails must not be reused on healthy nails. Use of cosmetic lacquer or artificial nails should be avoided during treatment.
Use in pregnancy & lactation: Exposure of pregnant rabbits to high systemic doses of amorolfine resulted in a slight increase of embryonic resorption (embryotoxicity). In view of the extremely low systemic exposure to amorolfine after use of the nail lacquer, a fetal risk in humans appears to be negligible. However, as no clinical experience exists with pregnancy and nursing, the use of Loceryl should be avoided during pregnancy and lactation.
Use in children: Owing to the lack of clinical experience available to date, children should not be treated with Loceryl.
Side Effects
In exceptional cases, a slight, transient periungual burning sensation was observed after the application of the nail lacquer.
Store at a temperature not exceeding 30°C. Protect from heat.
ATC Classification
D01AE16 - amorolfine ; Belongs to the class of other antifungals for topical use.
Nail lacquer 5% x 2.5 mL.
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