Loceryl Contraindications
March 20th, 2011
Loceryl Contraindications
LOCERYL nail lacquer must not be reused by patients who have shown hypersensitivity to the treatment.
Since there are no data on the use of LOCERYL in pregnant and lactating women, the use of LOCERYL nail lacquer should be avoided during pregnancy and lactation.
Warnings and Precautions
Occasionally, a slight transient burning sensation in the area of the nails was observed after application of nail lacquer. The application of lacquer to skin areas surrounding the nails should be avoided.
Use in Pregnancy
Category B3
Exposure of pregnant rats and rabbits to systemic amorolfine (≥ 10 mg/kg/day orally) resulted in increased resorptions (embryotoxicity). The significance of these findings to human embryotoxicity is not known. There are no data on the use of amorolfine in pregnant women.
Use in Lactation
In a peri- and postnatal study in rats, an increased mortality of newborn pups was observed at 10 mg/kg/day orally. There is no information on whether amorolfine passes into human breast milk. There are no data on the use of amorolfine in lactating women.
Use in Children
Owing to the lack of clinical experience available to date, children – particularly young children and infants – should not be treated with amorolfine.
Carcinogenicity and Genotoxicity
No animal carcinogenicity studies have been conducted on amorolfine. Amorolfine was not shown to be genotoxic in a standard battery of assays for gene mutations and chromosomal changes.
Adverse Effects
Of the 502 patients treated with amorolfine nail lacquer monotherapy, 3 (0.6%) experienced local adverse events such as itching and erythema. Of the 172 patients evaluated for safety in the combination group during the monotherapy period, 3 (1.8%) experienced the following adverse reactions: pruritis and vesicles (1), periungual scaling (1) and nail discolouration (1). In a sensitisation study involving 122 subjects, about one-tenth of patients experienced delayed hypersensitivity skin reactions.
Rare cases of nail disorder (nail discolouration, brittle nails (onychhorrexis) or broken nails) have been reported during treatment with LOCERYL nail lacquer. However these reactions may also be linked to the onychomycosis itself.
Very Rarely (<1/10000) burning sensation and contact dermatitis.
Interactions
There are no known interactions.