1. Name Of The Medicinal Product
Loceryl 0.25% w/w cream
2. Qualitative And Quantitative Composition
Loceryl cream contains 0.25% w/w amorolfine in the form of hydrochloride. Amorolfine is chemically described as cis-4-[(RS)-3[4-(1,1-Dimethylpropyl)phenyl]-2-methylpropyl]-2,6-dimethylmorpholine.
Amorolfine hydrochloride HSE 0.279 w/w
(equivalent to 0.25% w/w base)
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Cream.
4. Clinical Particulars
4.1 Therapeutic Indications
Dermatomycoses caused by dermatophytes: tinea pedis (athlete's foot), tinea cruris, tinea inguinalis, tinea corporis, tinea manuum. Pityriasis versicolor.
4.2 Posology And Method Of Administration
Dermatomycoses
Cream: To be applied to affected skin areas once daily following cleansing (in the evening).
The treatment should be continued without interruption until clinical cure, and for 3 - 5 days thereafter. The required duration of treatment depends on the species of fungi and on the localisation of the infection. In general, treatment should be continued for at least two to three weeks. With foot mycoses, up to six weeks of therapy may be necessary.
Elderly
There are no specific dosage recommendations for use in elderly patients.
Children
There are no specific dosage recommendations for children owing to the lack of clinical experience available to date.
4.3 Contraindications
Loceryl cream must not be reused by patients who have shown hypersensitivity to the active substance or to any of the excipients.
No experience exists of use during pregnancy and nursing, therefore, the use of Loceryl should be avoided during pregnancy and lactation.
4.4 Special Warnings And Precautions For Use
Avoid contact of Loceryl cream with eyes, ears and mucous membranes.
This medicinal product contains stearyl alcohol which may cause local skin reaction (e.g. contact dermatitis)
Owing to the lack of clinical experience available to date, the use of Loceryl 0.25% cream in children is not recommended.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
There are no specific studies involving concomitant treatment with other topical medicines. Use of nail varnish or artificial nails should be avoided during treatment.
4.6 Pregnancy And Lactation
Reproductive toxicology studies showed no evidence of teratogenicity in laboratory animals but embryotoxicity was observed at high oral doses. The systemic absorption of amorolfine during and after topical administration is very low and therefore the risk to the human foetus appears to be negligible. However, because there is no relevant experience Loceryl should be avoided during pregnancy and breast feeding. Breast-feeding women must not use the cream in the breast area.
4.7 Effects On Ability To Drive And Use Machines
Not relevant.
4.8 Undesirable Effects
Adverse drug reactions are rare and mostly mild in nature.
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4.9 Overdose
Accidental oral Ingestion
Loceryl is for topical use. In the event of accidental oral ingestion, an appropriate method of gastric emptying may be used.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Other antifungals for topical use ATC code: D01AE16
Loceryl is a topical antimycotic. Amorolfine belongs to a new chemical class, and its fungicidal action 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.
Amorolfine is a broad spectrum antimycotic. It is highly active (MIC < 2mcg/ml) in vitro against
yeasts: Candida, Cryptococcus, Malassezia
dermatophytes: Trichophyton, Microsporum, Epidermophyton
moulds: Hendersonula, Alternaria, Scopulariopsis
dematiacea: Cladosporium, Fonsecaea, Wangiella
dimorphic fungi: Coccidioides, Histoplasma, Sporothrix
With the exception of Actinomyces, bacteria are not sensitive to amorolfine. Propionibacterium acnes is only slightly sensitive.
5.2 Pharmacokinetic Properties
Amorolfine from cream penetrates into the stratum corneum. Nevertheless, systemic absorption is extremely low during and after therapeutic use.
5.3 Preclinical Safety Data
None stated.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Polyoxyl 40 stearate,
stearyl alcohol, paraffin
liquid,
white soft paraffin,
carbomer,
sodium hydroxide,
disodium edetate,
2 phenoxyethanol.
6.2 Incompatibilities
Not applicable
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
Loceryl cream should be stored below 30°C.
6.5 Nature And Contents Of Container
20g collapsible aluminium tube, sealed with an aluminium membrane and fitted with a plastic screw cap.
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
Galderma (UK) Limited
Meridien House
69-71 Clarendon Road
Watford
Herts.
WD17 1DS
UK
8. Marketing Authorisation Number(S)
PL 10590/0041
9. Date Of First Authorisation/Renewal Of The Authorisation
April 1999
10. Date Of Revision Of The Text
April 2010
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