Amorolfine 5% W/V Medicated Nail Lacquer
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amorolfine 5% w/v Medicated nail lacquer
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amorolfine 5% w/v Medicated nail lacquer contains 5% w/v amorolfine in the form of hydrochloride.
1ml of nail lacquer contains 55.74 mg amorolfine hydrochloride (equivalent to 50mg of amorolfine).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicated nail lacquer
Amorolfine 5% w/v Medicated nail lacquer is a clear colourless solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of mild cases of distal and lateral subungual onychomycoses caused by dermatophytes, yeasts and moulds limited up to 2 nails.
4.2 Posology and method of administration
Adults and Elderly
The nail lacquer should be applied to the affected finger or toe nails once weekly.
The patient should apply the nail lacquer as follows:
1. Before the first application Amorolfine 5% w/v Medicated nail lacquer, it is essential that the affected areas of nail (particularly the nail surfaces) should be filed down as thoroughly as possible using a nail file. The surface of the nail should then be cleansed and degreased using an alcohol cleaning pad. Before repeat application of Amorolfine 5% w/v Medicated nail lacquer, the affected nails should be filed down again as required, following cleansing with a cleaning pad to remove any remaining lacquer.
Caution: Nail files used for affected nails must not be used for healthy nails.
2. With one of the reusable applicators supplied, apply the nail lacquer to the entire surface of the affected nails and allow it to dry. After use, clean the applicator with the same cleaning pad used before for nail cleaning. Keep the bottle tightly closed.
For each nail to be treated, dip the applicator into the nail lacquer without wiping off any of the lacquer on the bottle neck.
Caution: When working with organic solvents (thinners, white spirit, etc.) wear impermeable gloves in order to protect the Amorolfine 5% w/v Medicated nail lacquer on the nails.
Treatment should be continued without interruption until the nail is regenerated and the affected areas are finally cured. The required frequency and duration of treatment depends essentially on intensity and localisation of the infection. In general, it is six months (finger nails) and nine to twelve months (toe nails). A review of the treatment is recommended at intervals of approximately three months.
Co-existent tinea pedis should be treated with an appropriate antimycotic cream.
Children
Due to the lack of clinical experience available, Amorolfine 5% w/v Medicated nail lacquer is not recommended for patients below the age of 18 years.
4.3 Contraindications
Amorolfine 5% w/v Medicated nail lacquer 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 Amorolfine 5% w/v Medicated nail lacquer should be avoided during pregnancy and lactation.
4.4 Special warnings and precautions for use
Avoid contact of the lacquer with eyes, ears and mucous membranes.
The following patients should be referred to the doctor:
• Patients with underlying conditions predisposing to fungal nail infections (such as peripheral circulatory disorders, diabetes mellitus, immunosuppression)
• Patients with nail dystrophy or destroyed nail plate.
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 Fertility, 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, Amorolfine 5% w/v Medicated nail lacquer should be avoided during pregnancy and breast feeding.
4.7 Effects on ability to drive and use machines
Not relevant.
4.8 Undesirable effects
Adverse drug reactions are rare. Nail disorders (e.g. nail discoloration, broken nails, brittle nails) may occur. These reactions can also be linked to the onychomycosis itself.
|
System Organ Class |
Frequency |
Adverse drug reaction |
|
Skin and subcutaneous tissue disorders |
Rare ( *1/10000, < 1/1000) |
Nail disorder, nail discoloration, onychoclasis |
|
Very rare ( i 1/10000) |
Skin burning sensation, contact dermatitis | |
|
Unknown frequency |
Erythema,pruritus, urticaria, blister |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Accidental oral ingestion
Amorolfine 5% w/v Medicated nail lacquer is for topical use. In the event of accidental oral ingestion, an appropriate method of gastric emptying may be used.
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Other antifungals for topical use ATC code: D01AE16
Amorolfine 5% w/v Medicated nail lacquer 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 nail lacquer penetrates into and diffuses through the nail plate and is thus able to eradicate poorly accessible fungi in the nail bed. Systemic absorption of the active ingredient is very low with this type of application.
Following prolonged use of Amorolfine 5% w/v Medicated nail lacquer, there is no indication of drug accumulation in the body.
5.3 Preclinical safety data
None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ammonio methacrylate copolymer A,
triacetin, butyl acetate, ethyl acetate, ethanol.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Protect from heat. Keep bottle tightly closed after use.
6.5 Nature and contents of container
Glass bottle.
Pack Size: 3ml
All packs contain cleansing swabs, spatulas and nail files.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Aspire Pharma Limited Bellamy House Winton Road Petersfield Hampshire GU32 3HA
8 MARKETING AUTHORISATION NUMBER(S)
PL 35533/0019
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
23/08/2012
10 DATE OF REVISION OF THE TEXT
01/05/2014