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Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS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
1 ml of Amorolfine 5% w/v Medicated Nail Lacquer contains amorolfine hydrochloride corresponding to 50 mg amorolfine.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Medicated Nail Lacquer Clear colourless solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of onychomycosis without matrix involvement caused by dermatophytes, yeasts or moulds.
4.2 Posology and method of administration
Amorolfine 5% w/v Medicated Nail Lacquer should be applied to the affected finger nails once or twice weekly or toe nails once weekly.
The patient should apply the nail lacquer as follows:
Before the first application of 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 the nail file supplied. The surface of the nail should then be cleansed and degreased using a cleaning swab (as supplied). 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 swab to remove any remaining lacquer.
Caution: Nail files used for affected nails must not be used for healthy nails.
With one of the reusable spatulas supplied, apply the nail lacquer to the entire surface of the affected nails and allow it to dry. After use, clean the spatula with the same cleaning swab used before for nail cleaning. Keep the bottle tightly closed.
For each nail to be treated, dip the spatula 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 lacquer on the nails.
Amorolfine 5% w/v Medicated Nail Lacquer is effective in moderately extensive onychomycosis.
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 twelvemonths (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.
Elderly
There are no specific dosage recommendations for use in elderly patients.
Paediatric population
There are no specific dosage recommendations for children owing to the lack of clinical experience available to date.
4.3
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Avoid contact of the lacquer with eyes, ears and mucous membranes. Use of nail varnish or artificial nails should be avoided during treatment.
4.5 Interaction with other medicinal products and other forms of interaction
No interactions studies have been performed.
4.6 Fertility, pregnancy and lactation
For Amorolfine 5% w/v Medicated Nail Lacquer no clinical data on exposed pregnancies are available. Reproductive toxicology studies showed no evidence of teratogenicity in laboratory animals, but embryotoxicity was observed at high oral doses of amorolfine. Considering the low systemic exposure of amorolfine at the proposed clinical use, adverse effects on the fetus are not expected, however, as a precautionary measure it is preferable to avoid the use of Amorolfine 5% w/v Medicated Nail Lacquer during pregnancy.
Breastfeeding
No effects on the suckling child are anticipated since the systemic exposure of the breast-feeding women to amorolfine is negligible. Amorolfine 5% w/v Medicated Nail Lacquer can be used during breast-feeding.
4.7 Effects on ability to drive and use machines
Amorolfine 5% w/v Medicated Nail Lacquer has no influence on the ability to drive and use machines.
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 (>1/10,000 to <1/1,000) |
Nail disorder, nail discoloration, onychoclasis, onychorrhexis |
|
Very rare ( <1/10,000) |
Skin burning sensation | |
|
Not known (cannot be estimated from the available |
Contact dermatitis |
data)
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 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Other antifungals for topical use ATC code: D01AE16
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.
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
Systemic effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ethanol anhydrous
Ammonio Methacrylate Copolymer (type A)
Ethyl acetate Butyl acetate Triacetin
6.2 Incompatibilities
None.
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
Amber glass type I or type III bottle stopped with HDPE cap with a Teflon liner
Pack Sizes:
2.5ml, 3ml, 5ml
All packs contain 30 cleansing swabs, 10 spatulas and 30 nail files.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
MG Pharma,
24, rue Erlanger 75016 PARIS,
France
8 MARKETING AUTHORISATION NUMBER(S)
PL 36143/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
01/11/2012
10 DATE OF REVISION OF THE TEXT
21/07/2014