Terbinafine Hydrochloride 1% Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Terbinafine Hydrochloride 1 % Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg terbinafine hydrochloride (equivalent to 8.89 mg terbinafine) in 1 g cream.
Excipient: 80 mg cetyl alcohol and cetostearyl alcohol in 1 g cream.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
White or almost white cream, with slight almond odour.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
The treatment of tinea pedis (Athlete’s foot) and tinea cruris (jock itch) caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes) and Epidermophyton floccosum.
4.2 Posology and method of administration
Terbinafine cream can be applied once or twice daily. Cleanse and dry the affected areas thoroughly before application of Terbinafine cream. Apply the cream to the affected skin and surrounding area in a thin layer and rub in lightly.
The likely durations of treatment are as follows: Tinea cruris: 1 to 2 weeks Tinea pedis: 1 week
Relief of clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, the diagnosis should be verified.
Children
The experience with topical Terbisil in children aged 16 and under is still limited and its use cannot therefore be recommended.
Use in the elderly
There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients.
Method of administration Via the topical route.
4.3 Contraindications
Known hypersensitivity to the active substance or any of the excipients.
4.4 Special warnings and precautions for use
Terbinafine cream is for external use only. Contact with the eyes should be avoided. If it gets into the eyes accidentally, the eyes should be washed with plenty of water and the patient should turn to an ophthalmologist if necessary.
The cream contains cetyl alcohol and cetostearyl alcohol which may cause local reactions (i.e. contact dematitis).
4.5 Interaction with other medicinal products and other forms of interaction
There are no known drug interactions with Terbinafine cream.
4.6 Pregnancy and lactation
Foetal toxicity and fertility studies in animals suggest no adverse effects.
There is no clinical experience with Terbinafine cream in pregnant women, therefore, unless the potential benefits outweigh any potential risks, Terbinafine cream should not be administered during pregnancy.
Terbinafine is excreted in breast milk and therefore mothers should not receive Terbinafine cream whilst breast-feeding.
4.7 Effects on ability to drive and use machines
There are no data available that terbinafine would affect driving ability or any other activity requiring concentration.
4.8 Undesirable effects
In the Therapeutic equivalence study with Terbisil 1% cream and Lamisil 1% cream (EQUATE) a total of 733 patients were exposed to either Terbisil (n=366) or Lamisil (n=367) during the 1 week of the treatment period, where 10.1% of the patients (74 patients) experienced at least one adverse event. A total number of adverse events related to the study medications was 20 events during the study.
|
Frequency Primary System Organ Class MedDRA V. 8.0 |
Common >1/100, >1/10 |
Frequency | |
|
General disorders and administration site conditions |
Application site irritation |
15.6 % | |
|
Application site pruritus |
3.6 % | ||
|
Application site warmth |
2.4 % | ||
|
Application site pain |
1.2 % | ||
|
Application site erythema |
1.2 % | ||
|
Pain* | |||
|
Application site hypersensitivity* |
* These adverse reactions did not occur during the study “Equate”.
Erythema, pruritus, warmth, pain or irritation (stinging, burning sensation) occasionally occur at the site of application. Treatment generally does not have to be discontinued for this reason. These symptoms must be distinguished from application site hypersensitivity reactions, which are rare but require discontinuation of therapy.
4.9 Overdose
Terbinafine cream is for external use only. If accidental ingestion of the cream occurs, appropriate method of gastric lavage can be used.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Antifungals for topical use ATC code: D01A E15
Terbinafine is an antimycotic with a broad-spectrum of anti-fungal activity belonging to the allylamine group. At low concentrations terbinafine is fungicidal against dermatophytes, moulds and certain dimorphic fungi. The activity against yeasts, e.g. Candida species is fungicidal or fungistatic depending on the species.
Terbinafine interferes with fungal sterol biosynthesis by the inhibition of squalene epoxidase in the fungal cell membrane, which leads to an intracellular accumulation of squalene, resulting in fungal cell death.
Terbinafine is used for the treatment of fungal infections of the skin and nails, which is caused by Trichophyton (e.g. T. rubrum, T.mentagrophytes) and
Epidermophyton floccosum. The following table outlines the range of minimum inhibitory concentrations (MIC) against the dermatophytes.
|
Organism |
MIC range (pg/ml) |
|
Trichophyton rubrum |
0.001 - 0.15 |
|
Trichophyton mentagrophytes |
0.0001 - 0.05 |
|
Edidermorphyton fluccosum |
0.001 - 0.05 |
5.2 Pharmacokinetic properties
Less than 5% of the dose is absorbed after topical application; systemic exposure is therefore very slight.
5.3 Preclinical safety data
Not applicable
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium hydroxide,
Benzyl alcohol,
Sorbitan stearate,
Cetyl palmitate,
Cetyl alcohol,
Cetostearyl alcohol,
Polysorbate 60,
Isopropyl myristate,
Water purified.
Incompatibilities
6.2
None known.
6.3 Shelf life
4 years
Shelf life after opening: 1 month.
6.4 Special precautions for storage
No special precautions for storage. Store in original container.
6.5 Nature and contents of container
Aluminium tube closed by polyethylene cap. The tubes are containing 7.5 g and 15 g cream.
6.6 Special precautions for disposal
No special instructions.
7 MARKETING AUTHORISATION HOLDER
Generics [UK] Limited 12 station close, Potters Bar Hertfordshire, EN6 1TL United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 04569/1021
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/03/2007
10 DATE OF REVISION OF THE TEXT
04/11/2008