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
Fungal infections of the skin caused by Trichophyton (e.g. T. rubrum, T.mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.
Yeast infections of the skin, principally those caused by the genus Candida (eg. C. albicans).
Pityriasis (tinea) versicolor due to Pityrosporum orbiculare (also known as Malassezia furfur).
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. In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night.
The likely durations of treatment are as follows:
Tinea corporis, cruris: 1 to 2 weeks Tinea pedis: 1 week Cutaneous candidiasis: 2 weeks Pityriasis versicolor: 2 weeks
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 terbinafine in children 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).
The product should be kept out of the reach of children.
4.5 Interaction with other medicinal products and other forms of interaction
There are no known drug interactions with Terbinafine cream.
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. In addition, infants must not be allowed to come into contact with any treated skin, including the breast.
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
Local symptoms such as pruritus, skin exfoliation, application site pain, application site irritation, pigmentation disorder, skin burning sensation, erythema, scab, etc. may occur at the site of application. These harmless symptoms must be distinguished from hypersensitivity reactions incl. rash, which are reported in sporadic cases and require discontinuation of therapy. In case of accidental contact with the eyes terbinafine may be irritating to the eyes. In rare cases the underlying fungal infection may be aggravated.
The frequencies of adverse events are ranked according to the following: very common (> 1/10), common (> 1/100 to < 1/10), uncommon (> 1/1,000 to < 1/100), rare (> 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
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.
Immune system disorders Not known: Hypersensitivity*
Eye disorders Rare: Eye irritation
Skin and subcutaneous tissue disorders Common: Skin exfoliation, pruritus, erythema
Uncommon: Skin lesion, scab, skin disorder, pigmentation disorder, skin burning sensation
Rare: Dry skin, dermatitis contact, eczema
General disorders and administration site conditions Uncommon: Pain, application site pain, application site irritation Rare: Condition aggravated *Based on post-marketing experience
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, T. verrucosum, T. violaceum), Microsporum canis 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 |
|
Trichophyton verrucosum |
0.001 - 0.006 |
|
Trichophyton violaceum |
0.001 - 0.1 |
|
Microsporum canis |
0.0001 - 0.1 |
|
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.
6.2 Incompatibilities
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.
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Aluminium tube closed by polyethylene cap. The tubes are containing 7.5 g, 15 g or 30 g cream.
Special precautions for disposal No special instructions.
09/04/2013