Lamisil is indicated for: Fungal infections of the skin caused by dermatophytes such as Trichophyton (eg. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum, e.g. tinea pedis, tinea corporis or tinea cruris.
Pityriasis versicolor (Tinea versicolor), due to Pityrosporum orbiculare (also known as Malassezia furfur. In addition for Lamisil Cream: Fungal infections of the skin caused by yeast, mainly those of the genus Candide jeg Candida albicans).
Posology and method of administration
Usual dosage
Adults and children over 12 years: Lamisil can be applied 1-2 times daily, depending on the indication. The affected skin area should be cleaned and dried thoroughly before the application.
The Cream and the DermGel should be applied in a thin layer to the affected skin and the surrounding area and rubbed in lightly.
In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal), the application of the Cream and the DermGel may be covered with a gauze strip, especially at night.
Usual treatment regimens
Cream
- Tinea pedis (interdigital), Tinea corporis/cruris: Once a day for one week.
- Tinea pedis plantaris (Mocassin-type): Twice a day for two weeks.
- Cutaneous candidiasis: Once or twice a day for one week.
- Pityriasis versicolor: Once or twice a day for two weeks
DermGel
- Tinea pedis (interdigital), Tinea corporis I cruris: Once a day for one week.
- Pityriasis versicolor: Once a day for one week.
The efficacy and safety of Lamisil DermGel has not been investigated in the moccasin type of tinea pedis (plantar affliction). 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 one week, the diagnosis should be verified. The efficacy of Lamisil Cream has not been investigated in patients with tinea pedis who have concomitant severe onychomycosis.
Special Dosage Recommendations
Elderly patients
There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those in younger patients.
Children
The safety and efficacy in children below the age of 12 years has not yet been systematically tested. Children below the age of 5 years should not be treated with Lamisil because of the lack of clinical experience.
Composition
Cream
- Active substance: Terbinafine hydrochloride.
- Excipients: sodium Hydroxide 30%, Benzyl alcohol, Sorbitan stearate, Cetyl Plamitate, Stearyl alcohol, Cetyl alcohol, polysorbate 60, Isopropyl myristate, Purified water.
DermGel
- Active substance: Terbinafine base.
- Excipients: Butylated hydroxytoluene, Sodium hydroxide, Benzyl alcohol, Sorbitan monolaurate, Carbomer 934 benzene free, Polysorbate 20, Isopropyl myristate, Ethanol 96%, purified water.
Pharmaceutical form and active substance per unit
- Cream: Terbinafine hydrochloride 10 mg/g.
- DermGel: Terbinafine 10 mg/g.
Contraindications
Hypersensitivity to terbinafine or to any of the excipients contained in the Cream, DermGel (see composition).
Warnings And Precautions
Lamisil is only intended for external use. Eye contact is to avoid.
Lamisil DermGel may be inating to the eyes and therefore should not be used on the face in case of accidental contact with the eyes, rinse immediately eyes and conjunctival thoroughly with running water, tamisil DermGel should be used with caution in patients with skin lesions, where the contained alcohol could be irritating.
Interactions
No drug interactions with Lamisil Cream, and DermGel are known to date.
Pregnancy and lactation
Pregnancy
There are no controlled studies in pregnant women. Reproduction studies in animals have not shown any risk to the fetus. In the local application of Lamisil less than 5% of the applied amount is absorbed. During pregnancy, Lamisil should not be used unless clearly necessary.
Lactation
Terbinafine is excreted in breast milk, although the amount involved is small. It is not known whether this small quantity in the breast milk can have a negative effect on the child. Lamisil should not be used in lactating women.
Effects on ability to drive and use machines
No relevant studies have been conducted.
Undesirable effects
Redness, ching or burning occasionally occur at the site of application however, treatment rarely has to be discontinued for this reason.
These harmless symptoms must be distinguished from allergic reactions, which are rare but require discontinuation of treatment. Such allergic reactions may be associated with redness, papules, blisters and pruritus which can also mandest beyond the contact area (so-called disseminated reactions
for more information about Lamisil review patient information leaflet: Lamisil patient information leaflet