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Lamisil
DermGelTM 1% Gel

 

Qualitative and quantitative composition
One gram of gel contains 10 mg terbinafine base.

For excipients, see List of excipients.

Pharmaceutical form
White to off-white glossy gel.

Clinical particulars
Therapeutic indications: Fungal infections of the skin caused by dermatophytes such as Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. Pityriasis (tinea) versicolor due to Pityrosporum orbiculare (also known as Malassezia furfur).

Posology and method of administration

For cutaneous use.

Adults: Lamisil DermGel is applied once daily for all indications. Cleanse and dry the affected areas thoroughly before applying Lamisil DermGel. The emulsion gel should be rubbed in lightly to the affected skin and surrounding area. In the case of intertriginous infection (submammary, interdigital, intergluteal, inguinal), the area to which the gel has been applied may be covered with gauze, especially at night.

 

Before first use, the sealing membrane of the tube must be pierced using the point incorporated into the screw cap.

 

Duration and frequency of treatment:

Tinea corporis, tinea cruris : 1 week, once a day

Tinea pedis (interdigital type) : 1 week, once a day

Pityriasis versicolor : 1 week, once a day


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.

Use of Lamisil DermGel in the elderly (>=65 years): There is no evidence to suggest that elderly patients require different dosages or experience side effects different from those in younger patients.

Use of Lamisil DermGel in children (<18 years): There is limited experience with the use of Lamisil DermGel in children, and, Lamisil DermGel is therefore not recommended for use in children.

Contraindications
Known hypersensitivity to terbinafine or to any of the excipients.

Special warnings and special precautions for use
Lamisil DermGel should be used with caution in patients with lesions where alcohol could be irritating. Lamisil DermGel is for external use only. It may be irritating to the eyes.


In case of accidental contact with the eyes, rinse eyes thoroughly with running water and consult a physician if any symptoms persist.

Interactions with other medicinal products and other forms of Interaction

No drug interactions are known with Lamisil DermGel.

Pregnancy and lactation
Pregnancy: Animal studies did not reveal any teratogenic or embryofetotoxic potential of terbinafine. No cases of malformations in humans have been reported with Lamisil to date. However, since clinical experience in pregnant women is very limited, Lamisil DermGel should not be used during pregnancy unless the potential benefits outweigh any potential risks.


Lactation: Terbinafine is excreted in breast milk and therefore, mothers should not use Lamisil DermGel whilst breastfeeding. In addition, infants must not come into contact with any treated skin area, including the breasts.

Effects on ability to drive and use machines
Cutaneous application of Lamisil DermGel does not affect the ability to drive and use machines.

Undesirable effects
Redness, itching or stinging may occur at the site application; however, treatment rarely has to be discontinued for this reason. These harmless symptoms must be distinguished from allergic reaction (such as pruritus, rash, bullous eruptions and hives) which are very rare [1] but require discontinuation of treatment.

Overdose
The low systemic absorption of topical terbinafine emulsion gel renders overdosage extremely unlikely. Accidental ingestion of the contents of one 30g tube of Lamisil DermGel, which contains 300mg terbinafine, is comparable to one Lamisil 250mg tablet (adult oral unit dose).

 

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