One gram contains 10 mg terbinafine hydrochloride, equivalent to 8.8 mg of terbinafine base.
Excipients/Inactive Ingredients: Sodium hydroxide; benzyl alcohol; sorbitan stearate; cetyl palmitate; cety alcohol; stearyl alcohol; polysorbate 60; isopropyl myristate; purified water.
Pharmacotherapeutic group: Antifungal for topical use. ATC Code: D01AE15.
Pharmacology: Pharmacodynamics: Mechanism of Action: Terbinafine interferes specifically with fungal sterol biosynthesis at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane. The enzyme squalene epoxidase is not linked to the cytochrome P-450 system. Terbinafine does not influence the metabolism of hormones or other drugs.
Terbinafine is an allylamine which has a broad spectrum of antifungal activity in the 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. At low concentrations terbinafine is fungicidal against dermatophytes, moulds and certain dimorphic fungi. The activity against yeast is fungicidal (e.g. Malassezia furfur) or fungistatic, depending on the species.
Pharmacokinetics: Absorption: Less than 5% of the dose is absorbed after topical application to humans; systemic bioavailability is therefore very low.
Distribution: Following application for 7 days, concentration of terbinafine in excess of those required for fungicidal activity are avialble in the affected stratum corneum for at least 7 days after treatment cessation.
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, e.g. interdigital type tinea pedis (athlete's foot), tinea cruris (dhobie (jock) itch) and tinea corporis (ringworm).
Pityriasis (tinea) versicolor caused by Pityrosporum orbiculare (also known as Malassezia furfur).
Yeast infection of the skin, principally those caused by the genus Candida (e.g. Candida albicans).
Treatment of plantar type tinea pedis (moccasin foot).
For cutaneous use only.
Elderly: There is no evidence to suggest that elderly patients require different dosages or experience side effects different to those in younger patients.
Adults and adolescent aged 12 years and over.
Duration and frequency of treatment: Interdigital type tinea pedis: Once a day for one week.
Plantar type tine pedis: Twice a day for two weeks.
Tinea corporis, tinea cruris: Once a day for one week.
Cutaneous candidiasis: Once or twice a day for one to two weeks.
Pityriasis versicolor: Once or twice a day for two weeks.
Clinical symptoms usually start to improve within a few days. irregular use or premature discontinuation of treatment carries the risk of recurrence.
If there are no signs of improvement within 2 weeks of first starting treatment, patients should see a doctor or pharmacist to verify diagnosis.
Method of administration: Before first use, the sealing membrane of the tube must be pierced using the point incorporated into the screw cap.
The affected area should be cleaned and dried thoroughly before application. The cream should be applied to the affected skin and surrounding area in a thin layer and rubbed it lightly.
In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal), the application may be covered with a gauze, especially at night.
Children: Not recommended for use in children below 12 years of age due to insufficient data on safety and efficacy.
Signs and symptoms: The low systemic absorption of topical terbinafine renders overdosage extremely unlikely during cutaneous use.
Accidental ingestion of one 30 g tube of cream, which contains 300 mg terbinafine base, is comparable to ingestion of one Terbinafine 250 mg tablet (adult oral unit dose).
Symptoms/signs of overdose following ingestion of terbinafine may include headache, nausea, epigastric pain and dizziness.
Further management should be as clinically indicated.
Contraindicated in patients with a prior hypersensitivity reaction to terbinafine or any other ingredient of the preparation.
May be irritating to the eyes. In case of accidental contact with the eyes, rinse eyes thoroughly with running water.
Keep out of the sight and reach of children.
Infants must not be allowed to come into contact with any treated skin, including the breast.
For external use only.
If applied to face keep away from eyes.
Contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
Ability to perform tasks that require judgement, motor or cognitive skills: Cutaneous application of terbinafine has no influence on the ability to drive and use machines.
Pregnancy: For terbinafine, no clinical data on exposed pregnancies are available. Animal studies do not indicate any harmful effects with respect to pregnancy or the health of the foetus. It is not appropriate for the consumer to use the product during pregnancy unless clearly necessary.
Lactation: Terbinafine is excreted into breast-milk. After topical use, only a low systemic exposure is expected. Terbinafine should only be used in a nursing mother if the expected benefit justifies the risk to the infant. In addition, infants must not be allowed to come into contact with any treated skin, including the breast.
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: 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), or not known (cannot be estimated from available data. Adverse reactions identified during post-marketing use are reported voluntarily from a population of uncertain size, the frequency of these reactions is not known but likely to be rare or very rare. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See table.)
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There are no clinically relevant drug interactions.
D01AE15 - terbinafine ; Belongs to the class of other antifungals for topical use.