Terbinafine

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Fungal infections of the skin caused by dermatophytes such as Trichophyton, Microsporum canis and Epidermophyton floccosum
• Yeast infections of the skin, principally caused by Candida albicans
• Pityriasis (tinea) versicolor due to Pityrosporum orbiculare
• Tinea pedis (athletes foot) (sol)

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Hypersensitivity to benzyl alcohol, cetyl alcohol, cetostearyl alcohol, propylene glycol or butylhydroxytoluene (E321)
• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Hyerkeratotic chronic plantar tinea pedis
• Application to lesions
• Facial application
• Contact with eyes
• Sun-exposure
• Severe skin scaling
• Flammable
• Application with other medicinal products on treated areas

Tinea pedis

• Topical (spo, gel): Apply to the affected area and surrounding skin, dly; Treatment duration: 1 week
• Topical (sol): Apply to both feet, as a single dose
• Topical (cre): Apply to the affected area and surrounding skin, 12-24hrly; Treatment duration: 1 week

Tinea cruris

• Topical (spo, gel): Apply to the affected area and surrounding skin, dly; Treatment duration: 1 week
• Topical (cre): Apply to the affected area and surrounding skin, 12-24hrly; Max treatment duration: 1-2 weeks

Tinea corporis

• Topical (spo, gel): Apply to the affected area and surrounding skin, dly; Treatment duration: 1 week
• Topical (cre): Apply to the affected area and surrounding skin, 12-24hrly; Max treatment duration: 4 weeks

Cutaneous candidiasis
Pityriasis vesicolor

• Topical (gel): Apply to the affected area and surrounding skin, dly; Treatment duration: 1 week
• Topical (spo): Apply to the affected area and surrounding skin, 12hrly; Treatment duration: 1 week
• Topical (cre): Apply to the affected area and surrounding skin, 12-24hrly; Treatment duration: 2 weeks

Relief of clinical symptoms usually occurs within a few days. If there are no signs of improvement after one week (sol) or two weeks (gel, spo, cre), the diagnosis should be re-evaluated

Irregular use or an inadequate treatment period increases the risk of the symptoms returning

See additional prescribing points

Not established for use in children

Pregnancy

• Caution;
• There is no clinical experience with topical terbinafine in pregnant women. Foetal toxicity studies in animals suggest no adverse effects. Terbinafine should not be used in pregnancy unless clearly necessary

Breastfeeding

• Caution; not recommended
• After topical use, only a low systemic exposure is expected. However, terbinafine should not be used during breastfeeding. In addition, infants must not be allowed to come into contact with any treated skin, including the breast

Fertility

• No effect of terbinafine on fertility have been seen in animal studies

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Skin and Subcutaneous Tissue Disorders

• Skin exfoliation
• Pruritis
• Urticaria
• Skin lesion
• Scab
• Pigmentation disorder
• Erythema
• Burning sensation
• Dry skin
• Contact dermatitis
• Bullous dermatitis
• Eczema
• Rash
• Application site pain
• Application site irritation
• Aggravated fungal condition

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions

Sensory Disorders

• Eye irritation

No information available 

None routine 

Method of administration

• Cleanse and dry the affected areas thoroughly before applying terbinafine
• Cream: The cream should be applied in a thin layer on and around the affected skin and rubbed in gently. In cases of reddened and weeping infection (under the breasts, between the fingers, buttocks or in the groin) the skin may be covered with a sterile compress after application of the cream, especially at night
• Spray: Apply from a distance of 5 to 10 cm. A sufficient amount of spray solution should be applied to wet the treatment area(s) thoroughly, and to cover the affected skin and surrounding area
• Solution: Apply once on both feet, even if lesions are visible on one foot only. This ensures elimination of the fungi (dermatophytes) that might be found in areas of the foot where no lesions are visible
• Apply a thin layer evenly between and all around the toes, as well as the sole and sides of the foot for up to 1.5 cm. The product should be left to dry to a film for 1-2 minutes. Patients should then wash their hands
• The solution should not be massaged into skin. For the best results, the treated area should not be washed for 24 hours after application
• Gel: Rub in lightly to the affected skin and surrounding area. In the case of intertriginous infection (submammary, interdigital, intergluteal or inguinal) the application may be covered with a light gauze, especially at night

Terbinafine is an allylamine, with broad spectrum antifungal activity. It inhibits squalene epoxidase in the fungal cell membrane, leading to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death.

Spectrum of activity: Most fungi (including dermatophytes, yeasts, dimorphic fungi)

Cream (per g) 10mg

• Almatil 1% (Pharmaplan)
• Lamisil (GSK) originator
• Terbane (Sandoz) 
• Terbaspor (Sandoz) 
• Terbicil 1% (Pharmacare) 

Gel (per g) 10mg

• Lamisil Derm Gel  (GSK) originator

Spray (per g) 10mg

• Lamisil (GSK) originator

Solution (per g) 10mg

• Lamisil FIlm Foaming Solution Once (GSK) originator

Also available in the following form: Tablet.