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Terbinafine STELLA Cream 1%
OTC

Terbinafine is an allylamine which has a broad spectrum of antifungal activity. At low concentrations terbinafine is fungicidal against dermatophytes, moulds and certain dimorphic fungi. The activity versus yeasts is fungicidal or fungistatic depending on the species.

Pack size Box of 1 tube of 10 g
Shelf-life 24 months
Composition Terbinafine hydrochloride
Dosage forms and strengths Topical Cream: 100 mg/10 g
Product code :

PRESCRIBING INFORMATION

Indications

  • Fungal infections of the skin caused by Trichophyton, Microsporum canis and Epidermophyton floccosum.
  • Yeast infections of the skin, principally those caused by the genus Candida (e.g. C.albicans).
  • Pityriasis (tinea) versicolor due to Pityrosporum orbiculare (also known as Malassezia furfur)

Dosage

  • Apply topically once or twice daily.

Duration of treatment

  • 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.

Usage

  • For topical use. 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.
  • Known hypersensitivity to terbinafine or any of the excipients contained in the cream.

Common

  • Skin exfoliation, pruritus.

Uncommon:

  • Skin lesion, scab, skin disorder, pigmentation disorder, erythema, skin burning sensation, pain, application site pain, irritation.

 

  • The cream should not be applied to the eye nor administered intravaginally or orally. Contact with the nose, mouth, and other mucous membranes should be avoided.
  • Patients should be advised to avoid the use of occlusive dressing or wrappings unless otherwise directed by their physicians.
  • Topical terbinafine is not indicated for the treatment of infections involving the nails.
  • Safety and efficacy of terbinafine in children younger than 12 years of age have not been established.
  • Terbinafine cream should not be administered during pregnancy, unless the potential benefits outweigh any potential risks. Mothers should not receive terbinafine cream whilst breast-feeding. Infants must not be allowed to come into contact with any treated skin, including the breast.
  • Terbinafine STELLA Cream 1% may cause local skin reactions (e.g. contact dermatitis), allergic reactions (possibly delayed).