Derbicil 1% Cream
Terbinafine Hydrochloride

Presentation
Derbicil 1% Cream : Each gram cream contains Terbinafine Hydrochloride INN 10 mg.

Description
Terbinafine is an allylamine. It has a broad spectrum of antifungal activity. At low concentration, terbinafine is fungicidal against dermatophytes, moulds and certain dimorphic fungi. The activity against yeasts is fungicidal or fungistatic depending on the species. Terbinafine interferes with fungal ergosterol biosynthesis by inhibiting the enzyme squalene 2,3-epioxidase at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting fungal cell death. Terbinafine has no effect on fungal or mammalian cytochrome P-450 system. It does not influence the metabolism of hormones or other drugs. Less than 5% of the dose is absorbed after topical application; systemic exposure is, therefore, very slight.

Indications and Uses
Derbicil cream is indicated in-
-Fungal infections of the skin like interdigital tinea pedis, tinea cruris or tinea corporis caused by dermatophytes such as Trichophyton rubrum, Trichophyton mentagrophytes or Epidermophyton floccosum and plantar tinea pedis caused by Trichophyton rubrum or Trichophyton mentagrophytes

-Yeast infections of the skin principally those caused by the genus Candida (e.g. Candida albicans).

-Pityriasis (tinea) versicolor due to Pityrosporum orbiculare (also known as Malassezia furfur).

Dosage and Administration
Derbicil cream can be applied once or twice daily. Clean 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 lightly. In case of intertriginous infections (submammary, interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night.
Usual duration of treatment: The duration of treatment varies according to the indication and severity of infection.
Tinea corporis/cruris: 1 week
Tinea pedis: 1 week
Cutaneous candidiasis: 1 week
Pityriasis versicolor: 2 weeks
Relief of clinical symptoms usually occurs within a few days. The treatment must be continued regularly and for adequate length of time. 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.

Contraindications
Terbinafine is contraindicated in patients with known hypersensitivity to terbinafine or to any other ingredients of the cream.

rbinafine cream is for external use only. As it may be irritating to the eyes, contact with the eyes should be avoided. In case of accidental contact with the eyes, rinse eyes immediately with water.

Side-effects
Redness, itching or stinging occasionally occur at the site of application. But use of the cream rarely has to be discontinued for this reason. These harmless reactions should, however, be distinguished from allergic reactions, which are rare but require discontinuation of treatment.

Use in Pregnancy and lactation
Pregnancy: Although animal studies show no fetal toxicity, use of terbinafine in pregnant women has not been confirmed by controlled trials. Terbinafine should, therefore, not be given to pregnant women unless the potential benefits clearly outweigh the risks.
Lactation: Since terbinafine is excreted in breast milk, it should not be given to mothers who are breastfeeding.

Use in children
Experience with topical terbinafine in children is limited and its use can not, therefore, be recommended.

Use in the elderly
There is no evidence to suggest that elderly patients require different dosages or experience side effects different from younger patients.

Drug interactions
There are no known drug interactions with terbinafine cream.

Overdosage
No case of overdosage has yet been reported with terbinafine cream. However, if accidental ingestion of terbinafine cream occurs, some adverse effects, such as headache, nausea, epigastric pain and dizziness are to be expected and in this case supportive measures for gastric emptying is recommended.

Commercial Pack
Derbicil 1% Cream: Each tube contains 5 gm cream.