Manufacturer: Douglas Pharmaceuticals manufactures Terbinafine-DP.

Uses:

The uses of Terbinafine-DP include:
Indications

Onychomycosis (fungal infection of the nail) caused by dermatophyte fungi.

Tinea capitis.

Fungal infections of the skin for the treatment of tinea corporis, tinea cruris, tinea pedis and yeast infections of the skin caused by the genus Candida (e.g. Candida albicans) where oral therapy is generally considered appropriate owing to the site, severity or extent of the infection.

Note: In contrast to topical Terbinafine, oral Terbinafine-DP is not effective in pityriasis versicolor.

Dosage and Administration

The duration of treatment varies according to the indication and the severity of the infection.

Children

No data are available in children under two years of age (usually < 12 kg).

Children weighing < 20 kg 62.5 mg

Children weighing 20 to 40 kg 125 mg

Children weighing > 40 kg 250 mg

Adults

250 mg once a day.

Skin infections

Recommended duration of treatment:

Tinea pedis (interdigital, plantar/moccasin type): 2 to 6 weeks.

Tinea corporis, cruris: 2 to 4 weeks.

Cutaneous candidiasis: 2 to 4 weeks.

Complete resolution of the signs and symptoms of infection may not occur until several weeks after mycological cure.

Hair and scalp infections

Recommended duration of treatment:

Tinea capitis: 4 weeks.

Tinea capitis occurs primarily in children.

Onychomycosis

For most patients the duration of successful treatment is 6-12 weeks.

Fingernail onychomycosis

Six weeks of therapy is sufficient for fingernail infections in most cases.

Toenail onychomycosis

Twelve weeks of therapy is sufficient for toenail infections in most cases.

Some patients with poor nail outgrowth may require longer treatment. The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

Use of Terbinafine 250 in the elderly

There is no evidence to suggest that elderly patients require different dosages or experience different side effects than younger patients. When prescribing tablets for patients in this age group, the possibility of pre-existing impairment of liver or kidney function should be considered (see Warnings and Precautions).

Use of Terbinafine 250 in children

In children above 2 years of age, oral Terbinafine-DP has been found to be well tolerated.