Terbinafine hydrochloride.
Active Ingredient: Terbinafine HCl 1% w/w (topical gel) or 1% w/v (lotion).
Pharmacology: Terbinafine is an allylamine derivative reported to have a broad-spectrum antifungal activity. It is considered to act through inhibition of fungal sterol synthesis. It works by preventing the formation of substances needed by the fungus to grow and develop, which causes weakness and death of the fungus. Terbinafine is fungicidal against dermatophytes, molds and certain dimorphic fungi and some yeast. It kills dermatophytes such as Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum and Pityriasis versicolor due to Pityrosporum orbiculare. It is also used to treat cutaneous candidiasis. Fungicidal concentrations in nails are maintained for several weeks after therapy is discontinued. Skin concentrations may be up to 75-fold higher than those in the blood. It may persist in the skin for up to 8 weeks after the antifungal has been discontinued.
Once daily antifungal treatment for tinea and other fungal skin infections - athlete's foot, jock itch, ringworm, Pityriasis versicolor and fungal nail infection.
Directions of Use: Cleanse and dry the infected area thoroughly with warm water before application. Apply a thin layer onto the infected area and its surroundings once daily. Rub in gently. Wash hands after use to avoid spreading the infection to self or to others. Duration of treatment is one to two weeks. To prevent recurrence, continue to treat the area for one to two weeks after signs or symptoms of infections have gone. Treatment can be repeated if necessary.
Symptoms of Terbinafine overdose are not well known. The adverse effects observed in humans suggest that the main symptoms in cases of accidental ingestion would be gastrointestinal, e.g. nausea and vomiting. Gastric lavage and/or symptomatic supportive treatment may then be required.
Not suitable for patients with known hypersensitivity to Terbinafine.
For external use only. Avoid contact with eyes, nose and mouth. Not to be
taken. If symptoms persist, consult a doctor.
Category B (FDA): It is not expected to harm an unborn baby. Consult a
doctor first before using Terbinafine products. Terbinafine is excreted in breast
milk.
Even though the amount absorbed through the skin in topical use is minimal,
breast-feeding mothers should avoid using Terbinafine products unless advised
by a doctor.
Terbinafine is generally well-tolerated. Occasionally, itching or redness may
occur at the area of application.
Terbinafine does not generally affect the concentration of other medications.
Store below 30°C. Protect from light. Keep cap tightly closed.
Shelf Life: 3 years from the date of manufacture.
D01AE15 - terbinafine ; Belongs to the class of other antifungals for topical use.
Freederm lotion 1% w/v
30 mL x 1's
Freederm topical gel 1% w/w
10 g x 1's
Sign Out
