Treatment of tinea corporis (body ringworm) and tinea cruris (jock itch) caused by Trichophyton mentagrophytes, T. rubrum, or Epidermophyton floccosum.
Treatment of tinea pedis (athlete's foot) caused by T. mentagrophytes, T. rubrum, or E. floccosum and plantar tinea pedis (moccasin type) caused by T. mentagrophytes or T. rubrum.
Pityriasis (Tinea) Versicolor
Treatment of pityriasis (tinea) versicolor caused by Malassezia furfur (Pityrosporum ovale).
Dosage and Administration
Administration
Topical Administration
Apply topically to the skin as a cream or solution.
Do not apply to the eye or administer orally or intravaginally.
Do not use on nails or scalp; avoid contact with the nose, mouth, and other mucous membranes.
Do not use the solution spray on the face.
Do not use with occlusive dressings or wrappings, unless otherwise directed by clinician.
Cream or Solution
The affected skin and surrounding areas should be washed with soap and water and dried completely before the drug is applied.
Apply a sufficient amount of cream or solution either once or twice daily (as directed); rub gently into affected area and surrounding skin.
If irritation or sensitivity occurs, discontinue the drug and initiate appropriate therapy.
General Precautions
Selection and Use of Antifungals
Prior to administration of terbinafine for dermatophytoses or pityriasis (tinea) versicolor, diagnosis should be confirmed either by direct microscopic examination of scrapings from infected tissue mounted in potassium hydroxide (KOH) or by culture.
Clinical improvement usually is evident within the first week of therapy, and patients treated for 1–2 weeks usually show continued improvement for several weeks after completion of treatment. If clinical improvement is not evidence within 2–6 weeks after completion of topical therapy, the diagnosis should be reevaluated.
Local Effects
The solution contains 28.7% alcohol which may be irritating or drying.
Possible Prescribing and Dispensing Errors
Ensure accuracy of prescription; similarity in spelling of lamotrigine (Lamictal®) and terbinafine (Lamisil®) may result in errors.
Specific Populations
Pregnancy
Category B.
Lactation
Distributed into milk following oral administration. Discontinue nursing or the drug.
Pediatric Use
Safety and efficacy not established in children <12 years of age.
Percutaneous absorption occurs following topical application of the cream or solution to intact skin.
Distribution
Extent
Penetration into stratum corneum is similar following topical application of the cream or solution.
Distributed into milk following oral administration.
Elimination
Metabolism
Systemically absorbed drug is extensively metabolized.
Elimination Route
Approximately 75% of cutaneously absorbed drug is eliminated in urine, principally as metabolites.
Half-life
Half-life when absorbed through the skin is approximately 21 hours.
Stability
Storage
Topical
Cream
20–25°C; may be stored at 5–30°C.
Solution
8–25°C; do not refrigerate.
Actions
May be fungicidal or fungistatic in action, depending on concentration of the drug and specific fungus tested.
Appears to interfere with sterol biosynthesis in susceptible fungi by inhibiting the enzyme squalene monooxygenase (squalene 2,3-epoxidase). The resulting accumulation of squalene (the usual substrate of the enzyme) in the cells and decreased amounts of sterols, especially ergosterol, may contribute to the antifungal effects.
Active against many fungi, including dermatophytes (Trichophyton, Microsporum, Epidermophyton), filamentous (e.g. Aspergillus), dimorphic (e.g., Blastomyces), and dematiaceous fungi and yeasts.
Dermatophytes: active in vitro and in clinical infections against T. rubrum, T. mentagrophytes, and E. floccosum. Also active in vitro against M. canis, M. gypseum, M. nanum, and T. verrucosum. More active than azole antifungals (e.g., fluconazole, itraconazole, ketoconazole) against dermatophytes.
Other fungi: active in vitro and in clinical infections against Malassezia furfur. Also active in vitro against some Candida, including C. albicans and C. parapsilosis. Less active than azole antifungals against Candida.
Advice to Patients
Importance of applying to affected areas as directed and avoiding contact with eyes, nose, mouth, or other mucous membranes. Importance of not using occlusive dressings, unless otherwise directed by clinician.
Advise patient not to use spray solution on the face. If accidental contact with eyes occurs, importance of rinsing eyes thoroughly with running water and consulting a clinician if symptoms persist.
Advise patients to wash their hands after touching the affected areas so that the infection is not spread to other areas of the body or to other individuals.
For patients with tinea pedis (athlete's foot), importance of wearing well-fitting, ventilated shoes and changing socks at least once daily.
Importance of completing full course of therapy, even if symptoms improve.
Importance of notifying clinician if improvement does not occur after 1 week of treatment.
Importance of consulting clinician if treated area becomes irritated (e.g., erythema, pruritus, burning, blistering, swelling, oozing).
Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
Importance of advising patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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