Brand name: LamISIL
Drug class: Allylamines

Medically reviewed by Drugs.com on Nov 10, 2024. Written by ASHP.

Introduction

Antifungal; synthetic allylamine structurally and pharmacologically related to naftifine.

Uses for Terbinafine Hydrochloride (Topical)

Dermatophytoses

Treatment of tinea corporis (body ringworm) and tinea cruris (jock itch, groin ringworm) caused by Epidermophyton floccosum, Trichophyton mentagrophytes, or T. rubrum.

Treatment of tinea pedis (athlete's foot, foot ringworm) caused by E. floccosum, T. mentagrophytes, or T. rubrum.

Topical antifungals usually effective for treatment of tinea corporis and tinea cruris. An oral antifungal may be necessary if tinea corporis or tinea cruris is extensive, dermatophyte folliculitis is present, the infection is chronic or does not respond to topical therapy, or patient is immunocompromised because of coexisting disease or concomitant therapy.

Topical antifungals usually effective for treatment of uncomplicated tinea pedis. An oral antifungal usually necessary if tinea pedis is extensive, the infection is chronic or does not respond to topical therapy, patient is immunocompromised because of coexisting disease or concomitant therapy, or the infection involves hyperkeratotic areas on soles or chronic moccasin-type (dry-type) tinea pedis.

Pityriasis Versicolor

Has been used for treatment of pityriasis versicolor (also known as tinea versicolor) caused by Malassezia furfur (Pityrosporum ovale).

Terbinafine Hydrochloride (Topical) Dosage and Administration

Administration

Topical Administration

Apply topically to skin as a 1% cream, 1% spray solution, or 1% gel.

Do not administer intravaginally; do not apply in or near the mouth or eyes.

Wash affected area with soap and water and dry completely prior to application. Wash hands after each application.

When using the cream, gently rub into affected areas and surrounding skin.

When using the spray solution, hold container 4–6 inches from the skin and spray a thin layer of solution over affected areas. Do not use the solution spray on the face.

Do not use with occlusive dressings or wrappings, unless otherwise directed by clinician.

Do not use for self-medication in children <12 years of age without consulting a clinician.

Dosage

Available as terbinafine hydrochloride or the base; dosage expressed in terms of terbinafine.

Pediatric Patients

Dermatophytoses

Tinea Corporis or Tinea Cruris

Topical

For self-medication in children ≥12 years of age (1% cream, 1% spray solution, 1% gel): Apply once daily (morning or night) for 1 week or as directed by clinician. Use amount sufficient to cover affected areas and surrounding skin.

Tinea Pedis

Topical

For self-medication of interdigital infections between toes in children ≥12 years of age (1% cream, 1% spray solution): Apply twice daily (morning and night) for 1 week or as directed by clinician. Alternatively, apply 1% gel once daily (at bedtime) for 1 week or as directed by clinician. Use amount sufficient to cover affected areas between toes.

For self-medication of tinea pedis involving bottom or sides of foot in children ≥12 years of age (1% cream): Apply twice daily (morning and night) for 2 weeks or as directed by a clinician. Use amount sufficient to cover all affected areas.

Adults

Dermatophytoses

Tinea Corporis or Tinea Cruris

Topical

For self-medication (1% cream, 1% spray solution, 1% gel): Apply once daily (morning or night) for 1 week or as directed by clinician. Use amount sufficient to cover affected areas and surrounding skin.

Tinea Pedis

Topical

For self-medication of interdigital infections between toes (1% cream, 1% spray solution): Apply twice daily (morning and night) for 1 week or as directed by clinician. Alternatively, apply 1% gel once daily (at bedtime) for 1 week or as directed by clinician. Use amount sufficient to cover affected areas between toes.

For self-medication of tinea pedis involving bottom or sides of foot (1% cream): Apply twice daily (morning and night) for 2 weeks or as directed by a clinician. Use amount sufficient to cover all affected areas.

Pityriasis Versicolor

Topical

Apply 1% cream or 1% spray solution twice daily for 1–2 weeks. Use amount sufficient to cover all affected areas.

Cautions for Terbinafine Hydrochloride (Topical)

Contraindications

• Hypersensitivity to terbinafine or any ingredient in the formulation.

Warnings/Precautions

Sensitivity Reactions

If irritation or sensitivity occurs, discontinue the drug and initiate appropriate therapy.

General Precautions

Selection and Use of Antifungals

Prior to initiation of treatment of dermatophytoses, diagnosis can be confirmed by direct microscopic examination of scrapings from infected tissue mounted in potassium hydroxide (KOH) or by culture using an appropriate medium.

Prior to initiation of treatment for pityriasis versicolor, confirm diagnosis by direct microscopic examination of scrapings from infected tissue mounted in KOH.

Clinical improvement usually evident within the first week of topical treatment, and patients treated for 1–2 weeks usually show continued improvement for several weeks after completion of treatment. If clinical improvement not evident within 2–6 weeks after completion of topical treatment, reevaluate diagnosis.

Specific Populations

Pregnancy

Category B.

Lactation

Distributed into milk following oral administration. Discontinue nursing or the drug.

Pediatric Use

Do not use for self-treatment in children <12 years of age unless directed by a clinician; safety and efficacy not established in this age group.

Common Adverse Effects

Irritation, burning/tingling, pruritus, dryness, skin exfoliation, erythematous rash.

Terbinafine Hydrochloride (Topical) Pharmacokinetics

Absorption

Following topical application to intact skin, systemic absorption occurs and low concentrations of terbinafine are attained in plasma.

Distribution

Extent

Penetration into stratum corneum is similar following topical application of 1% cream or 1% solution.

Distributed into milk following oral administration.

Elimination

Metabolism

Systemically absorbed drug is extensively metabolized.

Elimination Route

Approximately 75% of percutaneously absorbed drug is eliminated in urine, principally as metabolites.

Half-life

Half-life of percutaneously absorbed drug is approximately 21 hours.

Stability

Storage

Topical

Cream

20–25°C.

Gel

≤30°C.

Solution

8–25°C.

Actions and Spectrum

• Allylamine antifungal agent structurally and pharmacologically related to naftifine.

• 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.

• Spectrum of activity includes dermatophytes, yeasts, and some other fungi.

• Dermatophytes: Active in vitro against E. floccosum, T. mentagrophytes, T. rubrum, T. verrucosum, Microsporum canis, and M. gypseum. More active than azole antifungals (e.g., itraconazole, ketoconazole) against dermatophytes.

• Other fungi: Active in vitro 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 using topical preparations containing terbinafine as directed; importance of completing full course of treatment, even if symptoms improve.

• The cream, solution, and gel are for external use only; importance of avoiding contact with vagina, mouth, and eyes. If accidental contact with eyes occurs, importance of rinsing eyes thoroughly with water and consulting a clinician if symptoms persist.

• Importance of washing the affected areas with soap and water and drying completely before applying topical terbinafine; importance of washing hands after application.

• For patients with tinea pedis (athlete's foot, ringworm of the foot), importance of wearing well-fitting, ventilated shoes and changing shoes and socks at least once daily.

• Importance of consulting clinician if treated area shows signs of irritation or possible sensitization (e.g., erythema, pruritus, burning, blistering, swelling, oozing).

• Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.

• 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.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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