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Terbinafine (Topical) (Monograph)

Brand name: LamISIL
Drug class: Allylamines
- Squalene Epoxidase Inhibitors
VA class: DE102
Chemical name: 1-Naphthalenemethanamine,N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine hydrochloride
Molecular formula: C21H25N•ClH
CAS number: 78628-80-5

Medically reviewed by Drugs.com on Feb 20, 2024. Written by ASHP.

Introduction

Antifungal; synthetic allylamine structurally and pharmacologically related to naftifine.

Uses for Terbinafine (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 (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 (Topical)

Contraindications

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 (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

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.

Terbinafine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Gel

1%

LamISIL AT

Novartis

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

Terbinafine Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

1%*

LamISIL AT

Novartis

Terbinafine Hydrochloride Cream

Solution

1%

LamISIL AT Continuous Spray

Novartis

LamISIL AT Spray Pump

Novartis

AHFS DI Essentials™. © Copyright 2024, Selected Revisions March 1, 2016. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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