Skip to Content

Terbinafine Hydrochloride topical

Pronunciation

Class: Allylamines
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
Brands: Lamisil

Introduction

Antifungal; synthetic allylamine structurally and pharmacologically related to naftifine.1 2 8 12 19 28

Uses for Terbinafine Hydrochloride

Dermatophytoses

Treatment of tinea corporis (body ringworm)1 2 7 8 9 10 14 15 19 20 22 23 26 27 28 32 33 34 37 and tinea cruris (jock itch, groin ringworm)1 2 6 7 8 9 10 14 15 19 20 21 22 23 25 26 27 28 32 33 34 37 caused by Epidermophyton floccosum, Trichophyton mentagrophytes, or T. rubrum.1 7 8 9 14 32 33

Treatment of tinea pedis (athlete's foot, foot ringworm)1 2 3 4 5 7 8 10 14 19 20 22 23 26 27 28 32 35 caused by E. floccosum, T. mentagrophytes, or T. rubrum.1 7 8 14 32 36 37

Topical antifungals usually effective for treatment of tinea corporis and tinea cruris.7 8 9 10 14 32 37 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.7 8 9 14 15 32

Topical antifungals usually effective for treatment of uncomplicated tinea pedis.7 8 9 10 14 32 37 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.7 8 9 10 14 32 37

Pityriasis Versicolor

Has been used for treatment of pityriasis versicolor (also known as tinea versicolor) caused by Malassezia furfur (Pityrosporum ovale).14 19 30 31

Terbinafine Hydrochloride Dosage and Administration

Administration

Topical Administration

Apply topically to skin as a 1% cream,20 1% spray solution,21 22 or 1% gel.23

Do not administer intravaginally;20 21 22 23 do not apply in or near the mouth or eyes.20 21 22 23

Wash affected area with soap and water and dry completely prior to application.20 21 22 23 Wash hands after each application.20 21 22 23

When using the cream, gently rub into affected areas and surrounding skin.2

When using the spray solution, hold container 4–6 inches from the skin and spray a thin layer of solution over affected areas.22 Do not use the solution spray on the face.19

Do not use with occlusive dressings or wrappings, unless otherwise directed by clinician.1 19

Do not use for self-medication in children <12 years of age without consulting a clinician.20 21 22 23

Dosage

Available as terbinafine hydrochloride20 21 22 or the base;23 dosage expressed in terms of terbinafine.1

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.20 21 22 23 Use amount sufficient to cover affected areas and surrounding skin.20 21 22 23

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.20 22 Alternatively, apply 1% gel once daily (at bedtime) for 1 week or as directed by clinician.23 Use amount sufficient to cover affected areas between toes.20 21 22 23

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.20 Use amount sufficient to cover all affected areas.20

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.20 21 22 Use amount sufficient to cover affected areas and surrounding skin.20 21 22

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.20 22 Alternatively, apply 1% gel once daily (at bedtime) for 1 week or as directed by clinician.23 Use amount sufficient to cover affected areas between toes.20 21 22 23

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.20 Use amount sufficient to cover all affected areas.20

Pityriasis Versicolor
Topical

Apply 1% cream or 1% spray solution twice daily for 1–2 weeks.19 30 31 Use amount sufficient to cover all affected areas.19 30 31

Cautions for Terbinafine Hydrochloride

Contraindications

  • Hypersensitivity to terbinafine or any ingredient in the formulation.1 19

Warnings/Precautions

Sensitivity Reactions

If irritation or sensitivity occurs, discontinue the drug and initiate appropriate therapy.1 19 20 21 22 23

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.1 7 9 14 19 32

Prior to initiation of treatment for pityriasis versicolor, confirm diagnosis by direct microscopic examination of scrapings from infected tissue mounted in KOH.1 19

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.1 2 4 6 8 11 14 18 If clinical improvement not evident within 2–6 weeks after completion of topical treatment, reevaluate diagnosis.1

Specific Populations

Pregnancy

Category B.1 19

Lactation

Distributed into milk following oral administration.1 19 Discontinue nursing or the drug.1 19

Pediatric Use

Do not use for self-treatment in children <12 years of age unless directed by a clinician;20 21 22 23 safety and efficacy not established in this age group.1 19 20 21 22 23

Common Adverse Effects

Irritation, burning/tingling, pruritus, dryness, skin exfoliation, erythematous rash.1 19

Terbinafine Hydrochloride Pharmacokinetics

Absorption

Following topical application to intact skin, systemic absorption occurs and low concentrations of terbinafine are attained in plasma.1 19

Distribution

Extent

Penetration into stratum corneum is similar following topical application of 1% cream or 1% solution.1 19

Distributed into milk following oral administration.1 19

Elimination

Metabolism

Systemically absorbed drug is extensively metabolized.1 19

Elimination Route

Approximately 75% of percutaneously absorbed drug is eliminated in urine, principally as metabolites.1 19

Half-life

Half-life of percutaneously absorbed drug is approximately 21 hours.19

Stability

Storage

Topical

Cream

20–25°C.20

Gel

≤30°C.23

Solution

8–25°C.21 22

Actions and Spectrum

  • Allylamine antifungal agent1 2 3 4 6 12 18 19 25 26 27 28 29 structurally and pharmacologically related to naftifine.2 6 12 28 29

  • May be fungicidal or fungistatic in action, depending on concentration of the drug and specific fungus tested.1 2 3 4 11 15 19

  • Appears to interfere with sterol biosynthesis in susceptible fungi by inhibiting the enzyme squalene monooxygenase (squalene 2,3-epoxidase).1 2 19 The resulting accumulation of squalene (the usual substrate of the enzyme) in the cells and decreased amounts of sterols, especially ergosterol,1 2 19 may contribute to the antifungal effects.2

  • Spectrum of activity includes dermatophytes, yeasts, and some other fungi.1 2

  • Dermatophytes: Active in vitro against E. floccosum, T. mentagrophytes, T. rubrum, T. verrucosum, Microsporum canis, and M. gypseum.1 2 13 19 More active than azole antifungals (e.g., itraconazole, ketoconazole) against dermatophytes.5 5 15 25

  • Other fungi: Active in vitro against Malassezia furfur.13 Also active in vitro against some Candida, including C. albicans and C. parapsilosis.2 3 4 11 13 15 Less active than azole antifungals against Candida.2 26 28

Advice to Patients

  • Importance of using topical preparations containing terbinafine as directed;1 19 20 21 22 23 importance of completing full course of treatment, even if symptoms improve.1 19 20 21 22 23

  • The cream, solution, and gel are for external use only;20 21 22 23 importance of avoiding contact with vagina, mouth, and eyes.20 21 22 23 If accidental contact with eyes occurs, importance of rinsing eyes thoroughly with water and consulting a clinician if symptoms persist.19 20 21 22 23

  • Importance of washing the affected areas with soap and water and drying completely before applying topical terbinafine;20 21 22 23 importance of washing hands after application.20 21 22 23

  • 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.20 22 23

  • Importance of consulting clinician if treated area shows signs of irritation or possible sensitization (e.g., erythema, pruritus, burning, blistering, swelling, oozing).1 19 20 21 22 23

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1 19

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 19

  • Importance of advising patients of other important precautionary information.1 19 (See Cautions.)

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, 2004-2016, Selected Revisions March 1, 2016. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Novartis Pharmaceuticals Corporation. Lamisil (terbinafine hydrochloride) 1% cream prescribing information (dated 1997 Mar). In: Physicians’ desk reference. 52nd ed. Montvale, NJ: Medical Economics Company Inc; 1998;1859-61.

2. Balfour JA, Faulds D. Terbinafine: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in superficial mycoses. Drugs. 1992; 43: 259-84.

3. Savin RC. Treatment of chronic tinea pedis (athlete’s foot type) with topical terbinafine. J Am Acad Dermatol. 1990; 23:786-9. [PubMed 2229524]

4. Berman B, Ellis C, Leyden J et al. Efficacy of a 1-week, twice-daily regimen of terbinafine 1% cream in the treatment of interdigital tinea pedis. J Am Acad Dermatol. 1992; 26:956-60. [PubMed 1607415]

5. Smith EB, Noppakun N, Newton RC. A clinical trial of topical terbinafine (a new allylamine antifungal) in the treatment of tinea pedis. J Am Acad Dermatol. 1990; 23:790-4. [PubMed 2229525]

6. Greer DL, Jolly HW Jr. Treatment of tinea cruris with topical terbinafine. J Am Acad Dermatol. 1990; 23: 800-4. [PubMed 2229527]

7. Hay RJ. Dermatophytosis and other superficial mycoses. In: Mandell GL, Bennett, JE, Dolin R, eds. Mandell, Douglas, and Bennett's: Principles and Practice of Infectious Diseases. Vol 2. 7th ed. Philadelphia: Elsevier; 2010: 3345-55.

8. Piérard GE, Arrese JE, Piérard-Franchimont C. Treatment and prophylaxis of tinea infections. Drugs. 1996; 52:209-24. [PubMed 8841739]

9. Drake LA, Dincehart SM, Farmer ER et al. Guidelines of care for superficial mycotic infections of the skin: tinea corporis, tinea cruris, tinea faciei, tinea manuum, and tinea pedis. J Am Acad Dermatol. 1996; 34:282-6. [IDIS 363962] [PubMed 8642094]

10. Gupta AK, Einarson TR, Summerbell RC et al. An overview of topical antifungal therapy in dermatomycoses. A North American perspective. Drugs. 1998; 55:645-74. [PubMed 9585862]

11. Bergstresser PR, Elewski B, Hanifin J et al. Topical terbinafine and clotrimazole in interdigital tinea pedis: a multicenter comparison of cure and relapse rates with 1- and 4-week treatment regimens. J Am Acad Dermatol. 1993; 28:648-51. [PubMed 8463471]

12. Lyman CA, Walsh TJ. Systemically administered antifungal agents: a review of their clinical pharmacology and therapeutic applications. Drugs. 1992; 44:9-35. [PubMed 1379913]

13. Petranyi G, Meingassner JG, Mieth H. Antifungal activity of the allylamine derivative terbinafine in vitro. Antimicrob Agents Chemother. 1987; 31:1365-8. [PubMed 3674847]

14. American Academy of Pediatrics. Red Book: 2015 Report of the Committee on Infectious Diseases. 30th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2015.

15. El-Gohary M, van Zuuren EJ, Fedorowicz Z et al. Topical antifungal treatments for tinea cruris and tinea corporis. Cochrane Database Syst Rev. 2014; 8:CD009992. [PubMed 25090020]

16. Sandoz Pharmaceutical Corporation, East Hanover, NJ: Personal communication.

17. Reviewers’ comments (personal observations).

18. Evans EGV, Dodman B, Williamson DM et al. Comparison of terbinafine and clotrimazole in treating tinea pedis. BMJ. 1993; 307:645-7. [IDIS 320437] [PubMed 8401048]

19. Novartis Pharmaceuticals Corporation. Lamisil (terbinafine hydrochloride) 1% solution prescribing information. East Hanover, NJ; 1999 Feb.

20. Novartis Consumer Health, Inc. Lamisil AT (terbinafine hydrochloride) 1% cream patient information. Parsippany, NJ; 2008.

21. Novartis Consumer Health, Inc. Lamisil AT (terbinafine hydrochloride) 1% solution Spray Pump patient information. Parsippany, NJ; 2006.

22. Novartis Consumer Health, Inc. Lamisil AT (terbinafine hydrochloride) 1% solution continuous spray patient information. Parsippany, NJ.

23. Novartis Consumer Health, Inc. Lamisil AT (terbinafine) 1% gel patient information. Parsippany, NJ.

24. Aste N, Pau M, Pinna AL et al. Clinical efficacy and tolerability of terbinafine in patients with pityriasis versicolor. Mycoses. 1991; 34:353-7. [PubMed 1803242]

25. Millikan LE. Efficacy and tolerability of topical terbinafine in the treatment of tinea cruris. J Am Acad Dermatol. 1990; 23:795-9. [PubMed 2229526]

26. Kagawa S. Clinical efficacy of terbinafine in 629 Japanese patients with dermatomycosis. Clin Exp Dermatol. 1989; 14:114-5. [PubMed 2689013]

27. Villars V, Jones TC. Clinical efficacy and tolerability of terbinafine (Lamisil)—a new topical and systemic fungicidal drug for treatment of dermatomycoses. Clin Exp Dermatol. 1989; 14:124-7. [PubMed 2689015]

28. Shear NH, Villars VV, Marsolais C. Terbinafine: an oral and topical antifungal agent. Clin Dermatol. 1992; 9:487-95.

29. Smith EB. Topical antifungal drugs in the treatment of tinea pedis, tinea cruris, and tinea corporis. J Am Acad Dermatol. 1993; 28(5 Part 1):S24-8. [PubMed 8496408]

30. Vermeer BJ, Staats CC. The efficacy of a topical application of terbinafine 1% solution in subjects with pityriasis versicolor: a placebo-controlled study. Dermatology. 1997; 194 Suppl 1:22-4. [PubMed 9154397]

31. Rad F, Nik-Khoo B, Yaghmaee R et al. Terbinafin 1% Cream and Ketoconazole 2% Cream in the Treatment of Pityriasis Versicolor: A randomized comparative clinical trial. Pak J Med Sci. 2014 Nov-Dec; 30:1273-6. [PubMed 25674122]

32. Andrews MD, Burns M. Common tinea infections in children. Am Fam Physician. 2008; 77:1415-20. [PubMed 18533375]

33. Choudhary S, Bisati S, Singh A et al. Efficacy and Safety of Terbinafine Hydrochloride 1% Cream vs. Sertaconazole Nitrate 2% Cream in Tinea Corporis and Tinea Cruris: A Comparative Therapeutic Trial. Indian J Dermatol. 2013; 58:457-60. [PubMed 24249898]

34. Del Rosso JQ, Kircik LH. Optimizing topical antifungal therapy for superficial cutaneous fungal infections: focus on topical naftifine for cutaneous dermatophytosis. J Drugs Dermatol. 2013; 12(11 Suppl):s165-71. [PubMed 24196340]

35. Schopf R, Hettler O, Bräutigam M et al. Efficacy and tolerability of terbinafine 1% topical solution used for 1 week compared with 4 weeks clotrimazole 1% topical solution in the treatment of interdigital tinea pedis: a randomized, double-blind, multi-centre, 8-week clinical trial. Mycoses. 1999; 42:415-20. [PubMed 10536434]

36. Korting HC, Kiencke P, Nelles S et al. Comparable efficacy and safety of various topical formulations of terbinafine in tinea pedis irrespective of the treatment regimen: results of a meta-analysis. Am J Clin Dermatol. 2007; 8:357-64. [PubMed 18039018]

37. Ely JW, Rosenfeld S, Seabury Stone M. Diagnosis and management of tinea infections. Am Fam Physician. 2014; 90:702-10. [PubMed 25403034]

Hide