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Terbinafine (topical): Drug information

Terbinafine (topical): Drug information
(For additional information see "Terbinafine (topical): Patient drug information" and see "Terbinafine (topical): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • LamISIL AT Jock Itch [OTC];
  • LamISIL AT Spray [OTC] [DSC];
  • LamISIL AT [OTC]
Brand Names: Canada
  • LamISIL
Pharmacologic Category
  • Antifungal Agent, Topical
Dosing: Adult
Cutaneous candidiasis

Cutaneous candidiasis (off-label use): Topical: Cream 1%: Apply to affected area once or twice daily for 1 to 2 weeks (Lamisil Canadian product monograph).

Tinea infections

Tinea infections:

Tinea corporis/tinea cruris (OTC labeling): Topical:

Cream 1%, gel 1%, spray 1% (spray is for tinea cruris only): Apply to affected and surrounding area(s) once daily until clinical resolution, typically 1 week (Goldstein 2021; manufacturer's labeling).

Tinea pedis (OTC labeling)/tinea manuum (off-label use): Topical:

Cream 1%, gel 1%: Apply to affected and surrounding area(s) once or twice daily (cream) or once daily (gel) until 1 week after clinical resolution, typically for 2 weeks total (Korting 2001; Weinstein 2002; manufacturer's labeling).

Tinea versicolor (off-label use): Topical:

Cream 1%, spray 1%: Apply to affected area(s) and immediate surrounding skin twice daily for 1 to 2 weeks (Aste 1991; Vermeer 1997; Lamisil Canadian product monograph).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

(For additional information see "Terbinafine (topical): Pediatric drug information")

Pityriasis versicolor

Pityriasis (tinea) versicolor: Limited data available: Children ≥12 years and Adolescents: Topical: Solution (spray): Apply to affected area once daily for 1 week (Bradley 2017; Red Book [AAP 2015])

Tinea corporis

Tinea corporis (ringworm): Children ≥12 years and Adolescents: Topical: Cream, gel: Apply to affected area once daily for at least 1 week

Tinea cruris

Tinea cruris (jock itch): Children ≥12 years and Adolescents: Topical: Cream, gel, solution (spray): Apply to affected area once daily for at least 1 week

Tinea pedis

Tinea pedis (athlete’s foot): Children ≥12 years and Adolescents: Topical:

Cream: Apply between the toes to affected area twice daily for at least 1 week; apply on the bottom or sides of feet twice daily for 2 weeks

Gel: Apply to affected area once daily at bedtime for at least 1 week

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External, as hydrochloride:

LamISIL AT: 1% (12 g, 30 g, 42 g) [contains benzyl alcohol, cetyl alcohol]

LamISIL AT Jock Itch: 1% (12 g) [contains benzyl alcohol, cetyl alcohol]

Generic: 1% (15 g, 30 g)

Solution, External, as hydrochloride:

LamISIL AT Spray: 1% (125 mL [DSC]) [contains alcohol, usp, propylene glycol]

Generic Equivalent Available: US

May be product dependent

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External:

LamISIL: 1% (15 g, 30 g) [contains benzyl alcohol, cetyl alcohol]

Solution, External, as hydrochloride:

LamISIL: 1% (30 mL) [contains alcohol, usp, propylene glycol]

Administration: Adult

Topical: Wash affected area with soap and water prior to use and dry completely; wash hands after use.

Spray: Hold 4 to 6 inches from skin during application.

Administration: Pediatric

For external use only; avoid contact with eyes or mouth. Do not use on nails, scalp, or for vaginal yeast infections. Apply to clean, dry affected area in sufficient quantity to cover. Wash hands after use.

Use: Labeled Indications

Dermatologic fungal infections: Treatment of tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm).

Use: Off-Label: Adult

Cutaneous candidiasis; Tinea manuum; Tinea versicolor

Medication Safety Issues
Sound-alike/look-alike issues:

Terbinafine may be confused with terbutaline

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Dermatologic: Burning sensation of skin, contact dermatitis, exfoliation of skin, pruritus, skin irritation, skin rash, stinging of the skin, xeroderma

Local: Local irritation

Contraindications

There are no contraindications listed within the manufacturer's labeling.

Canadian labeling: Hypersensitivity to terbinafine or any component of the formulation

Warnings/Precautions

Concerns related to adverse events:

• Local irritation: If irritation/sensitivity develops, discontinue therapy and institute appropriate alternative therapy.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer's labeling.

Other warnings/precautions:

• Appropriate use: For topical use only. Not intended for ophthalmologic, oral, or vaginal administration. Do not use on nails or scalp.

Warnings: Additional Pediatric Considerations

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Shehab 2009).

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Systemic absorption is limited following topical application. If antifungal treatment cannot be delayed until after pregnancy, topical therapy when appropriate may be considered (Kaul 2017).

Breastfeeding Considerations

Following oral administration, terbinafine is present in breast milk (refer to the Terbinafine [Systemic] monograph for additional information).

Systemic absorption is limited following topical application. Breastfeeding mothers should not apply topical formulations to the breast and infants should avoid contact with treated skin.

Mechanism of Action

Synthetic allylamine derivative that inhibits squalene epoxidase, a key enzyme in sterol biosynthesis in fungi. This results in a deficiency in ergosterol within the fungal cell membrane and results in fungal cell death.

Pharmacokinetics

Absorption: Limited (<5%)

Distribution: Distributed to sebum and skin predominantly

Half-life elimination: 14 to 35 hours

Pricing: US

Cream (LamISIL AT External)

1% (per gram): $0.41

Cream (LamISIL AT Jock Itch External)

1% (per gram): $0.68

Cream (Terbinafine HCl External)

1% (per gram): $0.54

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Almatil (ZA);
  • Amizil (PH);
  • Antifan (CZ, EE);
  • Benafin (EG);
  • Binter (LK);
  • Derfin (BD);
  • Dermasil (IL);
  • Dermifene (PH);
  • Farbcil (GT);
  • Farbicil (CR, DO, HN, NI, PA, SV);
  • Finderm (ZA);
  • Finex (PY);
  • Fintrix (LK);
  • Fungasil (IE, MT);
  • Fungisafe (EG);
  • Funide (EC);
  • Futeshu (CN);
  • Hifen (VN);
  • Interbi (HK, ID);
  • Lamater (IE);
  • Lamifen (AE, BH, JO, LB, PH, QA, SA);
  • Lamisil (AE, AR, AT, AU, BE, BG, BH, BR, CH, CL, CO, CY, CZ, DK, EE, EG, ES, ET, FI, FR, GB, GR, HK, HR, ID, IL, IS, IT, JO, KR, KW, LB, LT, LU, LV, MT, MY, NL, NO, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SI, SK, TH, TR, TW, UY, ZA, ZW);
  • Lamisil AT (ID);
  • Lamisil Once (AE, AU, HK, KW, LB, PH, QA, SA, TH);
  • Lamisilate (FR);
  • Lamizyl (UA);
  • Lan Meishu (CN);
  • Lisim (SG);
  • Medisil (QA);
  • Micoset (CL);
  • Micozone (EC);
  • Mujonal (CN);
  • Murazol (KR);
  • Mycelvan (CR, DO, GT, HN, NI, PA, SV);
  • Otenol (MY);
  • Patir (IL);
  • Periafin (TW);
  • Ronasil Derm Gel (KR);
  • Sebifin (IN);
  • Skinabin (BD);
  • SolvEasy Tinea (NZ);
  • Terafan (ET);
  • Terbasil (IE);
  • Terbex (BD);
  • Terbicip (MY);
  • Terbifin (BD, ZW);
  • Terbin (EG);
  • Terbinorm (UA);
  • Terbisan (LK);
  • Terbisil (MT);
  • Terbiskin (VN);
  • Terekol (AR);
  • Terfex (VE);
  • Terfina (QA);
  • Terfine (TW);
  • Terfung (TW);
  • Tiersil Once (KR)


For country code abbreviations (show table)
  1. Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319. [PubMed 11487763]
  2. American Academy of Pediatrics (AAP). In: Kimberlin DW, Brady MT, Jackson MA, Long SA, eds. Red Book: 2015 Report of the Committee on Infectious Diseases. 30th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2015.
  3. Aste N, Pau M, Pinna AL, Colombo MD, Biggio P. Clinical efficacy and tolerability of terbinafine in patients with pityriasis versicolor. Mycoses. 1991;34(7-8):353-357. doi:10.1111/j.1439-0507.1991.tb00676.x [PubMed 1803242]
  4. Balfour JA, Faulds D. Terbinafine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in superficial mycoses. Drugs. 1992;43(2):259-284. doi:10.2165/00003495-199243020-00010 [PubMed 1372222]
  5. Bradley JS, Nelson JD, Barnett E, et al. Nelson's Pediatric Antimicrobial Therapy. 23rd ed. American Academy of Pediatrics; 2017.
  6. Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm [PubMed 6810084]
  7. Fan Y, Pan W, Wang G, et al. Isolated cutaneous granuloma caused by Candida glabrata: a rare case report and literature review. Mycopathologia. 2018;183(2):417-421. doi:10.1007/s11046-017-0228-3 [PubMed 29164434]
  8. Goldstein AO, Goldstein BG. Dermatophyte (tinea) infections. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 24, 2021.
  9. Gupta AK, Cooper EA. Update in antifungal therapy of dermatophytosis. Mycopathologia. 2008;166(5-6):353-367. doi:10.1007/s11046-008-9109-0 [PubMed 18478357]
  10. "Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  11. Kaul S, Yadav S, Dogra S. Treatment of dermatophytosis in elderly, children, and pregnant women. Indian Dermatol Online J. 2017;8(5):310-318. [PubMed 28979861]
  12. Korting HC, Tietz HJ, Bräutigam M, Mayser P, Rapatz G, Paul C. One week terbinafine 1% cream (Lamisil) once daily is effective in the treatment of interdigital tinea pedis: a vehicle controlled study. LAS-INT-06 Study Group. Med Mycol. 2001;39(4):335-340. doi:10.1080/mmy.39.4.335.340 [PubMed 11556763]
  13. Lamisil AT (terbinafine hydrochloride) [prescribing information]. Parsippany, NJ: Novartis Consumer Health, Inc; 2014.
  14. Lamisil AT Antifingal gel (terbinafine, topical) [prescribing information]. Parsippany, NJ: Novartis Consumer Health, Inc.; January 2010.
  15. Lamisil AT cream (terbinafine, topical) [prescribing information]. Warren, NJ: GSK Consumer Healthcare; May 2017.
  16. Lamisil AT spray (terbinafine, topical) [prescribing information]. Parsippany, NJ: Novartis Consumer Health, Inc.; January 2010.
  17. Lamisil (terbinafine hydrochloride) [product monograph]. Dorval, Quebec, Canada: Novartis Pharmaceuticals Canada Inc; August 2022.
  18. Savin R, Eisen D, Fradin MS, Lebwohl M. Tinea versicolor treated with terbinafine 1% solution. Int J Dermatol. 1999;38(11):863-865. doi:10.1046/j.1365-4362.1999.00730.x [PubMed 10583623]
  19. Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259. [PubMed 19188870]
  20. 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):22-24. doi:10.1159/000246179 [PubMed 9154397]
  21. Weinstein A, Berman B. Topical treatment of common superficial tinea infections. Am Fam Physician. 2002;65(10):2095-2102. [PubMed 12046779]
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