Embedded Files
Pharmacologic Category
Dosing: Adult
OTC labeling:
Tinea pedis: 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
Spray: Apply to affected area once daily for at least 1 week
Tinea corporis, Tinea cruris: Topical:
Cream: Apply to affected area once daily for 1 week
Gel: Apply to affected area once daily for 1 week
Spray: Apply to affected area once daily for 1 week
Canadian products [Rx only]:
Tinea pedis, Tinea corporis, Tinea cruris: Topical: Cream, Spray: Apply to affected area(s) once daily for at least 1 week
Cutaneous candidiasis: Topical: Cream: Apply to affected area once or twice daily for 1 to 2 weeks
Tinea versicolor: Topical:
Cream: Apply to affected area once or twice daily for 1 to 2 weeks
Spray: Apply to affected area twice daily for 1 week
* See Dosage and Administration in AHFS Essentials for additional information.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
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 (ringworm): Children ≥12 years and Adolescents: Topical: Cream, gel: Apply to affected area once daily for at least 1 week
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 (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
Use: Labeled Indications
Dermatologic fungal infections:
US products [OTC]: Treatment of tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm)
Canadian products [prescription only]: Treatment of dermatologic fungal skin infections (including tinea pedis, tinea cruris, tinea corporis, cutaneous candidiasis, and tinea versicolor) in adults.
* See Uses in AHFS Essentials for additional information.
Administration: 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.
Storage/Stability
Cream: Store at 20°C to 25°C (68°F to 77°F).
Gel: Store at ≤30°C (≤86°F).
Solution: Store at 8°C to 25°C (46°F to 77°F).
Medication Patient Education with HCAHPS Considerations
What is this drug used for?
• It is used to treat fungal infections of the skin.
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
• Severe skin irritation
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Medication Safety Issues
Sound-alike/look-alike issues:
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.
* See Cautions in AHFS Essentials for additional information.
Geriatric Considerations
Instruct patient or caregiver on appropriate use of topical terbinafine products.
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).
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).
Breast-Feeding 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.
Briggs' Drugs in Pregnancy & Lactation
Adverse Reactions
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
* See Cautions in AHFS Essentials for additional information.
Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects
None known.
Drug Interactions Open Interactions
There are no known significant interactions.
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, 24 g [DSC], 30 g, 36 g [DSC], 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)
Gel, External:
LamISIL Advanced: 1% (12 g [DSC]) [contains alcohol, usp]
Solution, External, as hydrochloride:
LamISIL AT Spray: 1% (125 mL [DSC]) [contains alcohol, usp, propylene glycol]
Dosage Forms: Canada
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
LamISIL: 1% (30 g) [contains benzyl alcohol, cetyl alcohol]
Solution, External, as hydrochloride:
LamISIL: 1% (30 mL) [contains alcohol, usp, propylene glycol]
Anatomic Therapeutic Chemical (ATC) Classification
- D01AE15
Generic Available (US)
May be product dependent
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.
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.
Pharmacodynamics/Kinetics
Absorption: Limited (<5%)
Distribution: Distributed to sebum and skin predominantly
Half-life elimination: 14 to 35 hours
Local Anesthetic/Vasoconstrictor Precautions
No information available to require special precautions
Effects on Dental Treatment
No significant effects or complications reported
Effects on Bleeding
No information available to require special precautions
Index Terms
Terbinafine HCl; Terbinafine Hydrochloride
FDA Approval Date
March 09, 1999
References
Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319.[PubMed 11487763]
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.
Bradley JS, Nelson JD, Barnett E, et al. Nelson's Pediatric Antimicrobial Therapy. 23rd ed. American Academy of Pediatrics; 2017.
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]
"Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278.[PubMed 9024461]
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]
Lamisil AT (terbinafine hydrochloride) [prescribing information]. Parsippany, NJ: Novartis Consumer Health, Inc; 2014.
Lamisil AT Antifingal gel (terbinafine, topical) [prescribing information]. Parsippany, NJ: Novartis Consumer Health, Inc.; January 2010.
Lamisil AT cream (terbinafine, topical) [prescribing information]. Warren, NJ: GSK Consumer Healthcare; May 2017.
Lamisil AT spray (terbinafine, topical) [prescribing information]. Parsippany, NJ: Novartis Consumer Health, Inc.; January 2010.
Lamisil (terbinafine hydrochloride) [product monograph]. Dorval, Quebec, Canada: Novartis Consumer Canada, Inc; May 2016.
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]
Brand Names: International
Amizil (PH); Antifan (CZ, EE); Benafin (EG); Binter (LK); Derfin (BD); Dermasil (IL); Dermifene (PH); Farbcil (GT); Farbicil (CR, DO, HN, NI, PA, SV); Finex (PY); Fintrix (LK); Fungasil (IE, MT); Funginix (DK); Fungisafe (EG); Fungizid (DE); 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, 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)
Last Updated 3/3/20
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