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Terbinafine (Topical)

Medically reviewed by Drugs.com. Last updated on Sep 29, 2020.

Pronunciation

(TER bin a feen)

Index Terms

  • Terbinafine HCl
  • Terbinafine Hydrochloride

Dosage Forms

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]

Brand Names: U.S.

  • LamISIL Advanced [OTC] [DSC]
  • LamISIL AT Jock Itch [OTC]
  • LamISIL AT Spray [OTC] [DSC]
  • LamISIL AT [OTC]

Pharmacologic Category

  • Antifungal Agent, Topical

Pharmacology

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.

Absorption

Limited (<5%)

Distribution

Distributed to sebum and skin predominantly

Half-Life Elimination

14 to 35 hours

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.

Contraindications

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

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

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

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

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.

Storage

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).

Drug Interactions

There are no known significant interactions.

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

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.

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).

Patient Education

What is this drug used for?

• It is used to treat fungal infections of the skin.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Severe skin irritation

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, 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 limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.