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Terbinafine (Topical)

Pronunciation

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, 30 g, 36 g, 42 g) [contains benzyl alcohol, cetyl alcohol]

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

Generic: 1% (12 g [DSC], 15 g, 24 g [DSC], 30 g)

Gel, External:

LamISIL Advanced: 1% (12 g) [contains alcohol, usp]

Solution, External, as hydrochloride:

LamISIL AT Spray: 1% (30 mL [DSC], 125 mL) [contains alcohol, usp, propylene glycol]

LamISIL Spray: 1% (30 mL [DSC]) [contains alcohol, usp]

Brand Names: U.S.

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

Pharmacologic Category

  • Antifungal Agent, Topical

Pharmacology

Synthetic allylamine derivative which inhibits squalene epoxidase, a key enzyme in sterol biosynthesis in fungi. This results in a deficiency in ergosterol within the fungal cell wall 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 once or 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 for at least 1 week

Solution: 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

Solution: 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

Tinea pedis: Children ≥12 years and Adolescents: Topical: [OTC labeling]:

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, Solution: Refer to adult dosing .

Tinea corporis, Tinea cruris: Children ≥12 years and Adolescents: [OTC labeling]: Refer to adult dosing.

Administration

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

Solution: Hold 4 to 6 inches from skin during use.

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

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

Adverse events were not observed in animal reproduction studies with systemic terbinafine. Systemic absorption is limited following topical application.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience burning, stinging, or itching. Have patient report immediately to prescriber severe skin irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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