Terbinafine

(Systemic)

Pharmacologic Category

Dosing: Adult

Note: Lamisil granules have been discontinued in the United States for more than 1 year.

Onychomycosis:

Continuous dosing: Oral: Tablet: 250 mg once daily for 6 weeks (fingernail) or 12 weeks (toenail).

Pulsed dosing (alternative dosing method) (off-label): Oral: Tablet: 250 mg once daily for 4 weeks, off for 4 weeks, then resume with 250 mg once daily for 4 weeks (Gupta 2013) or 250 mg twice daily for 1 week repeated every 4 weeks for 3 months (Takahata 2009; Yadav 2015). Note: Pulsed dosing is less effective but may reduce the risk of adverse effects, reduce cost, and improve patient compliance (Goldstein 2019).

Sporotrichosis, lymphocutaneous and cutaneous (alternative agent for patients who do not respond to itraconazole) (off-label use): Oral: Tablet: 500 mg twice daily (IDSA [Kauffman 2007]). Treat for 2 to 4 additional weeks after all lesions have resolved; usual duration is 3 to 6 months (Chapman 2004; IDSA [Kauffman 2007]).

Tinea infections:

Dermatophyte folliculitis (tinea barbae, Majocchi granuloma) (off-label use): Oral: Tablet: 250 mg once daily; duration is typically 2 to 6 weeks but may need to be extended (eg, in immunocompromised patients with slow response) (Bonifaz 2003; Chou 2016; Gega 2010; Ilkit 2012; Jackson 2019; Wang 2018; Zhou 2017).

Tinea capitis (off-label use): Oral: Tablet: 250 mg once daily for 4 to 6 weeks (El-Khalawany 2013; Gupta 2008; Treat 2019).

Tinea corporis/tinea cruris/tinea faciei (alternative agent) (off-label use): Note: Alternative treatment for patients with extensive skin involvement or in whom topical therapy failed.

Oral: Tablet: 250 mg once daily for 1 to 2 weeks (del Palacio Hernandez 1990; Farag 1994; Gupta 2008; Voravutinon 1993).

Tinea pedis/tinea manuum (alternative agent) (off-label use): Note: Alternative treatment for patients with extensive skin involvement or in whom topical therapy failed.

Oral: Tablet: 250 mg once daily for 2 weeks (Bell-Syer 2012; Gupta 2008; Tausch 1998; White 1991).

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

Use with caution; refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, clearance is decreased 50% in patients with CrCl ≤50 mL/minute.

Dosing: Hepatic Impairment: Adult

Contraindicated in chronic or active hepatic disease.

Dosing: Pediatric

Note: Lamisil granules have been discontinued in the US for more than 1 year.

Tinea capitis: Children ≥4 years and Adolescents: Oral: Granules:

<25 kg: 125 mg once daily for 6 weeks

25 to 35 kg: 187.5 mg once daily for 6 weeks

>35 kg: 250 mg once daily for 6 weeks

Onychomycosis: Limited data available (Gupta 1997): Children and Adolescents: Oral: Tablets:

10 to 20 kg: 62.5 mg once daily for 6 weeks (fingernails) or 12 weeks (toenails)

20 to 40 kg: 125 mg once daily for 6 weeks (fingernails) or 12 weeks (toenails)

>40 kg: 250 mg once daily for 6 weeks (fingernails) or 12 weeks (toenails)

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; however, clearance is decreased ~50% in adult patients with CrCl ≤50 mL/minute.

Dosing: Hepatic Impairment: Pediatric

Granules, tablets: Children ≥4 years and Adolescents: Use is contraindicated in chronic or active hepatic disease.

Calculations

Use: Labeled Indications

Onychomycosis (tablets only): Treatment of onychomycosis of the toenail or fingernail caused by dermatophytes (tinea unguium).

Tinea capitis (granules only): Treatment of tinea capitis in patients 4 years and older.

* See Uses in AHFS Essentials for additional information.

Use: Off-Label: Adult

Dermatophyte folliculitis (tinea barbae, Majocchi granuloma)Level of Evidence [C]

Data from a limited number of patients studied suggest that terbinafine may be beneficial for the treatment of dermatophyte folliculitis Ref; clinical experience also suggests the utility of terbinafine in managing dermatophyte folliculitis Ref.

Sporotrichosis (lymphocutaneous and cutaneous)Level of Evidence [G]

Based on the Infectious Diseases Society of America (IDSA) guidelines for the management of sporotrichosis, terbinafine (systemic) is an effective and recommended treatment option for patients with lymphocutaneous and cutaneous sporotrichosis who do not respond to first-line therapy with itraconazole Ref.

Tinea capitisLevel of Evidence [C]

Data from a limited number of patients studied suggest terbinafine tablets may be beneficial for the treatment of tinea capitis Ref; clinical experience also suggests the utility of terbinafine tablets in managing tinea capitis Ref.

Tinea corporis/tinea cruris/tinea facieiLevel of Evidence [B]

Data from a double-blind, randomized clinical study suggest that oral terbinafine may be effective in the treatment of widespread tinea corporis/tinea cruris Ref. Additional data from a limited number of patients studied also suggest terbinafine may be beneficial in the treatment of tinea corporis/tinea cruris Ref; clinical experience suggests the utility of terbinafine in managing tinea corporis/tinea cruris/tinea faciei Ref.

Tinea pedis/tinea manuumLevel of Evidence [A]

Data from 2 double-blind, randomized studies support the use of oral terbinafine in the treatment of tinea pedis and tinea manuum Ref. Access Full Off-Label Monograph

Level of Evidence Definitions

Level of Evidence Scale

Clinical Practice Guidelines

Sporotrichosis: IDSA, "Management of Sporotrichosis,” November 2007

Administration: Oral

Administer tablets without regard to meals. Administer granules with food; sprinkle granules on a spoonful of pudding or other soft, nonacidic food (eg, mashed potatoes); swallow entire spoonful without chewing; do not mix granules with applesauce or other fruit-based foods.

Administration: Pediatric

Oral:

Tablets: May be administered without regard to meals.

Granules: Should be taken with food; sprinkle on a spoonful of nonacidic food (eg, pudding, mashed potatoes); do not use applesauce or fruit-based foods; swallow granules whole without chewing.

Storage/Stability

Granules: Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

Tablets: Store below 25°C (77°F). Protect from light.

Extemporaneously Prepared

A 25 mg/mL oral suspension may be made using tablets. Crush twenty 250 mg tablets and reduce to a fine powder. Add small amount of a 1:1 mixture of Ora-Sweet® and Ora-Plus® and mix to a uniform paste; mix while adding the vehicle in geometric proportions to almost 200 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 200 mL. Label "shake well" and "refrigerate". Stable 42 days.

Nahata MC, Pai VB, and Hipple TF, Pediatric Drug Formulations, 5th ed, Cincinnati, OH: Harvey Whitney Books Co, 2004.

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

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

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

• It may be given to you for other reasons. Talk with the doctor.

Frequently reported side effects of this drug

• Headache

• Abdominal pain

• Common cold symptoms

• Diarrhea

• Passing gas

• Vomiting

• Nausea

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome like bruising or bleeding; severe loss of strength and energy; dark urine or yellow skin; pale skin; change in amount of urine passed; vision changes; change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance; or fever.

• Infection

• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin.

• Lupus like rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.

• Swollen glands

• Cough

• Chest pain

• Fast heartbeat

• Blood in the urine

• Change in taste

• Loss of taste

• Change in smell

• Loss of smell

• Weight loss

• Depression

• Lack of appetite

• Stevens-Johnson syndrome/toxic epidermal necrolysis like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in mouth, throat, nose, or eyes.

• 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:

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Lamisil: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020539s033lbl.pdf#page=11

Contraindications

Hypersensitivity to terbinafine or any component of the formulation; chronic or active hepatic disease

Warnings/Precautions

Concerns related to adverse effects:

• Allylamine antifungal hypersensitivity: Use caution in patients sensitive to allylamine antifungals (eg, naftifine, butenafine); cross-sensitivity to terbinafine may exist.

• Depression: Has been reported with use; instruct patients to report depressive symptoms/mood changes.

• Gastrointestinal effects: Taste disturbance (including loss of taste) may occur and severe cases resulting in decreased food intake, weight loss, anxiety or depression have been reported; resolution may be delayed (eg, several weeks to >1 year) following discontinuation of therapy or in some cases, disturbance may be permanent. Discontinue therapy in patients with symptoms of taste disturbance.

• Hematologic effects: Transient decreases in absolute lymphocyte counts were observed in clinical trials; severe neutropenia (reversible upon discontinuation) has also been reported. Monitor CBC in patients with preexisting immunosuppression if therapy is to continue >6 weeks. Discontinue therapy if ANC ≤1,000/mm3.

• Hepatic failure: Cases of hepatic failure, some leading to liver transplant or death, have been reported. May occur in patients with and without preexisting hepatic disease; severity of hepatic events and/or outcomes may be worse in patients with active or chronic hepatic disease. Perform baseline and periodic liver function tests; discontinue use if clinical evidence of liver injury develops (eg, nausea, anorexia, fatigue, vomiting, right upper abdominal pain, jaundice, dark urine, pale stools) or elevated liver function tests occur.

• Hypersensitivity: Serious skin and hypersensitivity reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis, drug reaction with eosinophilia and systemic symptoms [DRESS] syndrome) have occurred. If progressive skin rash or signs and symptoms of a hypersensitivity reaction occur, discontinue treatment.

• Ocular effects: Although rare, changes in the ocular lens and retina have been reported; discontinuation of therapy may be required.

• Respiratory effects: Smell disturbance (including loss of smell) has been reported; resolution may be delayed (eg, >1 year) following discontinuation of therapy or in some cases, disturbance may be permanent. Discontinue therapy in patients with symptoms of smell disturbance.

• Thrombotic microangiopathy: Cases of thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, have been reported (some fatal). Discontinue if TMA occurs; consider diagnosis of TMA with unexplained thrombocytopenia and anemia.

Disease-related concerns:

• Autoimmune disease (Lupus): Precipitation or exacerbation of cutaneous or systemic lupus erythematosus has been observed; discontinue if signs and/or symptoms develop.

• Hepatic impairment: Use is contraindicated in patients with active or chronic hepatic disease; clearance is reduced by ~50% in hepatic cirrhosis.

• Renal impairment: Use with caution in patients with renal dysfunction (CrCl ≤50 mL/minute); clearance is reduced by ~50%.

Other warnings/precautions:

• Appropriate use: Due to potential toxicity, confirmation of diagnostic testing of nail or skin specimens prior to treatment of onychomycosis or dermatomycosis is recommended.

* See Cautions in AHFS Essentials for additional information.

Geriatric Considerations

No specific information on use in the elderly is available; however, since many elderly will have creatinine clearances <50 mL/minute, this drug is not a drug of choice for elderly with onychomycosis.

Pregnancy Considerations

Published information related to the use of systemic terbinafine in pregnancy is limited (Gupta 1997; Sarkar 2003).

Systemic therapy for the treatment of onychomycosis or tinea capitis is not recommended during pregnancy (Kaul 2017; Murase 2014).

Breast-Feeding Considerations

Terbinafine is present in breast milk.

A breastfed child would receive ~4% of the maternal dose. Breastfeeding during systemic therapy is not recommended (Butler 2014).

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Briggs' Drugs in Pregnancy & Lactation

Terbinafine

Adverse Reactions

>10%: Central nervous system: Headache (7% to 13%)

1% to 10%:

Dermatologic: Skin rash (6%; children: 2%), pruritus (1% to 3%), urticaria (1%)

Gastrointestinal: Diarrhea (3% to 6%), vomiting (<1%; children: 5%), dyspepsia (4%), upper abdominal pain (children: 4%), dysgeusia (3%; may be severe and result in weight loss, anxiety, and depression), nausea (2% to 3%), abdominal pain (children: 2%), pharyngolaryngeal pain (children: 2%), toothache (children: 1%)

Hepatic: Liver enzyme disorder (3%)

Infection: Influenza (children: 2%)

Ophthalmic: Vision color changes (children: 5%; color confusion), decreased visual acuity (children: 1% to 2%)

Respiratory: Nasopharyngitis (children: 10%), cough (children: 6%), upper respiratory tract infection (children: 5%), nasal congestion (children: 2%), rhinorrhea (children: 2%)

Miscellaneous: Fever (<1%; children: 7%)

<1%, postmarketing, and/or case reports: Acute generalized exanthematous pustulosis, ageusia, agranulocytosis, alopecia, altered sense of smell, anaphylaxis, anemia, angioedema, anosmia, anxiety, arthralgia, auditory impairment, bullous dermatitis, cholestasis, cutaneous lupus erythematosus, depression, DRESS syndrome, erythema multiforme, exacerbation of psoriasis, exacerbation of systemic lupus erythematosus, exfoliative dermatitis, fatigue, flu-like symptoms, hemolytic-uremic syndrome, hepatic insufficiency, hepatic failure, hepatitis, hypersensitivity reaction, hypoesthesia, increased creatine phosphokinase, lens disease, malaise, myalgia, pancreatitis, pancytopenia, paresthesia, psoriasiform eruption, retinopathy, rhabdomyolysis, serum sickness-like reaction, severe neutropenia, skin photosensitivity, Stevens-Johnson syndrome, systemic lupus erythematosus, thrombocytopenia, thrombotic thrombocytopenic purpura, tinnitus, toxic epidermal necrolysis, vasculitis, vertigo, visual field defect

* See Cautions in AHFS Essentials for additional information.

Allergy and Idiosyncratic Reactions

Allylamine Antifungal Allergy

Metabolism/Transport Effects

Substrate of CYP1A2 (minor), CYP2C19 (minor), CYP2C9 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits CYP2D6 (moderate)

Drug Interactions Open Interactions

Ajmaline: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Ajmaline. Risk C: Monitor therapy

Amitriptyline: Terbinafine (Systemic) may increase the serum concentration of Amitriptyline. Management: Monitor for increased effects/toxicity of amitriptyline during concomitant administration with terbinafine. Reduced dosages of amitriptyline may be needed. Risk D: Consider therapy modification

Amphetamines: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Amphetamines. Management: Monitor for amphetamine toxicities (including serotonin syndrome) if used with a moderate CYP2D6 inhibitor. Initiate amphetamine therapy at lower doses, monitor frequently, and adjust doses as needed. Discontinue amphetamines if serotoinin syndrome occurs Risk C: Monitor therapy

ARIPiprazole: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy, indication, or dosage form. Consult full interaction monograph for specific recommendations. Risk C: Monitor therapy

Brexpiprazole: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Brexpiprazole. Management: If brexpiprazole is to be used together with both a moderate CYP2D6 inhibitor and a strong or moderate CYP3A4 inhibitor, the brexpiprazole dose should be reduced to 25% of the usual dose when treating indications other than major depressive disorder. Risk C: Monitor therapy

CloZAPine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of CloZAPine. Risk C: Monitor therapy

Codeine: CYP2D6 Inhibitors (Moderate) may diminish the therapeutic effect of Codeine. These CYP2D6 inhibitors may prevent the metabolic conversion of codeine to its active metabolite morphine. Risk C: Monitor therapy

CYP2D6 Substrates (High risk with Inhibitors): CYP2D6 Inhibitors (Moderate) may decrease the metabolism of CYP2D6 Substrates (High risk with Inhibitors). Exceptions: Tamoxifen. Risk C: Monitor therapy

Desipramine: Terbinafine (Systemic) may increase the serum concentration of Desipramine. Management: Monitor for increased effects/toxicity of desipramine during concomitant administration with terbinafine. Reduced dosages of desipramine may be needed. Risk D: Consider therapy modification

DOXOrubicin (Conventional): CYP2D6 Inhibitors (Moderate) may increase the serum concentration of DOXOrubicin (Conventional). Management: Seek alternatives to moderate CYP2D6 inhibitors in patients treated with doxorubicin whenever possible. One U.S. manufacturer (Pfizer Inc.) recommends that these combinations be avoided. Risk D: Consider therapy modification

Eliglustat: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Eliglustat. Management: Eliglustat dose is 84 mg daily with CYP2D6 inhibitors. Use is contraindicated (COI) when also combined with strong CYP3A4 inhibitors. When also combined with a moderate CYP3A4 inhibitor, use is COI in CYP2D6 EMs or IMs and should be avoided in CYP2D6 PMs. Risk D: Consider therapy modification

Fesoterodine: CYP2D6 Inhibitors may increase serum concentrations of the active metabolite(s) of Fesoterodine. Risk C: Monitor therapy

Imipramine: Terbinafine (Systemic) may increase the serum concentration of Imipramine. Management: Monitor for increased effects/toxicity of imipramine during concomitant administration with terbinafine. Reduced dosages of imipramine may be needed. Risk D: Consider therapy modification

Indoramin: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Indoramin. Risk C: Monitor therapy

Metoprolol: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Metoprolol. Risk C: Monitor therapy

Nebivolol: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Nebivolol. Risk C: Monitor therapy

Nortriptyline: Terbinafine (Systemic) may increase the serum concentration of Nortriptyline. Management: Monitor for increased effects/toxicity of nortriptyline during concomitant administration with terbinafine. Reduced dosages of nortriptyline may be needed. Risk D: Consider therapy modification

Perhexiline: CYP2D6 Inhibitors may increase the serum concentration of Perhexiline. Management: Consider alternatives to this combination if possible. If combined, monitor for increased perhexiline serum concentrations and toxicities (eg, hypoglycemia, neuropathy, liver dysfunction). Perhexiline dose reductions will likely be required. Risk D: Consider therapy modification

Pitolisant: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Pitolisant. Risk C: Monitor therapy

Propafenone: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Propafenone. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Risk C: Monitor therapy

RifAMPin: May decrease the serum concentration of Terbinafine (Systemic). Risk C: Monitor therapy

Saccharomyces boulardii: Antifungal Agents (Systemic, Oral) may diminish the therapeutic effect of Saccharomyces boulardii. Risk X: Avoid combination

Tamoxifen: CYP2D6 Inhibitors (Moderate) may decrease serum concentrations of the active metabolite(s) of Tamoxifen. Specifically, CYP2D6 inhibitors may decrease the metabolic formation of highly potent active metabolites. Management: Consider alternatives with less of an inhibitory effect on CYP2D6 activity when possible. Risk D: Consider therapy modification

Tamsulosin: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Tamsulosin. Risk C: Monitor therapy

Thioridazine: CYP2D6 Inhibitors may increase the serum concentration of Thioridazine. Risk X: Avoid combination

TraMADol: CYP2D6 Inhibitors (Moderate) may diminish the therapeutic effect of TraMADol. These CYP2D6 inhibitors may prevent the metabolic conversion of tramadol to its active metabolite that accounts for much of its opioid-like effects. Risk C: Monitor therapy

Monitoring Parameters

Liver function tests at baseline and periodically during treatment; CBC (if used >6 weeks; immunosuppressed patients only); taste and/or smell disturbances

Advanced Practitioners Physical Assessment/Monitoring

Use with caution in presence of hepatic or renal impairment.

Nursing Physical Assessment/Monitoring

Use with caution in presence of hepatic or renal impairment.

Product Availability

Lamisil granules have been discontinued in the United States for more than 1 year.

Dosage Forms: US

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

Packet, Oral:

LamISIL: 125 mg (1 ea [DSC], 14 ea [DSC]); 187.5 mg (1 ea [DSC], 14 ea [DSC]) [contains polyethylene glycol]

Tablet, Oral:

LamISIL: 250 mg [DSC]

Generic: 250 mg

Dosage Forms: Canada

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

Tablet, Oral:

LamISIL: 250 mg

Generic: 250 mg

Anatomic Therapeutic Chemical (ATC) Classification

D01BA02

Generic Available (US)

May be product dependent

Pricing: US

Tablets (Terbinafine HCl Oral)

250 mg (per each): $12.67 - $13.08

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: Children and Adults: >70%

Distribution: Distributed to sebum and skin predominantly

Protein binding: Plasma: >99%

Metabolism: Hepatic predominantly via CYP1A2, 3A4, 2C8, 2C9, and 2C19 to inactive metabolites

Bioavailability: Children 36% to 64%; Adults: 40%

Half-life elimination: Terminal half-life: 200 to 400 hours; very slow release of drug from skin and adipose tissues occurs; effective half-life: Children: 27 to 31 hours; Adults: ~36 hours

Time to peak, plasma: Children and Adults: Within 2 hours

Excretion: Urine (80%, primarily as inactive metabolites); feces (20%) (Debruyne 2001)

Clearance: Children (14 to 68 kg): 15.6 to 26.7 L/hour

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment: In CrCl ≤50 mL/minute, terbinafine clearance is decreased 50%.

Hepatic function impairment: In hepatic cirrhosis, terbinafine clearance is decreased 50%.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Taste disturbance.

Effects on Bleeding

No information available to require special precautions

Index Terms

Terbinafine HCl; Terbinafine Hydrochloride

References

Abdel-Rahman SM, Herron J, Fallon-Friedlander S, Hauffe S, Horowitz A, Rivière GJ. Pharmacokinetics of terbinafine in young children treated for tinea capitis [published correction appears in Pediatr Infect Dis J. 2006;25(8):760]. Pediatr Infect Dis J. 2005;24(10):886-891.[PubMed 16220086]

Abdel-Rahman SM, Nahata MC. Oral terbinafine: a new antifungal agent. Ann Pharmacother. 1997;31(4):445-456.[PubMed 9101008]

Amichai B, Grunwald MH. Adverse drug reactions of the new oral antifungal agents--terbinafine, fluconazole, and itraconazole. Int J Dermatol. 1998;37(6):410-415.[PubMed 9646122]

Angello JT, Voytovich RM, Jan SA. A cost/efficacy analysis of oral antifungals indicated for the treatment of onychomycosis: griseofulvin, itraconazole, and terbinafine. Am J Manag Care. 1997;3(3):443-450.[PubMed 10173095]

Bell-Syer SE, Khan SM, Torgerson DJ. Oral treatments for fungal infections of the skin of the foot. Cochrane Database Syst Rev. 2012;10:CD003584. doi: 10.1002/14651858.CD003584.pub2.[PubMed 23076898]

Bonifaz A, Ramírez-Tamayo T, Saúl A. Tinea barbae (tinea sycosis): experience with nine cases. J Dermatol. 2003;30(12):898-903.[PubMed 14739517]

Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: part II. Lactation. J Am Acad Dermatol. 2014;70(3):417.[PubMed 24528912]

Chapman SW, Pappas P, Kauffmann C, et al. Comparative evaluation of the efficacy and safety of two doses of terbinafine (500 and 1000 mg day(-1)) in the treatment of cutaneous or lymphocutaneous sporotrichosis. Mycoses. 2004;47(1-2):62-68.[PubMed 14998402]

Chou WY, Hsu CJ. A case report of Majocchi's granuloma associated with combined therapy of topical steroids and adalimumab. Medicine (Baltimore). 2016;95(2):e2245. doi: 10.1097/MD.0000000000002245.[PubMed 26765401]

Debruyne D, Coquerel A. Pharmacokinetics of antifungal agents in onychomycoses. Clin Pharmacokinet. 2001;40(6):441-472. doi: 10.2165/00003088-200140060-00005.[PubMed 11475469]

del Palacio Hernandez A, López Gómez S, González Lastra F, Moreno Palancar P, Iglesias Díez L. A comparative double-blind study of terbinafine (Lamisil) and griseofulvin in tinea corporis and tinea cruris. Clin Exp Dermatol. 1990;15(3):210-216.[PubMed 2194715]

Dwyer CM, White MI, Sinclair TS. Cholestatic jaundice due to terbinafine. Br J Dermatol. 1997;136(6):976-977. doi: 10.1111/j.1365-2133.1997.tb03954.x.[PubMed 9217846]

El-Khalawany M, Shaaban D, Hassan H, et al. A multicenter clinicomycological study evaluating the spectrum of adult tinea capitis in Egypt. Acta Dermatovenerol Alp Pannonica Adriat. 2013;22(4):77-82.[PubMed 24336943]

Farag A, Taha M, Halim S. One-week therapy with oral terbinafine in cases of tinea cruris/corporis. Br J Dermatol. 1994;131(5):684-686. doi: 10.1111/j.1365-2133.1994.tb04983.x.[PubMed 7999601]

Friedlander SF, Aly R, Krafchik B, et al; Tinea Capitis Study Group. Terbinafine in the treatment of Trichophyton tinea capitis: a randomized, double-blind, parallel-group, duration-finding study. Pediatrics. 2002;109(4):602-607. doi: 10.1542/peds.109.4.602.[PubMed 11927703]

Gega A, Ketsela G, Glavin FL, Soldevilla-Pico C, Schain D. Majocchi's granuloma after antithymocyte globulin therapy in a liver transplant patient. Transpl Infect Dis. 2010;12(2):143-145. doi: 10.1111/j.1399-3062.2009.00454.x.[PubMed 19761557]

Goldstein AO, Bhatia N. Onychomycosis: Management. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed July 16, 2019.

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]

Gupta AK, Paquet M, Simpson F, Tavakkol A. Terbinafine in the treatment of dermatophyte toenail onychomycosis: a meta-analysis of efficacy for continuous and intermittent regimens. J Eur Acad Dermatol Venereol. 2013;27(3):267-272. doi: 10.1111/j.1468-3083.2012.04584.x.[PubMed 22632057]

Gupta AK, Shear NH. Terbinafine: an update. J Am Acad Dermatol. 1997;37(6):979-988. doi: 10.1016/s0190-9622(97)70076-8.[PubMed 9418768]

Gupta AK, Sibbald RG, Knowles SR, Lynde CW, Shear NH. Terbinafine therapy may be associated with the development of psoriasis de novo or its exacerbation: four case reports and a review of drug-induced psoriasis. J Am Acad Dermatol. 1997;36(5, pt 2):858-862. doi: 10.1016/s0190-9622(97)70041-0.[PubMed 9146568]

Gupta AK, Sibbald RG, Lynde CW, et al. Onychomycosis in children: prevalence and treatment strategies. J Am Acad Dermatol. 1997;36(3, pt 1):395-402. doi: 10.1016/s0190-9622(97)80215-0.[PubMed 9091470]

Hawkins DM, Smidt AC. Superficial fungal infections in children. Pediatr Clin North Am. 2014;61(2):443-455. doi: 10.1016/j.pcl.2013.12.003.[PubMed 24636655]

Ilkit M, Durdu M, Karakaş M. Majocchi's granuloma: a symptom complex caused by fungal pathogens. Med Mycol. 2012;50(5):449-457. doi: 10.3109/13693786.2012.669503.[PubMed 22435879]

Jackson JD. Infectious folliculitis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed July 16, 2019.

Jones TC. Overview of the use of terbinafine (Lamisil) in children. Br J Dermatol. 1995;132(5):683-689. doi: 10.1111/j.1365-2133.1995.tb00711.x.[PubMed 7772471]

Kauffman CA, Bustamante B, Chapman SW, Pappas PG; Infectious Diseases Society of America. Clinical practice guidelines for the management of sporotrichosis: 2007 update by the Infectious Diseases Society of America. Clin Infect Dis. 2007;45(10):1255-1265. doi: 10.1086/522765.[PubMed 17968818]

Kaul S, Yadav S, Dogra S. Treatment of dermatophytosis in elderly, children, and pregnant women. Indian Dermatol Online J. 2017;8(5):310-318. doi: 10.4103/idoj.IDOJ_169_17.[PubMed 28979861]

Lamisil granules [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; March 2019.

Lamisil tablets [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; March 2019.

Lamisil (terbinafine hydrochloride) [product monograph]. Dorval, Quebec, Canada: Novartis Consumer Canada Inc; May 2016.

Murase JE, Heller MM, Butler DC. Safety of dermatologic medications in pregnancy and lactation: part I. Pregnancy. J Am Acad Dermatol. 2014;70(3):401. doi: 10.1016/j.jaad.2013.09.010.[PubMed 24528911]

Sarkar M, Rowland K, Koren G. Pregnancy outcomes following gestational exposure to terbinafine: a prospective comparative study. Abstracts of the Teratology Society 43rd Annual Meeting. June 21-26, 2003. Birth Defects Res A Clin Mol Teratol. 2003;67(5):313-394.[PubMed 12931704]

Savin RC. Oral terbinafine versus griseofulvin in the treatment of moccasin-type tinea pedis. J Am Acad Dermatol. 1990;23(4, pt 2):807-809. doi: 10.1016/0190-9622(90)70294-r.[PubMed 2229529]

Takahata Y, Hiruma M, Shiraki Y, Tokuhisa Y, Sugita T, Muto M. Treatment of dermatophyte onychomycosis with three pulses of terbinafine (500 mg day for a week). Mycoses. 2009;52(1):72-76. doi: 10.1111/j.1439-0507.2008.01531.x.[PubMed 18444971]

Tausch I, Decroix J, Gwiedzdzinski Z, et al. Short-term itraconazole versus terbinafine in the treatment of tinea pedis or manus. Int J Dermatol. 1998;37(2):140-142.[PubMed 9542675]

Terbinafine [prescribing information]. East Windosr, NJ: Aurobindo Pharma; July 2018.

Treat JR. Tinea capitis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed July 16, 2019.

Trépanier EF, Amsden GW. Current issues in onychomycosis. Ann Pharmacother. 1998;32(2):204-214. doi: 10.1345/aph.17006.[PubMed 9496407]

Vickers AE, Sinclair JR, Zollinger M, et al. Multiple cytochrome P-450s involved in the metabolism of terbinafine suggest a limited potential for drug-drug interactions. Drug Metab Dispos. 1999;27(9):1029-1038.[PubMed 10460803]

Voravutinon V. Oral treatment of tinea corporis and tinea cruris with terbinafine and griseofulvin: a randomized double blind comparative study. J Med Assoc Thai. 1993;76(7):388-393.[PubMed 8089640]

Wang X, Yang Y, Li R, Yu J. Two cases of dermatophytic granuloma successfully treated with terbinafine. Mycopathologia. 2018;183(3):611-614. doi: 10.1007/s11046-017-0237-2.[PubMed 29344845]

White JE, Perkins PJ, Evans EG. Successful 2-week treatment with terbinafine (Lamisil) for moccasin tinea pedis and tinea manuum. Br J Dermatol. 1991;125(3):260-262. doi: 10.1111/j.1365-2133.1991.tb14752.x.[PubMed 1911319]

Yadav P, Singal A, Pandhi D, Das S. Comparative efficacy of continuous and pulse dose terbinafine regimes in toenail dermatophytosis: a randomized double-blind trial. Indian J Dermatol Venereol Leprol. 2015;81(4):363-9. doi: 10.4103/0378-6323.158634.[PubMed 26087080]

Zhou S, Yang Y, Liu K, Huang S, Hu Y, Zhou X. A case report of widespread Majocchi's granuloma in a patient with systemic lupus erythematosus. Mycopathologia. 2017;182(5-6):577-581. doi: 10.1007/s11046-017-0109-9.[PubMed 28083794]

Brand Names: International

Amizil (PH); Antifin (CN, PK); Atifan (CZ, EE); Camisan (MY); Cutis (LK); Deolate (NZ); Derfin (BD); Dermafin (MY); Dermasil (IL); Dermatin (DE); Dermax (ZA); Dicil (EC); EU2000 (TH); Finex (PY); Fungasil (MT); Funginix (DK); Fungitech (TW); Fungizid (DE); Fungotek (UA); Fungster (BE); Funzal (CO); Interbi (HK, ID); L:isim (MY, SG); Lamifen (AE, BH, EG, JO, LB, PH, QA, SA); Lamisil (AE, AR, AT, AU, BB, BE, BF, BG, BH, BJ, BR, CH, CI, CL, CN, CO, CY, CZ, DK, EE, EG, ES, ET, FI, FR, GB, GH, GM, GN, GR, HK, HR, ID, IE, IL, IQ, IR, IS, IT, JO, JP, KE, KR, KW, LB, LR, LT, LU, LV, LY, MA, ML, MR, MT, MU, MW, MY, NE, NG, NL, NO, OM, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SC, SD, SE, SG, SI, SK, SL, SN, SY, TH, TN, TR, TW, TZ, UA, UG, UY, VE, VN, YE, ZM, ZW); Lamisil AT (ID); Lamisil Dermgel (FR, IL); Lamisil Once (AE, AU, EG, HK, KR, KW, LB, PH, QA, SA, TH, VN); Lamisilate (FR); Lammifen (KW); Lapiderm (KR); Micoset (CL); Micozone (EC); Muzona (HK); Mycelvan (CR, DO, GT, HN, NI, PA, SV); Nailderm (IE); Patir (IL); Periafin (TW); Ronasil Derm Gel (KR); Sebifin (IN); Skinabin (BD); SolvEasy Tinea Cream (AU); Tamsil (AU); Tenabin (KR); Terbex (BD); Terbicip (MY); Terbifin (BD, HK); Terbihexal (AU); Terbin (EG); Terbix (CR, DO, GT, HN, NI, PA); Terekol (AR); Terfex (VE); Terfine (TW); Terfung (TW); Tiersil Once (KR); Zabel (AU)

Last Updated 5/2/20

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