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Terbinafine (systemic): Drug information

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

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • ACT Terbinafine;
  • APO-Terbinafine;
  • Auro-Terbinafine;
  • DOM-Terbinafine [DSC];
  • LamISIL;
  • PMS-Terbinafine;
  • RIVA-Terbinafine [DSC];
  • Terbinafine-250
Pharmacologic Category
  • Antifungal Agent, Oral
Dosing: Adult
Onychomycosis

Onychomycosis:

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

Pulsed dosing (alternative dosing method) (off label):

Note: Optimal dosing regimen not established. Pulsed dosing is less effective than continuous dosing (Ref).

Oral: 250 mg once daily for 4 weeks, off for 4 weeks, then resume with 250 mg once daily for 4 weeks (Ref) or 500 mg/day in 1 or 2 divided doses for 1 week repeated every 4 weeks for 3 months (Ref).

Sporotrichosis, lymphocutaneous and cutaneous

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

Tinea infections

Tinea infections:

Dermatophyte folliculitis (tinea barbae, Majocchi granuloma) (off-label use): Oral: 250 mg once daily; duration is typically 2 to 6 weeks or until clinical resolution (Ref).

Tinea capitis (off-label use): Oral: 250 mg once daily for 4 to 6 weeks (Ref).

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

Oral: 250 mg once daily for 1 to 2 weeks (Ref).

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

Oral: 250 mg once daily for 2 weeks (Ref).

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function: Oral:

CrCl ≥50 mL/minute: No dosage adjustment necessary.

CrCl 20 to <50 mL/minute: Administer 50% of the usual dose (Ref).

CrCl <20 mL/minute: Use of alternative agent may be preferred (expert opinion); has not been adequately studied in this population. If necessary, administer 50% of usual dose and monitor frequently for adverse effects (eg, gastrointestinal, hepatic) (Ref).

Hemodialysis, intermittent (thrice weekly): Unlikely to be significantly dialyzed (highly protein bound, large Vd) (Ref):

Oral: Use of alternative agent may be preferred; has not been adequately studied in this population. If necessary, administer 50% of usual dose and monitor frequently for adverse effects (eg, gastrointestinal, hepatic) (Ref).

Peritoneal dialysis: Unlikely to be significantly dialyzed (highly protein bound, large Vd) (Ref):

Oral: Use of alternative agent may be preferred; has not been adequately studied in this population. If necessary, administer 50% of usual dose and monitor frequently for adverse effects (eg, gastrointestinal, hepatic) (Ref).

CRRT: Oral: Use of alternative agent may be preferred; has not been adequately studied in this population. If necessary, administer 50% of usual dose and monitor frequently for adverse effects (eg, gastrointestinal, hepatic) (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): Oral: Use of alternative agent may be preferred; has not been adequately studied in this population. If necessary, administer 50% of usual dose and monitor frequently for adverse effects (eg, gastrointestinal, hepatic) (Ref).

Dosing: Hepatic Impairment: Adult

Contraindicated in chronic or active hepatic disease.

Dosing: Older Adult

Use with caution; refer to adult dosing.

Dosing: Pediatric

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

Tinea capitis

Tinea capitis: Limited data available: Note: For Microsporum spp. infections, griseofulvin is preferred over terbinafine. If terbinafine is used, higher-dose regimens are preferred (Ref).

Standard-dose regimen: Children and Adolescents: Note: Dosing based on 4 to 6 mg/kg/day (Ref):

10 to <20 kg: Oral: 62.5 mg once daily.

20 to 40 kg: Oral: 125 mg once daily.

>40 kg: Oral: 250 mg once daily.

Duration of therapy: General: 6 weeks; Species-specific: Trichophyton tonsurans: 4 to 6 weeks; Microsporum canis: 6 to 12 weeks (Ref).

Higher-dose regimen (Ref): Children and Adolescents:

<25 kg: Oral: 125 mg once daily for 6 weeks.

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

>35 kg: Oral: 250 mg once daily for 6 weeks.

Onychomycosis

Onychomycosis: Limited data available (Ref): Children and Adolescents:

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

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

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

Dosing: Kidney 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

There are no pediatric-specific dosage adjustments provided in the manufacturer's labeling; use is contraindicated in adults with chronic or active hepatic disease.

Adverse Reactions (Significant): Considerations
Hepatotoxicity

Terbinafine may cause hepatotoxicity (ranging from mild and asymptomatic increased serum transaminases to hepatic failure) (Ref). Terbinafine liver injury may present as hepatocellular hepatitis or cholestatic hepatitis, with some cases progressing to vanishing bile duct syndrome (Ref). Most cases of hepatotoxicity are self-limited; although, persistent and severe hepatocellular injury cases have been reported, requiring discontinuation of therapy or in rare cases liver transplantation (Ref). Resolution may be delayed (eg, 3 to 6 months) following discontinuation of therapy (Ref). Acute hepatic failure due to terbinafine therapy is rare (Ref).

Mechanism: Non–dose-related; possible mechanisms include immunologic (part of a hypersensitivity reaction) or a metabolically mediated effect (formation of mono-GSH conjugate which binds to hepatobiliary proteins (Ref).

Onset: Varied; typically within the first 4 to 6 weeks of therapy (Ref).

Risk factors:

• HLA-A* 33:03 allele (Ref)

Hypersensitivity reactions (delayed)

Severe cutaneous adverse reactions (SCARs), including Stevens Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) (Ref), drug reaction with eosinophilia and systemic symptoms (DRESS) (Ref) and acute generalized exanthematous pustulosis (AGEP) (Ref) have been reported. Other delayed cutaneous reactions include pityriasis rosea (Ref), lichenoid eruptions (Ref), symmetrical drug-related intertriginous and flexural erythema (SDRIFE) (Ref) and subacute cutaneous lupus erythematosus (SCLE) (Ref).

Mechanism: Non–dose-related; immunologic. Delayed hypersensitivity reactions including SCARs are T-cell-mediated (Ref).

Onset: Delayed hypersensitivity reactions: Varied; SCARs usually occur 1 to 8 weeks after initiation (Ref), although AGEP may have a more rapid onset within 2 days (Ross 2018); re-exposure usually results in symptoms within 1 to 4 days (Ref). SCLE generally occurs within 4 to 8 weeks after initiation (Ref).

Risk factors:

• Females (SCLE) (Ref)

• Cross-reactivity: Terbinafine, an allylamine antifungal, is structurally similar to naftifine; although, documented cross-reactivity has not been established. No cross-reactivity between terbinafine and naftifine was noted on patch tests (Ref).

Taste & smell disturbances

Dysgeusia (including ageusia; bitter/sour > salty/sweet) (Ref) and altered sense of smell (including anosmia) 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.

Mechanism: Not well known; possible mechanisms include receptor dysfunction through the inhibition of cytochrome P450-dependent enzyme or alteration of the cell structure or function of taste-related neurons through interference of the cholesterol biosynthesis pathway (Ref).

Onset: Delayed; mean onset of taste loss was 35 days (Ref).

Risk factors (taste disturbance):

• Age (>55 years) (Ref)

• History of taste loss (Ref)

• Low body mass index (<21 kg/m2) (Ref)

Thrombotic microangiopathy

Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic-uremic syndrome, have been reported rarely (some fatal). Recurrent anemia and thrombocytopenia may occur within 2 weeks after discontinuation (Ref).

Mechanism: Non–dose-related; immunological (anti-ADAMTS-13 antibodies may be increased) (Ref).

Onset: Intermediate; in one case report, occurred within ~2 weeks after therapy initiation (Ref).

Adverse Reactions

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

>10%: Nervous system: Headache (13%)

1% to 10%:

Dermatologic: Pruritus (3%), skin rash (6%), urticaria (1%)

Gastrointestinal: Diarrhea (6%), dysgeusia (3%; may be severe and result in weight loss) (table 1), dyspepsia (4%)

Terbinafine (Systemic): Adverse Reaction: Dysgeusia

Drug (Terbinafine [Systemic])

Placebo

Number of Patients (Terbinafine [Systemic])

Number of Patients (Placebo)

3%

0.7%

465

137

Hepatic: Increased serum transaminases (3%) (table 2)

Terbinafine (Systemic): Adverse Reaction: Increased Serum Transaminases

Drug (Terbinafine [Systemic])

Placebo

Number of Patients (Terbinafine [Systemic])

Number of Patients (Placebo)

3%

1%

465

137

Postmarketing:

Cardiovascular: Vasculitis

Dermatologic: Acute generalized exanthematous pustulosis (Zaouak 2019), alopecia (Cohen 2020, Richert 2001), bullous dermatitis (Gupta 1998a), cutaneous lupus erythematosus (Lorentz 2008), erythema multiforme (Carstens 1994, Todd 1995), exacerbation of psoriasis (Cohen 2020, Gupta 1998a), exfoliative dermatitis (Gupta 1998a), lichenoid eruption (Cohen 2020), pityriasis rosea (George 2015), psoriasiform eruption (Cohen 2020), skin photosensitivity (Kuo 2014), Stevens-Johnson syndrome (Cohen 2020), toxic epidermal necrolysis (Carstens 1994)

Gastrointestinal: Ageusia (Doty 2005), cholestasis (Kyriakidis 2017), pancreatitis, vomiting

Hematologic & oncologic: Agranulocytosis (Aguilar 2001, Ornstein 1998), anemia (Filanovsky 2015), hemolytic-uremic syndrome, pancytopenia (Kovacs 1994), severe neutropenia (Kovacs 1994, Shapiro 1999), thrombocytopenia (Filanovsky 2015), thrombotic microangiopathy (Filanovsky 2015), thrombotic thrombocytopenic purpura (Filanovsky 2015)

Hepatic: Cholestatic hepatitis (Kyriakidis 2017), hepatic failure (Song 2005), hepatic impairment, hepatocellular hepatitis (Kyriakidis 2017)

Hypersensitivity: Anaphylaxis, angioedema, drug reaction with eosinophilia and systemic symptoms (Gupta 1998), serum sickness-like reaction

Nervous system: Altered sense of smell (Lareb Netherlands Pharmacovigilance Centre 2013), anosmia (Lareb Netherlands Pharmacovigilance Centre 2013), anxiety, depression, fatigue, hypoesthesia, malaise, paresthesia, vertigo

Neuromuscular & skeletal: Arthralgia, exacerbation of systemic lupus erythematosus (Cohen 2020), increased creatine phosphokinase in blood specimen, myalgia, rhabdomyolysis (Zhou 2020), systemic lupus erythematosus (Cohen 2020)

Ophthalmic: Decreased visual acuity, visual field defect

Otic: Auditory impairment, tinnitus

Respiratory: Flu-like symptoms

Miscellaneous: Fever

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.

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

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.

Dosage Forms: US

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

Tablet, Oral:

Generic: 250 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Terbinafine HCl Oral)

250 mg (per each): $12.67 - $13.02

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.

Dosage Forms: Canada

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

Tablet, Oral:

LamISIL: 250 mg

Generic: 250 mg

Administration: Adult

Oral: Administer without regard to meals.

Administration: Pediatric

Oral: Administer without regard to meals.

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

Use: Labeled Indications

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

Use: Off-Label: Adult

Dermatophyte folliculitis (tinea barbae, Majocchi granuloma); Sporotrichosis (lymphocutaneous and cutaneous); Tinea capitis; Tinea corporis/tinea cruris; Tinea pedis/tinea manuum

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

Terbinafine may be confused with terbutaline

LamISIL may be confused with LaMICtal, Lomotil

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

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

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

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

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

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

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

Atomoxetine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Atomoxetine. 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

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

ClomiPRAMINE: CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of ClomiPRAMINE. CYP2D6 Inhibitors (Moderate) may increase the serum concentration of ClomiPRAMINE. 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

CycloSPORINE (Systemic): Terbinafine (Systemic) may decrease the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy

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

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

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

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

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

DOXOrubicin (Conventional): CYP2D6 Inhibitors (Moderate) may increase the serum concentration of DOXOrubicin (Conventional). Risk X: Avoid combination

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

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

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

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

Iloperidone: CYP2D6 Inhibitors (Moderate) may decrease serum concentrations of the active metabolite(s) of Iloperidone. Specifically, concentrations of the metabolite P95 may be decreased. CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of Iloperidone. Specifically, concentrations of the metabolite P88 may be increased. CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Iloperidone. Risk C: Monitor therapy

Imipramine: CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of Imipramine. Concentrations of desipramine may be increased. CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Imipramine. Risk C: Monitor therapy

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

Lofepramine: CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of Lofepramine. The active metabolite of lofepramine is desipramine. Risk C: Monitor therapy

Mequitazine: CYP2D6 Inhibitors (Moderate) may increase the serum concentration of Mequitazine. Risk X: Avoid combination

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

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

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

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

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

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

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

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

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. Risk C: Monitor therapy

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

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

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

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

Saccharomyces boulardii: Antifungal Agents (Systemic and Oral [Non-Absorbable]) may diminish the therapeutic effect of Saccharomyces boulardii. Risk X: Avoid combination

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

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 to the use of moderate CYP2D6 inhibitors with tamoxifen when possible, as the combination may be associated with reduced clinical effectiveness of tamoxifen. Risk D: Consider therapy modification

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

Tetrabenazine: CYP2D6 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of Tetrabenazine. Specifically, concentrations of the active alpha- and beta-dihydrotetrabenazine metabolites may be increased. Risk C: Monitor therapy

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

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

TraMADol: CYP2D6 Inhibitors (Moderate) may decrease serum concentrations of the active metabolite(s) of TraMADol. CYP2D6 Inhibitors (Moderate) may increase the serum concentration of TraMADol. Risk C: Monitor therapy

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

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

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

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

Pregnancy Considerations

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

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

Breastfeeding 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.

Monitoring Parameters

LFTs at baseline and periodically during treatment; signs/symptoms of liver injury (eg, nausea, anorexia, fatigue, vomiting, right upper abdominal pain, jaundice, dark urine, pale stools); CBC (if used >6 weeks in immunodeficient patients or if clinical signs or symptoms of secondary infection occur); taste and/or smell disturbances; skin rash, signs/symptoms of hypersensitivity reaction.

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 (Adult Data Unless Noted)

Absorption: >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: 40% (as a result of first-pass metabolism).

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 5 to 11 years: 14.7 ± 4.3 hours (range: 9.8 to 25.7 hours) (Humbert 1998; Nejjam 1995).

Adults: ~36 hours.

Time to peak, plasma: Children and Adults: Within 2 hours (Abdel-Rahman 2005; manufacturer's labeling).

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

Clearance:

Children 4 to 8 years: 1.41 ± 2.5 L/hour/kg (Abdel-Rahman 2005).

Adults: 0.47 ± 0.21 L/hour/kg (Abdel-Rahman 2005).

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

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

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

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Lamifen | Lamisil | Negafen | Onchofin;
  • (AR) Argentina: Lamisil | Likana | Tacna | Terbinafina richet | Terekol;
  • (AT) Austria: Amisan | Amykal | Lamisil | Myconafin | Terbiderm | Terbinafin actavis;
  • (AU) Australia: Apo terbinafine | Genrx Terbinafine | Lamisil | Noumed terbinafine | Pharmacor Terbinafine | Sebifin | Tamsil | Terbihexal | Terbinafine | Terbinafine Actavis | Terbinafine an | Terbinafine Ga | Terbinafine sandoz | Terbix | Tinasil | Zabel;
  • (BD) Bangladesh: Derfin | Elvina | Infud | Mycofin | Mycofree | Skinabin | Terbex | Terbicon | Terbifin | Xfin;
  • (BE) Belgium: Doc Terbinafine | Lamisil | Terbinafin ab | Terbinafine apotex | Terbinafine Aurobindo | Terbinafine EG | Terbinafine sandoz | Terbinafine teva;
  • (BF) Burkina Faso: Onycal;
  • (BG) Bulgaria: Fungofin | Lamisil | Myconafine | Terbinafin | Ternafin;
  • (BR) Brazil: Ceremil | Cloridrato de terbinafina | Funtyl | Lamisil | Tertop | Zior;
  • (CH) Switzerland: Lamisil | Onymax | Terbifil | Terbinafin actavis | Terbinafin Axapharm | Terbinafin Helvepharm | Terbinafin teva | Terbinafin zentiva | Terbinax | Tineafin;
  • (CI) Côte d'Ivoire: Onycal;
  • (CL) Chile: Dermoxyl | Dicil | Elater | Farbicil | Finex | Lamisil | Micoset | Mucivil | Terbinafina | Terfex;
  • (CN) China: Bei jia | Ding ke | Lamisil | Lan mei shu;
  • (CO) Colombia: Bellex | Enisol | Farbicil | Filut | Funide | Funzal | Hongoderm | Incomic | K Micot | Kew | Lamicol | Lamisil | Terbiderm | Terbinafina | Tersag;
  • (CZ) Czech Republic: Lamisil | Onychon | Terbinafin actavis | Terbisil | Terfimed;
  • (DE) Germany: Amiada | Dermatin | Lamisil | Myconormin | Onymax | Terbiderm | Terbigalen | Terbina Q | Terbinafin | Terbinafin Acis | Terbinafin AL | Terbinafin Beta | Terbinafin CT | Terbinafin Dura | Terbinafin Heumann | Terbinafin hexal | Terbinafin Kwizda | Terbinafin pfizer | Terbinafin puren | Terbinafin q-pharm | Terbinafin sandoz | Terbinafin Stada | Terbinafin teva | Terbinafin Winthrop | Terbinafin-1 A Pharma | Terbinafin-isis | Terbinafine Aurobindo;
  • (DK) Denmark: Lamisil | Terbinafin 1a farma | Terbinafin hexal;
  • (DO) Dominican Republic: Farbicil | Fungoter | Lamisil | Micostop | Mycelvan | Nafin | Terekol;
  • (EC) Ecuador: Dermoxil | Dicil | Exifine | Finex | Fungistat | Funide | Lamidizol | Lamisil | Micostop | Micozone | Terbifung | Terbilazar | Terbinafina | Terbinox | Terfin | Terfinamed;
  • (EE) Estonia: Lamisil | Terbinafin | Terbinafin actavis | Terbinafin sandoz | Terbinafine Olainfarm | Terbinafine sandoz | Terbinafine terbano | Terbisil | Terbisil kid;
  • (EG) Egypt: Fungisafe | Lamifen | Lamisil | Mycomic | Terbifungin | Terbin | Terbinasil | Trerbi;
  • (ES) Spain: Fungicare | Lamisil | Talixane | Terbinafina Alter | Terbinafina Aurobindo | Terbinafina aurovitas | Terbinafina Combix | Terbinafina Kern Pharma | Terbinafina Normon | Terbinafina Pensa | Terbinafina pharmacia | Terbinafina Teva;
  • (ET) Ethiopia: Lamisil;
  • (FI) Finland: Lamisil | Terbinafiini Enna | Terbinafin alternova | Terbinafin Bmm Pharma | Terbinafin Galderma | Terbinafin hexal | Terbinafin pfizer | Terbinafin Ratiopharm;
  • (FR) France: Fungster | Terbinafine Actavis | Terbinafine almus | Terbinafine Alter | Terbinafine Arrow | Terbinafine bailleul | Terbinafine biogaran | Terbinafine Cristers | Terbinafine EG | Terbinafine evolugen | Terbinafine Isomed | Terbinafine pfizer | Terbinafine qualimed | Terbinafine ranbaxy | Terbinafine ratiopharm | Terbinafine RPG | Terbinafine sandoz | Terbinafine zydus;
  • (GB) United Kingdom: Lamisil | Terbinafine | Terbinafine relonchem;
  • (GR) Greece: Chemiderm | Funger | Lamisil | Terbafin | Terbinafine Aurobindo | Terbinafine/Target | Terfinor | Terilam | Termisil | Ternafinol | Thateron | Zakofin;
  • (HK) Hong Kong: Apo terbinafine | Erbinol | Jmp terbinafine | Lamisil | Synbinafine | Tebinisil | Terbifin | Terbinafina Farmoz | Terbinafine teva | Terfung;
  • (HR) Croatia: Lamisil | Terbinafin JGL | Terbinax | Verbinaf;
  • (HU) Hungary: Lamigard | Lamisil | Terbigen | Terbinafin Ratiopharm | Terbinafine pfizer | Terbinafine q pharma | Terbiner | Terbisil | Tineal;
  • (ID) Indonesia: Interbi;
  • (IE) Ireland: Fungafine | Fungasil | Lamater | Lamisil | Lanafine | Nailderm | Terbasil | Terbinafine rowa | Ternaf;
  • (IL) Israel: Lamisil | Terbinafine;
  • (IN) India: Acbro | Af-ter | Bdterbin | Daskil | Elifin | Exifine | Finecure | Finlin | Fintrix | Fungixit t | Fungotek | Funter | Hifen | Ifin | Keptafine | Lamisil | Lamiterb | Micoside | Phyte | Sebifin | Skitofine | Tebif | Tebina | Tebisure | Teraderm | Terbest | Terbicip | Terbifix | Terbiforce | Terbikem | Terbimax | Terbin | Terbinaforce | Terbinator | Terbinax | Terbinext | Terbitotal | Terbivolt | Terbized | Terbocet | Terbofin | Terbol | Terbotac | Terfast | Terfaze | Terfung | Tergosil | Tersig | Texifen | Tinafine | Tinafix | Topcos | Trfy | Turfine | Tyza | Zimig | Zoterb | Zygter;
  • (IT) Italy: Daskil | Lamisil | Micutan | Onymax | Terbinafina | Terbinafina Arrow | Terbinafina Aurobindo | Terbinafina Doc | Terbinafina EG | Terbinafina Mgi | Terbinafina San | Terbinafina sandoz | Terbinafina tecnigen;
  • (JO) Jordan: Lamisil | Terfinil | Tinasil;
  • (JP) Japan: Lamisil | Lipnol | Nedoril | Ramitect | Tebinaceil | Terbinafine | Terbinafine hydrochloride f | Terbinafine pfizer | Terbinal | Terby | Terfinabine | Termisil;
  • (KE) Kenya: Finamark | Fungisil | Fungiter | Lamifen | Lamisil | Mycofin | Oncosil | Skinabin | Tebif | Terbex | Terbifin | Terbin | Terbinaforce | Terbinol | Terbisil | Terbitack;
  • (KR) Korea, Republic of: Bacxil | Binasil | Cellnafine | Celtenafin | Cinafine | Curasil | Demisil | Dongsung terbinafine | Ernafin | Inno.n terbinafine hcl | Jw terbinafine | Lamipin | Lamisil | Lamitin | Lamonan | Laniten | Lapiderm | Lespo | Limecin | Lonasil | M ternafine | Micosil | Mujonal | Namuzole | Natocil | Ramihu | Raminafine | Ronacil | Samsung terbinafine | Selbina | Selnapin | Sentoes | Seoul terbinafine hci | Tabianfine | Tabinafine | Tbf | Tebafine | Tebina | Tebisil | Telbina | Temisil | Tenabin | Tenavine | Terbi | Terbiclin | Terbifine | Terbigen | Terbil | Terbin | Terbina | Terbinafine | Terbinafine HCL | Terbinafine ss | Terbinarin | Terbinex | Terbini | Termina | Terna | Ternabi | Ternabin | Terpin m | Terzol | Uninapin;
  • (KW) Kuwait: Exifine | Lamifen | Lamisil;
  • (LB) Lebanon: Apo terbinafine | Boderm | Lamifen | Laminox | Lamisil | Terafan;
  • (LT) Lithuania: Exifine | Lamisil | Terbinafin actavis | Terbinafin bijon | Terbinafin sandoz | Terbinafine Actavis | Terbinafine Bmm | Terbinafine sandoz | Terbisil | Terbisil kid;
  • (LU) Luxembourg: Doc Terbinafine | Lamisil;
  • (LV) Latvia: Lamisil | Terbinafine Olainfarm | Terbisil | Terbisil kid;
  • (MA) Morocco: Lifongid | Onifine | Teguma | Terbinafine Gt | Terfine | Terix;
  • (MX) Mexico: Abinifin | Allifort | Bifynason's | Binafex | Erbitrax | Erbitrax t | Fyterdin | Hudiclor | Lamisil | Losil t | Losil T | Mycelvan | Terbinafina | Terlisgen | Unasal;
  • (MY) Malaysia: Apo terbinafine | Exifine | Lamisil | Lisim | Onchofin | Terbicip | Terbinafine Cadila | Ternafin;
  • (NG) Nigeria: Multichris terbinafine | Terbinaforce;
  • (NL) Netherlands: Lamisil | Terbinafine | Terbinafine A | Terbinafine alpharma | Terbinafine apotex | Terbinafine Aurobindo | Terbinafine cf | Terbinafine Merck | Terbinafine PA | Terbinafine PCH | Terbinafine ratiopharm | Terbinafine sandoz | Terbinafine xiromed;
  • (NO) Norway: Lamisil | Terbinafin | Terbinafin Bmm Pharma | Terbinafin Copyfarm | Terbinafin hexal | Terbinafin orifarm | Terbinafine Aurobindo;
  • (NZ) New Zealand: Apo terbinafine | Deolate | Lamisil | Noumed terbinafine | Terbafin;
  • (PE) Peru: Dermoxyl | Finex | Fungustil | Funide | Lamidizol | Lamisil | Micofinal | Micostop | Micoterat | Micoterbin | Terbicel | Terbilab | Terbinafina | Terbisil | Terbispor | Terekol | Xilatril;
  • (PH) Philippines: Lamisil;
  • (PK) Pakistan: Ademac | Bina | Binafin | Binasil | Binzet | Caweda | Ckosil | Cutis | Daskil | Dermafin | Exinofin | Funasole | Funge | Fungi rid | Fungirid | Geosil | Lamicart | Lamisil | Lerbin | Logirid | Monofin | Mycoderm | Neoterbin | Novaterafine | Qtec | Retipro | Terabin | Terafin | Terbexin | Terbi | Terbicid | Terbiderm | Terbiderm forte | Terbifold | Terbilet | Terbimax | Terbimed | Terbin | Terbipearl | Terbisan | Terbiser | Terbisil | Terbitec | Terbix | Terbiz | Terbizor | Terbizor ds | Tersil | Tinabin | Tinadew | Tinea | Turbo;
  • (PL) Poland: Afugin | Erfin | Lamisil | Myconafine | Onymax | Terbinafin Bmm Pharma | Terbinafina | Terbinafine 1A Pharma | Terbinafine Aurobindo | Terbisil | Terbisil kid | Zelefion;
  • (PR) Puerto Rico: Lamisil | Terbinafine | Terbinafine HCL;
  • (PT) Portugal: Daskyl | Fungster | Lamisil | Terbin | Terbinafina | Terbinafina almus | Terbinafina parke davis | Terbinafina Stada | Termycol;
  • (PY) Paraguay: Finex | Lamisil | Limpex | Mircol | Terbiderm | Terbimax;
  • (QA) Qatar: Corbinal | Lamifen | Lamisil;
  • (RO) Romania: Terbisil;
  • (RU) Russian Federation: Atifin | Binafin | Bramisil | Cidocan | Exifine | Exiter | Fungoterbine | Lamisil | Medofloran | Onychon | Tebikur | Terbifin | Terbinafine | Terbinafine akrikhin | Terbinafine canon | Terbinafine hexal | Terbinafine mff | Terbinafine pfizer | Terbinafine sandoz | Terbinafine sar | Terbinafine teva | Terbinafine vertex | Terbinox | Terbisil | Termicon | Tigal sanovel;
  • (SA) Saudi Arabia: Lamifen | Lamisil | Negafen | Pms-terbinafin;
  • (SE) Sweden: Azurifin | Lamisil | Terbinafin 2care4 | Terbinafin actavis | Terbinafin Agp | Terbinafin Arrow | Terbinafin Bmm Pharma | Terbinafin Copyfarm | Terbinafin ebb | Terbinafin Galderma | Terbinafin hexal | Terbinafin Ivax | Terbinafin Mylan | Terbinafin Nordic drugs | Terbinafin Ratiopharm | Terbinafin Stada;
  • (SG) Singapore: Exifine | Lamisil;
  • (SI) Slovenia: Atifan | Lamisil | Terbinafine Arrow;
  • (SK) Slovakia: Brinaf | Lamisil | Mycodekan | Onychomed | Onychon | Terbinafin | Terbinafin actavis | Terbisil | Terfimed;
  • (TH) Thailand: Lamisil;
  • (TN) Tunisia: Lamisil | Onycal | Terbinafine Winthrop | Terbisil | Tercyd | Tinasil;
  • (TR) Turkey: Corbinal | Laminox | Lamisil | Mikonafin | Mycocur | Tekfin | Terafin | Terbin | Terbisil | Terbonile | Terinateva | Terminus | Tigal;
  • (TW) Taiwan: Camisan | Fungitech | Lamisil | Lisim | Terfine | Terfung;
  • (UA) Ukraine: Binafin | Exifine | Fungotek | Lamicon | Lamiderm | Lamifen | Mycofin | Terbinafin kv | Terbinafine | Terbinorm | Terbinox;
  • (UG) Uganda: Fungisafe | Terafine;
  • (UY) Uruguay: Lamisil | Terbimax | Terbinafina | Terfenam | Terfiren | Unex;
  • (VE) Venezuela, Bolivarian Republic of: Farbicil | Lamisil | Ofanthel | Perten | Terbinafina | Terfex;
  • (ZA) South Africa: ADCO terbinafine | Arrow terbinafine | Binacil | Dermax | Finderm | Lamisil | Lamispor | Terbi Clear | Terbicil;
  • (ZM) Zambia: Lamisil | Sebifin | Terbane | Terbinaforce | Terbofin;
  • (ZW) Zimbabwe: Lamisil | Terbifin
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