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Terbinafine (systemic): Pediatric drug information

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

For abbreviations, symbols, and age group definitions show table
Brand Names: Canada
  • APO-Terbinafine;
  • Auro-Terbinafine;
  • DOM-Terbinafine [DSC];
  • LamISIL [DSC];
  • PMS-Terbinafine;
  • RIVA-Terbinafine [DSC];
  • Terbinafine-250;
  • TEVA Terbinafine
Therapeutic Category
  • Antifungal Agent, Oral
Dosing: Pediatric
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).

Tinea capitis

Tinea capitis: Limited data available: Note: Preferred treatment agent varies based on causative pathogen (known or suspected). For infections caused by Trichophyton tonsurans (~95% of cases in the United States), terbinafine is considered superior to griseofulvin (Ref). For Microsporum spp. infections, griseofulvin is preferred over terbinafine. If terbinafine is used for Microsporum infections, 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.

Higher-dose regimen (Ref):

Children and Adolescents:

10 to <25 kg: Oral: 125 mg once daily.

25 to 35 kg: Oral: 187.5 mg once daily.

>35 kg: Oral: 250 mg once daily.

Duration of therapy: Typically ~4 to 6 weeks but may vary based on pathogen and clinical response; Microsporum canis may require treatment for longer duration (eg, up to 12 weeks) (Ref).

Tinea corporis, tinea cruris, and tinea pedis

Tinea corporis (ringworm), tinea cruris (jock itch), and tinea pedis (athlete's foot): Very limited data available: Note: Dosing is extrapolated from tinea capitis treatment studies; oral therapy should be reserved for disease that does not respond to topical therapy or for extensive/severe infection (Ref).

Children and Adolescents: Note: Dosing based on 4 to 6 mg/kg/day (Ref).

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

20 to 40 kg: Oral: 125 mg once daily (Ref).

>40 kg: Oral: 250 mg once daily (Ref).

Duration of therapy: Typically ≥2 weeks (Ref).

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: Liver 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.

Dosing: Adult

(For additional information see "Terbinafine (systemic): Drug information")

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 infection

Tinea infection:

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: For disease that is extensive or refractory to topical therapy (Ref).

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

Tinea pedis/tinea manuum (alternative agent) (off-label use): Note: For disease that is extensive or refractory to topical therapy (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: Liver Impairment: Adult

The liver dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Matt Harris, PharmD, MHS, BCPS, FAST, FCCP; Jeong Park, PharmD, MS, BCPS, FCCP, FAST; Arun Jesudian, MD; Sasan Sakiani, MD.

Note : No long-term pharmacokinetic or safety data are available for use in patients with cirrhosis (Ref).

Liver impairment prior to treatment initiation:

Child-Turcotte-Pugh class A to C: Oral: Use is contraindicated (Ref).

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* 33:01 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; immunologic (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 (Ref), alopecia (Ref), bullous dermatitis (Ref), cutaneous lupus erythematosus (Ref), erythema multiforme (Ref), exacerbation of psoriasis (Ref), exfoliative dermatitis (Ref), lichenoid eruption (Ref), pityriasis rosea (Ref), psoriasiform eruption (Ref), skin photosensitivity (Ref), Stevens-Johnson syndrome (Ref), toxic epidermal necrolysis (Ref)

Gastrointestinal: Ageusia (Ref), cholestasis (Ref), pancreatitis, vomiting

Hematologic & oncologic: Agranulocytosis (Ref), anemia (Ref), hemolytic-uremic syndrome, pancytopenia (Ref), severe neutropenia (Ref), thrombocytopenia (Ref), thrombotic microangiopathy (Ref), thrombotic thrombocytopenic purpura (Ref)

Hepatic: Cholestatic hepatitis (Ref), hepatic failure (Ref), hepatic impairment, hepatocellular hepatitis (Ref)

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

Nervous system: Altered sense of smell (Ref), anosmia (Ref), anxiety, depression, fatigue, hypoesthesia, malaise, paresthesia, vertigo

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

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. [DSC] = Discontinued product

Tablet, Oral:

LamISIL: 250 mg [DSC]

Generic: 250 mg

Extemporaneous Preparations

25 mg/mL Oral Suspension:

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.
Administration: Pediatric

Oral: Tablets: Administer without regard to meals.

Administration: Adult

Oral: Administer without regard to meals.

Storage/Stability

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

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

Treatment of onychomycosis of the toenail or fingernail due to susceptible dermatophytes (FDA approved in adults); has also been used in the treatment of tinea capitis, tinea corporis, tinea cruris, and tinea pedis.

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 drug interactions program by clicking on the “Launch drug interactions program” link above.

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 drug interactions program

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

Amitriptyline: CYP2D6 Inhibitors (Moderate) may increase serum concentration of Amitriptyline. CYP2D6 Inhibitors (Moderate) may increase active metabolite exposure of Amitriptyline. Risk C: Monitor

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

Amphetamines: CYP2D6 Inhibitors (Moderate) may increase 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

ARIPiprazole Lauroxil: CYP2D6 Inhibitors (Moderate) may increase active metabolite exposure of ARIPiprazole Lauroxil. Risk C: Monitor

ARIPiprazole: CYP2D6 Inhibitors (Moderate) may increase 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

Atomoxetine: CYP2D6 Inhibitors (Moderate) may increase serum concentration of Atomoxetine. Risk C: Monitor

Brexpiprazole: CYP2D6 Inhibitors (Moderate) may increase 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

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

ClomiPRAMINE: CYP2D6 Inhibitors (Moderate) may increase serum concentration of ClomiPRAMINE. CYP2D6 Inhibitors (Moderate) may increase active metabolite exposure of ClomiPRAMINE. Risk C: Monitor

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

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

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

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

Deutetrabenazine: CYP2D6 Inhibitors (Moderate) may increase active metabolite exposure of Deutetrabenazine. Risk C: Monitor

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

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

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

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

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

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

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

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

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

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

Lofepramine: CYP2D6 Inhibitors (Moderate) may increase active metabolite exposure of Lofepramine. The active metabolite of lofepramine is desipramine. Risk C: Monitor

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

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

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

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

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

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

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

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

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

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

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

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

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

Propafenone: CYP2D6 Inhibitors (Moderate) may increase serum concentration of Propafenone. Risk C: Monitor

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

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

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

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

Saccharomyces boulardii: Antifungal Agents (Systemic and Oral [Non-Absorbable]) may decrease therapeutic effects of Saccharomyces boulardii. Risk X: Avoid

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

Sofpironium: CYP2D6 Inhibitors (Moderate) may increase serum concentration of Sofpironium. Risk C: Monitor

Tamoxifen: CYP2D6 Inhibitors (Moderate) may decrease active metabolite exposure 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 serum concentration of Tamsulosin. Risk C: Monitor

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

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

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

TraMADol: CYP2D6 Inhibitors (Moderate) may increase serum concentration of TraMADol. CYP2D6 Inhibitors (Moderate) may decrease active metabolite exposure of TraMADol. Risk C: Monitor

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

Valbenazine: CYP2D6 Inhibitors (Moderate) may increase active metabolite exposure of Valbenazine. Risk C: Monitor

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

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

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).

Monitoring Parameters

AST/ALT prior to initiation, repeat if used >6 weeks; some experts have suggested that repeat testing at 6 weeks is unnecessary (Patel 2017); CBC (if used >6 weeks in immunocompromised patients).

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: Clearance is decreased 30% to 50% (Balfour 1992; Jensen 1989; manufacturer's labeling).

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

  • (AE) United Arab Emirates: Lamifen | Lamisil | Negafen | Onchofin;
  • (AR) Argentina: Fungueal | 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 | Mycocure | Mycofin | Mycofree | Skinabin | Terbex | Terbicare | Terbicon | Terbiderm | Terbifin | Terbikill | Terbimax | Terbinox | 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 | Donter | Elater | Farbicil | Finex | Fungra | 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 | Terbinafin teva | 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 | Dermoxyl | Dicil | Donter | Exifine | Finex | Fungistat | Funide | Lamidizol | Lamisil | Micostop | Micoxial | Micozone | Terbifung | Terbilazar | Terbinachem | Terbinafina | Terbinafina mk | Terbinafina nifa | Terbinox | Terbisil | Terbix | Terfin | Terfinamed | Vardenil;
  • (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 Actavis | 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 | Alnabin | Bdterbin | Daskil | Elifin | Exifine | Finecure | Finlin | Fintrix | Fungixit t | Fungotek | Funter | Hifen | Ifin | Keptafine | Lamisil | Lamiterb | Micoside | Mycosol | Phyte | Sebifin | Sinofin | Skitofine | Tebif | Tebina | Tebisure | Teraderm | Terbest | Terbicip | Terbicutis | Terbidor | Terbifix | Terbiforce | Terbikem | Terbimax | Terbin | Terbinaforce | Terbinator | Terbinax | Terbinext | Terbiroz | Terbitotal | Terbivolt | Terbized | Terbocet | Terbofin | Terbol | Terbotac | Terfast | Terfaze | Terfitis | 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 | Berafine | 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 | Ramiguard | 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 | Ternarine | 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 focus | 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;
  • (SR) Suriname: Apo terbinafine | Terbinafine Mylan | Terbinafine sandoz | Terbisil;
  • (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 | Lamisil | Terafine | Terbiderm forte | Terbinaforce;
  • (UY) Uruguay: Lamisil | Terbimax | Terbinafina | Terfenam | Terfiren | Unex;
  • (VE) Venezuela, Bolivarian Republic of: Farbicil | Lamisil | Ofanthel | Perten | Terbicrym | 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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