Terbinafine: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Myanmar prescribing information.

Generic Medicine Info

Indications and Dosage

Oral
Tinea corporis, Tinea cruris, Tinea pedis

Adult: 250 mg once daily. Treatment duration: 2-6 weeks (tinea pedis), 4 weeks (tinea corporis), 2-4 weeks (tinea cruris).

Oral
Nail fungal infections

Adult: 250 mg once daily for 6 weeks (fingernail) or 12 weeks (toenail).

Topical/Cutaneous
Tinea pedis

Adult: As 1% cream: Apply to affected area 1-2 times daily for 1 week (between toes) or 2 weeks (bottom or sides of feet). As spray: Spray between the toes bid for 1 week. As gel: Apply to affected area once daily for 1 week.
Child: ≥12 years As cream or spray: Same as adult dose. Dosage recommendations may vary among countries or individual products. Refer to country- or product-specific recommendations.

Topical/Cutaneous
Cutaneous candidiasis, Pityriasis versicolor

Adult: As 1% cream: Apply 1-2 times daily for 2 weeks.

Topical/Cutaneous
Tinea corporis, Tinea cruris

Adult: As 1% cream: Apply to affected area 1-2 times daily for 1-2 weeks. As 1% gel or spray: Apply to affected area once daily for 1 week.
Child: ≥12 years As 1% cream or spray: Same as adult dose. Dosage recommendations may vary among countries or individual products. Refer to country- or product-specific recommendations.

Renal Impairment

Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Chronic or active liver disease. Lactation.

Special Precautions

Patients with autoimmune disease (e.g. lupus erythematosus, psoriasis), immunodeficiency. Renal impairment. Children. Pregnancy.

Adverse Reactions

Significant: Depression, taste or smell disturbance, severe neutropenia, agranulocytosis, pancytopenia, thrombocytopenia, precipitation and exacerbation of cutaneous and systemic lupus erythematosus, exacerbation of psoriasis.
Eye disorders: Changes in ocular lens and retina.
Gastrointestinal disorders: Flatulence, dyspepsia, nausea, abdominal pain, diarrhoea.
General disorders and administration site conditions: Fever; application site pain or irritation (topical).
Metabolism and nutrition disorders: Decreased appetite.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Nervous system disorders: Headache.
Skin and subcutaneous tissue disorders: Pruritus, rash, urticaria.
Potentially Fatal: Hepatic failure, serious skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis, drug rash with eosinophilia and systemic symptoms), thrombotic microangiopathy (e.g. thrombotic thrombocytopenic purpura, haemolytic uraemic syndrome).

Pregnancy Category (US FDA)

PO/Topical: B

Monitoring Parameters

Perform LFT before treatment and periodically (after 4-6 weeks of treatment). Monitor CBC for therapy >6 weeks in immunosuppressed patients.

Overdosage

Symptoms: Headache, nausea, vomiting, epigastric pain, rash, frequent urination, and dizziness. Management: Symptomatic and supportive treatment. May administer activated charcoal to adsorb and eliminate the drug.

Drug Interactions

Increased effect or plasma concentration with CYP2C9 and CYP3A4 inhibitors (e.g. cimetidine, fluconazole, amiodarone). Decreased effect or plasma concentration with rifampicin. Terbinafine increases the effect of TCAs (e.g. desipramine), beta-blockers (e.g. atenolol), SSRIs (e.g. escitalopram), MAOIs (e.g. rasagiline) by inhibiting CYP2D6 enzyme. Decreases the clearance of caffeine. Increases the clearance of ciclosporin.

Action

Description: Terbinafine is a synthetic allylamine derivative that interferes with fungal sterol biosynthesis by inhibiting squalene epoxidase. This results in a deficiency in ergosterol and intracellular accumulation of squalene within the fungal cell membrane, leading to fungal cell death.
Pharmacokinetics:
Absorption: Well absorbed from the gastrointestinal tract (>70%). Bioavailability: Approx 40%. Time to peak plasma concentration: Within 2 hours.
Distribution: Distributed mainly to stratum corneum, sebum, hair, and nail matrix, bed, and plate. Enters breast milk. Plasma protein binding: >99%.
Metabolism: Rapidly and extensively metabolised in the liver mainly by CYP1A2, CYP3A4, CYP2C8, CYP2C9, and CYP2C19 to inactive metabolites. Undergoes first-pass metabolism.
Excretion: Mainly via urine (80%, as inactive metabolites); faeces (20%). Plasma elimination half-life: 200-400 hours (terminal); approx 36 hours (effective).

Chemical Structure

Storage

Store below 30°C. Protect from light.

MIMS Class

Antifungals / Topical Antifungals & Antiparasites

ATC Classification

D01AE15 - terbinafine ; Belongs to the class of other antifungals for topical use.
D01BA02 - terbinafine ; Belongs to the class of antifungals for systemic use.

References

Anon. Terbinafine (Systemic). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 22/04/2021.

Anon. Terbinafine (Systemic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 22/04/2021.

Anon. Terbinafine (Topical). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 22/04/2021.

Anon. Terbinafine (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 22/04/2021.

Buckingham R (ed). Terbinafine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 22/04/2021.

Dr Reddy’s New Zealand Ltd. Terbinafine-DRLA Tablets data sheet 2 June 2017. Medsafe. http://www.medsafe.govt.nz. Accessed 22/04/2021.

Joint Formulary Committee. Terbinafine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 22/04/2021.

Lamisil Aerosol Spray (GlaxoSmithKline Consumer Healthcare Holdings US LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 22/04/2021.

Lamisil AT 1% Gel (GlaxoSmithKline Consumer Healthcare UK Trading Limited). MHRA. https://products.mhra.gov.uk. Accessed 03/05/2021.

Nafine Cream (Prime Pharmaceutical Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 22/04/2021.

Terbinafine 250 mg Tablets (Dr Reddy’s Laboratories UK Ltd). MHRA. https://products.mhra.gov.uk. Accessed 22/04/2021.

Terbinafine Hydrochloride 1% Cream (Gedeon Richter Plc.). MHRA. https://products.mhra.gov.uk. Accessed 22/04/2021.

Terbinafine Hydrochloride Cream (Pharmacy Value Alliance LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 22/04/2021.

Terbinafine Hydrochloride Tablet (Breckenridge Pharmaceutical, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 22/04/2021.

Disclaimer: This information is independently developed by MIMS based on Terbinafine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2023 MIMS. All rights reserved. Powered by MIMS.com