Individual generic drug information

terbinafine

Reference monograph

Part of registered formulation

TERBINAFINE

Reference record: Terbinafine
Source: BNF 80 (2020–2021)
Printed source pages: 1322, 1323
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Terbinafine only.

Indications And Dose

Tinea pedis ▶TO THE SKIN USING CREAM ▶Adult: Apply 1–2 times a day for up to 1 week, to be applied thinly ▶BY MOUTH USING TABLETS ▶Adult: 250 mg once daily for 2-6 weeks Tinea corporis ▶TO THE SKIN USING CREAM ▶Adult: Apply 1–2 times a day for up to 1–2 weeks, to be applied thinly, review treatment after 2 weeks ▶BY MOUTH USING TABLETS ▶Adult: 250 mg once daily for 4 weeks Tinea cruris ▶TO THE SKIN USING CREAM ▶Adult: Apply 1–2 times a day for up to 1–2 weeks, to be applied thinly, review treatment after 2 weeks ▶BY MOUTH USING TABLETS ▶Adult: 250 mg once daily for 2-4 weeks Dermatophyte infections of the nails ▶BY MOUTH USING TABLETS ▶Adult: 250 mg once daily for 6 weeks-3 months (occasionally longer in toenail infections) Cutaneous candidiasis | Pityriasis versicolor ▶TO THE SKIN USING CREAM ▶Adult: Apply 1–2 times a day for 2 weeks, to be applied thinly, review treatment after 2 weeks

Source page 1322

Cautions

▶With oral use Psoriasis (risk of exacerbation). risk of lupus erythematosus ▶With topical use contact with eyes and mucous membranes should be avoided

Source page 1322

Exceptions To Legal Category

▶With topical use Preparations of terbinaﬁne hydrochloride (maximum 1%) can be sold to the public for use in those over 16 years for external use for the treatment of tinea pedis as a cream in a pack containing maximum 15 g, or for the treatment of tinea pedis and cruris as a cream in a pack containing maximum 15 g, or for the treatment of tinea pedis, cruris, and corporis as a spray in a pack containing maximum 30 mL spray or as a gel in a pack containing maximum 30 g gel.

Source page 1323

Safety

Extracted information for Terbinafine only.

Interactions

→Appendix 1: terbinaﬁne

Source page 1322

Side Effects

GENERAL SIDE-EFFECTS ▶Common or very common Skin reactions SPECIFIC SIDE-EFFECTS ▶Common or very common ▶With oral use Appetite decreased. arthralgia. diarrhoea. gastrointestinal discomfort. gastrointestinal disorder. headache. myalgia. nausea ▶Uncommon ▶With oral use Taste altered ▶With topical use Pain ▶Rare or very rare ▶With oral use Agranulocytosis. alopecia. cutaneous lupus erythematosus. dizziness. hepatic disorders. malaise. neutropenia. photosensitivity reaction. sensation abnormal. severe cutaneous adverse reactions (SCARs). systemic lupus erythematosus (SLE). thrombocytopenia. vertigo ▶Frequency not known ▶With oral use Anaemia. anxiety. depressive symptom. fatigue. fever. hearing impairment. inﬂuenza like illness. pancreatitis. pancytopenia. rhabdomyolysis. serum sickness-like reaction. smell altered. tinnitus. vasculitis. vision disorders ▶With topical use Hypersensitivity SIDE-EFFECTS, FURTHER INFORMATION Liver toxicity With oral use; discontinue treatment if liver toxicity develops (including jaundice, cholestasis and hepatitis). Serious skin reactions With oral use; discontinue treatment in progressive skin rash (including Stevens- Johnson syndrome and toxic epidermal necrolysis).

Source page 1322

Pregnancy

▶With topical use Manufacturer advises use only if potential beneﬁt outweighs risk— animal studies suggest no adverse effects. ▶With oral use Manufacturer advises use only if potential beneﬁt outweighs risk—no information available.

Source page 1322

Breast Feeding

▶With topical use Manufacturer advises avoid—present in milk. Less than 5% of the dose is absorbed after topical application of terbinaﬁne; avoid application to mother’s chest. ▶With oral use Avoid—present in milk.

Source page 1322

Hepatic Impairment

▶With oral use Manufacturer advises avoid (risk of increased exposure).

Source page 1322

Renal Impairment

Dose adjustments ▶With oral use Use half normal dose if eGFR less than 50 mL/minute/1.73 m2 and no suitable alternative available.

Source page 1322

Monitoring Requirements

▶With oral use Monitor hepatic function before treatment and then periodically after 4–6 weeks of treatment— discontinue if abnormalities in liver function tests.

Source page 1322

Dose and formulations

Extracted information for Terbinafine only.

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 9 ▶Terbinafine (Non-proprietary) Terbinafine (as Terbinafine hydrochloride) 250 mg Terbinafine 250mg tablets | 14 tablet P £18.11 DT = £1.80 | 28 tablet P £3.56–£34.93 ▶Lamisil (Novartis Pharmaceuticals UK Ltd) Terbinafine (as Terbinafine hydrochloride) 250 mg Lamisil 250mg tablets | 14 tablet P £21.30 DT = £1.80 | 28 tablet P £41.09 Cream EXCIPIENTS: May contain Benzyl alcohol, cetostearyl alcohol (including cetyl and stearyl alcohol), polysorbates ▶Terbinafine (Non-proprietary) Terbinafine hydrochloride 10 mg per 1 gram Terbinafine 1% cream | 15 gram P £3.17 DT = £1.54 | 30 gram P £6.33 DT = £3.08 ▶Lamisil (GlaxoSmithKline Consumer Healthcare) Terbinafine hydrochloride 10 mg per 1 gram Lamisil 1% cream | 30 gram P £8.76 DT = £3.08 ANTISEPTICS AND DISINFECTANTS › UNDECENOATES

Source page 1323

Clinical care

Extracted information for Terbinafine only.

Patient And Carer Advice

▶With oral use Manufacturer advises that patients should immediately report any signs or symptoms suggestive of liver dysfunction such as pruritus, unexplained persistent nausea, decreased appetite, anorexia, jaundice, vomiting, fatigue, right upper abdominal pain, dark urine, or pale stools. Patients with these symptoms should discontinue taking terbinaﬁne and the patient’s liver function should be immediately evaluated.

Source pages 1322, 1323

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

Apply 1–2 times a day for up to 1 week, to be

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1322

Adults

First line only; read the complete Indications and dose section above.

250 mg once daily for 2-6 weeks

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1322

Adults

First line only; read the complete Indications and dose section above.

Apply 1–2 times a day for up to 1–2 weeks, to be

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1322

Adults

First line only; read the complete Indications and dose section above.

250 mg once daily for 4 weeks

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1322

Adults

First line only; read the complete Indications and dose section above.

Apply 1–2 times a day for up to 1–2 weeks, to be

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1322

Adults

First line only; read the complete Indications and dose section above.

250 mg once daily for 2-4 weeks

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1322

Adults

First line only; read the complete Indications and dose section above.

250 mg once daily for 6 weeks-3 months

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1322

Adults

First line only; read the complete Indications and dose section above.

Apply 1–2 times a day for 2 weeks, to be applied

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1322

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.

Individual generic drug information

terbinafine

Reference monograph

Part of registered formulation

TERBINAFINE

Reference record: Terbinafine
Source: BNF 80 (2020–2021)
Printed source pages: 1322, 1323
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Terbinafine only.

Indications And Dose

Source page 1322

Cautions

▶With oral use Psoriasis (risk of exacerbation). risk of lupus erythematosus ▶With topical use contact with eyes and mucous membranes should be avoided

Source page 1322

Exceptions To Legal Category

Source page 1323

Safety

Extracted information for Terbinafine only.

Interactions

→Appendix 1: terbinaﬁne

Source page 1322

Side Effects

Source page 1322

Pregnancy

Source page 1322

Breast Feeding

Source page 1322

Hepatic Impairment

▶With oral use Manufacturer advises avoid (risk of increased exposure).

Source page 1322

Renal Impairment

Dose adjustments ▶With oral use Use half normal dose if eGFR less than 50 mL/minute/1.73 m2 and no suitable alternative available.

Source page 1322

Monitoring Requirements

▶With oral use Monitor hepatic function before treatment and then periodically after 4–6 weeks of treatment— discontinue if abnormalities in liver function tests.

Source page 1322

Dose and formulations

Extracted information for Terbinafine only.

Medicinal Forms

Source page 1323

Clinical care

Extracted information for Terbinafine only.

Patient And Carer Advice

Source pages 1322, 1323

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

Apply 1–2 times a day for up to 1 week, to be

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1322

Adults

First line only; read the complete Indications and dose section above.

250 mg once daily for 2-6 weeks

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1322

Adults

First line only; read the complete Indications and dose section above.

Apply 1–2 times a day for up to 1–2 weeks, to be

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1322

Adults

First line only; read the complete Indications and dose section above.

250 mg once daily for 4 weeks

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1322

Adults

First line only; read the complete Indications and dose section above.

Apply 1–2 times a day for up to 1–2 weeks, to be

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1322

Adults

First line only; read the complete Indications and dose section above.

250 mg once daily for 2-4 weeks

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1322

Adults

First line only; read the complete Indications and dose section above.

250 mg once daily for 6 weeks-3 months

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1322

Adults

First line only; read the complete Indications and dose section above.

Apply 1–2 times a day for 2 weeks, to be applied

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 1322

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.