▶Child 1–17 years (body-weight 40 kg and above): 250 mg
once daily for 2 - 4 weeks
Tinea capitis
▶BY MOUTH USING TABLETS
▶Child 1–17 years (body-weight 10–19 kg): 62. 5 mg once
daily for 4 weeks
▶Child 1–17 years (body-weight 20–39 kg): 125 mg once
daily for 4 weeks
▶Child 1–17 years (body-weight 40 kg and above): 250 mg
once daily for 4 weeks
Dermatophyte infections of the nails
▶BY MOUTH USING TABLETS
▶Child 1–17 years (body-weight 10–19 kg): 62. 5 mg once
daily for 6 weeks- 3 months (occasionally longer in
toenail infections)
▶Child 1–17 years (body-weight 20–39 kg): 125 mg once
daily for 6 weeks- 3 months (occasionally longer in
toenail infections)
▶Child 1–17 years (body-weight 40 kg and above): 250 mg
once daily for 6 weeks- 3 months (occasionally longer in
toenail infections)
Cutaneous candidiasis|Pityriasis versicolor
▶TO THE SKIN USING CREAM
▶Child:Apply 1 – 2 times a day for 2 weeks, to be applied
thinly, review treatment after 2 weekslUNLICENSED USENot licensed for use in children.
lCAUTIONS
▶With oral useautoimmune disease (risk of lupus-
erythematosus-like effect).psoriasis (risk of exacerbation)
▶With topical usecontact with eyes and mucous membranes
should be avoided
lINTERACTIONS→Appendix 1 : terbinafine
lSIDE-EFFECTS
GENERAL SIDE-EFFECTS
▶Common or very commonSkin reactions
SPECIFIC SIDE-EFFECTS
▶Common or very common
▶With oral useAppetite decreased.arthralgia.diarrhoea.
gastrointestinal discomfort.gastrointestinal disorder.
headache.myalgia.nausea
▶Uncommon
▶With oral useTaste altered.weight decreased
▶Rare or very rare
▶With oral useAgranulocytosis.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 useAnaemia.anxiety.depressive symptom.
fatigue.fever.hearing impairment.influenza like illness.
pancreatitis.pancytopenia.rhabdomyolysis.serum
sickness-like reaction.smell altered.vasculitis.vision
disorders
▶With topical useHypersensitivity
SIDE-EFFECTS, FURTHER INFORMATION
Liver toxicityWith oral use; discontinue treatment if
liver toxicity develops (including jaundice, cholestasis and
hepatitis).
Serious skin reactionsWith oral use; discontinue
treatment in progressive skin rash (including Stevens-
Johnson syndrome and toxic epidermal necrolysis).lPREGNANCY
▶With topical useManufacturer advises use only if potential
benefit outweighs risk—animalstudies suggest no adverse
effects.
▶With oral useManufacturer advises use only if potential
benefit outweighs risk—no information available.
lBREAST FEEDING
▶With topical useManufacturer 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 useAvoid—present in milk.
lHEPATIC IMPAIRMENT
▶With oral useManufacturer advises avoid—elimination
reduced.
lRENAL IMPAIRMENT
Dose adjustments▶With oral useUse half normal dose if
estimated glomerularfiltration rate less than
50 mL/minute/ 1. 73 m^2 and no suitable alternative
available.
lMONITORING REQUIREMENTS
▶With oral useMonitor hepatic function before treatment
and then periodically after 4 – 6 weeks of treatment—
discontinue if abnormalities in liver function tests.
lPATIENT AND CARER ADVICE
▶With oral useManufacturer 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.
lEXCEPTIONS TO LEGAL CATEGORYPreparations 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.lMEDICINAL 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 mgTerbinafine
250 mg tablets| 14 tabletP£ 18. 11 DT = £ 8. 46 | 28 tabletP
£ 5. 00 – £ 34. 93
▶Lamisil(Novartis Pharmaceuticals UK Ltd)
Terbinafine (as Terbinafine hydrochloride) 250 mgLamisil 250 mg
tablets| 14 tabletP£ 21. 30 DT = £ 8. 46 | 28 tabletP£ 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 gramTerbinafine 1 % cream
| 7. 5 gramP£ 1. 06 | 15 gramP£ 3. 17 DT = £ 0. 98 |
30 gramP£ 6. 33 DT = £ 1. 96
▶Lamisil(GlaxoSmithKline Consumer Healthcare)
Terbinafine hydrochloride 10 mg per 1 gramLamisil 1 % cream|
30 gramP£ 8. 76 DT = £ 1. 96
Lamisil AT 1 % cream| 15 gramG£ 3. 60 DT = £ 0. 98ANTISEPTICS AND DISINFECTANTS›
UNDECENOATESUndecenoic acid with zinc
undecenoate
lINDICATIONS AND DOSE
Treatment of athletes foot
▶TO THE SKIN
▶Child:Apply twice daily, continue use for 7 days after
lesions have healed continued→BNFC 2018 – 2019 Fungal skin infections 727
Skin13