lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Capsule
CAUTIONARY AND ADVISORY LABELS2, 8
▶Cycloserine (Non-proprietary)
Cycloserine 250 mgCycloserine 250 mg capsules|
100 capsuleP£ 442. 89 DT = £ 442. 89
Ethambutol hydrochloride 19-Mar-2018
lINDICATIONS AND DOSE
Tuberculosis, in combination with other drugs (standard
unsupervised 6 -month treatment)
▶BY MOUTH
▶Child: 20 mg/kg once daily for 2 months (initial phase)
Tuberculosis, in combination with other drugs
(intermittent supervised 6 -month treatment) (under
expert supervision)
▶BY MOUTH
▶Child: 30 mg/kg 3 times a week for 2 months (initial
phase)
Congenital tuberculosis, in combination with other drugs
▶BY MOUTH
▶Neonate: 20 mg/kg once daily for 2 months (initial
phase).lCONTRA-INDICATIONSOptic neuritis.poor vision
lCAUTIONSYoung children
CAUTIONS, FURTHER INFORMATION
▶Understanding warningsPatients who cannot understand
warnings about visual side-effects should, if possible, be
given an alternative drug. In particular, ethambutol should
be used with caution in children until they are at least
5 years old and capable of reporting symptomatic visual
changes accurately.
lINTERACTIONS→Appendix 1 : ethambutol
lSIDE-EFFECTS
▶Common or very commonHyperuricaemia.nerve disorders
.visual impairment
▶Rare or very rareNephritis tubulointerstitial
▶Frequency not knownAlveolitis allergic.appetite
decreased.asthenia.confusion.dizziness.eosinophilia.
fever.flatulence.gastrointestinal discomfort.gout.
hallucination.headache.jaundice.leucopenia.nausea.
nephrotoxicity.neutropenia.photosensitive lichenoid
eruption.sensation abnormal.severe cutaneous adverse
reactions (SCARs).skin reactions.taste metallic.
thrombocytopenia.tremor.vomiting
SIDE-EFFECTS, FURTHER INFORMATIONOcular toxicity is
more common where excessive dosage is used or if the
patient’s renal function is impaired. Early discontinuation
of the drug is almost always followed by recovery of
eyesight.
lPREGNANCYNot known to be harmful.
lBREAST FEEDINGAmount too small to be harmful.
lRENAL IMPAIRMENTRisk of optic nerve damage. Should
preferably be avoided in patients with renal impairment.
Dose adjustmentsIf creatinine clearance less than
30 mL/minute/ 1. 73 m^2 ,use 15 – 25 mg/kg (max. 2. 5 g)
3 times a week.
MonitoringIf creatinine clearance less than
30 mL/minute/ 1. 73 m^2 , monitor plasma-ethambutol
concentration.
lMONITORING REQUIREMENTS
▶‘Peak’concentration ( 2 – 2. 5 hours after dose) should be
2 – 6 mg/litre ( 7 – 22 micromol/litre);‘trough’(pre-dose)
concentration should be less than 1 mg/litre
( 4 micromol/litre).
▶Renal function should be checked before treatment.
▶Visual acuity should be tested by Snellen chart before
treatment with ethambutol.
▶In young children, routine ophthalmological monitoring
recommended.
lPRESCRIBING AND DISPENSING INFORMATIONThe RCPCH
and NPPG recommend that, when a liquid special of
ethambutol is required, the following strength is used:
400 mg/ 5 mL.
lPATIENT AND CARER ADVICE
Ocular toxicityThe earliest features of ocular toxicity are
subjective and patients should be advised to discontinue
therapy immediately if they develop deterioration in vision
and promptly seek further advice.
Medicines for Children leaflet: Ethambutol for the treatment of
tuberculosiswww.medicinesforchildren.org.uk/ethambutol-for-
the-treatment-of-tuberculosislMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug. Forms available from special-order
manufacturers include: oral suspension, oral solution
Tablet
CAUTIONARY AND ADVISORY LABELS 8
▶Ethambutol hydrochloride (Non-proprietary)
Ethambutol hydrochloride 100 mgEthambutol 100 mg tablets|
56 tabletP£ 12. 00 DT = £ 11. 51
Ethambutol hydrochloride 400 mgEthambutol 400 mg tablets|
56 tabletP£ 42. 74 DT = £ 42. 74Isoniazid
lINDICATIONS AND DOSE
Tuberculosis, in combination with other drugs (standard
unsupervised 6 -month treatment)
▶BY MOUTH, OR BY INTRAMUSCULAR INJECTION, OR BY
INTRAVENOUS INJECTION
▶Child: 10 mg/kg once daily (max. per dose 300 mg) for
6 months (initial and continuation phases)
Tuberculosis, in combination with other drugs
(intermittent supervised 6 -month treatment) (under
expert supervision)
▶BY MOUTH, OR BY INTRAMUSCULAR INJECTION, OR BY
INTRAVENOUS INJECTION
▶Child: 15 mg/kg 3 times a week (max. per dose 900 mg)
for 6 months (initial and continuation phases)
Congenital tuberculosis, in combination with other drugs
▶BY MOUTH, OR BY INTRAMUSCULAR INJECTION, OR BY
INTRAVENOUS INJECTION
▶Neonate: 10 mg/kg daily for 6 months (initial and
continuation phases).Prevention of tuberculosis in susceptible close contacts or
those who have become tuberculin positive
▶INITIALLYBYMOUTH,ORBYINTRAMUSCULARINJECTION,OR
BY INTRAVENOUS INJECTION
▶Neonate: 10 mg/kg daily for 6 months.▶Child 1 month–11 years: 10 mg/kg daily (max. per dose
300 mg) for 6 months, alternatively (by mouth)
10 mg/kg daily (max. per dose 300 mg) for 3 months, to
be taken in combination with rifampicin
▶Child 12–17 years: 300 mg daily for 6 months,
alternatively (by mouth) 300 mg daily for 3 months, to
be taken in combination with rifampicinlCONTRA-INDICATIONSDrug-induced liver disease
lCAUTIONSAcute porphyrias p. 603 .alcohol dependence.
diabetes mellitus.epilepsy.history of psychosis.HIV
infection.malnutrition.slow acetylator status (increased
risk of side-effects)BNFC 2018 – 2019 Tuberculosis 367
Infection5