ANTIMYCOBACTERIALS›RIFAMYCINS
Rifabutin
lINDICATIONS AND DOSE
Prophylaxis ofMycobacterium aviumcomplex infections
in immunosuppressed patients with low CD 4 count
▶BY MOUTH
▶Child 1 month–11 years: 5 mg/kg once daily (max. per
dose 300 mg), also consult product literature
▶Child 12–17 years: 300 mg once daily, also consult
product literature
Treatment of non-tuberculous mycobacterial disease, in
combination with other drugs
▶BY MOUTH
▶Child 1 month–11 years: 5 mg/kg once daily for up to
6 months after cultures negative
▶Child 12–17 years: 450 – 600 mg once daily for up to
6 months after cultures negative
Treatment of pulmonary tuberculosis, in combination
with other drugs
▶BY MOUTH
▶Child 12–17 years: 150 – 450 mg once daily for at least
6 monthslUNLICENSED USENot licensed for use in children.
lCAUTIONSAcute porphyrias p. 603 .discolours soft
contact lenses
lINTERACTIONS→Appendix 1 : rifabutin
lSIDE-EFFECTSAgranulocytosis.anaemia.arthralgia.
bronchospasm.chest pain.corneal deposits.decreased
leucocytes.dyspnoea.eosinophilia.fever.haemolysis.
hepatic disorders.influenza like illness.myalgia.nausea.
neutropenia.pancytopenia.skin reactions.
thrombocytopenia.urine discolouration.uveitis (more
common following high doses or concomitant use with
drugs that increase plasma concentration).vomiting
lALLERGY AND CROSS-SENSITIVITYContra-indicated in
patients with rifamycin hypersensitivity.
lCONCEPTION AND CONTRACEPTION
ImportantRifabutin induces hepatic enzymes and the
effectiveness of hormonal contraceptives is reduced;
alternative family planning advice should be offered.
lPREGNANCYManufacturer advises avoid—no information
available.
lBREAST FEEDINGManufacturer advises avoid—no
information available.
lHEPATIC IMPAIRMENT
Dose adjustmentsReduce dose in severe impairment.
MonitoringIn patients with pre-existing liver disease or
hepatic impairment monitor liver function regularly and
particularly frequently in thefirst 2 months; blood counts
should also be monitored in these patients.
lRENAL IMPAIRMENT
Dose adjustmentsUse half normal dose if estimated
glomerularfiltration rate less than 30 mL/minute/ 1. 73 m^2.
lMONITORING REQUIREMENTS
▶Renal functionshould be checked before treatment.
▶Hepatic functionshould be checked before treatment. If
there is no evidence of liver disease (and pre-treatment
liver function is normal), further checks are only necessary
if the patient develops fever, malaise, vomiting, jaundice
or unexplained deterioration during treatment. However,
hepatic function should be monitored on prolonged
therapy.
▶Blood counts should be monitored on prolonged therapy.
lPRESCRIBING AND DISPENSING INFORMATIONIf treatment
interruption occurs, re-introduce with low dosage and
increase gradually.lPATIENT AND CARER ADVICE
Soft contact lensesPatients or their carers should be advised
that rifabutin discolours soft contact lenses.
Hepatic disordersPatients or their carers should be told how
to recognise signs of liver disorder, and advised to
discontinue treatment and seek immediate medical
attention if symptoms such as persistent nausea,
vomiting, malaise or jaundice develop.lMEDICINAL 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
Capsule
CAUTIONARY AND ADVISORY LABELS8, 14
▶Mycobutin(Pfizer Ltd)
Rifabutin 150 mgMycobutin 150 mg capsules| 30 capsuleP
£ 90. 38Rifampicin
lINDICATIONS AND DOSE
Brucellosis in combination with other antibacterials|
Legionnaires disease in combination with other
antibacterials|Serious staphylococcal infections in
combination with other antibacterials
▶BY MOUTH, OR BY INTRAVENOUS INFUSION
▶Neonate: 5 – 10 mg/kg twice daily.▶Child 1–11 months: 5 – 10 mg/kg twice daily
▶Child 1–17 years: 10 mg/kg twice daily (max. per dose
600 mg)
Tuberculosis, in combination with other drugs
(intermittent supervised 6 -month treatment) (under
expert supervision)
▶BY MOUTH
▶Child: 15 mg/kg 3 times a week (max. per dose 900 mg)
for 6 months (initial and continuation phases)
Tuberculosis, in combination with other drugs (standard
unsupervised 6 -month treatment)
▶BY MOUTH
▶Child (body-weight up to 50 kg): 15 mg/kg once daily for
6 months (initial and continuation phases); maximum
450 mg per day
▶Child (body-weight 50 kg and above): 15 mg/kg once daily
for 6 months (initial and continuation phases);
maximum 600 mg per day
Congenital tuberculosis
▶BY MOUTH
▶Neonate: 15 mg/kg once daily for 6 months (initial and
continuation phases).Prevention of tuberculosis in susceptible close contacts or
those who have become tuberculin positive, in
combination with isoniazid
▶BY MOUTH
▶Child 1 month–11 years (body-weight up to
50 kg): 15 mg/kg daily for 3 months; maximum 450 mg
per day
▶Child 1 month–11 years (body-weight 50 kg and
above): 15 mg/kg daily for 3 months; maximum 600 mg
per day
▶Child 12–17 years (body-weight up to 50 kg): 450 mg daily
for 3 months
▶Child 12–17 years (body-weight 50 kg and above): 600 mg
daily for 3 months364 Bacterial infection BNFC 2018 – 2019
Infection5