lPRESCRIBING AND DISPENSING INFORMATIONTheFaculty
of Pain Medicinehas produced resources for healthcare
professionals around opioid prescribing:www.fpm.ac.uk/
faculty-of-pain-medicine/opioids-aware
lPATIENT AND CARER ADVICE
Driving and skilled tasksDrowsiness may affect
performance of skilled tasks (e.g. driving); effects of
alcohol enhanced. Driving at the start of therapy with
opioid analgesics, and following dose changes, should be
avoided.
For information on 2015 legislation regarding driving
whilst taking certain controlled drugs, including opioids,
seeDrugs and drivingunder Guidance on prescribing p. 1.eiiiiF 273Buprenorphine 19-Oct-2017
lDRUG ACTIONBuprenorphine is an opioid-receptor partial
agonist (it has opioid agonist and antagonist properties).lINDICATIONS AND DOSE
Moderate to severe pain
▶BY SUBLINGUAL ADMINISTRATION
▶Child (body-weight 16–25 kg): 100 micrograms every
6 – 8 hours
▶Child (body-weight 25–37.5 kg): 100 – 200 micrograms
every 6 – 8 hours
▶Child (body-weight 37.5–50 kg): 200 – 300 micrograms
every 6 – 8 hours
▶Child (body-weight 50 kg and
above): 200 – 400 micrograms every 6 – 8 hours
▶BY INTRAMUSCULAR INJECTION, OR BY SLOW INTRAVENOUS
INJECTION
▶Child 6 months–11 years: 3 – 6 micrograms/kg every
6 – 8 hours (max. per dose 9 micrograms/kg)
▶Child 12–17 years: 300 – 600 micrograms every 6 – 8 hourslUNLICENSED USESublingual tablets not licensed for use in
children under 6 years. Injection not licensed for use in
children under 6 months.
lCAUTIONSImpaired consciousness
lINTERACTIONS→Appendix 1 : opioids
lSIDE-EFFECTS
▶Common or very common
▶With sublingual useFatigue.postural hypotension.sleep
disorders
▶Uncommon
▶With sublingual useAnxiety.apnoea.appetite decreased.
atrioventricular block.coma.conjunctivitis.coordination
abnormal.cyanosis.depersonalisation.depression.
diarrhoea.diplopia.disorientation.dyspepsia.dyspnoea.
hypertension.pallor.paraesthesia.psychosis.seizure.
speech slurred.tinnitus.tremor.urinary disorder
▶Rare or very rare
▶With sublingual useAngioedema.bronchospasm
▶Frequency not known
▶With parenteral useAngioedema.bronchospasm.hepatic
disorders.psychotic disorder.vision blurred
▶With sublingual useCerebrospinalfluid pressure increased.
circulation impaired.haemorrhagic diathesis.hepatic
disorders.oral disorders.syncope
Overdose The effects of buprenorphine are only partially
reversed by naloxone.
lBREAST FEEDINGPresent in low levels in breast milk.
MonitoringNeonates should be monitored for drowsiness,
adequate weight gain, and developmental milestones.
lRENAL IMPAIRMENTAvoid use or reduce dose; opioid
effects increased and prolonged; increased cerebral
sensitivity.lPRE-TREATMENT SCREENINGDocumentation of viral
hepatitis status is recommended before commencing
therapy for opioid dependence.
lMONITORING REQUIREMENTSMonitor liver function;
when used in opioid dependence baseline liver function
test is recommended before commencing therapy, and
regular liver function tests should be performed
throughout treatment.
lDIRECTIONS FOR ADMINISTRATIONSublingual tabletsmay
be halved.
lPATIENT AND CARER ADVICEPatients or carers should be
given advice on how to administer buprenorphine
products.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Solution for injection
▶Temgesic(Indivior UK Ltd)
Buprenorphine (as Buprenorphine hydrochloride)
300 microgram per 1 mlTemgesic 300 micrograms/ 1 ml solution for
injection ampoules| 5 ampouleP£ 2. 46 c
Sublingual tablet
CAUTIONARY AND ADVISORY LABELS2, 26
▶Buprenorphine (Non-proprietary)
Buprenorphine (as Buprenorphine hydrochloride)
200 microgramBuprenorphine 200 microgram sublingual tablets
sugar free sugar-free| 50 tabletP£ 5. 04 DT = £ 5. 04 c
Buprenorphine (as Buprenorphine hydrochloride)
400 microgramBuprenorphine 400 microgram sublingual tablets
sugar free sugar-free| 7 tabletP£ 1. 60 DT = £ 1. 60 csugar-
free| 50 tabletP£ 10. 07 DT = £ 10. 07 c
Buprenorphine (as Buprenorphine hydrochloride)
2mgBuprenorphine 2 mg sublingual tablets sugar free sugar-free|
7 tabletP£ 8. 35 DT = £ 0. 93 c
Buprenorphine (as Buprenorphine hydrochloride)
8mgBuprenorphine 8 mg sublingual tablets sugar free sugar-free|
7 tabletP£ 22. 50 DT = £ 1. 81 c
▶Natzon(Morningside Healthcare Ltd)
Buprenorphine (as Buprenorphine hydrochloride)
400 microgramNatzon 0. 4 mg sublingual tablets sugar-free|
7 tabletP£ 1. 60 DT = £ 1. 60 c
Buprenorphine (as Buprenorphine hydrochloride) 2 mgNatzon
2 mg sublingual tablets sugar-free| 7 tabletP£ 6. 35 DT =
£ 0. 93 c
Buprenorphine (as Buprenorphine hydrochloride) 8 mgNatzon
8 mg sublingual tablets sugar-free| 7 tabletP£ 19. 05 DT =
£ 1. 81 c
▶Prefibin(Sandoz Ltd)
Buprenorphine (as Buprenorphine hydrochloride)
400 microgramPrefibin 0. 4 mg sublingual tablets sugar-free|
7 tabletP£ 1. 60 DT = £ 1. 60 c
Buprenorphine (as Buprenorphine hydrochloride) 2 mgPrefibin
2 mg sublingual tablets sugar-free| 7 tabletP£ 5. 38 DT =
£ 0. 93 c
Buprenorphine (as Buprenorphine hydrochloride) 8 mgPrefibin
8 mg sublingual tablets sugar-free| 7 tabletP£ 16. 15 DT =
£ 1. 81 c
▶Subutex(Indivior UK Ltd)
Buprenorphine (as Buprenorphine hydrochloride)
400 microgramSubutex 0. 4 mg sublingual tablets sugar-free|
7 tabletP£ 1. 60 DT = £ 1. 60 c
Buprenorphine (as Buprenorphine hydrochloride) 2 mgSubutex
2 mg sublingual tablets sugar-free| 7 tabletP£ 6. 35 DT =
£ 0. 93 c
Buprenorphine (as Buprenorphine hydrochloride) 8 mgSubutex
8 mg sublingual tablets sugar-free| 7 tabletP£ 19. 05 DT =
£ 1. 81 c
▶Temgesic(Indivior UK Ltd)
Buprenorphine (as Buprenorphine hydrochloride)
200 microgramTemgesic 200 microgram sublingual tablets sugar-
free| 50 tabletP£ 5. 04 DT = £ 5. 04 c
Buprenorphine (as Buprenorphine hydrochloride)
400 microgramTemgesic 400 microgram sublingual tablets sugar-
free| 50 tabletP£ 10. 07 DT = £ 10. 07 c274 Pain BNFC 2018 – 2019
Nervous system4