▶ Child 6–23 months: 120 mg every 4–6 hours; maximum
▶ Child 2–3 years: 180 mg every 4–6 hours; maximum
▶ Child 4–5 years: 240 mg every 4–6 hours; maximum
▶ Child 6–7 years: 240–250 mg every 4–6 hours;
▶ Child 8–9 years: 360–375 mg every 4–6 hours;
▶ Child 10–11 years: 480–500 mg every 4–6 hours;
▶ Child 12–15 years: 480–750 mg every 4–6 hours;
▶ Child 16–17 years: 0.5–1 g every 4–6 hours; maximum
▶ Child 3–11 months: 60–125 mg every 4–6 hours as
required; maximum 4 doses per day
▶ Child 1–4 years: 125–250 mg every 4–6 hours as
required; maximum 4 doses per day
▶ Child 5–11 years: 250–500 mg every 4–6 hours as
required; maximum 4 doses per day
▶ Child 12–17 years: 500 mg every 4–6 hours
Post-immunisation pyrexia in infants
▶ Child 2–3 months: 60 mg for 1 dose, then 60 mg after
▶ Child 4 months: 60 mg for 1 dose, then 60 mg after
4–6 hours; maximum 4 doses per day
▶ Adult: 1 g for 1 dose, to be taken as soon as migraine
▶ In children Paracetamol oral suspension 500 mg/5 mL not
licensed for use in children under 16 years.g Not
licensed for use as prophylaxis of post-immunisation
pyrexia following immunisation with meningococcal
l CAUTIONS Before administering, check when paracetamol
last administered and cumulative paracetamol dose over
previous 24 hours . body-weight under 50 kg . chronic
alcohol consumption . chronic dehydration . chronic
malnutrition . hepatocellular insufficiency . long-term use
(especially in those who are malnourished)
CAUTIONS, FURTHER INFORMATION g Some patients
may be at increased risk of experiencing toxicity at
therapeutic doses, particularly those with a body-weight
under 50 kg and those with risk factors for hepatotoxicity.
Clinical judgement should be used to adjust the dose of
oral and intravenous paracetamol in these patients.
Co-administration of enzyme-inducing antiepileptic
medications may increase toxicity; doses should be
l INTERACTIONS → Appendix 1: paracetamol
▶ Rare or very rare Thrombocytopenia
▶ With rectal use Anorectal erythema
▶ With intravenous use Hypersensitivity . hypotension . leucopenia . malaise . neutropenia
▶ With rectal use Angioedema . liver injury . skin reactions
▶ With intravenous use Flushing . skin reactions .tachycardia
▶ With oral use Agranulocytosis . bronchospasm . hepatic
function abnormal .rash . severe cutaneous adverse
▶ With rectal use Agranulocytosis . blood disorder. severe
cutaneous adverse reactions (SCARs)
Overdose Liver damage and less frequently renal damage
Nausea and vomiting, the only early features of
poisoning, usually settle within 24 hours. Persistence
beyond this time, often associated with the onset of right
subcostal pain and tenderness, usually indicates
development of hepatic necrosis.
For specific details on the management of poisoning, see
Paracetamol, under Emergency treatment of poisoning
l PREGNANCY Not known to be harmful.
l BREAST FEEDING Amount too small to be harmful.
l HEPATIC IMPAIRMENT Dose-related toxicity—avoid large
Dose adjustments ▶ In adults Increase infusion dose
interval to every 6 hours if eGFR less than
▶ In children Increase infusion dose interval to every
6 hours if estimated glomerular filtration rate less than
l DIRECTIONS FOR ADMINISTRATION
▶ With intravenous use For intravenous infusion (Perfalgan ®),
give in Glucose 5% or Sodium Chloride 0.9%; dilute to a
concentration of not less than 1 mg/mL and use within an
hour; may also be given undiluted. For children under
l PRESCRIBING AND DISPENSING INFORMATION BP directs
that when Paediatric Paracetamol Oral Suspension or
Paediatric Paracetamol Mixture is prescribed Paracetamol
Oral Suspension 120 mg/5 mL should be dispensed.
Medicines for Children leaflet: Paracetamol for mild-to-moderate
pain www.medicinesforchildren.org.uk/paracetamol-mildmoderate-pain
l PROFESSION SPECIFIC INFORMATION
Dental practitioners’ formulary
Paracetamol Tablets may be prescribed.
Paracetamol Soluble Tablets 500 mg may be prescribed.
Paracetamol Oral Suspension may be prescribed.
l EXCEPTIONS TO LEGAL CATEGORY Paracetamol capsules or
tablets can be sold to the public provided packs contain no
more than 32 capsules or tablets; pharmacists can sell
multiple packs up to a total quantity of 100 capsules or
tablets in justifiable circumstances.
l MEDICINAL 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
CAUTIONARY AND ADVISORY LABELS 29, 30
▶ Paracetamol (Non-proprietary)
Paracetamol 500 mg Paracetamol 500mg caplets | 100 tablet
Paracetamol 500mg tablets | 100 tablet P £2.13 DT = £1.81 | 1000 tablet P £15.94–£18.10
Paracetamol 1 gram Paracetamol 1g tablets | 100 tablet P £2.49
Paracetamol 500 mg Mandanol 500mg caplets | 100 tablet P £1.17 DT = £1.81
Mandanol 500mg tablets | 100 tablet P £1.17 DT = £1.81
▶ Paravict (Ecogen Europe Ltd)
Paracetamol 500 mg Paravict 500mg tablets | 100 tablet P £1.62 DT = £1.81
CAUTIONARY AND ADVISORY LABELS 30
▶ Paracetamol (Non-proprietary)
Paracetamol 80 mg Paracetamol 80mg suppositories | 10 suppository p £10.00
Paracetamol 120 mg Paracetamol 120mg suppositories | 10 suppository p £12.39 DT = £12.39
Paracetamol 125 mg Paracetamol 125mg suppositories |
10 suppository p £15.00 DT = £13.80
Paracetamol 240 mg Paracetamol 240mg suppositories | 10 suppository p £22.01 DT = £22.01
Paracetamol 250 mg Paracetamol 250mg suppositories | 10 suppository p £27.60 DT = £27.60
Paracetamol 500 mg Paracetamol 500mg suppositories | 10 suppository p £36.50 DT = £36.50
Paracetamol 1 gram Paracetamol 1g suppositories | 10 suppository p £60.00 DT = £59.50
▶ Alvedon (Intrapharm Laboratories Ltd)
Paracetamol 60 mg Alvedon 60mg suppositories |
10 suppository p £11.95 DT = £11.95
Paracetamol 125 mg Alvedon 125mg suppositories | 10 suppository p £13.80 DT = £13.80
Paracetamol 250 mg Alvedon 250mg suppositories | 10 suppository p £27.60 DT = £27.60
CAUTIONARY AND ADVISORY LABELS 30
▶ Paracetamol (Non-proprietary)
Paracetamol 24 mg per 1 ml Paracetamol 120mg/5ml oral
suspension paediatric | 100 ml p £1.23–£1.50 | 500 ml p £5.75–
sugar-free | 500 ml p £5.95 sugar-free | 1000 ml p £11.90
Paracetamol 50 mg per 1 ml Paracetamol 250mg/5ml oral
suspension | 100 ml p £1.40–£1.75 DT = £1.75 | 500 ml p £7.00–
sugar-free | 500 ml p £5.83–£5.85 sugar-free | 1000 ml p £11.65
Paracetamol 100 mg per 1 ml Paracetamol 500mg/5ml oral
suspension sugar free sugar-free | 150 ml P £24.00 DT = £24.00
▶ Calpol (McNeil Products Ltd)
Paracetamol 24 mg per 1 ml Calpol Infant 120mg/5ml oral
Calpol Infant 120mg/5ml oral suspension sugar free sugar-free | 200 ml p £3.78
Paracetamol 50 mg per 1 ml Calpol Six Plus 250mg/5ml oral
Calpol Six Plus 250mg/5ml oral suspension sugar free sugar-free |
100 ml p £2.64 sugar-free | 200 ml p £4.40 DT = £2.34
CAUTIONARY AND ADVISORY LABELS 29, 30
▶ Paracetamol (Non-proprietary)
Paracetamol 500 mg Paracetamol 500mg soluble tablets | 100 tablet P s DT = £6.79
▶ Altridexamol (TriOn Pharma Ltd)
Paracetamol 1 gram Altridexamol 1000mg effervescent tablets
sugar-free | 50 tablet P £6.59
▶ Paracetamol (Non-proprietary)
Paracetamol 10 mg per 1 ml Paracetamol 500mg/50ml solution for
infusion bottles | 10 bottle P £11.00 (Hospital only)
Paracetamol 500mg/50ml solution for infusion vials | 10 vial P £14.40
Paracetamol 1g/100ml solution for infusion bottles | 10 bottle P s
Paracetamol 100mg/10ml solution for infusion ampoules | 20 ampoule P £12.00
▶ Perfalgan (Bristol-Myers Squibb Pharmaceuticals Ltd)
Paracetamol 10 mg per 1 ml Perfalgan 1g/100ml solution for
infusion vials | 12 vial P £14.96
Perfalgan 500mg/50ml solution for infusion vials | 12 vial P £13.60
CAUTIONARY AND ADVISORY LABELS 30
▶ Paracetamol (Non-proprietary)
Paracetamol 24 mg per 1 ml Paracetamol 120mg/5ml oral solution
paediatric sugar free sugar-free | 2000 ml p £23.80 DT = £23.80
Paracetamol 100 mg per 1 ml Paracetamol 500mg/5ml oral
solution sugar free sugar-free | 150 ml P £24.00 sugar-free | 200 ml P £18.00 DT = £18.00
▶ Paracetamol (Non-proprietary)
Paracetamol 650 mg Paracetamol 650mg oral powder sachets | 10 sachet G s
CAUTIONARY AND ADVISORY LABELS 29, 30
▶ Paracetamol (Non-proprietary)
Paracetamol 500 mg Paracetamol 500mg capsules | 32 capsule p
£0.68–£1.23 DT = £0.98 | 100 capsule P £3.06 DT = £3.06
CAUTIONARY AND ADVISORY LABELS 30
▶ Calpol Fastmelts (McNeil Products Ltd)
Paracetamol 250 mg Calpol Six Plus Fastmelts 250mg tablets sugarfree | 24 tablet p £4.12 DT = £4.12
Combinations available: Co-codamol, p. 453 . Dihydrocodeine
ANALGESICS › NON-OPIOID, CENTRALLY ACTING
▶ Adult: Initially 60 mg 3 times a day, adjusted according
to response; usual dose 30–90 mg 3 times a day
▶ Elderly: Initially 30 mg 3 times a day, adjusted
according to response; usual dose 30–90 mg 3 times a
l CONTRA-INDICATIONS Convulsive disorders . not indicated
l CAUTIONS Elderly . urinary retention
l INTERACTIONS → Appendix 1: nefopam
l PREGNANCY No information available—avoid unless no
l HEPATIC IMPAIRMENT Manufacturer advises caution.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: oral suspension
CAUTIONARY AND ADVISORY LABELS 2, 14
▶ Nefopam hydrochloride (Non-proprietary)
Nefopam hydrochloride 30 mg Nefopam 30mg tablets | 90 tablet P £68.39 DT = £7.77
ANALGESICS › NON-STEROIDAL ANTIINFLAMMATORY DRUGS
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, aspirin p. 121, codeine phosphate p. 454.
Mild to moderate pain | Pyrexia
▶ Adult: 1–2 tablets every 4–6 hours as required, dose to
be dispersed in water; maximum 8 tablets per day
l INTERACTIONS → Appendix 1: aspirin . opioids
no strength is stated, tablets or dispersible tablets,
respectively, containing codeine phosphate 8 mg and
aspirin 400 mg should be dispensed.
l LESS SUITABLE FOR PRESCRIBING Aspirin with codeine is
less suitable for prescribing.
l EXCEPTIONS TO LEGAL CATEGORY Aspirin with codeine can
be sold to the public provided packs contain no more than
32 capsules or tablets; pharmacists can sell multiple packs
up to a total quantity of 100 capsules or tablets in
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 13, 21, 32
▶ Aspirin with codeine (Non-proprietary)
Codeine phosphate 8 mg, Aspirin 400 mg Co-codaprin
8mg/400mg dispersible tablets | 100 tablet P £97.55 DT =
£93.41m ▶ Codis (Reckitt Benckiser Healthcare (UK) Ltd)
Codeine phosphate 8 mg, Aspirin 500 mg Codis 500 dispersible
tablets sugar-free | 32 tablet p £3.23m
▶ Aspirin with codeine (Non-proprietary)
Codeine phosphate 8 mg, Aspirin 400 mg Aspirin and Codeine
with pupillary responses vital for neurological assessment)
.raised intracranial pressure (opioid analgesics interfere
with pupillary responses vital for neurological assessment)
l CAUTIONS Adrenocortical insufficiency (reduced dose is
respiratory function (avoid in chronic obstructive
hypertrophy (in adults). shock . urethral stenosis (in
▶ Dependence Repeated use of opioid analgesics is associated
with the development of psychological and physical
dependence; although this is rarely a problem with
therapeutic use, caution is advised if prescribing for
patients with a history of drug dependence.
▶ Palliative care In the control of pain in terminal illness, the
cautions listed should not necessarily be a deterrent to the
common on initiation). palpitations .respiratory
depression (with high doses) . skin reactions . urinary
retention . vertigo . visual impairment. vomiting (more
common on initiation). withdrawal syndrome (in adults)
▶ Uncommon Drug dependence . dysphoria
SIDE-EFFECTS, FURTHER INFORMATION Respiratory
depression Respiratory depression is a major concern
with opioid analgesics and it may be treated by artificial
ventilation or be reversed by naloxone.
Dependence and withdrawal Psychological
dependence rarely occurs when opioids are used
therapeutically (e.g. for pain relief), but tolerance can
develop during long-term treatment.
Overdose Opioids (narcotic analgesics) cause coma,
respiratory depression, and pinpoint pupils. For details on
the management of poisoning, see Opioids, under
Emergency treatment of poisoning p. 1359 and consider
the specific antidote, naloxone hydrochloride.
l PREGNANCY Respiratory depression and withdrawal
symptoms can occur in the neonate if opioid analgesics are
used during delivery; also gastric stasis and inhalation
pneumonia has been reported in the mother if opioid
analgesics are used during labour.
l TREATMENT CESSATION Avoid abrupt withdrawal after
long-term treatment; they should be withdrawn gradually
l PRESCRIBING AND DISPENSING INFORMATION The Faculty
of Pain Medicine has produced resources for healthcare
professionals around opioid prescribing: www.fpm.ac.uk/
faculty-of-pain-medicine/opioids-aware
Driving and skilled tasks Drowsiness 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
For information on 2015 legislation regarding driving
whilst taking certain controlled drugs, including opioids,
see Drugs and driving under Guidance on prescribing p. 1.
l DRUG ACTION Buprenorphine is an opioid-receptor partial
agonist (it has opioid agonist and antagonist properties).
▶ BY SUBLINGUAL ADMINISTRATION
▶ Child (body-weight 16–25 kg): 100 micrograms every
▶ Child (body-weight 25–37.5 kg): 100–200 micrograms
▶ Child (body-weight 37.5–50 kg): 200–300 micrograms
▶ Child (body-weight 50 kg and above):
200–400 micrograms every 6–8 hours
▶ Adult: 200–400 micrograms every 6–8 hours
▶ BY INTRAMUSCULAR INJECTION, OR BY SLOW INTRAVENOUS
▶ Child 6 months–11 years: 3–6 micrograms/kg every
6–8 hours (max. per dose 9 micrograms/kg) continued→
▶ Child 12–17 years: 300–600 micrograms every 6–8 hours
▶ Adult: 300–600 micrograms every 6–8 hours
▶ BY SUBLINGUAL ADMINISTRATION
▶ BY SLOW INTRAVENOUS INJECTION
Adjunct in the treatment of opioid dependence
▶ BY SUBLINGUAL ADMINISTRATION USING SUBLINGUAL TABLETS
▶ Adult: Initially 0.8–4 mg for 1 dose on the first day,
adjusted in steps of 2–4 mg daily if required; usual dose
12–24 mg daily; maximum 32 mg per day
▶ BY MOUTH USING ORAL LYOPHILISATE
▶ Adult: Initially 2 mg daily, followed by 2–4 mg if
required on day one, adjusted in steps of 2–6 mg daily
if required, for adjustment of dosing interval following
stabilisation, consult product literature; maximum
DOSE EQUIVALENCE AND CONVERSION
▶ For opioid substitution therapy, in patients taking
methadone who want to switch to buprenorphine, the
dose of methadone should be reduced to a maximum of
30 mg daily before starting buprenorphine treatment—
consult product literature. For sublingual tablets, if the
dose of methadone is over 10 mg daily, buprenorphine
can be started at a dose of 4 mg daily and titrated
according to requirements; if the methadone dose is
below 10 mg daily, buprenorphine can be started at a
Moderate, non-malignant pain unresponsive to non-opioid
▶ BY TRANSDERMAL APPLICATION USING PATCHES
▶ Adult: Initially 5 micrograms/hour up to every 7 days,
dose adjustments—when starting, analgesic effect
should not be evaluated until the system has been
worn for 72 hours (to allow for gradual increase in
plasma-buprenorphine concentration)—if necessary,
dose should be adjusted at intervals of at least 3 days
using a patch of the next strength or a combination of
2 patches applied in different places (applied at same
time to avoid confusion). Maximum 2 patches can be
Moderate to severe chronic cancer pain in patients who
have not previously received strong opioid analgesic |
Severe pain unresponsive to non-opioid analgesics in
patients who have not previously received strong opioid
▶ BY TRANSDERMAL APPLICATION USING PATCHES
▶ Adult: Initially 35 micrograms/hour up to every
96 hours, dose adjustment—when starting, analgesic
effect should not be evaluated until the system has
been worn for 24 hours (to allow for gradual increase in
plasma-buprenorphine concentration)—if necessary,
dose should be adjusted at intervals of no longer than
96 hours using a patch of the next strength or using
2 patches of the same strength (applied at same time to
avoid confusion). Maximum 2 patches can be used at
Moderate to severe chronic cancer pain in patients who
have previously received strong opioid analgesic | Severe
pain unresponsive to non-opioid analgesics in patients
who have previously received strong opioid analgesic
▶ BY TRANSDERMAL APPLICATION USING PATCHES
▶ Adult: The initial dose should be based on previous
24-hour opioid requirement, consult product
literature, dose adjustment—when starting, analgesic
effect should not be evaluated until the system has
been worn for 24 hours (to allow for gradual increase in
plasma-buprenorphine concentration)—if necessary,
dose should be adjusted at intervals of no longer than
96 hours using a patch of the next strength or using
2 patches of the same strength (applied at same time to
avoid confusion). Maximum 2 patches can be used at
▶ For Bupeaze ®: It may take approximately 30 hours for
the plasma-buprenorphine concentration to decrease
by 50% after patch is removed.
Moderate to severe chronic cancer pain in patients who
have not previously received strong opioid analgesic |
Severe pain unresponsive to non-opioid analgesics in
patients who have not previously received strong opioid
▶ BY TRANSDERMAL APPLICATION USING PATCHES
▶ Adult: Initially 35 micrograms/hour up to every
96 hours, dose adjustment—when starting, analgesic
effect should not be evaluated until the system has
been worn for 24 hours (to allow for gradual increase in
plasma-buprenorphine concentration)—if necessary,
dose should be adjusted at intervals of no longer than
96 hours using a patch of the next strength or using
2 patches of the same strength (applied at same time to
avoid confusion). Maximum 2 patches can be used at
Moderate to severe chronic cancer pain in patients who
have previously received strong opioid analgesic | Severe
pain unresponsive to non-opioid analgesics in patients
who have previously received strong opioid analgesic
▶ BY TRANSDERMAL APPLICATION USING PATCHES
▶ Adult: The initial dose should be based on previous
24-hour opioid requirement, consult product
literature, dose adjustment—when starting, analgesic
effect should not be evaluated until the system has
been worn for 24 hours (to allow for gradual increase in
plasma-buprenorphine concentration)—if necessary,
dose should be adjusted at intervals of no longer than
96 hours using a patch of the next strength or using
2 patches of the same strength (applied at same time to
avoid confusion). Maximum 2 patches can be used at
▶ For Buplast ®: It may take approximately 30 hours for the
plasma-buprenorphine concentration to decrease by
Moderate, non-malignant pain unresponsive to non-opioid
▶ BY TRANSDERMAL APPLICATION USING PATCHES
▶ Adult: Initially 5 micrograms/hour up to every 7 days,
dose adjustments—when starting, analgesic effect
should not be evaluated until the system has been
worn for 72 hours (to allow for gradual increase in
plasma-buprenorphine concentration)—if necessary,
dose should be adjusted at intervals of at least 3 days
using a patch of the next strength or a combination of
2 patches applied in different places (applied at same
time to avoid confusion). Maximum 2 patches can be
▶ For Bupramyl ®: It may take approximately 12 hours for
the plasma-buprenorphine concentration to decrease
by 50% after patch is removed.
Moderate, non-malignant pain unresponsive to non-opioid
▶ BY TRANSDERMAL APPLICATION USING PATCHES
▶ Adult: Initially 5 micrograms/hour up to every 7 days,
dose adjustments—when starting, analgesic effect
should not be evaluated until the system has been
worn for 72 hours (to allow for gradual increase in
plasma-buprenorphine concentration)—if necessary,
dose should be adjusted at intervals of at least 3 days
using a patch of the next strength or a combination of
2 patches applied in different places (applied at same
time to avoid confusion). Maximum 2 patches can be
▶ For Butec ®: It may take approximately 12 hours for the
plasma-buprenorphine concentration to decrease by
Adjunct in the treatment of opioid dependence
▶ Adult: (consult product literature)
▶ Weekly Buvidal ® has a terminal half-life ranging from
▶ Monthly Buvidal ® has a terminal half-life ranging from
Moderate to severe chronic cancer pain in patients who
have not previously received strong opioid analgesic |
Severe pain unresponsive to non-opioid analgesics in
patients who have not previously received strong opioid
▶ BY TRANSDERMAL APPLICATION USING PATCHES
▶ Adult: Initially 35 micrograms/hour up to every
72 hours, dose adjustment—when starting, analgesic
effect should not be evaluated until the system has
been worn for 24 hours (to allow for gradual increase in
plasma-buprenorphine concentration)—if necessary,
dose should be adjusted at intervals of no longer than
72 hours using a patch of the next strength or using
2 patches of the same strength (applied at same time to
avoid confusion). Maximum 2 patches can be used at
any one time, for breakthrough pain, consider
200–400 micrograms buprenorphine sublingually
Moderate to severe chronic cancer pain in patients who
have previously received strong opioid analgesic | Severe
pain unresponsive to non-opioid analgesics in patients
who have previously received strong opioid analgesic
▶ BY TRANSDERMAL APPLICATION USING PATCHES
▶ Adult: The initial dose should be based on previous
24-hour opioid requirement, consult product
literature, dose adjustment—when starting, analgesic
effect should not be evaluated until the system has
been worn for 24 hours (to allow for gradual increase in
plasma-buprenorphine concentration)—if necessary,
dose should be adjusted at intervals of no longer than
72 hours using a patch of the next strength or using
2 patches of the same strength (applied at same time to
avoid confusion). Maximum 2 patches can be used at
any one time, for breakthrough pain, consider
200–400 micrograms buprenorphine sublingually
▶ For Hapoctasin ®: It may take approximately 25 hours for
the plasma-buprenorphine concentration to decrease
by 50% after patch is removed.
Moderate, non-malignant pain unresponsive to non-opioid
▶ BY TRANSDERMAL APPLICATION USING PATCHES
▶ Adult: Initially 5 micrograms/hour up to every 7 days,
dose adjustments—when starting, analgesic effect
should not be evaluated until the system has been
worn for 72 hours (to allow for gradual increase in
plasma-buprenorphine concentration)—if necessary,
dose should be adjusted at intervals of at least 3 days
using a patch of the next strength or a combination of
2 patches applied in different places (applied at same
time to avoid confusion). Maximum 2 patches can be
▶ For Panitaz ®: It may take approximately 12 hours for the
plasma-buprenorphine concentration to decrease by
Moderate to severe chronic cancer pain in patients who
have not previously received strong opioid analgesic |
Severe pain unresponsive to non-opioid analgesics in
patients who have not previously received strong opioid
▶ BY TRANSDERMAL APPLICATION USING PATCHES
▶ Adult: Initially 35 micrograms/hour up to every
72 hours, dose adjustment—when starting, analgesic
effect should not be evaluated until the system has
been worn for 24 hours (to allow for gradual increase in
plasma-buprenorphine concentration)—if necessary,
dose should be adjusted at intervals of no longer than
72 hours using a patch of the next strength or using
2 patches of the same strength (applied at same time to
avoid confusion). Maximum 2 patches can be used at
Moderate to severe chronic cancer pain in patients who
have previously received strong opioid analgesic | Severe
pain unresponsive to non-opioid analgesics in patients
who have previously received strong opioid analgesic
▶ BY TRANSDERMAL APPLICATION USING PATCHES
▶ Adult: The initial dose should be based on previous
24-hour opioid requirement, consult product
literature, dose adjustment—when starting, analgesic
effect should not be evaluated until the system has
been worn for 24 hours (to allow for gradual increase in
plasma-buprenorphine concentration)—if necessary,
dose should be adjusted at intervals of no longer than
72 hours using a patch of the next strength or using
2 patches of the same strength (applied at same time to
avoid confusion). Maximum 2 patches can be used at
▶ For Prenotrix ®: It may take approximately 25 hours for
the plasma-buprenorphine concentration to decrease
by 50% after patch is removed.
Moderate, non-malignant pain unresponsive to non-opioid
▶ BY TRANSDERMAL APPLICATION USING PATCHES
▶ Adult: Initially 5 micrograms/hour up to every 7 days,
dose adjustments—when starting, analgesic effect
should not be evaluated until the system has been
worn for 72 hours (to allow for gradual increase in
plasma-buprenorphine concentration)—if necessary,
dose should be adjusted at intervals of at least 3 days
using a patch of the next strength or a combination of
2 patches applied in different places (applied at same
time to avoid confusion). Maximum 2 patches can be
used at any one time continued→
▶ For Reletrans ®: It may take approximately 12 hours for
the plasma-buprenorphine concentration to decrease
by 50% after patch is removed.
Moderate to severe chronic cancer pain in patients who
have not previously received strong opioid analgesic |
Severe pain unresponsive to non-opioid analgesics in
patients who have not previously received strong opioid
▶ BY TRANSDERMAL APPLICATION USING PATCHES
▶ Adult: Initially 35 micrograms/hour up to every
96 hours, dose adjustment—when starting, analgesic
effect should not be evaluated until the system has
been worn for 24 hours (to allow for gradual increase in
plasma-buprenorphine concentration)—if necessary,
dose should be adjusted at intervals of no longer than
96 hours using a patch of the next strength or using
2 patches of the same strength (applied at same time to
avoid confusion). Maximum 2 patches can be used at
Moderate to severe chronic cancer pain in patients who
have previously received strong opioid analgesic | Severe
pain unresponsive to non-opioid analgesics in patients
who have previously received strong opioid analgesic
▶ BY TRANSDERMAL APPLICATION USING PATCHES
▶ Adult: The initial dose should be based on previous
24-hour opioid requirement, consult product
literature, dose adjustment—when starting, analgesic
effect should not be evaluated until the system has
been worn for 24 hours (to allow for gradual increase in
plasma-buprenorphine concentration)—if necessary,
dose should be adjusted at intervals of no longer than
96 hours using a patch of the next strength or using
2 patches of the same strength (applied at same time to
avoid confusion). Maximum 2 patches can be used at
▶ For Relevtec ®: It may take approximately 30 hours for
the plasma-buprenorphine concentration to decrease
by 50% after patch is removed.
Moderate, non-malignant pain unresponsive to non-opioid
▶ BY TRANSDERMAL APPLICATION USING PATCHES
▶ Adult: Initially 5 micrograms/hour up to every 7 days,
dose adjustments—when starting, analgesic effect
should not be evaluated until the system has been
worn for 72 hours (to allow for gradual increase in
plasma-buprenorphine concentration)—if necessary,
dose should be adjusted at intervals of at least 3 days
using a patch of the next strength or a combination of
2 patches applied in different places (applied at same
time to avoid confusion). Maximum 2 patches can be
▶ For Sevodyne ®: It may take approximately 12 hours for
the plasma-buprenorphine concentration to decrease
by 50% after patch is removed.
Moderate to severe chronic cancer pain in patients who
have not previously received strong opioid analgesic |
Severe pain unresponsive to non-opioid analgesics in
patients who have not previously received strong opioid
▶ BY TRANSDERMAL APPLICATION USING PATCHES
▶ Adult: Initially 35 micrograms/hour up to every
96 hours, dose adjustment—when starting, analgesic
effect should not be evaluated until the system has
been worn for 24 hours (to allow for gradual increase in
plasma-buprenorphine concentration)—if necessary,
dose should be adjusted at intervals of no longer than
96 hours using a patch of the next strength or using
2 patches of the same strength (applied at same time to
avoid confusion). Maximum 2 patches can be used at
any one time, for breakthrough pain, consider
200–400 micrograms buprenorphine sublingually
Moderate to severe chronic cancer pain in patients who
have previously received strong opioid analgesic | Severe
pain unresponsive to non-opioid analgesics in patients
who have previously received strong opioid analgesic
▶ BY TRANSDERMAL APPLICATION USING PATCHES
▶ Adult: The initial dose should be based on previous
24-hour opioid requirement, consult product
literature, dose adjustment—when starting, analgesic
effect should not be evaluated until the system has
been worn for 24 hours (to allow for gradual increase in
plasma-buprenorphine concentration)—if necessary,
dose should be adjusted at intervals of no longer than
96 hours using a patch of the next strength or using
2 patches of the same strength (applied at same time to
avoid confusion). Maximum 2 patches can be used at
any one time, for breakthrough pain, consider
200–400 micrograms buprenorphine sublingually
▶ For Transtec ®: It may take approximately 30 hours for
the plasma-buprenorphine concentration to decrease
by 50% after patch is removed.
▶ With oral use in children Sublingual tablets not licensed for
use in children under 6 years.
▶ With transdermal use in adults
Do not confuse the formulations of transdermal patches
which are available as 72-hourly, 96-hourly and 7-day
patches, see Prescribing and dispensing information.
GENERAL CAUTIONS Impaired consciousness
▶ With transdermal use Fever or external heat. other opioids
should not be administered within 24 hours of patch
removal (long duration of action)
▶ When used for adjunct in the treatment of opioid
dependence Hepatitis B infection . hepatitis C infection . pre-existing liver enzyme abnormalities
▶ With transdermal use Manufacturer advises monitor patients
using patches for increased side-effects if fever present
(increased absorption possible); avoid exposing
application site to external heat (may also increase
BUVIDAL ® Susceptibility to QT-interval prolongation
l INTERACTIONS → Appendix 1: opioids
▶ Common or very common Anxiety (in adults). appetite
decreased (in adults). depression (in adults). diarrhoea (in
adults). dyspnoea (in adults). syncope (in adults).tremor
▶ With parenteral use Arthralgia (in adults). asthenia (in
adults). asthma (in adults). behaviour abnormal (in
adults). chest pain (in adults). chills (in adults). cough (in
adults). dysmenorrhoea (in adults). eye disorders (in
adults). fever (in adults). gastrointestinal discomfort (in
oedema (in adults). speech disorder (in adults).thinking
abnormal (in adults). vasodilation (in adults). withdrawal
syndrome neonatal . yawning (in adults)
▶ With sublingual use Fatigue . sleep disorders
▶ With parenteral use Procedural dizziness (in adults)
▶ With sublingual use Angioedema . bronchospasm
contractions involuntary . psychotic disorder. vasodilation
▶ With parenteral use Angioedema . bronchospasm . death (in
adults). hepatic disorders . hepatic encephalopathy (in
adults). psychotic disorder. vision blurred
▶ With transdermal use Biliary colic . depersonalisation. seizure . withdrawal syndrome neonatal
Overdose The effects of buprenorphine are only partially
l BREAST FEEDING Present in low levels in breast milk.
Monitoring Neonates should be monitored for drowsiness,
adequate weight gain, and developmental milestones.
l HEPATIC IMPAIRMENT Manufacturer advises caution; avoid
in severe impairment (limited information available).
For transdermal patch, manufacturer advises consider
avoiding in severe impairment.
Dose adjustments ▶ In adults For oral lyophilisate,
manufacturer advises initial dose reduction in mild to
l RENAL IMPAIRMENT Avoid use or reduce dose; opioid
effects increased and prolonged; increased cerebral
l PRE-TREATMENT SCREENING Documentation of viral
hepatitis status is recommended before commencing
therapy for opioid dependence.
l MONITORING REQUIREMENTS Monitor liver function;
when used in opioid dependence baseline liver function
test is recommended before commencing therapy, and
regular liver function tests should be performed
l DIRECTIONS FOR ADMINISTRATION
▶ In children Sublingual tablets may be halved.
▶ In adults Manufacturer advises oral lyophilisates should be
placed on the tongue and allowed to dissolve. Patients
should be advised not to swallow for 2 minutes and not to
consume food or drink for at least 5 minutes after
BUTRANS ® Apply patch to dry, non-irritated, non-hairy
skin on upper torso, removing after 7 days and siting
replacement patch on a different area (avoid same area for
PRENOTRIX ® Manufacturer advises apply patch to dry,
non-irritated, non-hairy skin on upper torso, removing
after no longer than 72 hours and siting replacement patch
on a different area (avoid same area for at least 7 days).
72 hours and siting replacement patch on a different area
(avoid same area for at least 7 days).
BUTEC ®, BUPRAMYL ®, PANITAZ ®, RELETRANS ®,
SEVODYNE ® Manufacturer advises apply patch to dry,
non-irritated, non-hairy skin on upper torso or upper
outer arm, removing after 7 days and siting replacement
patch on a different area (avoid same area for at least
TRANSTEC ® Apply patch to dry, non-irritated, non-hairy
skin on upper torso, removing after no longer than
96 hours and siting replacement patch on a different area
(avoid same area for at least 6 days).
BUPEAZE ®, BUPLAST ®, RELEVTEC ® Manufacturer advises
apply patch to dry, non-irritated, non-hairy skin on upper
torso, removing after no longer than 96 hours and siting
replacement patch on a different area (avoid same area for
l PRESCRIBING AND DISPENSING INFORMATION
Transdermal buprenorphine patches are not suitable for
acute pain or in those patients whose analgesic
requirements are changing rapidly because the long time
to steady state prevents rapid titration of the dose.
Transdermal patches are available as 72-hourly, 96-hourly
and 7-day formulations; prescribers and dispensers must
ensure that the correct preparation is prescribed and
dispensed. Preparations that should be applied up to every
72 hours include Hapoctasin ® and Prenotrix ®. Preparations
that should be applied up to every 96 hours include
Bupeaze ®, Buplast ®, Relevtec ®, and Transtec ®.
Preparations that should be applied up to every 7 days
include Bupramyl ®, Butec ®, BuTrans ®, Panitaz ®,
Reletrans ®, and Sevodyne ®. Espranor ® oral lyophilisate has
different bioavailability to other buprenorphine products
and is not interchangeable with them—consult product
literature before switching between products.
l PATIENT AND CARER ADVICE Patients or carers should be
given advice on how to administer buprenorphine
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Methadone and buprenorphine for the management of opioid
dependence (January 2007) NICE TA114
▶ In adults Oral methadone and buprenorphine are
recommended for maintenance therapy in the
management of opioid dependence. Patients should be
committed to a supportive care programme including a
flexible dosing regimen administered under supervision
for at least 3 months, until compliance is assured.
Selection of methadone or buprenorphine should be made
on a case-by-case basis, but methadone should be
prescribed if both drugs are equally suitable.
www.nice.org.uk/guidance/TA114
Scottish Medicines Consortium (SMC) decisions
▶ In adults The Scottish Medicines Consortium has advised
(June 2017) that buprenorphine oral lyophilisate
(Espranor ®) is accepted for restricted use within NHS
Scotland as substitution treatment for opioid dependence
for patients in whom methadone is not suitable. This
advice is contingent upon the continuing availability of
the patient access scheme in NHS Scotland or a list price
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (January
2017) that buprenorphine transdermal patches (Butec ®)
are accepted for restricted use within NHS Scotland for the
treatment of chronic non-malignant pain of moderate
intensity when an opioid is necessary for obtaining
adequate analgesia in elderly patients (over 65 years).
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Buprenorphine (as Buprenorphine hydrochloride)
300 microgram per 1 ml Temgesic 300micrograms/1ml solution for
injection ampoules | 5 ampoule P £2.46c
CAUTIONARY AND ADVISORY LABELS 2, 26
▶ Buprenorphine (Non-proprietary)
Buprenorphine (as Buprenorphine hydrochloride)
400 microgram Buprenorphine 400microgram sublingual tablets
sugar free sugar-free | 7 tablet P £1.60 DT = £1.36csugarfree | 50 tablet P £10.07 DT = £10.07c
Buprenorphine (as Buprenorphine hydrochloride)
2 mg Buprenorphine 2mg sublingual tablets sugar free sugar-free | 7 tablet P £8.35 DT = £6.44c
Buprenorphine (as Buprenorphine hydrochloride)
Buprenorphine (as Buprenorphine hydrochloride)
400 microgram Natzon 0.4mg sublingual tablets sugar-free | 7 tablet P £1.60 DT = £1.36c
Buprenorphine (as Buprenorphine hydrochloride) 2 mg Natzon
2mg sublingual tablets sugar-free | 7 tablet P £6.35 DT =
Buprenorphine (as Buprenorphine hydrochloride) 8 mg Natzon
8mg sublingual tablets sugar-free | 7 tablet P £19.05 DT =
£18.14c ▶ Prefibin (Sandoz Ltd)
Buprenorphine (as Buprenorphine hydrochloride)
400 microgram Prefibin 0.4mg sublingual tablets sugar-free |
Buprenorphine (as Buprenorphine hydrochloride) 2 mg Prefibin
2mg sublingual tablets sugar-free | 7 tablet P £5.38 DT =
Buprenorphine (as Buprenorphine hydrochloride) 8 mg Prefibin
8mg sublingual tablets sugar-free | 7 tablet P £16.15 DT =
£18.14c ▶ Subutex (Indivior UK Ltd)
Buprenorphine (as Buprenorphine hydrochloride)
400 microgram Subutex 0.4mg sublingual tablets sugar-free | 7 tablet P £1.36 DT = £1.36c
Buprenorphine (as Buprenorphine hydrochloride) 2 mg Subutex
2mg sublingual tablets sugar-free | 7 tablet P £4.45 DT =
Buprenorphine (as Buprenorphine hydrochloride) 8 mg Subutex
8mg sublingual tablets sugar-free | 7 tablet P £13.34 DT =
£18.14c ▶ Temgesic (Indivior UK Ltd)
Buprenorphine (as Buprenorphine hydrochloride)
200 microgram Temgesic 200microgram sublingual tablets sugarfree | 50 tablet P £5.04 DT = £5.04c
Buprenorphine (as Buprenorphine hydrochloride)
Buprenorphine (as Buprenorphine hydrochloride)
200 microgram Tephine 200microgram sublingual tablets sugar-free
| 50 tablet P £4.27 DT = £5.04c
Buprenorphine (as Buprenorphine hydrochloride)
400 microgram Tephine 400microgram sublingual tablets sugar-free
| 50 tablet P £8.54 DT = £10.07c
CAUTIONARY AND ADVISORY LABELS 2
▶ BuTrans (Napp Pharmaceuticals Ltd)
Buprenorphine 5 microgram per 1 hour BuTrans
5micrograms/hour transdermal patches | 4 patch P £17.60 DT =
Buprenorphine 10 microgram per 1 hour BuTrans
10micrograms/hour transdermal patches | 4 patch P £31.55 DT =
Buprenorphine 15 microgram per 1 hour BuTrans
15micrograms/hour transdermal patches | 4 patch P £49.15 DT =
Buprenorphine 20 microgram per 1 hour BuTrans
20micrograms/hour transdermal patches | 4 patch P £57.46 DT =
£57.46c ▶ Bupeaze (Dr Reddy’s Laboratories (UK) Ltd)
Buprenorphine 35 microgram per 1 hour Bupeaze
35micrograms/hour transdermal patches | 4 patch P £9.47 DT =
Buprenorphine 52.5 microgram per 1 hour Bupeaze
52.5micrograms/hour transdermal patches | 4 patch P £13.99 DT
Buprenorphine 70 microgram per 1 hour Bupeaze
70micrograms/hour transdermal patches | 4 patch P £17.99 DT =
Buprenorphine 35 microgram per 1 hour Buplast
35micrograms/hour transdermal patches | 4 patch P £15.80 DT =
Buprenorphine 52.5 microgram per 1 hour Buplast
52.5micrograms/hour transdermal patches | 4 patch P £23.71 DT
Buprenorphine 70 microgram per 1 hour Buplast
70micrograms/hour transdermal patches | 4 patch P £31.60 DT =
Buprenorphine 5 microgram per 1 hour Bupramyl
5micrograms/hour transdermal patches | 4 patch P £7.04 DT =
Buprenorphine 10 microgram per 1 hour Bupramyl
10micrograms/hour transdermal patches | 4 patch P £12.62 DT =
Buprenorphine 20 microgram per 1 hour Bupramyl
20micrograms/hour transdermal patches | 4 patch P £22.98 DT =
£57.46c ▶ Butec (Qdem Pharmaceuticals Ltd)
Buprenorphine 5 microgram per 1 hour Butec 5micrograms/hour
transdermal patches | 4 patch P £7.92 DT = £17.60c
Buprenorphine 10 microgram per 1 hour Butec
10micrograms/hour transdermal patches | 4 patch P £14.20 DT =
Buprenorphine 15 microgram per 1 hour Butec
15micrograms/hour transdermal patches | 4 patch P £22.12 DT =
Buprenorphine 20 microgram per 1 hour Butec
20micrograms/hour transdermal patches | 4 patch P £25.86 DT =
£57.46c ▶ Hapoctasin (Actavis UK Ltd)
Buprenorphine 35 microgram per 1 hour Hapoctasin
35micrograms/hour transdermal patches | 4 patch P £9.48 DT =
Buprenorphine 52.5 microgram per 1 hour Hapoctasin
52.5micrograms/hour transdermal patches | 4 patch P £14.23 DT
Buprenorphine 70 microgram per 1 hour Hapoctasin
70micrograms/hour transdermal patches | 4 patch P £18.96 DT =
£31.60c ▶ Panitaz (Dr Reddy’s Laboratories (UK) Ltd)
Buprenorphine 5 microgram per 1 hour Panitaz 5micrograms/hour
transdermal patches | 4 patch P £7.04 DT = £17.60c
Buprenorphine 10 microgram per 1 hour Panitaz
10micrograms/hour transdermal patches | 4 patch P £12.62 DT =
Buprenorphine 20 microgram per 1 hour Panitaz
20micrograms/hour transdermal patches | 4 patch P £22.98 DT =
£57.46c ▶ Reletrans (Sandoz Ltd)
Buprenorphine 5 microgram per 1 hour Reletrans
5micrograms/hour transdermal patches | 4 patch P £7.92 DT =
Buprenorphine 10 microgram per 1 hour Reletrans
10micrograms/hour transdermal patches | 4 patch P £14.20 DT =
Buprenorphine 15 microgram per 1 hour Reletrans
15micrograms/hour transdermal patches | 4 patch P £22.12 DT =
Buprenorphine 20 microgram per 1 hour Reletrans
20micrograms/hour transdermal patches | 4 patch P £25.86 DT =
£57.46c ▶ Relevtec (Sandoz Ltd)
Buprenorphine 35 microgram per 1 hour Relevtec
35micrograms/hour transdermal patches | 4 patch P £11.06 DT =
Buprenorphine 52.5 microgram per 1 hour Relevtec
52.5micrograms/hour transdermal patches | 4 patch P £16.60 DT
Buprenorphine 70 microgram per 1 hour Relevtec
70micrograms/hour transdermal patches | 4 patch P £22.12 DT =
£31.60c ▶ Sevodyne (Aspire Pharma Ltd)
Buprenorphine 5 microgram per 1 hour Sevodyne
5micrograms/hour transdermal patches | 4 patch P £7.92 DT =
Buprenorphine 10 microgram per 1 hour Sevodyne
10micrograms/hour transdermal patches | 4 patch P £14.20 DT =
Buprenorphine 20 microgram per 1 hour Sevodyne
20micrograms/hour transdermal patches | 4 patch P £25.86 DT =
£57.46c ▶ Transtec (Napp Pharmaceuticals Ltd)
Buprenorphine 35 microgram per 1 hour Transtec
35micrograms/hour transdermal patches | 4 patch P £15.80 DT =
Buprenorphine 52.5 microgram per 1 hour Transtec
52.5micrograms/hour transdermal patches | 4 patch P £23.71 DT
Buprenorphine 70 microgram per 1 hour Transtec
70micrograms/hour transdermal patches | 4 patch P £31.60 DT =
CAUTIONARY AND ADVISORY LABELS 2
EXCIPIENTS: May contain Aspartame, gelatin
▶ Espranor (Martindale Pharmaceuticals Ltd)
Buprenorphine (as Buprenorphine hydrochloride) 2 mg Espranor
2mg oral lyophilisates sugar-free | 7 tablet P £6.35 DT =
Buprenorphine (as Buprenorphine hydrochloride) 8 mg Espranor
8mg oral lyophilisates sugar-free | 7 tablet P £19.05 DT =
Prolonged-release solution for injection
Buprenorphine 355.56 mg per 1 ml Buvidal 96mg/0.27ml
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, paracetamol p. 444.
Moderate pain (using co-codamol 8/500 preparations
▶ Adult: 8/500–16/1000 mg every 4–6 hours as required;
Moderate pain (using co-codamol 15/500 preparations
▶ Adult: 15/500–30/1000 mg every 4–6 hours as required;
Moderate to severe pain (using co-codamol 30/500
▶ Adult: 30/500–60/1000 mg every 4–6 hours as required;
▶ Adult: 2 tablets every 4–6 hours as required; maximum
▶ Adult: 2 tablets every 4–6 hours as required; maximum
▶ Adult: 2 capsules every 4–6 hours as required;
SOLPADOL ® EFFERVESCENT TABLETS
▶ BY MOUTH USING EFFERVESCENT TABLETS
▶ Adult: 2 tablets every 4–6 hours as required, tablets to
be dispersed in water; maximum 8 tablets per day
develops . conditions where inhibition of peristalsis should
be avoided . known ultra-rapid codeine metabolisers
l CAUTIONS Acute abdomen . alcohol dependence . avoid
abrupt withdrawal after long-term treatment. cardiac
▶ Variation in metabolism The capacity to metabolise codeine
to morphine can vary considerably between individuals;
there is a marked increase in morphine toxicity in patients
l INTERACTIONS → Appendix 1: opioids . paracetamol
Overdose Liver damage (and less frequently renal damage)
following overdosage with paracetamol.
l BREAST FEEDING Avoid—although amount of codeine
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