in their capacity to metabolise codeine—risk of morphine
l HEPATIC IMPAIRMENT Manufacturer advises caution in
mild to moderate impairment; avoid in severe impairment.
Dose adjustments Manufacturer advises consider dose
reduction in mild to moderate impairment.
l RENAL IMPAIRMENT Reduce dose or avoid codeine;
increased and prolonged effect; increased cerebral
l PRESCRIBING AND DISPENSING INFORMATION Co-codamol
is a mixture of codeine phosphate and paracetamol; the
proportions are expressed in the form x/y, where x and y
are the strengths in milligrams of codeine phosphate and
When co-codamol tablets, dispersible (or effervescent)
tablets, or capsules are prescribed and no strength is
stated, tablets, dispersible (or effervescent) tablets, or
capsules, respectively, containing codeine phosphate 8 mg
and paracetamol 500 mg should be dispensed.
The Drug Tariff allows tablets of co-codamol labelled
‘dispersible’ to be dispensed against an order for
‘effervescent’ and vice versa.
l LESS SUITABLE FOR PRESCRIBING Co-codamol is less
l EXCEPTIONS TO LEGAL CATEGORY Co-codamol 8/500 can
be sold to the public in certain circumstances; for
exemptions see Medicines, Ethics and Practice, London,
Pharmaceutical Press (always consult latest edition).
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 2(does not apply to the
▶ Co-codamol (Non-proprietary)
Codeine phosphate 8 mg, Paracetamol 500 mg Co-codamol
8mg/500mg tablets | 100 tablet P £2.70 DT = £2.70m | 500 tablet P £13.50m | 1000 tablet P £27.00m
Codeine phosphate 15 mg, Paracetamol 500 mg Co-codamol
15mg/500mg tablets | 100 tablet P £15.00 DT = £4.12m
Codeine phosphate 30 mg, Paracetamol 500 mg Co-codamol
£1.09m | 100 tablet P £7.53 DT = £3.63m
Codeine phosphate 60 mg, Paracetamol 1 gram Co-codamol
60mg/1000mg tablets | 100 tablet P £11.85m ▶ Codipar (Advanz Pharma)
Codeine phosphate 15 mg, Paracetamol 500 mg Codipar
15mg/500mg tablets | 100 tablet P £8.25 DT = £4.12m ▶ Emcozin (M & A Pharmachem Ltd)
Codeine phosphate 30 mg, Paracetamol 500 mg Emcozin
30mg/500mg tablets | 100 tablet P £2.55 DT = £3.63m ▶ Kapake (Galen Ltd)
Codeine phosphate 30 mg, Paracetamol 500 mg Kapake
30mg/500mg tablets | 100 tablet P £7.10 DT = £3.63m ▶ Migraleve Yellow (McNeil Products Ltd)
Codeine phosphate 8 mg, Paracetamol 500 mg Migraleve Yellow
tablets | 16 tablet P sm ▶ Panadol Ultra (GlaxoSmithKline Consumer Healthcare)
Codeine phosphate 12.8 mg, Paracetamol 500 mg Panadol Ultra
12.8mg/500mg tablets | 20 tablet p £2.61 DT = £3.61m ▶ Solpadeine Max (Omega Pharma Ltd)
Codeine phosphate 12.8 mg, Paracetamol 500 mg Solpadeine Max
Codeine phosphate 30 mg, Paracetamol 500 mg Solpadol
Codeine phosphate 30 mg, Paracetamol 500 mg Zapain
30mg/500mg tablets | 100 tablet P £3.11 DT = £3.63m
CAUTIONARY AND ADVISORY LABELS 2(does not apply to the
EXCIPIENTS: May contain Aspartame
ELECTROLYTES: May contain Sodium
▶ Co-codamol (Non-proprietary)
Codeine phosphate 8 mg, Paracetamol 500 mg Co-codamol
8mg/500mg effervescent tablets | 100 tablet P £8.75 DT =
Codeine phosphate 30 mg, Paracetamol 500 mg Co-codamol
30mg/500mg effervescent tablets | 32 tablet P £5.40 DT =
£2.30m | 100 tablet P £19.20 DT = £7.19m ▶ Codipar (Advanz Pharma)
Codeine phosphate 15 mg, Paracetamol 500 mg Codipar
15mg/500mg effervescent tablets sugar-free | 100 tablet P £8.25
DT = £8.25m ▶ Paracodol (Bayer Plc)
Codeine phosphate 8 mg, Paracetamol 500 mg Paracodol
8mg/500mg effervescent tablets | 32 tablet p s DT = £2.28m ▶ Solpadol (Sanofi)
Codeine phosphate 30 mg, Paracetamol 500 mg Solpadol
30mg/500mg effervescent tablets | 32 tablet P £2.59 DT =
£2.30m | 100 tablet P £8.90 DT = £7.19m
CAUTIONARY AND ADVISORY LABELS 2(does not apply to the 8/500
EXCIPIENTS: May contain Sulfites
▶ Co-codamol (Non-proprietary)
Codeine phosphate 8 mg, Paracetamol 500 mg Co-codamol
8mg/500mg capsules | 100 capsule P £16.92 DT = £16.92m
Codeine phosphate 15 mg, Paracetamol 500 mg Co-codamol
15mg/500mg capsules | 100 capsule P £7.25–£8.85 DT =
Codeine phosphate 30 mg, Paracetamol 500 mg Co-codamol
30mg/500mg capsules | 100 capsule P £7.01 DT = £4.83m ▶ Codipar (Advanz Pharma)
Codeine phosphate 15 mg, Paracetamol 500 mg Codipar
15mg/500mg capsules | 100 capsule P £7.25 DT = £8.85m ▶ Kapake (Galen Ltd)
Codeine phosphate 30 mg, Paracetamol 500 mg Kapake
30mg/500mg capsules | 100 capsule P £7.10 DT = £4.83m ▶ Solpadol (Sanofi)
Codeine phosphate 30 mg, Paracetamol 500 mg Solpadol
30mg/500mg capsules | 100 capsule P £6.74 DT = £4.83m ▶ Tylex (UCB Pharma Ltd)
Codeine phosphate 30 mg, Paracetamol 500 mg Tylex
30mg/500mg capsules | 100 capsule P £7.93 DT = £4.83m ▶ Zapain (Advanz Pharma)
Codeine phosphate 30 mg, Paracetamol 500 mg Zapain
30mg/500mg capsules | 100 capsule P £3.85 DT = £4.83m
▶ Child 12–17 years: 30 mg 3–4 times a day; usual dose
▶ Adult: 30 mg 3–4 times a day; usual dose 15–60 mg
▶ Adult: 30–60 mg every 4 hours if required; maximum
▶ Adult: 30–60 mg every 4 hours if required
Short-term treatment of acute moderate pain
▶ BY MOUTH, OR BY INTRAMUSCULAR INJECTION
▶ Child 12–17 years: 30–60 mg every 6 hours if required for
maximum 3 days; maximum 240 mg per day
▶ Adult: 15–30 mg 3–4 times a day
MHRA/CHM ADVICE (JULY 2013) CODEINE FOR ANALGESIA:
RESTRICTED USE IN CHILDREN DUE TO REPORTS OF MORPHINE
Codeine should only be used to relieve acute moderate
pain in children older than 12 years and only if it cannot
be relieved by other painkillers such as paracetamol or
children with obstructive sleep apnoea who received
codeine after tonsillectomy or adenoidectomy:
. in children aged 12–18 years, the maximum daily dose
of codeine should not exceed 240 mg. Doses may be
taken up to four times a day at intervals of no less than
6 hours. The lowest effective dose should be used and
duration of treatment should be limited to 3 days
. codeine is contra-indicated in all children (under
18 years) who undergo the removal of tonsils or
adenoids for the treatment of obstructive sleep apnoea
. codeine is not recommended for use in children whose
breathing may be compromised, including those with
neuromuscular disorders, severe cardiac or respiratory
conditions, respiratory infections, multiple trauma or
. codeine is contra-indicated in patients of any age who
are known to be ultra-rapid metabolisers of codeine
(CYP2D6 ultra-rapid metabolisers)
. codeine should not be used in breast-feeding mothers
because it can pass to the baby through breast milk
. parents and carers should be advised on how to
recognise signs and symptoms of morphine toxicity,
and to stop treatment and seek medical attention if
signs or symptoms of toxicity occur (including reduced
consciousness, lack of appetite, somnolence,
constipation, respiratory depression, ’pin-point’
MHRA/CHM ADVICE (APRIL 2015) CODEINE FOR COUGH AND
COLD: RESTRICTED USE IN CHILDREN
Do not use codeine in children under 12 years as it is
associated with a risk of respiratory side effects. Codeine
is not recommended for adolescents (12–18 years) who
have problems with breathing. When prescribing or
dispensing codeine-containing medicines for cough and
cold, consider that codeine is contra-indicated in:
. children younger than 12 years old
. patients of any age known to be CYP2D6 ultra-rapid
the removal of tonsils or adenoids for the treatment of
obstructive sleep apnoea . conditions where abdominal
distension develops . conditions where inhibition of
peristalsis should be avoided . known ultra-rapid codeine
l CAUTIONS Acute abdomen . cardiac arrhythmias . gallstones . not recommended for adolescents aged
12–18 years with breathing problems
▶ 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
Biliary spasm . hypothermia . mood altered . sexual
▶ With oral use Abdominal cramps . addiction . appetite
decreased . depression . drug reaction with eosinophilia
l BREAST FEEDING Avoid—although amount usually too
small to be harmful, mothers vary considerably in their
capacity to metabolise codeine—risk of morphine overdose
▶ With oral use Manufacturer advises caution in mild to
moderate impairment; avoid in severe impairment.
▶ With intravenous use Manufacturer advises avoid.
Dose adjustments ▶ With oral use Manufacturer advises
dose reduction in mild to moderate impairment.
l RENAL IMPAIRMENT Avoid use or reduce dose; opioid
effects increased and prolonged and increased cerebral
l PRESCRIBING AND DISPENSING INFORMATION BP directs
that when Diabetic Codeine Linctus is prescribed, Codeine
Linctus formulated with a vehicle appropriate for
administration to diabetics, whether or not labelled
‘Diabetic Codeine Linctus’, shall be dispensed or supplied.
Medicines for Children leaflet: Codeine phosphate for pain
www.medicinesforchildren.org.uk/codeine-phosphate-pain-0
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
solution, solution for injection
CAUTIONARY AND ADVISORY LABELS 2
▶ Codeine phosphate (Non-proprietary)
Codeine phosphate 60 mg Codeine 60mg tablets | 28 tablet P £1.89 DT = £1.53m
▶ Codeine phosphate (Non-proprietary)
Codeine phosphate 60 mg per 1 ml Codeine 60mg/1ml solution for
injection ampoules | 10 ampoule P £24.10–£24.19 DT =
CAUTIONARY AND ADVISORY LABELS 2
▶ Codeine phosphate (Non-proprietary)
Codeine phosphate 3 mg per 1 ml Codeine 15mg/5ml linctus sugar
Codeine phosphate 5 mg per 1 ml Codeine 25mg/5ml oral solution
| 500 ml P £6.64 DT = £6.64m ▶ Galcodine (Thornton & Ross Ltd)
Codeine phosphate 3 mg per 1 ml Galcodine 15mg/5ml linctus
Combinations available: Aspirin with codeine, p. 447
Diamorphine hydrochloride 10-Jun-2016
▶ BY INTRAMUSCULAR INJECTION, OR BY SUBCUTANEOUS
▶ Adult: 5 mg every 4 hours if required
▶ BY SLOW INTRAVENOUS INJECTION
▶ Adult: 1.25–2.5 mg every 4 hours if required
Acute pain (heavier, well-muscled patients)
▶ BY INTRAMUSCULAR INJECTION, OR BY SUBCUTANEOUS
▶ Adult: Up to 10 mg every 4 hours if required
▶ BY SLOW INTRAVENOUS INJECTION
▶ Adult: 2.5–5 mg every 4 hours if required
Chronic pain not currently treated with a strong opioid
▶ BY SUBCUTANEOUS INJECTION, OR BY INTRAMUSCULAR
▶ Adult: Initially 2.5–5 mg every 4 hours, adjusted
▶ Adult: Initially 5–10 mg, adjusted according to
response, dose to be administered over 24 hours
▶ BY SLOW INTRAVENOUS INJECTION
▶ Adult: 2.5–5 mg, dose to be administered at a rate of
▶ BY SLOW INTRAVENOUS INJECTION
▶ Adult: 5 mg, followed by 2.5–5 mg if required, dose to
be administered at a rate of 1–2 mg/minute
▶ Elderly: 2.5 mg, followed by 1.25–2.5 mg if required,
dose to be administered at a rate of 1–2 mg/minute
Myocardial infarction (frail patients)
▶ BY SLOW INTRAVENOUS INJECTION
▶ Adult: 2.5 mg, followed by 1.25–2.5 mg if required,
dose to be administered at a rate of 1–2 mg/minute
l CONTRA-INDICATIONS Delayed gastric emptying . phaeochromocytoma
l CAUTIONS CNS depression . severe cor pulmonale . severe
l INTERACTIONS → Appendix 1: opioids
l BREAST FEEDING Therapeutic doses unlikely to affect
infant; withdrawal symptoms in infants of dependent
mothers; breast-feeding not best method of treating
l HEPATIC IMPAIRMENT Manufacturer advises caution.
Dose adjustments Manufacturer advises dose reduction.
l RENAL IMPAIRMENT Avoid use or reduce dose; opioid
effects increased and prolonged; increased cerebral
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: solution for
injection, powder for solution for injection
Powder for solution for injection
▶ Diamorphine hydrochloride (Non-proprietary)
Diamorphine hydrochloride 5 mg Diamorphine 5mg powder for
solution for injection ampoules | 5 ampoule P £11.36–£14.95 DT =
Diamorphine hydrochloride 10 mg Diamorphine 10mg powder for
solution for injection ampoules | 5 ampoule P £16.56–£16.95 DT =
Diamorphine hydrochloride 30 mg Diamorphine 30mg powder for
solution for injection ampoules | 5 ampoule P £16.52–£17.95 DT =
Diamorphine hydrochloride 100 mg Diamorphine 100mg powder
for solution for injection ampoules | 5 ampoule P £42.39–£57.95
Diamorphine hydrochloride 500 mg Diamorphine 500mg powder
for solution for injection ampoules | 5 ampoule P £187.70–
▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶ Child 4–11 years: 0.5–1 mg/kg every 4–6 hours (max. per
▶ Child 12–17 years: 30 mg every 4–6 hours
▶ Adult: 30 mg every 4–6 hours as required
▶ BY DEEP SUBCUTANEOUS INJECTION, OR BY INTRAMUSCULAR
▶ Adult: Up to 50 mg every 4–6 hours if required
▶ BY MOUTH USING MODIFIED-RELEASE MEDICINES
▶ Child 12–17 years: 60–120 mg every 12 hours
▶ Adult: 60–120 mg every 12 hours
▶ Child 12–17 years: 40–80 mg 3 times a day; maximum
▶ Adult: 40–80 mg 3 times a day; maximum 240 mg per
l CAUTIONS Pancreatitis . severe cor pulmonale
l INTERACTIONS → Appendix 1: opioids
▶ With oral use Biliary spasm . bronchospasm . hypothermia . sexual dysfunction . ureteral spasm
l BREAST FEEDING Use only if potential benefit outweighs
l HEPATIC IMPAIRMENT Manufacturer advises caution;
Dose adjustments Manufacturer advises dose reduction, if
l RENAL IMPAIRMENT Avoid use or reduce dose; opioid
effects increased and prolonged and increased cerebral
l PROFESSION SPECIFIC INFORMATION
Dental practitioners’ formulary
Dihydrocodeine tablets 30 mg may be prescribed.
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 2, 25
▶ DHC Continus (Napp Pharmaceuticals Ltd)
Dihydrocodeine tartrate 60 mg DHC Continus 60mg tablets | 56 tablet P £5.20 DT = £5.20m
Dihydrocodeine tartrate 90 mg DHC Continus 90mg tablets | 56 tablet P £8.66 DT = £8.66m
Dihydrocodeine tartrate 120 mg DHC Continus 120mg tablets | 56 tablet P £10.95 DT = £10.95m
CAUTIONARY AND ADVISORY LABELS 2
▶ Dihydrocodeine tartrate (Non-proprietary)
Dihydrocodeine tartrate 40 mg DF 118 Forte 40mg tablets | 100 tablet P £11.51 DT = £11.51m
▶ Dihydrocodeine tartrate (Non-proprietary)
Dihydrocodeine tartrate 50 mg per 1 ml Dihydrocodeine 50mg/1ml
solution for injection ampoules | 10 ampoule P £115.80 DT =
CAUTIONARY AND ADVISORY LABELS 2
▶ Dihydrocodeine tartrate (Non-proprietary)
Dihydrocodeine tartrate 2 mg per 1 ml Dihydrocodeine 10mg/5ml
oral solution | 150 ml P £9.83 DT = £9.83m
Dihydrocodeine with paracetamol
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, paracetamol p. 444.
Mild to moderate pain (using 10/500 preparations only)
▶ Adult: 10/500–20/1000 mg every 4–6 hours as required;
Severe pain (using 20/500 preparations only)
▶ Adult: 20/500–40/1000 mg every 4–6 hours as required;
Severe pain (using 30/500 preparations only)
▶ Adult: 30/500–60/1000 mg every 4–6 hours as required;
DOSE EQUIVALENCE AND CONVERSION
▶ A mixture of dihydrocodeine tartrate and paracetamol;
the proportions are expressed in the form x/y, where x
and y are the strengths in milligrams of dihydrocodeine
MHRA/CHM ADVICE: DIHYDROCODEINE WITH PARACETAMOL (CODYDRAMOL): PRESCRIBE AND DISPENSE BY STRENGTH TO
MINIMISE RISK OF MEDICATION ERROR (JANUARY 2018)
The MHRA has advised that dihydrocodeine with
paracetamol preparations are prescribed and dispensed
by strength to minimise dispensing errors and the risk of
accidental opioid overdose—see Prescribing and
l CAUTIONS Alcohol dependence . before administering,
check when paracetamol last administered and cumulative
paracetamol dose over previous 24 hours . chronic
l INTERACTIONS → Appendix 1: opioids . paracetamol
reactions (SCARs).thrombocytopenia
Overdose Liver damage (and less frequently renal damage)
following overdosage with paracetamol.
l BREAST FEEDING Amount of dihydrocodeine too small to
be harmful but use only if potential benefit outweighs risk.
l HEPATIC IMPAIRMENT Manufacturer advises consider
avoiding in mild to moderate impairment; avoid in severe
Dose adjustments Manufacturer advises dose reduction in
mild to moderate impairment, if used.
l RENAL IMPAIRMENT Reduce dose or avoid dihydrocodeine;
increased and prolonged effect; increased cerebral
l PRESCRIBING AND DISPENSING INFORMATION The MHRA
advises when prescribing dihydrocodeine with
paracetamol, the tablet strength and dose must be clearly
indicated; when dispensing dihydrocodeine with
paracetamol, ensure the prescribed strength is supplied—
contact the prescriber if in doubt.
The BP defines Co-dydramol Tablets as containing
dihydrocodeine tartrate 10 mg and paracetamol 500 mg.
l LESS SUITABLE FOR PRESCRIBING Dihydrocodeine with
paracetamol is less suitable for prescribing.
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 2, 29, 30
▶ Dihydrocodeine with paracetamol (Non-proprietary)
£0.79m | 100 tablet P £3.00 DT = £2.63m | 500 tablet P £13.15m
£6.82m ▶ Eroset (M & A Pharmachem Ltd)
Dihydrocodeine tartrate 10 mg, Paracetamol 500 mg Eroset
Dihydrocodeine tartrate 7.46 mg, Paracetamol 500 mg Paramol
Dihydrocodeine tartrate 20 mg, Paracetamol 500 mg Remedeine
tablets | 56 tablet P £5.87m | 112 tablet P £11.13 DT =
Dihydrocodeine tartrate 30 mg, Paracetamol 500 mg Remedeine
Forte tablets | 56 tablet P £6.82 DT = £6.82m
▶ Adult: Initially 1 tablet every 6 hours, then increased if
necessary up to 3 tablets every 6 hours, dose to be
l CAUTIONS Diabetes mellitus . palliative care (not
recommended). phaeochromocytoma
l INTERACTIONS → Appendix 1: antihistamines, sedating . opioids
l BREAST FEEDING No information available.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
mild to moderate impairment; avoid in severe impairment.
Dose adjustments Manufacturer advises dose reduction in
mild to moderate impairment; adjust according to
l RENAL IMPAIRMENT Avoid use or reduce dose; opioid
effects increased and prolonged and increased cerebral
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Dipipanone hydrochloride with cyclizine (Non-proprietary)
Dipipanone hydrochloride 10 mg, Cyclizine hydrochloride
30 mg Dipipanone 10mg / Cyclizine 30mg tablets | 50 tablet P £440.65 DT = £440.65b
Chronic intractable pain not currently treated with a
▶ Child 16–17 years: Initially 12 micrograms/hour every
72 hours, alternatively initially 25 micrograms/hour
every 72 hours, when starting, evaluation of the
analgesic effect should not be made before the system
has been worn for 24 hours (to allow for the gradual
increase in plasma-fentanyl concentration)—previous
analgesic therapy should be phased out gradually from
time of first patch application, dose should be adjusted
at 48–72 hour intervals in steps of
12–25 micrograms/hour if necessary, more than one
patch may be used at a time (but applied at the same
time to avoid confusion)—consider additional or
alternative analgesic therapy if dose required exceeds
300 micrograms/hour (important: it takes 17 hours or
more for the plasma-fentanyl concentration to
decrease by 50%— replacement opioid therapy should
be initiated at a low dose and increased gradually)
▶ Adult: Initially 12 micrograms/hour every 72 hours,
alternatively initially 25 micrograms/hour every
72 hours, when starting, evaluation of the analgesic
effect should not be made before the system has been
worn for 24 hours (to allow for the gradual increase in
plasma-fentanyl concentration)—previous analgesic
therapy should be phased out gradually from time of
first patch application, dose should be adjusted at
48–72 hour intervals in steps of
12–25 micrograms/hour if necessary, more than one
patch may be used at a time (but applied at the same
time to avoid confusion)—consider additional or
alternative analgesic therapy if dose required exceeds
300 micrograms/hour (important: it takes 17 hours or
more for the plasma-fentanyl concentration to
decrease by 50%— replacement opioid therapy should
be initiated at a low dose and increased gradually)
Chronic intractable pain currently treated with a strong
▶ Child 2–17 years: Initial dose based on previous 24-hour
opioid requirement (consult product literature), for
evaluating analgesic efficacy and dose increments, see
under Chronic intractable pain not currently treated with
a strong opioid analgesic, for conversion from long term
oral morphine to transdermal fentanyl, see Pain
management with opioids under Prescribing in palliative
▶ Adult: Initial dose based on previous 24-hour opioid
requirement (consult product literature), for evaluating
analgesic efficacy and dose increments, see under
Chronic intractable pain not currently treated with a
strong opioid analgesic, for conversion from long term
oral morphine to transdermal fentanyl, see Pain
management with opioids under Prescribing in palliative
Spontaneous respiration: analgesia and enhancement of
▶ BY SLOW INTRAVENOUS INJECTION
▶ Adult: Initially 50–100 micrograms (max. per dose
200 micrograms), dose maximum on specialist advice,
then 25–50 micrograms as required
▶ Adult: 3–4.8 micrograms/kg/hour, adjusted according
Assisted ventilation: analgesia and enhancement of
▶ BY SLOW INTRAVENOUS INJECTION
▶ Adult: Initially 300–3500 micrograms, then
100–200 micrograms as required
▶ Adult: Initially 10 micrograms/kg, dose to be given over
10 minutes, then 6 micrograms/kg/hour, adjusted
according to response, may require up to
180 micrograms/kg/hour during cardiac surgery
Assisted ventilation: analgesia and respiratory depression
▶ BY SLOW INTRAVENOUS INJECTION
▶ Adult: Initially 300–3500 micrograms, then
100–200 micrograms as required
▶ Adult: Initially 10 micrograms/kg, dose to be given over
10 minutes, then 6 micrograms/kg/hour, adjusted
according to response, may require up to
180 micrograms/kg/hour during cardiac surgery
Breakthrough pain in patients receiving opioid therapy
▶ BY BUCCAL ADMINISTRATION USING LOZENGES
▶ Child 16–17 years: Initially 200 micrograms, dose to be
given over 15 minutes, then 200 micrograms after
15 minutes if required, no more than 2 dose units for
each pain episode; if adequate pain relief not achieved
with 1 dose unit for consecutive breakthrough pain
episodes, increase the strength of the dose unit until
adequate pain relief achieved with 4 lozenges or less
daily, if more than 4 episodes of breakthrough pain
each day, adjust background analgesia
▶ Adult: Initially 200 micrograms, dose to be given over
15 minutes, then 200 micrograms after 15 minutes if
required, no more than 2 dose units for each pain
episode; if adequate pain relief not achieved with
1 dose unit for consecutive breakthrough pain
episodes, increase the strength of the dose unit until
adequate pain relief achieved with 4 lozenges or less
daily, if more than 4 episodes of breakthrough pain
each day, adjust background analgesia
▶ BY BUCCAL ADMINISTRATION USING BUCCAL FILMS
▶ Adult: Initially 200 micrograms, adjusted according to
response, consult product literature for information on
dose adjustments, maximum 1.2 mg per episode of
breakthrough pain; leave at least 4 hours between
treatment of episodes of breakthrough pain, if more
than 4 episodes of breakthrough pain each day occur
on more than 4 consecutive days, adjust background
DOSE EQUIVALENCE AND CONVERSION
▶ Fentanyl films are not bioequivalent to other fentanyl
▶ Fentanyl preparations for the treatment of
breakthrough pain are not interchangeable; if patients
are switched from another fentanyl-containing
preparation, a new dose titration is required.
DOSES AT EXTREMES OF BODY-WEIGHT
Breakthrough pain in patients receiving opioid therapy
▶ BY MOUTH USING SUBLINGUAL TABLETS
▶ Adult: Initially 100 micrograms, then 100 micrograms
after 15–30 minutes if required, dose to be adjusted
according to response—consult product literature, no
more than 2 dose units 15–30 minutes apart, for each
pain episode; max. 800 micrograms per episode of
breakthrough pain; leave at least 2 hours between
treatment of episodes of breakthrough pain, if more
than 4 episodes of breakthrough pain each day, adjust
Breakthrough pain in patients receiving opioid therapy
▶ BY MOUTH USING BUCCAL TABLET
▶ Adult: Initially 100 micrograms, then 100 micrograms
after 30 minutes if required, dose to be adjusted
according to response—consult product literature, no
more than 2 dose units for each pain episode; max.
800 micrograms per episode of breakthrough pain;
leave at least 4 hours between treatment of episodes of
breakthrough pain during titration
Breakthrough pain in patients receiving opioid therapy
▶ BY INTRANASAL ADMINISTRATION
▶ Adult: Initially 50 micrograms, dose to be administered
into one nostril, then 50 micrograms after 10 minutes if
required, dose to be adjusted according to response,
maximum 2 sprays for each pain episode and minimum
4 hours between treatment of each pain episode, if
more than 4 breakthrough pain episodes daily, adjust
Breakthrough pain in patients receiving opioid therapy
▶ BY INTRANASAL ADMINISTRATION
▶ Adult: Initially 100 micrograms, adjusted according to
response, dose to be administered into one nostril
only, maximum 2 sprays for each pain episode and
minimum 4 hours between treatment of each pain
episode, if more than 4 breakthrough pain episodes
daily, adjust background analgesia
EXPOSURE, PARTICULARLY IN CHILDREN (OCTOBER 2018)
Accidental exposure to transdermal fentanyl can occur if
a patch is swallowed or transferred to another individual.
Always fully inform patients and their carers about
directions for safe use of fentanyl patches, including the
. not exceeding the prescribed dose;
. following the correct frequency of patch application,
avoiding touching the adhesive side of patches, and
washing hands after application;
. not cutting patches and avoiding exposure of patches
to heat including via hot water;
. ensuring that old patches are removed before applying
. following instructions for safe storage and properly
disposing of used patches or those which are not
Patients and carers should be advised to seek immediate
medical attention if overdose is suspected—see Sideeffects and Patient and carer advice for further
GENERAL CAUTIONS Cerebral tumour. diabetes mellitus
(with Actiq ® and Cynril ® lozenges). impaired
▶ With buccal use mucositis—absorption from oral
preparations may be increased, caution during dose
▶ With transdermal use Transdermal fentanyl 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. Risk of
fatal respiratory depression, particularly in patients not
previously treated with a strong opioid analgesic;
manufacturer recommends use only in opioid tolerant
▶ With intravenous use Repeated intra-operative doses should
be given with care since the resulting respiratory
depression can persist postoperatively and occasionally it
may become apparent for the first time postoperatively
when monitoring of the patient might be less intensive.
l INTERACTIONS → Appendix 1: opioids
▶ With parenteral use Apnoea . hypertension . movement
disorders . muscle rigidity . post procedural complications . respiratory disorders . vascular pain
▶ With sublingual use Asthenia . dyspnoea . oral disorders
discomfort. hypertension . insomnia . malaise . muscle
complaints . peripheral oedema . sensation abnormal . temperature sensation altered .tremor
▶ With parenteral use Airway complication of anaesthesia . chills . hiccups . hypothermia
impaired . depression . emotional lability . erectile
dysfunction . gastrointestinal discomfort. impaired gastric
disorder. sleep disorders .taste altered .throat tightness . tremor. vision blurred
discomfort. gastrointestinal disorders . gingival
slurred .taste altered .thinking abnormal .throat oedema .
vasodilation . vision disorders . weight decreased . withdrawal syndrome neonatal
▶ With intranasal use Diarrhoea . epistaxis . fatigue . fever. hot
abnormal . stomatitis .taste altered .throat irritation
▶ With transdermal use Myoclonus . withdrawal syndrome
SIDE-EFFECTS, FURTHER INFORMATION Muscle rigidity
Intravenous administration of fentanyl can cause muscle
rigidity, which may involve the thoracic muscles.
Manufacturer advises administration by slow intravenous
injection to avoid; higher doses may require
premedication with benzodiazepines and muscle
Transdermal use Monitor patients using patches for
increased side-effects if fever is present (increased
absorption possible); avoid exposing application site to
external heat, for example a hot bath or sauna (may also
▶ With buccal use or intranasal use or sublingual
use Manufacturer advises avoid during treatment and for
5 days after last administration—present in milk.
▶ With intravenous use Manufacturer advises avoid during
treatment and for 24 hours after last administration—
▶ With transdermal use Manufacturer advises avoid during
treatment and for 72 hours after removal of patch—present
l HEPATIC IMPAIRMENT Manufacturer advises caution (risk
Dose adjustments Manufacturer advises cautious dose
l RENAL IMPAIRMENT Avoid use or reduce dose; opioid
effects increased and prolonged and increased cerebral
l DIRECTIONS FOR ADMINISTRATION
arm, removing after 72 hours and siting replacement patch
on a different area (avoid using the same area for several
▶ With intravenous use in adults For intravenous infusion
(Sublimaze), give continuously or intermittently in Glucose
▶ With buccal use in adults For buccal films, moisten mouth,
place film on inner lining of cheek (pink side to cheek),
hold for at least 5 seconds until it sticks, and leave to
dissolve (15–30 minutes); if more than 1 film required do
not overlap, but use another area of the mouth. Avoid
liquids for 5 minutes after application; avoid food until the
▶ With buccal use Patients should be advised to place the
lozenge in the mouth against the cheek and move it
around the mouth using the applicator; each lozenge
should be sucked over a 15 minute period. In patients with
a dry mouth, water may be used to moisten the buccal
mucosa. Patients with diabetes should be advised each
lozenge contains approximately 2 g glucose.
INSTANYL ® Patient should sit or stand during
EFFENTORA ® Place tablet between cheek and gum and
leave to dissolve; if more than 1 tablet required, place
second tablet on the other side of the mouth; tablet may
alternatively be placed under the tongue (sublingually).
l PRESCRIBING AND DISPENSING INFORMATION
▶ With transdermal use Prescriptions for fentanyl patches can
be written to show the strength in terms of the release rate
and it is acceptable to write ’Fentanyl 25 patches‘ to
prescribe patches that release fentanyl 25 micrograms per
hour. The dosage should be expressed in terms of the
interval between applying a patch and replacing it with a
new one, e.g. ’one patch to be applied every 72 hours’. The
total quantity of patches to be supplied should be written
▶ With transdermal use Patients and carers should be
informed about safe use, including correct administration
and disposal, strict adherence to dosage instructions, and
the symptoms and signs of opioid overdosage. Patches
should be removed immediately in case of breathing
difficulties, marked drowsiness, confusion, dizziness, or
impaired speech, and patients and carers should seek
▶ In adults Patients or carers should be given advice on how
to administer fentanyl buccal films or fentanyl lozenges.
Patients or carers should be given advice on how to
administer fentanyl nasal spray.
Medicines for Children leaflet: Fentanyl lozenges for pain
www.medicinesforchildren.org.uk/fentanyl-lozenges-pain
Medicines for Children leaflet: Fentanyl patches for pain
www.medicinesforchildren.org.uk/fentanyl-patches-pain
PECFENT ® Avoid concomitant use of other nasal
Patients or carers should be given advice on how to
INSTANYL ® Avoid concomitant use of other nasal
Patients or carers should be given advice on how to
EFFENTORA ® Patients or carers should be given advice on
how to administer Effentora ® buccal tablets.
Patients should be advised not to eat or drink until the
tablet is completely dissolved; after 30 minutes, if any
remnants remain, they may be swallowed with a glass of
water. Patients with a dry mouth should be advised to
drink water to moisten the buccal mucosa before
administration of the tablets; if appropriate effervescence
does not occur, a switch of therapy may be advised.
ABSTRAL ® Patients should be advised not to eat or drink
until the tablet is completely dissolved.
In patients with a dry mouth, the buccal mucosa may be
moistened with water before administration of tablet.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (September
2008) that PecFent ® nasal spray should be restricted for
use within NHS Scotland for the management of
breakthrough pain in adult patients using opioid therapy
for chronic cancer pain, when other short-acting opioids
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised that
Instanyl ® nasal spray should be restricted for use within
NHS Scotland for the management of breakthrough pain in
adult patients using opioid therapy for chronic cancer
pain, when other short-acting opioids are unsuitable.
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised that
Effentora ® buccal tablets should be restricted for the
management of breakthrough pain in adult patients using
opioid therapy for chronic cancer pain, when other short
acting opioids are unsuitable.
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (January
2009) that Abstral ® sublingual tablets should be restricted
for the management of breakthrough pain in adult
patients using opioid therapy for chronic cancer pain,
when other short acting opioids are unsuitable.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: solution for
injection, infusion, solution for infusion
Fentanyl (as Fentanyl citrate) 50 microgram per 1 ml Fentanyl
100micrograms/2ml solution for injection ampoules |
10 ampoule P £7.00–£14.33 DT = £14.32b
Fentanyl (as Fentanyl citrate) 50 microgram per 1 ml Sublimaze
500micrograms/10ml solution for injection ampoules |
CAUTIONARY AND ADVISORY LABELS 2
Fentanyl (as Fentanyl citrate) 50 microgram per 1 dose Instanyl
50micrograms/dose nasal spray | 6 dose P £35.70b
Fentanyl (as Fentanyl citrate) 100 microgram per 1 dose Instanyl
100micrograms/dose nasal spray | 6 dose P £35.70b
Fentanyl (as Fentanyl citrate) 200 microgram per 1 dose Instanyl
200micrograms/dose nasal spray | 6 dose P £35.70b ▶ PecFent (Kyowa Kirin Ltd)
Fentanyl (as Fentanyl citrate) 100 microgram per 1 dose PecFent
100micrograms/dose nasal spray | 8 dose P £36.48b | 32 dose P £145.92b
Fentanyl (as Fentanyl citrate) 400 microgram per 1 dose PecFent
400micrograms/dose nasal spray | 8 dose P £36.48 DT =
£36.48b | 32 dose P £145.92 DT = £145.92b
CAUTIONARY AND ADVISORY LABELS 2
ELECTROLYTES: May contain Sodium
Fentanyl (as Fentanyl citrate) 100 microgram Effentora
100microgram buccal tablets sugar-free | 4 tablet P £19.96b
sugar-free | 28 tablet P £139.72 DT = £139.72b
Fentanyl (as Fentanyl citrate) 200 microgram Effentora
200microgram buccal tablets sugar-free | 4 tablet P £19.96b
sugar-free | 28 tablet P £139.72 DT = £139.72b
Fentanyl (as Fentanyl citrate) 400 microgram Effentora
400microgram buccal tablets sugar-free | 4 tablet P £19.96b
sugar-free | 28 tablet P £139.72 DT = £139.72b
Fentanyl (as Fentanyl citrate) 600 microgram Effentora
600microgram buccal tablets sugar-free | 4 tablet P £19.96b
sugar-free | 28 tablet P £139.72 DT = £139.72b
Fentanyl (as Fentanyl citrate) 800 microgram Effentora
800microgram buccal tablets sugar-free | 4 tablet P £19.96b
sugar-free | 28 tablet P £139.72 DT = £139.72b
Fentanyl (as Fentanyl citrate) 50 microgram per 1 ml Fentanyl
2.5mg/50ml solution for infusion vials | 1 vial P £5.50b
CAUTIONARY AND ADVISORY LABELS 2, 26
Fentanyl (as Fentanyl citrate) 100 microgram Abstral
100microgram sublingual tablets sugar-free | 10 tablet P £49.99
DT = £49.99bsugar-free | 30 tablet P £149.70b
Fentanyl (as Fentanyl citrate) 200 microgram Abstral
200microgram sublingual tablets sugar-free | 10 tablet P £49.99
DT = £49.99bsugar-free | 30 tablet P £149.70b
Fentanyl (as Fentanyl citrate) 300 microgram Abstral
300microgram sublingual tablets sugar-free | 10 tablet P £49.99
DT = £49.99bsugar-free | 30 tablet P £149.70b
Fentanyl (as Fentanyl citrate) 400 microgram Abstral
400microgram sublingual tablets sugar-free | 10 tablet P £49.99
DT = £49.99bsugar-free | 30 tablet P £149.70b
Fentanyl (as Fentanyl citrate) 600 microgram Abstral
600microgram sublingual tablets sugar-free | 30 tablet P £149.70
Fentanyl (as Fentanyl citrate) 800 microgram Abstral
800microgram sublingual tablets sugar-free | 30 tablet P £149.70
CAUTIONARY AND ADVISORY LABELS 2
▶ Durogesic DTrans (Janssen-Cilag Ltd)
Fentanyl 12 microgram per 1 hour Durogesic DTrans
12micrograms/hour transdermal patches | 5 patch P £12.59 DT =
Fentanyl 25 microgram per 1 hour Durogesic DTrans
25micrograms/hour transdermal patches | 5 patch P £17.99 DT =
Fentanyl 50 microgram per 1 hour Durogesic DTrans
50micrograms/hour transdermal patches | 5 patch P £33.66 DT =
Fentanyl 75 microgram per 1 hour Durogesic DTrans
75micrograms/hour transdermal patches | 5 patch P £46.99 DT =
Fentanyl 100 microgram per 1 hour Durogesic DTrans
100micrograms/hour transdermal patches | 5 patch P £57.86 DT
= £57.86b ▶ Fencino (Ethypharm UK Ltd)
Fentanyl 12 microgram per 1 hour Fencino 12micrograms/hour
transdermal patches | 5 patch P £8.46 DT = £12.59b
Fentanyl 25 microgram per 1 hour Fencino 25micrograms/hour
transdermal patches | 5 patch P £12.10 DT = £17.99b
Fentanyl 50 microgram per 1 hour Fencino 50micrograms/hour
transdermal patches | 5 patch P £22.62 DT = £33.66b
Fentanyl 75 microgram per 1 hour Fencino 75micrograms/hour
transdermal patches | 5 patch P £31.54 DT = £46.99b
Fentanyl 100 microgram per 1 hour Fencino 100micrograms/hour
transdermal patches | 5 patch P £38.88 DT = £57.86b ▶ Fentalis (Sandoz Ltd)
Fentanyl 25 microgram per 1 hour Fentalis Reservoir
25micrograms/hour transdermal patches | 5 patch P £22.89 DT =
Fentanyl 50 microgram per 1 hour Fentalis Reservoir
50micrograms/hour transdermal patches | 5 patch P £42.77 DT =
Fentanyl 75 microgram per 1 hour Fentalis Reservoir
75micrograms/hour transdermal patches | 5 patch P £59.62 DT =
Fentanyl 100 microgram per 1 hour Fentalis Reservoir
100micrograms/hour transdermal patches | 5 patch P £73.49 DT
= £57.86b ▶ Matrifen (Teva UK Ltd)
Fentanyl 12 microgram per 1 hour Matrifen 12micrograms/hour
transdermal patches | 5 patch P £7.52 DT = £12.59b
Fentanyl 25 microgram per 1 hour Matrifen 25micrograms/hour
transdermal patches | 5 patch P £10.76 DT = £17.99b
Fentanyl 50 microgram per 1 hour Matrifen 50micrograms/hour
transdermal patches | 5 patch P £20.12 DT = £33.66b
Fentanyl 75 microgram per 1 hour Matrifen 75micrograms/hour
transdermal patches | 5 patch P £28.06 DT = £46.99b
Fentanyl 100 microgram per 1 hour Matrifen 100micrograms/hour
transdermal patches | 5 patch P £34.59 DT = £57.86b ▶ Mezolar Matrix (Sandoz Ltd)
Fentanyl 12 microgram per 1 hour Mezolar Matrix
12micrograms/hour transdermal patches | 5 patch P £7.53 DT =
Fentanyl 25 microgram per 1 hour Mezolar Matrix
25micrograms/hour transdermal patches | 5 patch P £10.77 DT =
Fentanyl 37.5 microgram per 1 hour Mezolar Matrix
37.5microgram/hour transdermal patches | 5 patch P £15.46 DT
Fentanyl 50 microgram per 1 hour Mezolar Matrix
50micrograms/hour transdermal patches | 5 patch P £20.13 DT =
Fentanyl 75 microgram per 1 hour Mezolar Matrix
75micrograms/hour transdermal patches | 5 patch P £28.07 DT =
Fentanyl 100 microgram per 1 hour Mezolar Matrix
100micrograms/hour transdermal patches | 5 patch P £34.60 DT
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