The properties listed below are those particular to the
combination only. For the properties of the components
please consider, oxycodone hydrochloride p. 466, naloxone
Severe pain requiring opioid analgesia in patients not
currently treated with opioid analgesics
▶ Adult: Initially 10/5 mg every 12 hours (max. per dose
40/20 mg every 12 hours), dose to be increased
according to response; patients already receiving
opioid analgesics can start with a higher dose
Second-line treatment of symptomatic severe to very
severe idiopathic restless legs syndrome after failure of
▶ Adult: Initially 5/2.5 mg every 12 hours, adjusted
weekly according to response, usual dose 10/5 mg
every 12 hours; maximum 60/30 mg per day
DOSE EQUIVALENCE AND CONVERSION
▶ Dose quantities are expressed in the form x/y where x
and y are the strengths in milligrams of oxycodone and
l INTERACTIONS → Appendix 1: opioids
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, 25
▶ Targinact (Napp Pharmaceuticals Ltd)
Naloxone hydrochloride 2.5 mg, Oxycodone hydrochloride
5 mg Targinact 5mg/2.5mg modified-release tablets | 28 tablet P £21.16 DT = £21.16b
Naloxone hydrochloride 5 mg, Oxycodone hydrochloride
10 mg Targinact 10mg/5mg modified-release tablets | 56 tablet P £42.32 DT = £42.32b
Naloxone hydrochloride 10 mg, Oxycodone hydrochloride
20 mg Targinact 20mg/10mg modified-release tablets |
56 tablet P £84.62 DT = £84.62b
Naloxone hydrochloride 20 mg, Oxycodone hydrochloride
40 mg Targinact 40mg/20mg modified-release tablets | 56 tablet P £169.28 DT = £169.28b
Postoperative analgesia | Severe chronic pain
▶ BY SUBCUTANEOUS INJECTION, OR BY INTRAMUSCULAR
▶ Adult: 7.7–15.4 mg every 4 hours if required
▶ Elderly: Initially 7.7 mg every 4 hours if required
▶ Adult: Use 25 to 50% of the corresponding
subcutaneous/intramuscular dose
▶ BY SUBCUTANEOUS INJECTION, OR BY INTRAMUSCULAR
Do not confuse with papaverine.
l CONTRA-INDICATIONS Heart failure secondary to chronic
lung disease . phaeochromocytoma
l CAUTIONS Supraventricular tachycardia
l INTERACTIONS → Appendix 1: opioids
l SIDE-EFFECTS Biliary spasm . dysuria . hypothermia . mood
altered . sexual dysfunction . ureteral spasm
l BREAST FEEDING Therapeutic doses unlikely to affect
l HEPATIC IMPAIRMENT Manufacturer advises consider
Dose adjustments Manufacturer advises dose reduction, if
l RENAL IMPAIRMENT Avoid use or reduce dose; opioid
effects increased and prolonged and increased cerebral
l PRESCRIBING AND DISPENSING INFORMATION The name
Omnopon ® was formerly used for papaveretum
Papaveretum is a mixture of 253 parts of morphine
hydrochloride, 23 parts of papaverine hydrochloride and
20 parts of codeine hydrochloride.
l LESS SUITABLE FOR PRESCRIBING Papaveretum is less
l MEDICINAL FORMS Forms available from special-order
manufacturers include: solution for injection
▶ Adult: 50 mg every 3–4 hours, dose to be taken
preferably after food, usual dose 25–100 mg every
3–4 hours; maximum 600 mg per day
▶ BY SUBCUTANEOUS INJECTION, OR BY INTRAMUSCULAR
INJECTION, OR BY INTRAVENOUS INJECTION
▶ Adult: 30 mg every 3–4 hours as required; maximum
▶ BY SUBCUTANEOUS INJECTION, OR BY INTRAMUSCULAR
INJECTION, OR BY INTRAVENOUS INJECTION
▶ Adult: 45–60 mg every 3–4 hours as required;
l CONTRA-INDICATIONS Acute porphyrias p. 1058 . heart
failure secondary to chronic lung disease . patients
dependent on opioids (can precipitate withdrawal)
l INTERACTIONS → Appendix 1: opioids
altered . myalgia . paraesthesia . sexual dysfunction . sleep
disorders . syncope .toxic epidermal necrolysis .tremor. ureteral spasm
Overdose Effects only partially reversed by naloxone.
l BREAST FEEDING Use with caution—limited information
l HEPATIC IMPAIRMENT Manufacturer advises caution in
severe impairment (risk of increased bioavailability).
Dose adjustments Manufacturer advises consider dose
reduction in severe impairment.
l RENAL IMPAIRMENT Avoid use or reduce dose; opioid
effects increased and prolonged and increased cerebral
l LESS SUITABLE FOR PRESCRIBING Pentazocine is less
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 2, 21
▶ Pentazocine (Non-proprietary)
Pentazocine hydrochloride 25 mg Pentazocine 25mg tablets | 28 tablet P £25.36 DT = £24.99c
CAUTIONARY AND ADVISORY LABELS 2, 21
▶ Pentazocine (Non-proprietary)
Pentazocine hydrochloride 50 mg Pentazocine 50mg capsules | 28 capsule P £29.78 DT = £28.50c
▶ Adult: 50–150 mg every 4 hours
▶ BY SUBCUTANEOUS INJECTION, OR BY INTRAMUSCULAR
▶ Adult: 25–100 mg, then 25–100 mg after 4 hours, for
debilitated patients use dose described for elderly
▶ Elderly: Initially 25 mg, then 25–100 mg after 4 hours
▶ BY SLOW INTRAVENOUS INJECTION
▶ Adult: 25–50 mg, then 25–50 mg after 4 hours, for
debilitated patients use dose described for elderly
▶ Elderly: Initially 25 mg, then 25–50 mg after 4 hours
▶ BY SUBCUTANEOUS INJECTION, OR BY INTRAMUSCULAR
▶ Adult: 50–100 mg, then 50–100 mg after 1–3 hours if
required; maximum 400 mg per day
▶ Adult: 25–100 mg, dose to be given 1 hour before
operation, for debilitated patients use dose described
▶ Elderly: 25 mg, dose to be given 1 hour before
▶ BY SUBCUTANEOUS INJECTION, OR BY INTRAMUSCULAR
▶ Adult: 25–100 mg every 2–3 hours if required, for
debilitated patients use dose described for elderly
▶ Elderly: Initially 25 mg every 2–3 hours if required
l CONTRA-INDICATIONS Phaeochromocytoma
l CAUTIONS Accumulation of metabolites may result in
neurotoxicity . cardiac arrhythmias . not suitable for severe
continuing pain . severe cor pulmonale
l INTERACTIONS → Appendix 1: opioids
Biliary spasm . dysuria . hypothermia
▶ With oral use Agitation . mood altered . muscle rigidity . sexual dysfunction . ureteral spasm
▶ With parenteral use Anxiety . asthenia . coordination
abnormal . delirium . seizure . syncope .tremor
Overdose Convulsions reported in overdosage.
l BREAST FEEDING Present in milk but not known to be
l HEPATIC IMPAIRMENT Manufacturer advises caution in
mild to moderate impairment; avoid in severe impairment.
Dose adjustments Manufacturer advises dose reduction in
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. Forms available
from special-order manufacturers include: capsule, oral
solution, solution for injection
CAUTIONARY AND ADVISORY LABELS 2
▶ Pethidine hydrochloride (Non-proprietary)
Pethidine hydrochloride 50 mg Pethidine 50mg tablets | 50 tablet P £49.92 DT = £49.92b
▶ Pethidine hydrochloride (Non-proprietary)
Pethidine hydrochloride 50 mg per 1 ml Pethidine 50mg/1ml
solution for injection ampoules | 10 ampoule P £5.11 DT =
£5.11b Pethidine 100mg/2ml solution for injection ampoules | 10 ampoule P £4.66 DT = £4.66b
l DRUG ACTION Sufentanil is a potent, highly-selective μopioid receptor agonist.
Acute moderate-to-severe post-operative pain
▶ BY SUBLINGUAL ADMINISTRATION
▶ Adult (specialist supervision in hospital): 15 micrograms
every 20 minutes if required for a maximum of 72 hours
l CAUTIONS Brain tumour. head injury . history of
(including increased intracranial pressure and impaired
l INTERACTIONS → Appendix 1: opioids
▶ Common or very common Dyspepsia .fever. muscle
▶ Uncommon Apnoea . asthenia . chills . paraesthesia
l PREGNANCY Manufacturer advises avoid—toxicity in
l BREAST FEEDING Manufacturer advises avoid—risk of
opioid effects or toxicity in the infant.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
moderate to severe impairment (limited information
l RENAL IMPAIRMENT Manufacturer advises caution and
close monitoring in severe impairment—limited
l DIRECTIONS FOR ADMINISTRATION Manufacturer advises
doses should be administered using patient controlled
analgesia administration device—consult product
l PATIENT AND CARER ADVICE Manufacturer advises
patients should avoid eating and drinking, and minimise
talking, for 10 minutes after each dose. Patients should be
instructed on appropriate use of the patient controlled
analgesia administration device—consult product
Driving and skilled tasks Manufacturer advises patients
should be counselled on the effects on driving and skilled
tasks—increased risk of dizziness and visual disturbances.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 3, 26
Sufentanil (as Sufentanil citrate) 15 microgram Zalviso
15microgram sublingual tablets sugar-free | 800 tablet P £1,065.00 (Hospital only)b
Moderate to severe acute pain which can be managed only
▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶ Adult: Initially 50 mg every 4–6 hours, adjusted
according to response, on the first day of treatment, an
additional dose of 50 mg may be taken 1 hour after the
initial dose; maximum 700 mg in the first 24 hours;
▶ BY MOUTH USING MODIFIED-RELEASE MEDICINES
▶ Adult: Initially 50 mg every 12 hours, adjusted
according to response; maximum 500 mg per day
MHRA/CHM ADVICE: TAPENTADOL (PALEXIA ®): RISK OF SEIZURES
AND REPORTS OF SEROTONIN SYNDROME WHEN COADMINISTERED WITH OTHER MEDICINES (JANUARY 2019)
Tapentadol can induce seizures and should be prescribed
with caution in patients with a history of seizure
disorders or epilepsy. Seizure risk may be increased in
patients taking other medicines that lower seizure
threshold, for example, antidepressants such as selective
serotonin reuptake inhibitors (SSRIs), serotoninnoradrenaline reuptake inhibitors (SNRIs), tricyclic
antidepressants, and antipsychotics.
Serotonin syndrome has been reported when
tapentadol is used in combination with serotonergic
antidepressants—withdrawal of the serotonergic
medicine, together with supportive symptomatic care,
usually brings about a rapid improvement in serotonin
l INTERACTIONS → Appendix 1: opioids
involuntary . oedema . sensation abnormal . urinary
l BREAST FEEDING Avoid—no information available.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
moderate impairment; avoid in severe impairment (no
Dose adjustments Manufacturer advises reduce initial daily
dose in moderate impairment. For immediate-release
tablets, initiate at 50 mg up to every 8 hours; for oral
l RENAL IMPAIRMENT Manufacturer advises avoid in severe
impairment (no information available).
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (June 2011)
that tapentadol (Palexia ® SR) is accepted for restricted use
within NHS Scotland for the management of severe
chronic pain in adult patients, which can be adequately
managed only with opioid analgesics, when morphine
sulfate modified-release has failed to provide adequate
pain control or is not tolerated.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 2
EXCIPIENTS: May contain Propylene glycol
Tapentadol (as Tapentadol hydrochloride) 20 mg per 1 ml Palexia
20mg/ml oral solution sugar-free | 100 ml P £17.80 DT =
£17.80bsugar-free | 200 ml P £35.60b
CAUTIONARY AND ADVISORY LABELS 2, 25
Tapentadol (as Tapentadol hydrochloride) 50 mg Palexia SR 50mg
tablets | 28 tablet P £12.46 DT = £12.46b | 56 tablet P £24.91b
Tapentadol (as Tapentadol hydrochloride) 100 mg Palexia SR
100mg tablets | 56 tablet P £49.82 DT = £49.82b
Tapentadol (as Tapentadol hydrochloride) 150 mg Palexia SR
150mg tablets | 56 tablet P £74.73 DT = £74.73b
Tapentadol (as Tapentadol hydrochloride) 200 mg Palexia SR
200mg tablets | 56 tablet P £99.64 DT = £99.64b
Tapentadol (as Tapentadol hydrochloride) 250 mg Palexia SR
250mg tablets | 56 tablet P £124.55 DT = £124.55b
CAUTIONARY AND ADVISORY LABELS 2
Tapentadol (as Tapentadol hydrochloride) 50 mg Palexia 50mg
tablets | 28 tablet P £12.46 DT = £12.46b | 56 tablet P £24.91b
Tapentadol (as Tapentadol hydrochloride) 75 mg Palexia 75mg
tablets | 28 tablet P £18.68 DT = £18.68b | 56 tablet P £37.37b
Tramadol hydrochloride 07-Sep-2018
▶ BY INTRAMUSCULAR INJECTION, OR BY INTRAVENOUS
INJECTION, OR BY INTRAVENOUS INFUSION
▶ Adult: 50–100 mg every 4–6 hours, intravenous
injection to be given over 2–3 minutes
▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶ Child 12–17 years: Initially 100 mg, then 50–100 mg
every 4–6 hours; Usual maximum 400 mg/24 hours
▶ Adult: Initially 100 mg, then 50–100 mg every
4–6 hours; Usual maximum 400 mg/24 hours
Moderate to severe chronic pain
▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶ Child 12–17 years: Initially 50 mg, then, adjusted
according to response; Usual maximum
▶ Adult: Initially 50 mg, then, adjusted according to
response; Usual maximum 400 mg/24 hours
▶ Adult: Initially 100 mg, then 50 mg every
10–20 minutes if required up to total maximum 250 mg
(including initial dose) in first hour, then 50–100 mg
every 4–6 hours, intravenous injection to be given over
2–3 minutes; maximum 600 mg per day continued→
Moderate to severe pain (with modified-release 12-hourly
▶ BY MOUTH USING MODIFIED-RELEASE MEDICINES
▶ Child 12–17 years: 50–100 mg twice daily, increased if
necessary to 150–200 mg twice daily, doses exceeding
the usual maximum not generally required; Usual
▶ Adult: 50–100 mg twice daily, increased if necessary to
150–200 mg twice daily, doses exceeding the usual
maximum not generally required; Usual maximum
Moderate to severe pain (with modified-release 24-hourly
▶ BY MOUTH USING MODIFIED-RELEASE MEDICINES
▶ Child 12–17 years: Initially 100–150 mg once daily,
increased if necessary up to 400 mg once daily; Usual
▶ Adult: Initially 100–150 mg once daily, increased if
necessary up to 400 mg once daily; Usual maximum
▶ BY MOUTH USING MODIFIED-RELEASE TABLETS
▶ Child 12–17 years: Initially 150 mg once daily, increased
if necessary up to 400 mg once daily
▶ Adult: Initially 150 mg once daily, increased if
necessary up to 400 mg once daily
Do not confuse modified-release 12-hourly preparations
with 24-hourly preparations, see Prescribing and
hypnotics . acute intoxication with opioids . compromised
respiratory function (in children). not suitable for narcotic
withdrawal treatment. uncontrolled epilepsy
l CAUTIONS Excessive bronchial secretions . history of
opioid-dependent patients . not suitable in some types of
reasons . variation in metabolism
▶ General anaesthesia Not recommended for analgesia during
potentially light planes of general anaesthesia (possibly
increased intra-operative recall reported).
▶ Variation in metabolism The capacity to metabolise tramadol
can vary considerably between individuals; there is a risk
of developing side-effects of opioid toxicity in patients
reduced in poor tramadol metabolisers.
▶ Postoperative use Manufacturer advises extreme caution
when used for postoperative pain relief in children—
reports of rare, but life threatening adverse events after
tonsillectomy and/or adenoidectomy for obstructive sleep
apnoea; if used, monitor closely for symptoms of opioid
l INTERACTIONS → Appendix 1: opioids
▶ Common or very common Fatigue
▶ Frequency not known Asthma exacerbated . hypoglycaemia
▶ With parenteral use Circulatory collapse . gastrointestinal
▶ With oral use Anxiety . blood disorder. gastrointestinal
disorder. hyperkinesia . hypertension . paraesthesia . syncope .tremor. urinary disorder
l PREGNANCY Embryotoxic in animal studies—
l BREAST FEEDING Amount probably too small to be
harmful, but manufacturer advises avoid.
l HEPATIC IMPAIRMENT Manufacturers advise caution (risk
of delayed elimination); some oral preparations should be
avoided in severe impairment—consult product literature.
Dose adjustments Manufacturers advise consider
l RENAL IMPAIRMENT Avoid use or reduce dose; opioid
effects increased and prolonged and increased cerebral
sensitivity occurs. Caution (avoid for oral drops) in severe
l TREATMENT CESSATION Manufacturer advises consider
tapering the dose gradually to prevent withdrawal
l DIRECTIONS FOR ADMINISTRATION Tramadol
hydrochloride orodispersible tablets should be sucked and
then swallowed. May also be dispersed in water. Some
tramadol hydrochloride modified-release capsule
preparations may be opened and the contents swallowed
immediately without chewing—check individual
For intravenous infusion, dilute in Glucose 5% or Sodium
l PRESCRIBING AND DISPENSING INFORMATION Modifiedrelease preparations are available as 12-hourly or
24-hourly formulations. Non-proprietary preparations of
modified-release tramadol may be available as either
12-hourly or 24-hourly formulations; prescribers and
dispensers must ensure that the correct formulation is
prescribed and dispensed. Branded preparations that
should be given 12-hourly include Invodol ® SR, Mabron ®,
Maneo ®, Marol ®, Maxitram® SR, Oldaram®, Tilodol ® SR,
Tramquel ® SR, Tramulief ® SR, Zamadol ® SR, Zeridame ® SR
and Zydol SR ®. Preparations that should be given
24-hourly include Tradorec XL ®, Zamadol ® 24hr, and Zydol
l PATIENT AND CARER ADVICE Patients or carers should be
given advice on how to administer tramadol hydrochloride
Medicines for Children leaflet: Tramadol for pain
www.medicinesforchildren.org.uk/tramadol-pain
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, 25
▶ Brimisol PR (Bristol Laboratories Ltd)
Tramadol hydrochloride 100 mg Brimisol PR 100mg tablets |
60 tablet P £18.00c ▶ Invodol SR (Ennogen Healthcare Ltd)
Tramadol hydrochloride 100 mg Invodol SR 100mg tablets | 60 tablet P £5.55c
Tramadol hydrochloride 150 mg Invodol SR 150mg tablets | 60 tablet P £8.31c
Tramadol hydrochloride 100 mg Mabron 100mg modified-release
Tramadol hydrochloride 150 mg Mabron 150mg modified-release
Tramadol hydrochloride 200 mg Mabron 200mg modified-release
tablets | 60 tablet P £31.04c ▶ Maneo (Mylan)
Tramadol hydrochloride 100 mg Maneo 100mg modified-release
Tramadol hydrochloride 150 mg Maneo 150mg modified-release
Tramadol hydrochloride 200 mg Maneo 200mg modified-release
tablets | 60 tablet P £14.20c ▶ Marol (Teva UK Ltd)
Tramadol hydrochloride 100 mg Marol 100mg modified-release
Tramadol hydrochloride 150 mg Marol 150mg modified-release
Tramadol hydrochloride 200 mg Marol 200mg modified-release
tablets | 60 tablet P £14.19c ▶ Tilodol SR (Sandoz Ltd)
Tramadol hydrochloride 100 mg Tilodol SR 100mg tablets | 60 tablet P £15.52c
Tramadol hydrochloride 150 mg Tilodol SR 150mg tablets |
Tramadol hydrochloride 100 mg Tradorec XL 100mg tablets | 30 tablet P £14.10c
Tramadol hydrochloride 200 mg Tradorec XL 200mg tablets | 30 tablet P £14.98c
Tramadol hydrochloride 300 mg Tradorec XL 300mg tablets |
30 tablet P £22.47c ▶ Tramulief SR (Advanz Pharma)
Tramadol hydrochloride 100 mg Tramulief SR 100mg tablets | 60 tablet P £6.98c
Tramadol hydrochloride 150 mg Tramulief SR 150mg tablets | 60 tablet P £10.48c
Tramadol hydrochloride 150 mg Zamadol 24hr 150mg modifiedrelease tablets | 28 tablet P £10.70c
Tramadol hydrochloride 200 mg Zamadol 24hr 200mg modifiedrelease tablets | 28 tablet P £14.26c
Tramadol hydrochloride 300 mg Zamadol 24hr 300mg modifiedrelease tablets | 28 tablet P £21.39c
Tramadol hydrochloride 100 mg Zeridame SR 100mg tablets | 60 tablet P £17.21c
Tramadol hydrochloride 150 mg Zeridame SR 150mg tablets |
Tramadol hydrochloride 50 mg Zydol SR 50mg tablets | 60 tablet P £4.60 DT = £4.60c
Tramadol hydrochloride 100 mg Zydol SR 100mg tablets | 60 tablet P £17.22c
Tramadol hydrochloride 150 mg Zydol SR 150mg tablets |
Tramadol hydrochloride 150 mg Zydol XL 150mg tablets | 30 tablet P £12.18c
Tramadol hydrochloride 200 mg Zydol XL 200mg tablets | 30 tablet P £17.98c
Tramadol hydrochloride 300 mg Zydol XL 300mg tablets |
Tramadol hydrochloride 400 mg Zydol XL 400mg tablets | 30 tablet P £32.47c
▶ Zytram SR (Qdem Pharmaceuticals Ltd)
Tramadol hydrochloride 100 mg Zytram SR 100mg tablets | 60 tablet P £6.94c
Tramadol hydrochloride 150 mg Zytram SR 150mg tablets | 60 tablet P £10.39c
Tramadol hydrochloride 200 mg Zytram SR 200mg tablets | 60 tablet P £14.19c
CAUTIONARY AND ADVISORY LABELS 2, 13
▶ Tramadol hydrochloride (Non-proprietary)
Tramadol hydrochloride 50 mg per 1 ml Tramadol 100mg/2ml
solution for injection ampoules | 5 ampoule P £4.90 DT =
£4.00c | 10 ampoule P £10.00c ▶ Zamadol (Meda Pharmaceuticals Ltd)
Tramadol hydrochloride 50 mg per 1 ml Zamadol 100mg/2ml
solution for injection ampoules | 5 ampoule P £5.49 DT =
£4.00c ▶ Zydol (Grunenthal Ltd)
Tramadol hydrochloride 50 mg per 1 ml Zydol 100mg/2ml solution
for injection ampoules | 5 ampoule P £4.00 DT = £4.00c
CAUTIONARY AND ADVISORY LABELS 2, 25
Tramadol hydrochloride 50 mg Maxitram SR 50mg capsules | 60 capsule P £4.55 DT = £7.24c
Tramadol hydrochloride 100 mg Maxitram SR 100mg capsules | 60 capsule P £12.14 DT = £14.47c
Tramadol hydrochloride 150 mg Maxitram SR 150mg capsules |
60 capsule P £18.21 DT = £21.71c
Tramadol hydrochloride 50 mg Tramquel SR 50mg capsules | 60 capsule P £7.24 DT = £7.24c
Tramadol hydrochloride 100 mg Tramquel SR 100mg capsules | 60 capsule P £14.47 DT = £14.47c
Tramadol hydrochloride 150 mg Tramquel SR 150mg capsules |
60 capsule P £21.71 DT = £21.71c
Tramadol hydrochloride 50 mg Zamadol SR 50mg capsules | 60 capsule P £7.24 DT = £7.24c
Tramadol hydrochloride 100 mg Zamadol SR 100mg capsules | 60 capsule P £14.47 DT = £14.47c
Tramadol hydrochloride 150 mg Zamadol SR 150mg capsules |
60 capsule P £21.71 DT = £21.71c
Tramadol hydrochloride 200 mg Zamadol SR 200mg capsules | 60 capsule P £28.93 DT = £28.93c
CAUTIONARY AND ADVISORY LABELS 2, 13
▶ Tramadol hydrochloride (Non-proprietary)
Tramadol (as Tramadol hydrochloride) 100 mg per 1 ml Tramadol
100mg/ml oral drops | 10 ml P £3.50 DT = £3.50c
CAUTIONARY AND ADVISORY LABELS 2
▶ Tramadol hydrochloride (Non-proprietary)
DT = £2.43c ▶ Zamadol (Meda Pharmaceuticals Ltd)
CAUTIONARY AND ADVISORY LABELS 2
▶ Zamadol Melt (Meda Pharmaceuticals Ltd)
Tramadol hydrochloride 50 mg Zamadol Melt 50mg tablets sugarfree | 60 tablet P £7.12 DT = £7.12c
Combinations available: Tramadol with paracetamol, p. 474
Tramadol with dexketoprofen 24-Apr-2018
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, tramadol hydrochloride p. 471,
▶ Adult: 75/25 mg every 8 hours as required for up to
▶ Elderly: 75/25 mg every 8 hours as required for up to
5 days; Usual maximum 150/50 mg/24 hours
DOSE EQUIVALENCE AND CONVERSION
▶ Dose expressed as x/y mg of tramadol/dexketoprofen.
l INTERACTIONS → Appendix 1: NSAIDs . opioids
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 2, 22
▶ Skudexa (A. Menarini Farmaceutica Internazionale SRL) A
Dexketoprofen 25 mg, Tramadol hydrochloride 75 mg Skudexa
75mg/25mg tablets | 10 tablet P £3.68c | 20 tablet P £5.52 DT = £5.52c
Tramadol with paracetamol 22-Feb-2018
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, paracetamol p. 444, tramadol hydrochloride
▶ Child 12–17 years: 75/650 mg every 6 hours as required
▶ Adult: 75/650 mg every 6 hours as required
DOSE EQUIVALENCE AND CONVERSION
▶ The proportions are expressed in the form x/y, where x
and y are the strengths in milligrams of tramadol and
l INTERACTIONS → Appendix 1: opioids . paracetamol
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 2, 13, 29, 30
ELECTROLYTES: May contain Sodium
Tramadol hydrochloride 37.5 mg, Paracetamol 325 mg Tramacet
37.5mg/325mg effervescent tablets sugar-free | 60 tablet P £9.68
CAUTIONARY AND ADVISORY LABELS 2, 25, 29, 30
▶ Tramadol with paracetamol (Non-proprietary)
Tramadol hydrochloride 37.5 mg, Paracetamol 325 mg Tramadol
37.5mg / Paracetamol 325mg tablets | 60 tablet P £2.27–£9.68 DT
Tramadol hydrochloride 75 mg, Paracetamol 650 mg Tramadol
75mg / Paracetamol 650mg tablets | 30 tablet P £19.50 DT =
£19.50c ▶ Tramacet (Grunenthal Ltd)
Tramadol hydrochloride 37.5 mg, Paracetamol 325 mg Tramacet
37.5mg/325mg tablets | 60 tablet P £9.68 DT = £2.35c ▶ Trapadex (Noumed Life Sciences Ltd)
Tramadol hydrochloride 37.5 mg, Paracetamol 325 mg Trapadex
37.5mg/325mg tablets | 60 tablet P s DT = £2.35c
Other drugs used for Headache Clonidine hydrochloride,
p. 145 . Sumatriptan, p. 481 . Verapamil hydrochloride, p. 164
ANTIHISTAMINES › SEDATING ANTIHISTAMINES
Prevention of vascular headache | Prevention of classical
migraine | Prevention of common migraine | Prevention
▶ Adult: Initially 500 micrograms once daily, then
increased to 1.5 mg once daily, dose to be increased
gradually and taken at night, alternatively increased to
1.5 mg daily in 3 divided doses, doses to be increased
gradually; increased if necessary up to 4.5 mg daily
(max. per dose 3 mg), this dose is rarely necessary
▶ Child 5–17 years: Initially 500 micrograms once daily,
dose to be taken at night, then increased to up to
1.5 mg daily in divided doses, dose to be increased
gradually, max. single dose (at night) 1 mg
l UNLICENSED USE 1.5 mg tablets not licensed for use in
l CONTRA-INDICATIONS Acute porphyrias p. 1058
l INTERACTIONS → Appendix 1: antihistamines, sedating
▶ Rare or very rare Aggression . anxiety . arthralgia . central
▶ Frequency not known Hepatic disorders
l PREGNANCY Avoid unless potential benefit outweighs risk.
l BREAST FEEDING Amount probably too small to be
harmful, but manufacturer advises avoid.
l HEPATIC IMPAIRMENT Manufacturer advises caution.
Dose adjustments Manufacturer advises consider dose
l RENAL IMPAIRMENT Use with caution.
Medicines for Children leaflet: Pizotifen to prevent migraine
headaches www.medicinesforchildren.org.uk/pizotifen-preventmigraine-headaches
Driving and skilled tasks Drowsiness may affect
performance of skilled tasks (e.g. driving); effects of
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 solution
CAUTIONARY AND ADVISORY LABELS 2
Pizotifen (as Pizotifen hydrogen malate)
500 microgram Pizotifen 500microgram tablets | 28 tablet P £8.50 DT = £1.02 | 60 tablet P £27.00
Pizotifen (as Pizotifen hydrogen malate) 1.5 mg Pizotifen 1.5mg
tablets | 28 tablet P £8.50 DT = £1.35
Treatment of a migraine attack should be guided by response
to previous treatment and the severity of the attacks. A
simple analgesic such as aspirin p. 121, paracetamol p. 444
(preferably in a soluble or dispersible form) or a NSAID is
often effective; concomitant antiemetic treatment may be
required. If treatment with an analgesic is inadequate, an
attack may be treated with a specific antimigraine compound
such as a 5HT1-receptor agonist (‘triptan’). Ergot alkaloids
are rarely required now; oral preparations are associated
with many side-effects and should be avoided in
cerebrovascular or cardiovascular disease.
Excessive use of acute treatments for migraine (opioid and
non-opioid analgesics, 5HT1-receptor agonists, and
ergotamine) is associated with medication-overuse headache
(analgesic-induced headache); therefore, increasing
consumption of these medicines needs careful management.
Most migraine headaches respond to analgesics such as
aspirin or paracetamol but because peristalsis is often
reduced during migraine attacks the medication may not be
sufficiently well absorbed to be effective; dispersible or
effervescent preparations are therefore preferred.
Compound preparations containing analgesics and
The NSAID tolfenamic acid p. 476 is licensed specifically
for the treatment of an acute attack of migraine; diclofenac
potassium p. 1135, flurbiprofen p. 1140, and ibuprofen
p. 1141 are also licensed for use in migraine.
A 5HT1-receptor agonist is of considerable value in the
treatment of an acute migraine attack. The 5HT1-receptor
agonists (‘triptans’) act on the 5HT (serotonin) 1B/1D
receptors and they are therefore sometimes referred to as
5HT1B/1D-receptor agonists. A 5HT1-receptor agonist may be
used during the established headache phase of an attack and
is the preferred treatment in those who fail to respond to
conventional analgesics. 5HT1-receptor agonists are not
indicated for the treatment of hemiplegic, basilar, or
The 5HT1-receptor agonists available for treating migraine
are almotriptan p. 478, eletriptan p. 479, frovatriptan p. 479,
naratriptan p. 480, rizatriptan p. 480, sumatriptan p. 481,
and zolmitriptan p. 482. If a patient does not respond to one
5HT1-receptor agonist, an alternative 5HT1-receptor agonist
should be tried. For patients who have prolonged attacks
that frequently recur despite treatment with a
5HT1-receptor agonist, combination therapy with a NSAID
such as naproxen can be considered. Sumatriptan or
zolmitriptan are also used to treat cluster headache.
The value of ergotamine tartrate p. 478 for migraine is
limited by difficulties in absorption and by its side-effects,
particularly nausea, vomiting, abdominal pain, and muscular
cramps; it is best avoided. The recommended doses of
ergotamine tartrate preparations should not be exceeded
and treatment should not be repeated at intervals of less
To avoid habituation the frequency of administration of
ergotamine tartrate should be limited to no more than twice
a month. It should never be prescribed prophylactically but
in the management of cluster headache a low dose is
occasionally given for 1 to 2 weeks [unlicensed indication].
Antiemetics, such as metoclopramide hydrochloride p. 432
or domperidone p. 431, or phenothiazine and antihistamine
antiemetics, relieve the nausea associated with migraine
attacks. Antiemetics may be given by intramuscular injection
or rectally if vomiting is a problem. Metoclopramide
hydrochloride and domperidone have the added advantage
of promoting gastric emptying and normal peristalsis; a
single dose should be given at the onset of symptoms. Oral
analgesic preparations containing metoclopramide
hydrochloride are a convenient alternative.
Where migraine attacks are frequent, possible provoking
factors such as stress, irregular life-style (e.g. lack of sleep),
or chemical triggers (e.g. alcohol and nitrates) should be
sought; combined oral contraceptives may also provoke
Preventive treatment for migraine should be considered
. suffer at least two attacks a month;
. suffer an increasing frequency of headaches;
. suffer significant disability despite suitable treatment for
. cannot take suitable treatment for migraine attacks.
Prophylaxis is also necessary in some rare migraine
subtypes and those at risk of migrainous infarction.
The beta-blockers propranolol hydrochloride p. 150,
atenolol p. 152, metoprolol tartrate p. 154, nadolol p. 149,
and timolol maleate p. 151 are all effective. Propranolol
hydrochloride is the most commonly used.
Tricyclic antidepressants [unlicensed indication],
gabapentin p. 315 [unlicensed indication], topiramate p. 331,
sodium valproate p. 327 [unlicensed indication], and valproic
acid p. 354 [unlicensed indication] are also effective for
preventing migraine. See Conception and contraception, and
Pregnancy in the topiramate drug monograph for
information on use in females of childbearing potential and
Valproic acid and sodium valproate are highly teratogenic.
They must not be used in females of childbearing potential
unless the conditions of the Pregnancy Prevention
Programme are met and alternative treatments are
ineffective or not tolerated, and must not be used during
pregnancy for migraine prophylaxis. For further information
see Important safety information, Conception and
contraception, and Pregnancy in the valproic acid and sodium
antidepressants. It is of limited value and may cause weight
Botulinum toxin type A p. 407 is licensed for the
prophylaxis of headaches in adults with chronic migraine.
Cluster headache and the trigeminal autonomic
Cluster headache rarely responds to standard analgesics.
Sumatriptan given by subcutaneous injection is the drug of
choice for the treatment of cluster headache. If an injection is
unsuitable, sumatriptan nasal spray or zolmitriptan nasal
spray [both unlicensed use] may be used. Alternatively, 100%
oxygen at a rate of 10–15 litres/minute for 10–20 minutes is
Prophylaxis of cluster headache is considered if the attacks
are frequent, last over 3 weeks, or if they cannot be treated
effectively. Verapamil hydrochloride p. 164 or lithium [both
unlicensed use] are used for prophylaxis.
Prednisolone p. 678 can be used for short-term
prophylaxis of episodic cluster headache [unlicensed use]
either as monotherapy, or in combination with verapamil
hydrochloride during verapamil titration.
Ergotamine tartrate, used on an intermittent basis is an
alternative for patients with short bouts, but it should not be
The other trigeminal autonomic cephalalgias, paroxysmal
conjunctival injection and tearing, are seen rarely and are
Other drugs used for Migraine Amitriptyline hydrochloride,
p. 372 . Candesartan cilexetil, p. 175 . Clonidine
hydrochloride, p. 145 . Cyclizine, p. 430 . Trifluoperazine,
Paracetamol with isometheptene
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, paracetamol p. 444.
Treatment of acute attacks of migraine
▶ Adult: 2 capsules, dose to be taken at onset of attack,
followed by 1 capsule every 1 hour if required,
maximum of 5 capsules in 12 hours
l CONTRA-INDICATIONS Acute porphyrias p. 1058
l INTERACTIONS → Appendix 1: paracetamol . sympathomimetics, vasoconstrictor
l PATIENT AND CARER ADVICE Patient counselling is advised
l LESS SUITABLE FOR PRESCRIBING Isometheptene with
paracetamol is less suitable for prescribing (more effective
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 30
Isometheptene mucate 65 mg, Paracetamol 325 mg Midrid
325mg/65mg capsules | 30 capsule P £7.50
Paracetamol with metoclopramide
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, paracetamol p. 444, metoclopramide
▶ Adult: 2 tablets, to be taken at the onset of attack,
followed by 2 tablets every 4 hours if required;
▶ BY MOUTH USING EFFERVESCENT POWDER SACHETS
▶ Adult: 2 sachets, to be taken at the onset of attack,
followed by 2 sachets every 4 hours if required, sachets
to be dissolved in a quarter tumblerful of water;
Metoclopramide can cause severe extrapyramidal
effects, particularly in young adults.
l CAUTIONS Treatment should not exceed 3 months due to
l INTERACTIONS → Appendix 1: metoclopramide . paracetamol
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 13, 17, 30
Metoclopramide hydrochloride 5 mg, Paracetamol
500 mg Paramax sachets sugar-free | 42 sachet P £12.52 DT =
CAUTIONARY AND ADVISORY LABELS 17, 30
Metoclopramide hydrochloride 5 mg, Paracetamol
500 mg Paramax tablets | 42 tablet P £9.64 DT = £9.64
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, metoclopramide
▶ Adult: 1 sachet, sachet to be mixed in water, and dose
to be taken at the start of the attack, then 1 sachet after
2 hours if required; maximum 3 sachets per day
Metoclopramide can cause severe extrapyramidal
effects, particularly in children and young adults.
l CAUTIONS Treatment should not exceed 3 months due to
l INTERACTIONS → Appendix 1: aspirin . metoclopramide
l PRESCRIBING AND DISPENSING INFORMATION Flavours of
oral powder formulations may include lemon.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 13, 21, 32
EXCIPIENTS: May contain Aspartame
Metoclopramide hydrochloride 10 mg, Aspirin DL-Lysine
900 mg MigraMax oral powder sachets sugar-free | 6 sachet P £6.61 DT = £6.61
▶ Adult: 200 mg, dose to be taken at onset, then 200 mg
distinct episodes). history of gastro-intestinal perforation
related to previous NSAID therapy . history of recurrent
gastro-intestinal ulceration (two or more distinct
episodes). severe heart failure
l CAUTIONS Allergic disorders . cardiac impairment (NSAIDs
may impair renal function). cerebrovascular disease .
coagulation defects . connective-tissue disorders . Crohn’s
disease . peripheral arterial disease .risk factors for
cardiovascular events . ulcerative colitis (may be
exacerbated). uncontrolled hypertension
l INTERACTIONS → Appendix 1: NSAIDs
l SIDE-EFFECTS Agranulocytosis . angioedema . aplastic
anaemia . asthma . confusion . constipation . Crohn’s
thromboembolism . malaise . meningitis aseptic (patients
with connective-tissue disorders such as systemic lupus
(more common in patients with pre-existing renal
impairment).respiratory disorders . severe cutaneous
adverse reactions (SCARs). skin reactions . thrombocytopenia .tinnitus .tremor. vertigo . visual
SIDE-EFFECTS, FURTHER INFORMATION For information
about cardiovascular and gastrointestinal side-effects, and
a possible exacerbation of symptoms in asthma, see Nonsteroidal anti-inflammatory drugs. p. 1130
l ALLERGY AND CROSS-SENSITIVITY Contra-indicated in
patients with a history of hypersensitivity to aspirin or any
other NSAID—which includes those in whom attacks of
asthma, angioedema, urticaria or rhinitis have been
precipitated by aspirin or any other NSAID.
l CONCEPTION AND CONTRACEPTION Caution—long-term
use of some NSAIDs is associated with reduced female
fertility, which is reversible on stopping treatment.
l PREGNANCY Avoid unless the potential benefit outweighs
the risk. Avoid during the third trimester (risk of closure of
fetal ductus arteriosus in utero and possibly persistent
pulmonary hypertension of the newborn); onset of labour
may be delayed and duration may be increased.
l BREAST FEEDING Amount too small to be harmful. Use
with caution during breast-feeding.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
mild to moderate impairment; avoid in severe impairment.
l RENAL IMPAIRMENT Avoid if possible or use with caution.
Dose adjustments The lowest effective dose should be used
for the shortest possible duration.
Monitoring In renal impairment monitor renal function;
sodium and water retention may occur and renal function
may deteriorate, possibly leading to renal failure.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 21
▶ Tolfenamic acid (Non-proprietary)
Tolfenamic acid 200 mg Tolfenamic acid 200mg tablets | 10 tablet P £24.62–£24.63 DT = £24.63
Tolfenamic acid 200 mg Clotam Rapid 200mg tablets |
10 tablet P £12.75 DT = £24.63
ANTIHISTAMINES › SEDATING ANTIHISTAMINES
hydrochloride and codeine phosphate
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, paracetamol p. 444, codeine phosphate
▶ Child 12–14 years: Initially 1 tablet, (pink tablet) to be
taken at onset of attack, or if it is imminent, followed
by 1 tablet every 4 hours if required, (yellow tablet) to
be taken following initial dose; maximum 1 pink and
▶ Child 15–17 years: Initially 2 tablets, (pink tablets) to be
taken at onset of attack or if it is imminent, followed by
2 tablets every 4 hours if required, (yellow tablets) to be
taken following initial dose; maximum 2 pink and
▶ Adult: Initially 2 tablets, (pink tablets) to be taken at
onset of attack or if it is imminent, followed by
2 tablets every 4 hours if required, (yellow tablets) to be
taken following initial dose; maximum 2 pink and
l INTERACTIONS → Appendix 1: antihistamines, sedating . opioids . paracetamol
l PRESCRIBING AND DISPENSING INFORMATION See cocodamol p. 453 for Migraleve Yellow preparations.
l LESS SUITABLE FOR PRESCRIBING
MIGRALEVE ® Migraleve ® is less suitable for prescribing.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 2, 17, 30
▶ Migraleve Pink (McNeil Products Ltd)
Buclizine hydrochloride 6.25 mg, Codeine phosphate 8 mg,
Paracetamol 500 mg Migraleve Pink tablets | 12 tablet p
£3.79m | 24 tablet p £6.08m | 48 tablet P £3.97m ▶ Migraleve Yellow (McNeil Products Ltd)
Codeine phosphate 8 mg, Paracetamol 500 mg Migraleve Yellow
CALCITONIN GENE-RELATED PEPTIDE
l DRUG ACTION Erenumab is a human monoclonal antibody
that binds to the calcitonin-gene related peptide (CGRP)
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