Moderate to severe pain (with modified-release 12 -hourly
preparations)
▶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
maximum 400 mg/ 24 hours
Moderate to severe pain (with modified-release 24 -hourly
preparations)
▶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
maximum 400 mg/ 24 hours
ZYDOL®XL
Moderate to severe pain
▶BY MOUTH USING MODIFIED-RELEASE TABLETS
▶Child 12–17 years:Initially 150 mg once daily, increased
if necessary up to 400 mg once dailyIMPORTANT SAFETY INFORMATION
Do not confuse modified-release 12 -hourly preparations
with 24 -hourly preparations, seePrescribing and
dispensing information.lCONTRA-INDICATIONSAcute intoxication with alcohol.
acute intoxication with analgesics.acute intoxication with
hypnotics.acute intoxication with opioids.not suitable
for narcotic withdrawal treatment.uncontrolled epilepsy
lCAUTIONSExcessive bronchial secretions.history of
epilepsy—use tramadol only if compelling reasons.
impaired consciousness.not suitable as a substitute in
opioid-dependent patients.not suitable in some types of
general anaesthesia.susceptibility to seizures—use
tramadol only if compelling reasons
CAUTIONS, FURTHER INFORMATION
▶General anaesthesiaNot recommended for analgesia during
potentially light planes of general anaesthesia (possibly
increased intra-operative recall reported).
lINTERACTIONS→Appendix 1 : opioids
lSIDE-EFFECTS
GENERAL SIDE-EFFECTS
▶Common or very commonFatigue
▶UncommonPostural hypotension
▶Rare or very rareDyspnoea.epileptiform seizure.
respiratory disorders.sleep disorders.vision blurred
▶Frequency not knownAsthma exacerbated.hypoglycaemia
SPECIFIC SIDE-EFFECTS
▶Uncommon
▶With parenteral useCirculatory collapse.gastrointestinal
discomfort.skin eruption
▶Rare or very rare
▶With parenteral useAngioedema.appetite change.
behaviour abnormal.cognitive disorder.dysuria.
hypersensitivity.mood altered.movement disorders.
muscle weakness.perception disorders.psychiatric
disorder.sensation abnormal
▶Frequency not known
▶With oral useAnxiety.blood disorder.gastrointestinal
disorder.hyperkinesia.hypertension.paraesthesia.
syncope.tremor.urinary disorder
lPREGNANCYEmbryotoxic inanimalstudies—
manufacturers advise avoid.
lBREAST FEEDINGAmount probably too small to be
harmful, but manufacturer advises avoid.
lHEPATIC IMPAIRMENTCaution (avoid fororal drops)in
severe impairment.
lRENAL IMPAIRMENTAvoid use or reduce dose; opioid
effects increased and prolonged and increased cerebralsensitivity occurs. Caution (avoid fororal drops) in severe
impairment.
lDIRECTIONS FOR ADMINISTRATIONTramadol
hydrochlorideorodispersible tabletsshould 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
preparations.
Forintravenous infusion, dilute in Glucose 5 % or Sodium
Chloride 0. 9 %.
lPRESCRIBING AND DISPENSING INFORMATIONModified-
release 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 includeInvodol®SR,Mabron®,
Maneo®,Marol®,Maxitram®SR,Oldaram®,Tilodol®SR,
Tramquel®SR,Tramulief®SR,Zamadol®SR,Zeridame®SR
andZydol SR®. Preparations that should be given
24 -hourly includeTradorec XL®,Zamadol® 24 hr, andZydol
XL®.
lPATIENT AND CARER ADVICEPatients or carers should be
given advice on how to administer tramadol hydrochloride
orodispersible tablets.
Medicines for Children leaflet: Tramadol for pain
http://www.medicinesforchildren.org.uk/tramadol-for-painlMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug. Forms available from special-order
manufacturers include: oral suspension
Modified-release tablet
CAUTIONARY AND ADVISORY LABELS2, 25
▶Tramadol hydrochloride (Non-proprietary)
Tramadol hydrochloride 50 mgTramadol 50 mg modified-release
tablets| 60 tabletPsDT = £ 4. 60 c
Tramadol hydrochloride 100 mgTramadol 100 mg modified-release
tablets| 60 tabletP£ 6. 95 – £ 44. 80 c
Tramadol hydrochloride 150 mgTramadol 150 mg modified-release
tablets| 60 tabletP£ 10. 40 – £ 57. 85 c
Tramadol hydrochloride 200 mgTramadol 200 mg modified-release
tablets| 60 tabletP£ 14. 20 – £ 69. 60 c
Tramadol hydrochloride 300 mgTramadol 300 mg modified-release
tablets| 30 tabletPsc
Tramadol hydrochloride 400 mgTramadol 400 mg modified-
release tablets| 28 tabletPsc
▶Brimisol PR(Bristol Laboratories Ltd)
Tramadol hydrochloride 100 mgBrimisol PR 100 mg tablets|
60 tabletP£ 18. 00 c
▶Invodol SR(Ennogen Healthcare Ltd)
Tramadol hydrochloride 100 mgInvodol SR 100 mg tablets|
60 tabletP£ 14. 61 c
Tramadol hydrochloride 150 mgInvodol SR 150 mg tablets|
60 tabletP£ 21. 91 c
Tramadol hydrochloride 200 mgInvodol SR 200 mg tablets|
60 tabletP£ 29. 22 c
▶Mabron(Teva UK Ltd, Morningside Healthcare Ltd)
Tramadol hydrochloride 100 mgMabron 100 mg modified-release
tablets| 60 tabletP£ 15. 52 c
Tramadol hydrochloride 150 mgMabron 150 mg modified-release
tablets| 60 tabletP£ 23. 28 c
Tramadol hydrochloride 200 mgMabron 200 mg modified-release
tablets| 60 tabletP£ 31. 04 c
▶Maneo(Mylan)
Tramadol hydrochloride 100 mgManeo 100 mg modified-release
tablets| 60 tabletP£ 6. 95 c
Tramadol hydrochloride 150 mgManeo 150 mg modified-release
tablets| 60 tabletP£ 10. 40 c
Tramadol hydrochloride 200 mgManeo 200 mg modified-release
tablets| 60 tabletP£ 14. 20 c
▶Marol(Teva UK Ltd)
Tramadol hydrochloride 100 mgMarol 100 mg modified-release
tablets| 60 tabletP£ 6. 94 c288 Pain BNFC 2018 – 2019
Nervous system4