Summer 2010 - The British Pain Society

Pain
controlled
Constipation
restrained1
T0045 Date of preparation of item: January 2010.
By harnessing the synergistic effect of 37.5 mg tramadol and 325 mg
paracetamol, 1-4 Tramacet delivers the same level of analgesia as 30/300 mg
co-codamol – with 46% less constipation. 1 When patients can’t tolerate
co-codamol, consider Tramacet – and now there’s a new presentation,
Tramacet effervescent tablets.
TRAMACET 37.5 mg/325 mg, film-coated and effervescent tablets. Refer to
the Summary of Product Characteristics (SPC) for full details on side effects,
warnings, contra-indications and overdose before prescribing. Presentation:
Each film-coated and effervescent tablet contains 37.5 mg tramadol hydrochloride
and 325 mg paracetamol. Film-coated tablets are pale yellow. Effervescent tablets
are orange flavoured round shaped flat with bevelled edges, off white to slightly
rosy coloured with some coloured speckles. One effervescent tablet contains
0.4 mg sunset yellow and 179.4 mg sodium. Indication: Symptomatic treatment
of moderate to severe pain; in patients whose moderate to severe pain is
considered to require a combination of tramadol and paracetamol. Dosage and
method of administration: Oral use. Film-coated tablets must be swallowed
whole (not be broken or chewed) with sufficient liquid. Effervescent tablets should
be taken dissolved in a glass of drinking water. Adults, elderly and children over
12 years: Initial dose of two tablets; additional doses (not less than 6 hours
interval) up to 8 tablets (300 mg tramadol and 2600 mg paracetamol) per day.
Treat no longer than necessary, otherwise monitor. Children below 12 years:
Not recommended. Renal insufficiency: Not for use in patients with severe
insufficiency (creatinine clearance < 10 ml/min). Increase dosing to 12-hourly
intervals in moderate insufficiency (creatinine clearance between 10 and 30
ml/min). Hepatic insufficiency: Not for use in severe impairment. Consider dosing
in moderate impairment. Contra-indications: Hypersensitivity to ingredients,
acute intoxication with alcohol, hypnotic medicinal products, centrally-acting
analgesics, opioids or psychotropic medicinal products. Current treatment with
monoamine oxidase inhibitors (MAOIs) or within 14 days of use. Severe hepatic
impairment. Epilepsy not controlled by treatment. Special Warnings and
precautions: Not recommended in cases of severe respiratory insufficiency,
severe renal insufficiency, and severe hepatic impairment. Paracetamol
overdosage may cause hepatic toxicity. Use with caution in patients susceptible
to seizures or being treated with medication to lower seizure threshold, especially
selective serotonin re-uptake inhibitors (SSRIs), tricyclic antidepressants (TCAs),
antipsychotics, centrally acting analgesics or local anaesthesia, due to the risk of
convulsions. Concomitant use of opioid agonists-antagonists is not recommended.
Use with caution in patients who have cranial trauma, biliary tract disorders,
in a state of shock, in an altered state of consciousness, with respiratory
dysfunction, or with an increased intracranial pressure. Tramadol cannot suppress
morphine withdrawal symptoms. Tramadol can cause withdrawal symptoms,
dependence or abuse. Avoid using during light planes of anaesthesia. In addition
for the effervescent tablets: Sunset yellow E110 may cause allergic reactions.
Sodium content to be taken into consideration by patients on a controlled
sodium diet. Interactions: Concomitant use is not recommended with alcohol,
carbamazepine and other enzyme inducers, and opioid agonists-antagonists.
Consider concomitant use with serotoninergic medicines such as SSRIs and
triptans, due to risk of Serotonin Syndrome. Other opioid derivatives (including
antitussive drugs, substitutive treatments), benzodiazepines and barbiturates
may increase the risk of respiratory depression. Other central nervous system
depressants (anxiolytics, hypnotics, sedative antidepressants, sedative
antihistamines, neuroleptics, centrally-acting antihypertensive drugs, thalidomide,
baclofen), can increase the risk of central depression and medicines such as
bupropion, SSRIs, TCAs and neuroleptics can increase the risk of convulsions.
Evaluate prothrombin time periodically if given with warfarin like compounds.
Other drugs known to inhibit CYP3A4 (ketoconazole and erythromycin),
might inhibit the metabolism of tramadol (N-demethylation) and the active
O-demethylated metabolite. Concomitant use with metoclopramide or
domperidone may increase the absorption of paracetamol and cholestyramine
may reduce the absorption. In limited cases, use of ondansetron increased
tramadol requirement in postoperative pain. May affect ability to drive or
operate machinery; effects are enhanced by alcohol or other CNS depressants.
Pregnancy and lactation: Do not use. Undesirable effects: Very common
( ≥1/10): dizziness, somnolence, nausea. Common ( ≥1/100,