Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: M & A Pharmachem Ltd, Allenby Laboratories Wigan, Road, Westhoughton, Bolton BL5, 2AL
For the relief of severe pain.
Codeine is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen (alone).
For oral administration.
The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician.
One or two tablets not more frequently than every 4-6 hours, up to a maximum of 8 tablets in any 24 hour period.
Same as for adults, however a reduced dose may be required (see section 4.4).
Children aged 16-18 years: One or two tablets every 6 hours when necessary up to a maximum of 8 tablets in 24 hours.
Children aged 12-15 years: One tablet every 6 hours when necessary up to a maximum of 4 tablets in 24 hours.
Children aged less than 12 years: Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine (see section 4.3 and 4.4).
Dosage should be adjusted accordingly to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciable increased incidence of undesirable side effects.
Symptoms of paracetamol overdosage in the first 24 hours are sweating, pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, hypotension, cerebral oedema, coma and death. Prothrombin time may increase with deteriorating liver function.
Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage.
Cardiac arrhythmias and pancreatitis have been reported.
Liver damage is possible in adults who have taken 10 g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of Paracetamol are ingested), become irreversibly bound to liver tissue.
Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has any of the following risk factors:
a) is on long term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.
b) regularly consumes ethanol in excess of recommended amounts
c) is likely to be gluathine deplete e.g. eating disorders, cystic fibrosis, HIV, infection, starvation, cachexia.
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention and any patient who has ingested around 7.5 g or more of paracetamol in the proceeding 4 hours should undergo gastric lavage.. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines (see BNF overdose section).
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to at least 48 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N- acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.
The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.
Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co- ingested, including alcohol, or the overdose is very large.
Symptoms of codeine overdosage include cold clammy skin, skeletal muscle flaccidity, confusion, convulsions, dizziness, drowsiness, nervousness or restlessness, miosis, bradycardia, dyspnoea, unconsciousness, circulatory failure and deepening coma. The pupils may be pinpoint in size; Nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely.
In severe overdose with codeine, apnoea, circulatory collapse, cardiac arrest and death may occur (from respiratory failure).
This should include general symptomatic and supportive measures including a clear airway and the institution of controlled ventilation and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350mg or a child more than 5mg/kg. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated.
Intensive support therapy may be required to correct respiratory failure and shock due to the effects of codeine. In addition the specific narcotic antagonist, naloxone hydrochloride, may be used to rapidly counteract the severe respiratory depression and coma. Naloxone has a short half-life so large and repeated doses may be required in a seriously poisoned patient. A dose of 0.4-2 mg is given intravenously or intramuscularly to adults, this is repeated at intervals of 2-3 minutes if necessary. Up to a total of 10 mg of naloxone may be given. In children doses of naloxone of 5-10 mcg/kg bodyweight may be given intravenously or intramuscularly. Observe for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken.
Codeine is not dialysable.
36 months.
Do not store above 25°C. Store in the original package.
Blister pack strips, constructed from 250 micron PVC film lidded with aluminium foil containing 10, 20, 30, 50 or 100 tablets per strip.
Not applicable.
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