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Table of Contents
ACTIVE INGREDIENTS
Percentage w/v
Specification
Dextromethorphan HBr
0.050
EP
Doxylamine succinate
0.025
USP
Paracetamol
2.000
Pseudoephidrine HCl
0.200
BP
4.9.1 Symptoms
Paracetamol:
Symptoms of paracetamol overdosage in the first 24 hours are 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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported.
Liver damage is likely in adults who have taken 10g 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.
Other symptoms may include CNS depression, cardiovascular effects and renal damage.
4.9.2 Treatment of overdose
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 7.5g or more of paracetamol in the preceeding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N- acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.
Analgesic/antipyretic.
Dextromethorphan HBr:
Anti-tussive.
Doxylamine succinate:
Antihistamine, anticholinergic
Pseudoephidrine hydrochloride:
Sympathomimetic agent - nasal decongestant
Metabolised in the liver and excreted in the urine as glucuronide and sulphate conjugates.
Metabolised in the liver and excreted as unchanged dextromethorphan and demethylated morphinian compounds.
Is believed to to be metabolised in the liver and excreted mainly as metabolites in the urine
Is resistant to metabolism by monoamine oxidase and is largely excreted unchanged in the urine
Patient Information Leaflets (PILs):
Link to this document from your website: http://www.medicines.org.uk/emc/medicine/20331/SPC/
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