OralMild to moderate painAdult: Each tab contains paracetamol 500 mg and codeine phosphate 8 mg: 1-2 tab 4-6 hrly. Max: 8 tab/24 hr. Each 5 mL oral soln contains paracetamol 120 mg and codeine phosphate 12 mg: 15 mL 4 hrly as needed.
Child: Tab: 12-18 yr 1-2 tab 6 hrly. Max: 8 tab/24 hr. Oral soln: 3-6 yr 5 mL 3 or 4 times daily; 7-12 yr 10 mL 3 or 4 times daily.
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Post-op pain management in childn who underwent tonsillectomy and/or adenoidectomy.
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Patient w/ paralytic ileus, GI obstruction, adrenal insufficiency, CNS depression, history of drug abuse or acute alcoholism, head trauma, prostatic hyperplasia and/or urinary stricture, pre-existing resp disease, thyroid dysfunction, known G6PD deficiency, history of seizure disorder. Hepatic or renal impairment. Pregnancy and lactation.
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Nausea, vomiting, constipation, abdominal pain, pruritus, dizziness, drowsiness, lightheadedness, shortness of breath, sedation, euphoria, dysphoria, voice disorder, dyspnoea, allergic reactions, rash, thrombocytopenia, agranulocytosis.
Potentially Fatal: Hepatotoxicity. Rarely, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis, toxic epidermal necrolysis.
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May impair ability to drive and operate machinery.
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Monitor relief of pain, resp and mental status, BP, bowel function and signs or symptoms of hypogonadism or hypoadrenalism.
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Symptoms: Paracetamol: Pallor, nausea, vomiting, anorexia, abdominal pain, metabolic acidosis, glucose metabolism disturbances, liver damage. In severe cases, encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, acute renal failure and death. Codeine: Nausea, vomiting, CNS and resp depression, pinpoint pupils, convulsion, coma. Management: Paracetamol: If presented w/in 1 hr of poisoning, admin activated charcoal. If needed, admin IV N-acetylcysteine or oral methionine. Codeine: Symptomatic and supportive treatment. Consider activated charcoal if an adult presents w/in 1 hr of ingestion. Admin naloxone if in state of coma or resp depression. Repeated doses may be needed in a seriously poisoned patient.
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Increased paracetamol absorption w/ metoclopramide and domperidone. May increase risk of bleeding w/ warfarin and other coumarins. Codeine may antagonise GI effects of metoclopramide and domperidone. Increased CNS depression w/ CNS depressants (e.g. anaesth, anxiolytics, hypnotics, TCAs, and antipsychotics).
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Sedative effects may be potentiated when used w/ alcohol.
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Paracetamol may cause false-positive result for urinary 5-hydroxyindoleacetic acid.
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Description:
Mechanism of Action: Paracetamol, a para-aminophenol derivative, exhibits analgesic action by peripheral blockage of pain impulse generation; produces antipyresis by inhibiting the hypothalamic heat-regulating centre; and its weak anti-inflammatory activity is related to inhibition of prostaglandin synthesis in the CNS. Codeine, a phenanthrene derivative, binds to opiate receptor in the CNS, causing inhibition of ascending pain pathways.
Pharmacokinetics:
Absorption: Readily absorbed from GI tract. Bioavailability: 53% (codeine). Time to peak plasma concentration: Approx 10-60 min (paracetamol); approx 1 hr (codeine).
Distribution: Distributed into most body tissues; crosses the placenta and present in breast milk. Volume of distribution: Approx 1 L/kg (paracetamol); approx 3-6 L/kg (codeine). Plasma protein binding: 10-25% (paracetamol); approx 7-25% (codeine).
Metabolism: Paracetamol: Undergoes hepatic metabolism. N-acetyl-p-benzoquinoneimine (minor metabolite) is produced in minute amounts mainly by CYP2E1 and CYP3A4 isoenzymes in the liver and kidney. Codeine: Metabolised by O- and N-demethylation in the liver to morphine, norcodeine, normorphine, hydrocodone and other metabolites.
Excretion: Paracetamol: Via urine mainly as glucuronide and sulfate conjugates w/ <5% excreted as unchanged drug. Codeine: Via urine mainly as conjugates w/ glucuronic acid. Half-life: Approx 1-3 hr (paracetamol); 3-4 hr (codeine).
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Store between 20-25°C. Protect from light.
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Acetaminophen and Codeine Solution (Qualitest Pharmaceuticals). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 22/08/2014. Anon. Acetaminophen and Codeine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 22/08/2014. Anon. Acetaminophen. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 22/08/2014. Anon. Codeine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 22/08/2014. Buckingham R (ed). Codeine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 22/08/2014. Buckingham R (ed). Paracetamol. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 22/08/2014. Codeine Use in Certain Children After Tonsillectomy and/or Adenoidectomy: Drug Safety Communication - Risk of Rare, But Life-Threatening Adverse Events or Death. U.S. FDA. https://www.fda.gov/. Accessed 22/08/2014.
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