Paracetamol + Codeine

Generic Medicine Info
Indications and Dosage
Mild to moderate pain
Adult: 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.
Post-op pain management in childn who underwent tonsillectomy and/or adenoidectomy.
Special Precautions
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.
Adverse Reactions
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.
Patient Counseling Information
May impair ability to drive and operate machinery.
Monitoring Parameters
Monitor relief of pain, resp and mental status, BP, bowel function and signs or symptoms of hypogonadism or hypoadrenalism.
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.
Drug Interactions
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).
Food Interaction
Sedative effects may be potentiated when used w/ alcohol.
Lab Interference
Paracetamol may cause false-positive result for urinary 5-hydroxyindoleacetic acid.
Description: 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.
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).
Store between 20-25°C. Protect from light.
MIMS Class
Analgesics (Non-Opioid) & Antipyretics / Analgesics (Opioid)
Acetaminophen and Codeine Solution (Qualitest Pharmaceuticals). DailyMed. Source: U.S. National Library of Medicine. Accessed 22/08/2014.

Anon. Acetaminophen and Codeine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 22/08/2014.

Anon. Acetaminophen. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 22/08/2014.

Anon. Codeine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 22/08/2014.

Buckingham R (ed). Codeine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. Accessed 22/08/2014.

Buckingham R (ed). Paracetamol. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. 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. Accessed 22/08/2014.

Disclaimer: This information is independently developed by MIMS based on Paracetamol + Codeine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by
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