codeine and paracetamol

N02AJ06

Forms & Strengths

Tablet: Codeine phosphate 8 mg / Paracetamol 500 mg
Tablet: Codeine phosphate 15 mg / Paracetamol 500 mg
Tablet: Codeine phosphate 30 mg / Paracetamol 500 mg
Effervescent tablet: Codeine phosphate 30 mg / Paracetamol 500 mg
Elixir/Syrup: Codeine phosphate 2 mg to 3 mg / Paracetamol 24 mg to 32 mg per mL

Adult Dosing

Mild to moderate pain: 1 to 2 tablets (containing 8 mg to 30 mg codeine and 500 mg paracetamol) every 4 to 6 hours as needed
Maximum single dose: 1000 mg paracetamol / 60 mg codeine
Maximum daily dose: 4000 mg paracetamol and 240 mg codeine within a 24-hour period
Duration of use: Limit short-term use to 3 days to minimize risk of dependence and toxicity

Pediatric Dosing

Contraindicated in children under 12 years of age
Contraindicated for post-operative management in children younger than 18 years following tonsillectomy or adenoidectomy
Adolescents 12 to 18 years: Not recommended for those with compromised respiratory function
Adolescents 12 to 18 years (when indicated): 0.5 mg/kg to 1 mg/kg codeine component every 6 hours as needed, not to exceed maximum paracetamol weight-based limits (60 mg/kg/day)

Indications

Mechanism of Action

Paracetamol: Inhibits central prostaglandin synthesis through central nervous system cyclooxygenase (COX) inhibition, providing antipyretic and analgesic effects
Codeine: Weak mu-opioid receptor agonist; produces analgesia via central nervous system action after being metabolized by CYP2D6 into active morphine metabolites

Contraindications

Hypersensitivity to codeine, paracetamol, or any component of the formulation
Significant respiratory depression or acute severe bronchial asthma
Known or suspected gastrointestinal obstruction, including paralytic ileus
Children under 12 years of age
Post-operative pain management in children and adolescents undergoing tonsillectomy or adenoidectomy
Known CYP2D6 ultra-rapid metabolizers
Severe hepatic impairment or active liver disease

Adverse Reactions

Central nervous system: Drowsiness, dizziness, sedation, headache, euphoria, dysphoria
Gastrointestinal: Constipation, nausea, vomiting, dry mouth, abdominal pain
Respiratory: Respiratory depression, dyspnea
Skin/Allergic: Pruritus, rash, urticaria, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome
Hepatic: Transient elevation of liver transaminases, hepatotoxicity with overdose
Other: Dependence, tolerance, withdrawal symptoms with prolonged use

Drug Interactions

CNS depressants (alcohol, benzodiazepines, sedatives, general anesthetics): Increased risk of profound sedation, respiratory depression, coma, and death
CYP2D6 inhibitors (fluoxetine, paroxetine, bupropion): Decreased conversion of codeine to its active analgesic metabolite morphine, reducing efficacy
CYP3A4 inducers/inhibitors: May affect codeine metabolism pathways
Monoamine oxidase inhibitors (MAOIs): Risk of severe, potentially fatal central nervous system excitation or depression; avoid concurrent use or within 14 days
Warfarin and coumarin anticoagulants: Prolonged concurrent use of high-dose paracetamol may increase bleeding risk
Enzyme-inducing drugs (phenytoin, carbamazepine, rifampin): Increased risk of paracetamol-induced hepatotoxicity due to enhanced CYP-mediated toxic metabolite production

Curated Content: Needs Vetting Before Put to Clinical Use