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NERVOUS SYSTEM › ANALGESICS › OPIOIDS › Opioids in combination with non-opioid analgesics
oxycodone and paracetamol
N02AJ17
Forms & Strengths
- Tablet: Oxycodone hydrochloride 5 mg / Paracetamol 325 mg
- Tablet: Oxycodone hydrochloride 5 mg / Paracetamol 500 mg
- Capsule: Oxycodone hydrochloride 5 mg / Paracetamol 500 mg
Adult Dosing
- Initial: 1 to 2 tablets every 4 to 6 hours as needed for pain
- Maximum daily dose: Limited by the paracetamol component, not to exceed 4000 mg of paracetamol per day from all sources
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established
- Use is generally not recommended in children and adolescents
Indications
- Management of moderate to moderately severe acute pain where use of an opioid analgesic is appropriate
Mechanism of Action
- Oxycodone: Full mu-opioid receptor agonist acting primarily in the central nervous system to inhibit ascending pain pathways
- Paracetamol: Inhibits prostaglandin synthesis in the central nervous system and peripherally blocks pain impulse generation
Contraindications
- Significant respiratory depression
- Acute or severe bronchial asthma or hypercarbia
- Known or suspected paralytic ileus
- Hypersensitivity to oxycodone, paracetamol, or any component of the formulation
- Severe hepatic impairment or active liver disease
Adverse Reactions
- Central nervous system: Somnolence, dizziness, headache, sedation
- Gastrointestinal: Nausea, vomiting, constipation, dry mouth
- Respiratory: Respiratory depression
- Skin: Pruritus, rash, sweating
- Hepatic: Transient elevations in transaminases (associated with paracetamol overdose)
Drug Interactions
- CNS depressants (alcohol, benzodiazepines, other opioids): May cause profound sedation, respiratory depression, coma, and death
- CYP3A4 and CYP2D6 inhibitors (e.g., macrolides, azole antifungals, SSRIs): May increase oxycodone plasma concentrations
- CYP3A4 inducers (e.g., rifampin, carbamazepine): May decrease oxycodone efficacy
- Mixed agonist/antagonist opioid analgesics: May precipitate withdrawal symptoms or reduce analgesic effect
- Warfarin: Concomitant chronic high-dose paracetamol may increase bleeding risk
Curated Content: Needs Vetting Before Put to Clinical Use