dihydrocodeine and paracetamol

N02AJ01

Forms & Strengths

Tablet: Dihydrocodeine tartrate 10 mg / Paracetamol 500 mg
Tablet: Dihydrocodeine tartrate 20 mg / Paracetamol 500 mg
Tablet: Dihydrocodeine tartrate 30 mg / Paracetamol 500 mg
Effervescent tablets and capsules available in various international formulations

Adult Dosing

Mild to moderate pain: 1 to 2 tablets every 4 to 6 hours as needed
Maximum daily dose: Paracetamol component must not exceed 4000 mg in 24 hours
Maximum daily dose: Dihydrocodeine component generally not to exceed 240 mg in 24 hours
Dose reduction required in hepatic or renal impairment

Pediatric Dosing

Not recommended for children under 12 years of age
Adolescents 12 to 18 years: Use lowest effective dose for shortest duration; not recommended if breathing problems are present

Indications

Management of moderate to severe pain where the use of an opioid is appropriate and paracetamol alone is insufficient

Mechanism of Action

Dihydrocodeine: Weak central mu-opioid receptor agonist, providing analgesia via action in the central nervous system
Paracetamol (Acetaminophen): Central inhibition of prostaglandin synthesis and elevation of pain threshold

Contraindications

Hypersensitivity to dihydrocodeine, paracetamol, or any excipient
Significant respiratory depression with hypoxia or hypercapnia
Acute or severe bronchial asthma
Paralytic ileus or suspected surgical abdomen
Severe acute hepatic impairment or active liver disease
Concomitant use of monoamine oxidase inhibitors (MAOIs) or within 14 days of cessation

Adverse Reactions

Common: Constipation, nausea, vomiting, dizziness, drowsiness, headache
Less common: Dry mouth, confusion, urinary retention, pruritus, rash, sweating
Serious: Respiratory depression, hypotension, hepatotoxicity (due to paracetamol overdose), dependence and abuse potential

Drug Interactions

CNS depressants (alcohol, sedatives, hypnotics, anesthetics): Increased risk of profound sedation, respiratory depression, coma, and death
CYP2D6 inhibitors: May reduce the analgesic efficacy of dihydrocodeine
MAOIs: Risk of severe or fatal serotonergic reactions and central nervous system excitation or depression
Warfarin and coumarin anticoagulants: Prolonged chronic use of high-dose paracetamol may increase bleeding risk
Enzyme inducers (e.g., rifampin, carbamazepine): May increase the formation of hepatotoxic paracetamol metabolites

Curated Content: Needs Vetting Before Put to Clinical Use