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dextropropoxyphene, combinations excl. psycholeptics

N02AC54

Forms & Strengths

Oral capsules containing dextropropoxyphene napsylate combined with paracetamol (acetaminophen)
Oral tablets containing dextropropoxyphene hydrochloride combined with aspirin or paracetamol
Note: Most formulations have been globally withdrawn due to cardiac toxicity

Adult Dosing

Dextropropoxyphene hydrochloride: 65 mg orally every 4 hours as needed for pain, maximum 390 mg/day
Dextropropoxyphene napsylate: 100 mg orally every 4 hours as needed for pain, maximum 600 mg/day
Dose adjustments required for hepatic and renal impairment

Pediatric Dosing

Safety and efficacy not established in pediatric patients
Use is generally contraindicated in children and adolescents

Indications

Management of mild to moderate acute pain
Historically used as an alternative to codeine combinations (largely obsolete due to safety withdrawals)

Mechanism of Action

Mu-opioid receptor agonist providing central analgesic effects
Weak inhibition of serotonin and norepinephrine reuptake
Combined with non-opioid analgesics (paracetamol/aspirin) for synergistic pain relief

Contraindications

Hypersensitivity to dextropropoxyphene, paracetamol, or aspirin
Significant respiratory depression
Acute or severe bronchial asthma in an unmonitored setting
Known or suspected paralytic ileus
History of suicide ideation, depression, or concurrent psychotropic substance abuse
Severe hepatic or renal impairment

Adverse Reactions

Dizziness, sedation, lightheadedness, and somnolence
Nausea, vomiting, constipation, and abdominal pain
Respiratory depression
QT interval prolongation and severe cardiac arrhythmias
Hepatotoxicity (primarily due to paracetamol component in overdose)

Drug Interactions

Central nervous system depressants (alcohol, sedatives, tranquilizers, hypnotics) leading to profound sedation and respiratory depression
CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) increasing plasma concentrations of dextropropoxyphene
MAO inhibitors leading to severe central nervous system excitation or depression
Warfarin and other coumarin anticoagulants (risk of increased bleeding with combination components)

Curated Content: Needs Vetting Before Put to Clinical Use