Oxycodone
Regulatory sources consulted
- aemps-cima-70687
- crediblemeds.org
- flockhart-cyp-table
Approved indications
- Treatment of severe pain, which can only be adequately managed with opioid analgesics. Oxycodone is indicated in adults and adolescents from 12 years of age.
Contraindications
Absolute
- Hypersensitivity to the active substance. Severe respiratory depression with hypoxia. Elevated blood carbon dioxide levels (hypercapnia). Severe chronic obstructive pulmonary disease. Cor pulmonale. Severe bronchial asthma. Paralytic ileus.
Clinical warnings
- Boxed warning · RISK OF ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS. — FDA
Drug interactions
- HighBenzodiazepines and other CNS depressants (e.g., alcohol, other opioids, sedatives)N05BA
Mechanism: Pharmacodynamic synergism resulting in profound sedation, respiratory depression, coma, and death.
Recommendation: Avoid concomitant use. If necessary, limit dosages and durations of both drugs and monitor the patient closely.
AEMPS CIMA
- HighCYP3A4 inhibitors (e.g., clarithromycin, ketoconazole, ritonavir)J01FA09
Mechanism: Inhibition of oxycodone metabolism, leading to increased plasma concentrations and a higher risk of toxicity.
Recommendation: Monitor closely for opioid adverse effects. Consider an oxycodone dose reduction.
AEMPS CIMA
Adverse events
Common (≥1%)
somnolence · dizziness · headache · constipation · nausea · vomiting · pruritus
Rare but serious
respiratory depression · paralytic ileus · severe hypotension · adrenal insufficiency · anaphylaxis · seizures
Pregnancy and lactation
FDA category: C (US old system)
Use during pregnancy and labor is not recommended due to the risk of respiratory depression in the neonate. Prolonged use during pregnancy can cause neonatal withdrawal syndrome. Oxycodone is excreted in breast milk; breastfeeding is not recommended.