PERCODAN-DEMI
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PERCODAN-DEMI (PERCODAN-DEMI).
Oxycodone is a full mu-opioid receptor agonist; aspirin inhibits cyclooxygenase (COX-1 and COX-2), reducing prostaglandin synthesis.
| Metabolism | Oxycodone is primarily metabolized by CYP3A4 and CYP2D6 to noroxycodone and oxymorphone. Aspirin is hydrolyzed to salicylate, primarily metabolized by conjugation and oxidation. |
| Excretion | Renal: ~90% (oxycodone: ~60% as metabolites, ~10% unchanged; aspirin: ~80% as salicylates, ~10% unchanged). Biliary/fecal: minor. |
| Half-life | Oxycodone: 3-4 hours; salicylate (aspirin): 2-3 hours at low doses, 15-30 hours at high doses; terminal half-life clinically relevant for dosing interval (q4-6h). |
| Protein binding | Oxycodone: 45% bound to albumin; salicylate: 80-90% bound to albumin (saturable, decreases at high doses). |
| Volume of Distribution | Oxycodone: 2.6 L/kg; salicylate: 0.15-0.2 L/kg. Oxycodone Vd indicates extensive tissue distribution; salicylate Vd reflects limited distribution in plasma and interstitial fluid. |
| Bioavailability | Oral: Oxycodone 60-87%; aspirin 80-100% (but rapidly hydrolyzed to salicylate; systemic salicylate bioavailability ~100% after oral administration). |
| Onset of Action | Oral: 15-30 minutes for analgesic effect (oxycodone); 30 minutes for antipyretic/anti-inflammatory effect (aspirin). |
| Duration of Action | Oral: 4-6 hours for analgesia; antipyretic effect lasts 3-4 hours; anti-inflammatory effect persists longer, up to 8-12 hours. Note: prolonged with hepatic impairment. |
1 tablet (oxycodone 2.25 mg/aspirin 325 mg) orally every 6 hours as needed for pain; maximum 4 tablets in 24 hours.
| Dosage form | TABLET |
| Renal impairment | Avoid use if GFR <30 mL/min; for GFR 30-59 mL/min, consider reducing dose or extending dosing interval to every 8-12 hours due to oxycodone accumulation. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce oxycodone dose by 50% (use oxycodone 1.125 mg/aspirin 325 mg) and monitor; Child-Pugh C: avoid use. |
| Pediatric use | Not recommended for pediatric patients due to aspirin content (risk of Reye syndrome); for children >12 years, weight-based oxycodone dose: 0.1-0.2 mg/kg/dose every 4-6 hours, maximum 5 mg per dose, with aspirin dosing per pediatric guidelines. |
| Geriatric use | Initiate at 1 tablet (oxycodone 2.25 mg/aspirin 325 mg) orally every 6 hours as needed; titrate cautiously; monitor for renal function, sedation, and constipation. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PERCODAN-DEMI (PERCODAN-DEMI).
| Breastfeeding | Oxycodone is excreted in breast milk. M/P ratio approximately 3.1:1. Use with caution; monitor infant for sedation, respiratory depression, and constipation. Avoid in breastfeeding mothers with ultra-rapid metabolizer CYP2D6 genotype. |
| Teratogenic Risk | First trimester: Limited data, but consistent use may associate with minor malformations. Second and third trimesters: Chronic use may cause neonatal withdrawal syndrome. High doses near term may cause respiratory depression in the neonate. |
| Fetal Monitoring |
■ FDA Black Box Warning
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF OXYCODONE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; and RISK OF SERIOUS GASTROINTESTINAL ADVERSE EVENTS DUE TO ASPIRIN.
| Serious Effects |
Significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment; known or suspected gastrointestinal obstruction, including paralytic ileus; hypersensitivity to oxycodone, aspirin, or any component of the product; children and teenagers with viral infections due to risk of Reye's syndrome; and patients with bleeding disorders (e.g., hemophilia) or on anticoagulant therapy.
| Precautions | Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; ultra-rapid metabolizers of oxycodone; neonatal opioid withdrawal syndrome; risks from concomitant use with benzodiazepines or other CNS depressants; gastrointestinal adverse events including bleeding and perforation; Reye's syndrome; renal and hepatic impairment; adrenal insufficiency; severe hypotension; seizures; and hypogonadism. |
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| Fetal heart rate monitoring during labor; assess neonatal respiratory function and Apgar scores. Monitor maternal respiratory rate, blood pressure, and signs of opioid withdrawal or toxicity. |
| Fertility Effects | Chronic use may disrupt menstrual cycle and reduce fertility due to opioid-induced hypothalamic-pituitary-gonadal axis suppression. Reversible upon discontinuation. |