Oxycodone and Aspirin

Pronunciation

(oks i KOE done & AS pir in)

U.S. Brand Names

Endodan®; Percodan®

Synonyms

Aspirin and Oxycodone

Generic Available

Yes

Canadian Brand Names

Endodan®; Oxycodan®; Percodan®

Use

Management of moderate to severe pain

Use - Dental

Treatment of postoperative pain

Restrictions

C-II

Pregnancy Risk Factor

Pregnancy Implications

See individual agents.

Lactation

Enters breast milk/use caution

Contraindications

Hypersensitivity to oxycodone, salicylates, other NSAIDs, or any component of the formulation; patients with the syndrome of asthma, rhinitis, and nasal polyps; inherited or acquired bleeding disorders (including factor VII and factor IX deficiency); do not use in children (<16 years of age) in the presence of viral infections (chickenpox or flu symptoms), with or without fever, due to a potential association with Reye's syndrome; significant respiratory depression; hypercarbia; known or suspected paralytic ileus; acute or severe bronchial asthma; pregnancy (3rd trimester)

Warnings/Precautions

Use with caution in patients with hypersensitivity reactions to other phenanthrene derivative opioid agonists (morphine, hydrocodone, hydromorphone, levorphanol, oxycodone, oxymorphone), respiratory diseases including asthma, emphysema, or COPD. Use with caution in pancreatitis or biliary tract disease, acute alcoholism (including delirium tremens), adrenocortical insufficiency, CNS depression/coma, kyphoscoliosis (or other skeletal disorder which may alter respiratory function), hypothyroidism (including myxedema), prostatic hyperplasia, urethral stricture, and toxic psychosis.

Use with caution in the elderly, debilitated, severe hepatic or renal dysfunction. Hemodynamic effects (hypotension, orthostasis) may be exaggerated in patients with dehydration, hypovolemia, concurrent vasodilating drugs, or in patients with head injury. Respiratory depressant effects and capacity to elevate CSF pressure may be exaggerated in presence of head injury, other intracranial lesion, or pre-existing elevation of intracranial pressure. Tolerance or drug dependence may result from extended use. Healthcare provider should be alert to problems of abuse, misuse, and diversion. Taper dose gradually to avoid withdrawal symptoms in physically dependent patients.

Use with caution in patients with platelet and bleeding disorders, erosive gastritis, or peptic ulcer disease. Heavy ethanol use (>3 drinks/day) can increase bleeding risks. Discontinue use if tinnitus or impaired hearing occurs. Patients with sensitivity to tartrazine dyes, nasal polyps and asthma may have an increased risk of salicylate sensitivity. Surgical patients should avoid ASA if possible, for 1-2 weeks prior to surgery, to reduce the risk of excessive bleeding.

Adverse Reactions

Note: Also refer to individual agents

Common (frequency not defined):

Central nervous system: Dizziness, drowsiness, lightheadedness, sedation

Dermatologic: Pruritus

Gastrointestinal: Nausea, vomiting, constipation

<1%, postmarketing, and/or case reports (limited to important or life-threatening): Allergic reaction, anaphylaxis, anaphylactoid reaction, angioedema, apnea, asthma, bradycardia, bronchospasm, circulatory depression, confusion, duodenal ulcer, dysphoria, dyspnea, ecchymosis, euphoria, gastric ulcer, gastrointestinal bleeding, hallucination, hemorrhage, hepatitis, hepatotoxicity, hypotension, hypoglycemia, hyperglycemia, ileus, interstitial nephritis, intestinal obstruction, laryngeal edema, metabolic acidosis, pancreatitis, papillary necrosis, paresthesia, purpura, pulmonary edema, proteinuria, rash, renal failure, respiratory alkalosis, respiratory depression, Reye syndrome, rhabdomyolysis, seizure, shock, thrombocytopenia, tinnitus

Drug Interactions

Oxycodone: Substrate of CYP2D6 (major)

Aspirin: Substrate of CYP2C8/9 (minor)

Also see individual agents.

CYP2D6 inhibitors: May decrease the effects of oxycodone. Example inhibitors include chlorpromazine, delavirdine, fluoxetine, miconazole, paroxetine, pergolide, quinidine, quinine, ritonavir, and ropinirole.

Increased effect/toxicity with CNS depressants, TCAs, dextroamphetamine

Mechanism of Action

Oxycodone, as with other narcotic (opiate) analgesics, blocks pain perception in the cerebral cortex by binding to specific receptor molecules (opiate receptors) within the neuronal membranes of synapses. This binding results in a decreased synaptic chemical transmission throughout the CNS thus inhibiting the flow of pain sensations into the higher centers. Mu and kappa are the two subtypes of the opiate receptor which oxycodone binds to to cause analgesia.

Aspirin inhibits prostaglandin synthesis by decreasing the activity of the enzyme, cyclooxygenase, which results in decreased formation of prostaglandin precursors, acts on the hypothalamic heat-regulating center to reduce fever, blocks thromboxane synthetase action which prevents formation of the platelet-aggregating substance thromboxane A2

Pharmacodynamics/Kinetics

See individual agents.

Dosage

Oral (based on oxycodone combined salts):

Children: Maximum oxycodone: 5 mg/dose; maximum aspirin dose should not exceed 4 g/day. Doses should be given every 6 hours as needed.

Mild-to-moderate pain: Initial dose, based on oxycodone content: : 0.05-0.1 mg/kg/dose

Severe pain: Initial dose, based on oxycodone content : 0.3 mg/kg/dose

Adults: Percodan®: 1 tablet every 6 hours as needed for pain; maximum aspirin dose should not exceed 4 g/day.

Dosing adjustment in hepatic impairment: Dose should be reduced in patients with severe liver disease.

Test Interactions

May cross-react with urine tests for cocaine or marijuana.

Dietary Considerations

May be taken with food or water.

Patient Education

See individual agents. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Nursing Implications

Monitor for pain relief, respiratory and mental status, blood pressure, constipation

Dental Health: Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Nausea, sedation, constipation, and xerostomia (normal salivary flow resumes upon discontinuation). May have anticoagulant effects which may affect bleeding time. The elderly are a high-risk population for adverse effects from NSAIDs. As many as 60% of elderly patients with GI complications from NSAIDs can develop peptic ulceration and/or hemorrhage asymptomatically. Concomitant disease and drug use contribute to the risk of GI adverse effects. Enhanced analgesia has been seen with therapeutic doses of narcotics; duration of action may be increased. Elderly may also be particularly susceptible to the CNS depressant effects of narcotics.

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Dental Comment

Oxycodone, as with other narcotic analgesics, is recommended only for limited acute dosing (ie, 3 days or less). Oxycodone has an addictive liability, especially when given long-term. The oxycodone with aspirin could have anticoagulant effects and could possibly affect bleeding times.

Mental Health: Effects on Mental Status

Drowsiness and fatigue are common. May cause agitation, anxiety, lethargy, mental impairment, restlessness, nervousness, or confusion; may rarely cause hallucinations, depression, or paradoxical CNS stimulation.

Mental Health: Effects on Psychiatric Treatment

Concurrent use with psychotropics may cause additive sedation; use lower doses of both agents. Oxycodone may cause severe hypotension after concurrent administration with drugs which compromise vasomotor tone (eg, phenothiazines); monitor blood pressure. May cause GI side effects which may be further exacerbated with concurrent SSRI, lithium, or valproic acid use; monitor. May cause platelet abnormalities which may be further exacerbated with concurrent SSRI use; monitor. Salicylate can displace phenytoin and valproic acid leading to a decrease in phenytoin and an increase in valproic acid levels; monitor.

Dosage Forms

Tablet: Oxycodone hydrochloride 4.5 mg, oxycodone terephthalate 0.38 mg, and aspirin 325 mg

Endodan®, Percodan®: Oxycodone hydrochloride 4.5 mg, oxycodone terephthalate 0.38 mg, and aspirin 325 mg

References

Dionne RA, "New Approaches to Preventing and Treating Postoperative Pain," J Am Dent Assoc , 1992, 123(6):26-34.

Gobetti JP, "Controlling Dental Pain," J Am Dent Assoc , 1992, 123(6):47-52.

Mokhlesi B, Leikin JB, Murray P, et al, "Adult Toxicology in Critical Care: Part II: Specific Poisonings," Chest , 2003, 123(3):897-922.

"Principles of Analgesic Use in the Treatment of Acute Pain and Cancer Pain," 5th ed, Glenview, IL: American Pain Society, 2003.

International Brand Names

Endodan® (CA); Oxycodan® (CA); Percodan® (CA)

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