Drug Guide
Oxycodone Hydrochloride and Acetaminophen
Classification
Therapeutic: Analgesic (Pain Relief)
Pharmacological: Opioid Agonist and Non-Opioid Analgesic combination
FDA Approved Indications
- Management of moderate to severe pain
Mechanism of Action
Oxycodone binds to opioid receptors in the brain and spinal cord, altering the perception and response to pain; acetaminophen inhibits prostaglandin synthesis in the central nervous system, potentiating the analgesic effect.
Dosage and Administration
Adult: Dosage varies; typically, 5-10 mg oxycodone with 325-500 mg acetaminophen every 6 hours as needed. Adjust based on severity of pain and patient response.
Pediatric: Not approved for children under 12 years of age; dosing depends on weight and age under pediatric guidance.
Geriatric: Start at lower end of dosing range due to increased risk of adverse effects.
Renal Impairment: Use with caution; dosage adjustment may be necessary.
Hepatic Impairment: Use with caution; monitor liver function.
Pharmacokinetics
Absorption: Well absorbed orally.
Distribution: Oxycodone crosses the blood-brain barrier; acetaminophen distributes widely.
Metabolism: Metabolized primarily in the liver via conjugation and CYP enzymes (for oxycodone).
Excretion: Excreted mainly in urine, as conjugates; some in feces.
Half Life: Oxycodone: approximately 3-4.5 hours; acetaminophen: 1-3 hours.
Contraindications
- Severe respiratory depression
- Acute intoxication with alcohol or other CNS depressants
- Severe hepatic impairment
Precautions
- History of hypersensitivity
- Risk of addiction, abuse, and misuse
- Use cautiously in elderly, patients with pulmonary disease, or head injury.
Adverse Reactions - Common
- Nausea (Common)
- Drowsiness (Common)
- Constipation (Common)
- Dizziness (Common)
Adverse Reactions - Serious
- Respiratory depression (Serious)
- Liver toxicity (acetaminophen overdose) (Serious)
- Addiction, overdose, and death (Serious)
Drug-Drug Interactions
- CNS depressants (benzodiazepines, sedatives)
- Alcohol
- Other opioids
- MAO inhibitors
Drug-Food Interactions
- Alcohol, which increases sedation and hepatotoxicity risk
Drug-Herb Interactions
- Kava kava, valerian, or other CNS depressant herbs
Nursing Implications
Assessment: Monitor pain levels, respiratory status, liver function, and signs of misuse or abuse.
Diagnoses:
- Risk of respiratory depression
- Ineffective airway clearance
- Impaired liver function
Implementation: Administer around the clock or as needed per prescription; monitor vital signs and pain response; educate about hepatic function and signs of overdose.
Evaluation: Pain relief achieved without significant adverse effects; liver function remains stable.
Patient/Family Teaching
- Do not exceed prescribed dose; any signs of overdose or liver problems should be reported immediately.
- Avoid alcohol and other CNS depressants.
- Do not operate heavy machinery until effects are known.
- Keep medication out of reach of children.
Special Considerations
Black Box Warnings:
- Risk of addiction, abuse, and misuse leading to overdose and death.
- Serious or fatal respiratory depression.
Genetic Factors: Genetic variations in CYP2D6 may affect oxycodone metabolism, influencing efficacy and safety.
Lab Test Interference: Potential interference with liver function tests due to acetaminophen.
Overdose Management
Signs/Symptoms: Respiratory depression, extreme drowsiness, unresponsiveness, cold and clammy skin, pinpoint pupils, nausea, vomiting, and coma.
Treatment: Administer naloxone promptly, support airway and breathing, provide symptomatic treatment, and monitor until emergency services arrive.
Storage and Handling
Storage: Store at room temperature, away from moisture, heat, and light.
Stability: Stable under normal conditions; check expiration date regularly.