|
| U.S. Brand
Names |
|
| OxyContin®; OxyIR™;
Percolone™; Roxicodone™ |

|
|
| Generic
Available |
|
|
No |

|
|
| Canadian Brand
Names |
|
| Supeudol® |

|
|
| Synonyms |
|
|
Dihydrohydroxycodeinone; Oxycodone Hydrochloride |

|
|
| Pharmacological Index |
|
|
Analgesic, Narcotic |

|
|
| Use |
|
|
Dental: Treatment of postoperative pain
Medical: Management of moderate to severe pain, normally used in combination
with non-narcotic analgesics |

|
|
| Restrictions |
|
|
C-II |

|
|
| Pregnancy Risk
Factor |
|
|
B/D (if used for prolonged periods or in high doses at
term) |

|
|
| Contraindications |
|
|
Hypersensitivity to oxycodone or any component |

|
|
| 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, COPD, or severe liver or renal insufficiency; some preparations
contain sulfites which may cause allergic reactions; dextromethorphan has
equivalent antitussive activity but has much lower toxicity in accidental
overdose; tolerance or drug dependence may result from extended
use |

|
|
| Adverse
Reactions |
|
|
>10%:
Cardiovascular: Hypotension
Central nervous system: Fatigue, drowsiness, dizziness
Gastrointestinal: Nausea, vomiting
Neuromuscular & skeletal: Weakness
1% to 10%:
Central nervous system: Nervousness, headache, restlessness, malaise,
confusion
Gastrointestinal: Anorexia, stomach cramps, xerostomia, constipation, biliary
spasm
Genitourinary: Ureteral spasms, decreased urination
Local: Pain at injection site
Respiratory: Dyspnea, shortness of breath
<1%: Mental depression, hallucinations, paradoxical CNS stimulation,
increased intracranial pressure, skin rash, urticaria, paralytic ileus,
histamine release, physical and psychological dependence |

|
|
| Overdosage/Toxicology |
|
|
Symptoms of overdose include CNS depression, respiratory depression, miosis
Treatment: Naloxone 2 mg I.V. (0.01 mg/kg for children) with repeat
administration as necessary up to a total of 10 mg |

|
|
| Drug
Interactions |
|
|
CYP2D6 enzyme substrate
Increased toxicity: CNS depressants, monoamine oxidase inhibitors, general
anesthetics, and tricyclic antidepressants may potentiate the effects of opiate
agonists; dextroamphetamine may enhance the analgesic effect of opiate agonists
|

|
|
| Stability |
|
|
Tablets should be stored at room temperature. |

|
|
| Mechanism of
Action |
|
|
Binds to opiate receptors in the CNS, causing inhibition of ascending pain
pathways, altering the perception of and response to pain; produces generalized
CNS depression |

|
|
| Pharmacodynamics/Kinetics |
|
|
Onset of pain relief: Oral: Within 10-15 minutes
Peak effect: 0.5-1 hour
Duration: 4-5 hours; up to 12 hours for controlled release
Metabolism: In the liver
Elimination: In urine |

|
|
| Usual Dosage |
|
|
Oral:
Children:
6-12 years: 1.25 mg every 6 hours as needed
>12 years: 2.5 mg every 6 hours as needed
Adults: 5 mg every 6 hours as needed
Controlled release: Adults: 10 mg every 12 hours around-the-clock
Dosing adjustment in hepatic impairment: Reduce dosage in patients
with severe liver disease |

|
|
| Dietary
Considerations |
|
|
Alcohol: Additive CNS effect, avoid use |

|
|
| Monitoring
Parameters |
|
|
Pain relief, respiratory and mental status, blood
pressure |

|
|
| Reference Range |
|
|
Blood level of 5 mg/L associated with fatality |

|
|
| Mental Health: Effects
on Mental Status |
|
|
Drowsiness and dizziness are common; may cause nervousness, restlessness or
confusion; may rarely cause depression or hallucinations |

|
|
| Mental Health:
Effects on Psychiatric
Treatment |
|
|
Psychotropics may alter the analgesic effects of opioids; monitor for change
in pain relief |

|
|
| Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
|
|
No information available to require special precautions |

|
|
| Dental Health:
Effects on Dental Treatment |
|
|
1% to 10% of patients experience dry mouth |

|
|
| Patient
Information |
|
|
If self-administered, use exactly as directed (do not increase dose or
frequency); may cause physical and/or psychological dependence. While using this
medication, do not use alcohol and other prescription or OTC medications
(especially sedatives, tranquilizers, antihistamines, or pain medications)
without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids
unless instructed to restrict fluid intake). May cause hypotension, dizziness,
drowsiness, impaired coordination, or blurred vision (use caution when driving,
climbing stairs, or changing position - rising from sitting or lying to
standing, or when engaging in tasks requiring alertness until response to drug
is known); nausea, vomiting or dry mouth (frequent mouth care, small frequent
meals, chewing gum, or sucking lozenges may help); constipation (increased
exercise, fluids, or dietary fruit and fiber may help - if constipation remains
an unresolved problem, consult prescriber about use of stool softeners). Report
persistent dizziness or headache; excessive fatigue or sedation; changes in
mental status; changes in urinary elimination or pain on urination; weakness or
trembling; blurred vision; or shortness of breath. Pregnancy/breast-feeding
precautions: Inform prescriber if you are or intend to be pregnant. If you
are breast-feeding, take medication immediately after breast-feeding or 3-4
hours prior to next feeding. |

|
|
| Nursing
Implications |
|
|
Observe patient for excessive sedation, respiratory depression, implement
safety measures, assist with ambulation |

|
|
| Dosage Forms |
|
|
Capsule, as hydrochloride, immediate release (OxyIR™):
5 mg
Liquid, oral, as hydrochloride: 5 mg/5 mL (500 mL)
Solution, oral concentrate, as hydrochloride: 20 mg/mL (30 mL)
Tablet, as hydrochloride: 5 mg
Endocodone®: 5 mg
Percolone™: 5 mg
Roxicodone™: 10 mg, 30 mg
Tablet, controlled release, as hydrochloride
(OxyContin®): 10 mg, 20 mg, 40 mg, 80 mg
|

|
|
| References |
|
|
"Drugs for Pain," Med Lett Drugs Ther, 1998, 40(1033):79-84.
Kalso E and Vainio A,
"Morphine and Oxycodone Hydrochloride in the Management of Cancer Pain," Clin
Pharmacol Ther, 1990, 47(5):639-46.
Turturro MA and O'Toole KS, "Oxycodone-Induced Pulmonary Edema," Am J
Emerg Med, 1991, 9(2):201-3. |

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