Oxycodone and Ibuprofen

Pronunciation

(oks i KOE done & eye byoo PROE fen)

U.S. Brand Names

Combunox™

Synonyms

Ibuprofen and Oxycodone

Generic Available

Use

Short-term (

7 days) management of acute, moderate-to-severe pain

Restrictions

C-II

Pregnancy Risk Factor

C/D (3rd trimester)

Pregnancy Implications

As with other NSAID-containing products, this agent should be avoided in late pregnancy because it may cause premature closure of the ductus arteriosus.

Lactation

Enters breast milk/contraindicated

Contraindications

Hypersensitivity to oxycodone, other opioids, ibuprofen, aspirin, other NSAIDs, or any component of the formulation; patients with suspected paralytic ileus; pregnancy (3rd trimester)

Warnings/Precautions

Use with caution in elderly or debilitated patients, and those with severe hepatic or renal dysfunction, hypothyroidism, Addison's disease, prostatic hyperplasia, or urethral stricture. Respiratory depression is possible; use with caution in patients with underlying respiratory depression, acute or severe asthma, or hypercarbia. Patients with head injury, increased intracranial pressure, acute abdominal condition, active peptic ulcer disease, history of upper GI disease, impaired thyroid function, hypertension, edema, heart failure, and any bleeding disorder should use this agent cautiously. Patients are at risk for gastrointestinal ulceration and bleeding even during short-term therapy. Tolerance or drug dependence may result from extended use. Oxycodone suppresses the cough reflex; use caution postoperatively and in patients with pulmonary disease. Rare incidents of aseptic meningitis have been reported with ibuprofen's use. Safety and efficacy in pediatric patients have not been established.

Adverse Reactions

>10%:

Central nervous system: Dizziness (5% to 19%), somnolence (7% to 17%)

Gastrointestinal: Nausea (9% to 25%)

2% to 10%:

Cardiovascular: Vasodilation (<1% to 3%)

Central nervous system: Headache (10%), fever (3%)

Gastrointestinal: Constipation (<1% to 5%), vomiting (5%), diarrhea (2%), dyspepsia (<1% to 2%), flatulence (1%)

Neuromuscular & skeletal: Weakness (3%)

Miscellaneous: Diaphoresis (2%)

<2% (Limited to important or life-threatening): Abdominal enlargement/pain, anemia, amblyopia, anxiety, arthritis, back pain, chest pain, chills, edema, euphoria, hyperkinesias, hypertonia, hypokalemia, hypotension, hypoxia, ileus, infection, LFTs increased, lung disorder, pharyngitis, syncope, rash, tachycardia, taste perversion, thrombophlebitis, urinary retention

Overdosage/Toxicology

Symptoms of toxicity may include respiratory depression, CNS depression, metabolic acidosis, seizures, hypotension, blood loss, coma, miosis, and renal failure. In cases of acute overdose, ipecac-induced emesis or gastric lavage may be used to empty the stomach. Emesis is most effective if within 30 minutes of ingestion, and is not recommended in patients who are not fully conscious or who have ingested >400 mg/kg of the ibuprofen component. Naloxone is the antidote for oxycodone. Repeat administration as necessary up to a total of 10 mg may be used to reverse toxic effects of the opiate. Treatment of NSAID overdose is supportive with symptomatic management as necessary; activated charcoal may be used to reduce the absorption and reabsorption of ibuprofen.

Drug Interactions

Oxycodone: Substrate of CYP2D6

Ibuprofen: Substrate (minor) of CYP2C8/9, 2C19; Inhibits CYP2C8/9 (strong)

See individual agents.

Ethanol/Nutrition/Herb Interactions

Based on oxycodone component:

Ethanol: Avoid or limit ethanol (may increase CNS depression). Watch for sedation.

Based on ibuprofen component:

Ethanol: Avoid ethanol (may enhance gastric mucosal irritation).

Food: Food or milk are recommended to decrease gastric irritation.

Herb/Nutraceutical: Avoid cat's claw, dong quai, evening primrose, feverfew, garlic, ginger, ginkgo, red clover, horse chestnut, green tea, ginseng (all have antiplatelet activity).

Stability

Store between 15°C to 30°C (59°F to 86°F).

Mechanism of Action

Based on oxycodone component: Binds to opiate receptors in the CNS, altering the perception of and response to pain; suppresses cough in medullary center; produces generalized CNS depression

Based on ibuprofen component: Inhibits prostaglandin synthesis by decreasing the activity of the enzyme, cyclooxygenase, which results in decreased formation of prostaglandin precursors

Pharmacodynamics/Kinetics

Also see individual agents.

Absorption: Ibuprofen, oxycodone: rapidly absorbed

Protein binding: Ibuprofen: 99%; Oxycodone: 45%

Metabolism: Oxycodone: Hepatic to metabolites, noroxycodone (major), and oxymorphone (minor)

Bioavailability: Oxycodone: increased with food (25%)

Half-life elimination: Ibuprofen: 1.8-2.6 hours; Oxycodone: 3.1-3.7 hours

Time to peak, serum: Ibuprofen: 1.6-3.1 hours; Oxycodone 1.3-2.1 hours

Excretion: Ibuprofen: Urine (<0.2% unchanged); Oxycodone: Urine (~4 % unchanged)

Dosage

Oral: Adults: Pain: Take 1 tablet every 6 hours as needed (maximum: 4 tablets/24 hours); do not take for longer than 7 days

Monitoring Parameters

Respiratory function

Dietary Considerations

Take with or without food.

Dosage Forms

Tablet [film-coated]: Oxycodone hydrochloride 5 mg and ibuprofen 400 mg

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