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Ibuprofen / Oxycodone Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Pain

1 tablet every 6 hours as necessary

Not to exceed 4 tablets in a 24 hour period

Duration of therapy not to exceed 7 days

Usual Pediatric Dose for Pain

14 to 17 years:
1 tablet every 6 hours as necessary

Not to exceed 4 tablets in any 24-hour period

Duration of therapy not to exceed 7 days

Renal Dose Adjustments

Use not recommended in severe renal dysfunction. Renal function may be further compromised by the use of ibuprofen due to its antiprostaglandin effect. Renal blood flow in patients with reduced renal function is dependent upon renal prostaglandin synthesis. However, if ibuprofen-oxycodone administered, periodic monitoring of renal function is recommended.

Liver Dose Adjustments

Should be used cautiously with liver dysfunction due to the hepatic effects of ibuprofen and the hepatic metabolism of oxycodone. If a previous liver test was abnormal, then evaluation for evidence of the development of more severe hepatic reactions is recommended. Ibuprofen-oxycodone therapy should be discontinued if abnormal liver function tests persist or worsen, if clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (for example, eosinophilia, rash, etc.).

Precautions

Oxycodone has an abuse liability similar to morphine. This should be considered when prescribing or dispensing ibuprofen-oxycodone in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

Oxycodone may cause life-threatening respiratory depression. Ibuprofen-oxycodone should be used with caution in patients who are elderly or with significant chronic obstructive pulmonary disease, cor pulmonale, substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression. Usual recommended doses of ibprofen-oxycodone may cause significant respiratory depression in these patients.

Ibuprofen-oxycodone, like other narcotic analgesics, should be administered with caution in elderly patients and those with severe renal and/or liver disease, severe pulmonary impairment , hypothyroidism, Addison's disease, acute alcoholism, convulsive disorders, CNS depression or coma, delirium tremens, kyphoscoliosis associated with respiratory depression, toxic psychosis, prostatic hypertrophy, urethral stricture, history of hypotension, circulatory shock, head injury, increased intracranial pressure, acute undiagnosed abdominal pain, biliary tract disease, and general debilitation.

Serious gastrointestinal toxicity, such as bleeding, ulceration, and perforation, can occur at any time with or without warning symptoms, in patients receiving nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen. Ibuprofen-oxycodone should be used with extreme caution in patients with prior history of ulcer disease or gastrointestinal bleeding. Caution should be exercised when using NSAIDs in the elderly and debilitated since most of the spontaneous reports of fatal GI adverse events are in this population. Patients that consume 3 or more alcoholic drinks per day and/or smoke may be at a higher risk of stomach bleeding. Since even short-term therapy with ibuprofen-oxycodone is not without risk, alternate therapies that do not involve NSAIDs should be considered in high-risk patients.

Ibuprofen-oxycodone use is considered contraindicated in the treatment of patients with the "triad" of asthma, nasal polyps, and aspirin or other nonsteroidal anti-inflammatory agent hypersensitivity (i.e., angioedema, bronchospasm, urticaria, rhinitis). Reports of fatal reactions have been reported in these patients as a result of a possible cross sensitization to NSAIDs.

Renal function may be further compromised by the use of ibuprofen in patients with renal dysfunction, heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Renal blood flow in patients with renal dysfunction, edematous disorders, or hypovolemic states is dependent upon renal prostaglandin synthesis. Ibuprofen-oxycodone therapy is not recommended in patients with serious renal dysfunction. However, if ibuprofen-oxycodone must be used, periodic monitoring of renal function is recommended.

Ibuprofen-oxycodone is considered contraindicated for use during the third trimester of pregnancy.

In patients with considerable dehydration, it is advisable to rehydrate prior to initiating ibuprofen-oxycodone therapy.

Caution should be exercised when using ibuprofen-oxycodone in patients with intrinsic coagulation defects and those on anticoagulation therapy, because ibuprofen can inhibit platelet aggregation and increase prolong bleeding time (but within the normal range). The prolonged bleeding effect may be exaggerated in patients with underlying hemostatic defects.

Dialysis

Renal function may be further compromised by the use of ibuprofen-oxycodone in cases of severe renal dysfunction due to the antiprostaglandin effect of ibuprofen.

Based on two studies, ibuprofen is not removed by dialysis using Cordis Dow and Travenol dialyzers. Dialysis clearance averaged 23 mL/min with less than 4% of the drug removed during a 4 hour dialysis session. There are no data on the hemodialysis clearance of oxycodone.

There are no data on the peritoneal dialysis clearance of ibuprofen and oxycodone.

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