Adult Dosing
Acute moderate-to-severe pain
- Recommended dose: 400 mg/5 mg PO qd-qid PRN x 7 days
- Max: 4 tabs/day
Note:
- Consider the lowest effective dose for the shortest duration consistent with individual patient treatment goals
Pediatric Dosing
- Safety and effectiveness in pediatric patients <14 yrs have not been established
Acute moderate-to-severe pain
Children >14 yrs
- Recommended dose: 400 mg/5 mg PO qd-qid PRN x 7 days
- Max: 4 tabs/day
Note:
- Consider the lowest effective dose for the shortest duration consistent with individual patient treatment goals
[Outline]
See Supplemental Patient Information
- NSAIDs may increase the risk of serious and potentially fatal cardiovascular thrombotic events, MI, and stroke. This risk further increases with the duration of use and with the presence of cardiovascular disease/risk factors for CV disease [US Black Box Warning]
- Inform patients about the signs/symptoms of serious CV events and the steps to take if they occur. Use the lowest effective dose for the shortest duration possible to minimize the potential risk for an adverse CV event
- Increased risk of serious GI events may occur on concurrent use of aspirin and an NSAID
- Therapy may cause onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events
- Use cautiously in hypertensive patients. Closely monitor blood pressure (BP) during the initiation of NSAID treatment and throughout the course of therapy
- Patients taking thiazides or loop diuretics may have impaired response to these agents during therapy with NSAIDs
- Cautiously administer therapy in patients with congestive heart failure or fluid retention, as it may cause fluid retention and edema
- NSAIDs may increase the risk of serious and fatal GI events such as bleeding, ulceration, and perforation of the stomach or intestines. Such events may occur at any time during use and without warning symptoms. The risk for serious GI events is higher in elderly patients [US Black Box Warning]
- Use cautiously in patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding. Factors that increase the risk for GI bleeding in patients receiving NSAID therapy include concomitant use of oral corticosteroids, antiplatelet or anticoagulant drugs, longer duration of NSAID therapy, smoking, alcohol use, older age, and poor general health status
- If a serious GI adverse event is suspected, discontinue therapy and promptly institute an alternative therapy
- Oxycodone component of this combination drug is an opioid agonist and a Schedule II controlled substance; this drug may have the potential for being abused by abusers, people with addiction disorders, and are subject to diversion. Consider this when prescribing or dispensing this formulation
- Oxycodone may produce dose-related respiratory depression, particularly in elderly or debilitated patients; it also affects the center that controls respiratory rhythm and may produce irregular and periodic breathing
- Use cautiously in patients with significant COPD or cor pulmonale and in patients having substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression
- Therapy may cause severe hypotension, especially in blood volume depleted patients or after concomitant administration with drugs that compromise vasomotor tone. Also, this drug may produce orthostatic hypotension in ambulatory patients. Use cautiously in patients with circulatory shock
- Respiratory depressant effects of opioids and their capacity to elevate CSF pressure may be significantly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure
- Therapy may obscure the diagnosis or clinical course of patients with acute abdominal conditions
- Anaphylactoid reactions may occur in patients without known prior exposure to therapy; avoid using this drug in patients with aspirin triad or a history of angioedema. The triad typically occurs in asthmatic patients who experience rhinitis with/without nasal polyps, or who exhibit potentially fatal bronchospasm after taking aspirin or other NSAIDs
- Prolonged use of therapy may cause renal papillary necrosis and other renal injury. Renal toxicity was observed in patients in whom renal prostaglandins have a role in the maintenance of renal perfusion. Use with caution in patients at greatest risk for this reaction such as the elderly, those with renal impairment, heart failure, liver dysfunction, and those taking diuretics or ACE inhibitors
- Therapy is not recommended in patients with advanced kidney disease. However, if therapy must be initiated, due to the NSAID component, closely monitor patient’s kidney function
- Serious and potentially fatal skin reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis may occur during therapy; discontinue therapy at the first appearance of skin rash or other sign of hypersensitivity
- Starting at 30 weeks gestation, avoid therapy in pregnant women as it may cause premature closure of the ductus arteriosus
- Oxycodone may produce additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression
- Ibuprofen/oxycodone cannot be used to treat corticosteroid insufficiency or as a substitute for corticosteroids
- The pharmacological activity of this drug in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, noninflammatory painful conditions
- Therapy may cause spasm of the sphincter of Oddi and may cause increase in the serum amylase level
- Therapy may suppress the cough reflex
- Rare cases of severe hepatic reactions including jaundice, fulminant hepatitis, liver necrosis, and hepatic failure have been reported during therapy; periodically perform liver function tests. Discontinue therapy immediately if abnormal liver tests persist or worsen, if clinical signs and symptoms of liver disease develop, or if systemic manifestations occur
- Evaluation of hemoglobin and hematocrit values at regular intervals in patients on long-term treatment with NSAIDs is recommended as therapy may cause anemia, possibly due to fluid retention, occult or gross GI blood loss
- NSAIDs inhibit platelet aggregation and prolong bleeding time in certain patients; closely monitor patients with coagulation disorders or those receiving anticoagulants
- Ibuprofen component of this combination drug may cause aseptic meningitis with fever and coma, particularly in patients with systemic lupus erythematosus (SLE) and related connective tissue diseases
- Administer cautiously in patients with preexisting asthma or aspirin-sensitive asthma as it may cause severe bronchospasm, which can be fatal
- Monitor for signs or symptoms of GI bleeding during treatment. In case of long-term therapy, CBC and a chemistry profile should be checked periodically
Cautions: Use cautiously in
- Severe renal impairment
- Severe hepatic impairment
- Severe pulmonary impairment
- Postoperative patients
- Acute abdomen
- Biliary disorder
- Acute pancreatitis
- Delirium tremens
- Kyphoscoliosis associated with respiratory depression
- Toxic psychosis
- Prostatic hypertrophy
- Urethral stricture
- CNS depression or coma
- Seizure disorder
- Hx of GI bleed or PUD
- GI bleed or PUD risk
- Alcohol or drug abuse
- Hypothyroidism
- Adrenal insufficiency
- Urinary tract obstruction
- Elderly or debilitated patients
Supplemental Patient Information
- Caution patients not to perform hazardous tasks such as driving a vehicle or operating machinery while on medication
- Inform patients to promptly report their physician if signs or symptoms of unexplained weight gain or edema occurs
Pregnancy Category:C (prior to 30 weeks gestation); D (starting at 30 weeks gestation)
Breastfeeding: Ibuprofen is a preferred choice as an analgesic or antiinflammatory agent in nursing mothers, because of its low levels in breastmilk, short half-life, and use in infants in doses much higher than those excreted in breastmilk. Drowsiness can occur in infants of mothers using maximum doses of oxycodone. Newborn infants are sensitive to the effects of even small dosages of narcotic analgesics particularly in the first week of life. It is best to limit maternal intake of oral oxycodone (and combinations) and to supplement analgesia with a nonnarcotic analgesic if necessary. Oxycodone elimination decreases in young infants and inter-individual variability exists. Monitor the infant for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants. Immediately contact a physician if the baby shows signs of increased sleepiness, difficulty breastfeeding, breathing difficulties, or limpness. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 1 June 2011). Oxycodone is excreted in human milk. Withdrawal symptoms and/or respiratory depression have been observed in neonates whose mothers are receiving narcotic analgesics during pregnancy. Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of the drug, taking into account the importance of the drug to the mother.
US Trade Name(s)
US Availability
ibuprofen/oxycodone (generic)
Combunox (ibuprofen/oxycodone)
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]