Oxycodone/Ibuprofen

DEA Class; OTC

Common Brand Names; Combunox

Analgesics, NSAID/Opioid Combos

Fixed combination tablet combines the opioid analgesic agent, oxycodone HCl, with the nonsteroidal anti- inflammatory (NSAID) agent, ibuprofen

Oxycodone: Binds to opiate receptors within neuronal membranes of synapses, which in turn blocks pain perception in the cerebral cortex; inhibits the flow of pain sensations into the higher centers

Ibuprofen: Inhibits synthesis of prostaglandins in body tissues by inhibiting cyclooxygenase; at least 2 isoenzymes, cyclooxygenase-1 (COX-1) & -2 (COX-2)

Indicated for short-term management of acute, moderate to severe pain

Use lowest effective dose for the shortest duration consistent with individual patient treatment goals

Coronary artery bypass graft (CABG) surgery, treatment of peri-operative pain; increased incidence of myocardial infarction and stroke

Hypersensitivity to ibuprofen, other NSAIDs, oxycodone, or any component of the formulation

ASA allergy

Acute or severe bronchial asthma

Known or suspected gastrointestinal obstruction

Significant respiratory depression

Hypercarbia

>10%

Dizziness (5-19%)

Drowsiness (7-17%)

Nausea (9-25%)

1-10%

Constipation (1-5%)

Diarrhea (2%)

Dyspepsia (1-2%)

Flatulence (1%)

Hypotension (1-3%)

Vomiting (5%)

Headache (10%)

Fever (3%)

Diaphoresis (2%)

Weakness (1-3%)

Cases of serotonin syndrome, a potentially life-threatening condition, reported with concomitant use of serotonergic drugs; this may occur within the recommended dosage range; the onset of symptoms generally occur within several hours to a few days of concomitant use, but may occur later than that; discontinue therapy immediately if serotonin syndrome is suspected

Pregnancy Category: C <30 weeks gestation; category D if 30 weeks gestation or greater because of potential for NSAIDs to cause premature closure of the ductus arteriosus

Lactation

Drug is present in breast milk; published lactation studies report variable concentrations of drug in breast milk with administration of immediate-release formulation to nursing mothers in early postpartum period

Adults

oxycodone/ibuprofen

Tablet: Schedule II

• 5mg/400mg