Combunox was shown to be more effective than ibuprofen, oxycodone, or placebo alone. The measurement of pain relief was based on the magnitude of pain and the reduction in pain intensity.3
Combunox is dosed as 1 tablet as needed for pain, with a daily maximum of 4 tablets. Multiple doses of Combunox have not yet been studied. The maximum length of treatment is 1 week. Combunox has not yet been studied in patients under 14 years old.3
Warnings and Contraindications
Patients with a history of ibuprofen or oxycodone allergy should not receive Combunox. Additionally, patients with respiratory depression, hypercarbia, severe bronchial asthma, or paralytic ileus should not take Combunox. Caution should be used in patients with a history of allergic reaction to other opiate medications.
Potential drug interactions may occur with anticholinergic medications, CNS depressants, mixed agonist/antagonist opioid analgesics, monoamine oxidase inhibitors, neuromuscular blocking agents, other NSAIDs, diuretics, lithium, methotrexate, and warfarin.3
Combunox is in Pregnancy Category C and should be avoided altogether in the third trimester because ibuprofen has the potential to inhibit labor via the inhibition of prostaglandin synthesis. Additionally, oxycodone use immediately prior to delivery may result in respiratory depression in the infant.3
In clinical studies, the most commonly reported adverse effects were nausea (8.8%), vomiting (5.3%), flatulence (1.0%), somnolence (7.3%), dizziness (5.1%), and sweating (1.6%).
Combunox is a Schedule II medication, and health care providers should be aware of its potential for abuse or diversion. Appropriate vigilance should be exercised.
When dispensing Combunox or any combination product that contains an OTC analgesic, the pharmacist should take a few moments to remind patients that they should not take any other OTC analgesics without consulting their prescribers. The pharmacist should mention that Combunox contains ibuprofen, and list several brands of OTC ibuprofen. Should a prescriber instruct patients to treat breakthrough pain with additional ibuprofen, the pharmacist should keep in mind that the absolute maximum recommended daily dose of ibuprofen is 3.2 g in healthy adults.
Dr. Holmberg is a pharmacist at Phoenix Children's Hospital, Phoenix, Ariz.
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