Monograph Details

Pain & Pyrexia > Narcotic analgesics
COMBUNOX
Manufacturer
Forest Laboratories
Legal Classification
CII
Pharmacological Class
Opioid + NSAID.
Generic Name
Oxycodone HCl 5mg, ibuprofen 400mg; scored tabs.
Indications
Short-term (≤7days) management of acute, moderate to severe pain.
Children
<14 yrs: not recommended.
Adults
≥14 yrs: 1 tab every 6 hours as needed; max 7 days' therapy.
Contraindications
Severe respiratory depression. Asthma. Aspirin allergy. Hypercarbia. Paralytic ileus. History of angioedema. During or within 14 days of MAOIs. Advanced renal disease: not recommended. 3rd trimester pregnancy. Coronary artery bypass graft surgery.
Precautions
Impaired pulmonary, hepatic, renal, thyroid, or adrenocortical function. Monitor renal and hepatic function; discontinue if either develops. Respiratory depression. Cor pulmonale. COPD. CNS depression. Coma. Head injury. Increased intracranial pressure. Convulsive disorders. Delirium tremens. Circulatory shock. Edema. Hypertension. Cardiac failure. Bleeding disorders. Kyphoscoliosis (with respiratory depression). Toxic psychosis. History of upper GI disease. Active peptic ulcer. GI or GU obstruction. Acute abdomen. Biliary tract disease. Acute pancreatitis. Post-op use. Volume depleted. Dehydrated. Acute alcoholism. Drug abusers. Debilitated. Elderly. Pregnancy (Cat.C, see Contraindications). Labor & delivery, nursing mothers: not recommended.
Interactions
See Contraindications. Avoid aspirin. Potentiation with alcohol, other CNS depressants, anticholinergics, MAOIs, tricyclics, phenothiazines, muscle relaxants. May increase risk of bleeding with anticoagulants, oral steroids, smoking, alcohol. Possible withdrawal symptoms with mixed opioid agonist/antagonists. May increase toxicity of methotrexate, lithium. May reduce efficacy of, and increase risk of renal failure with, ACE inhibitors, diuretics.
Adverse Reactions
GI upset, constipation, dizziness, sweating, headache, rash (discontinue if occurs), CNS/respiratory/circulatory depression, hypotension, elevated liver enzymes, decreased hemoglobin. See literature re: risk of cardiovascular events.
How Supplied
Tabs—100