Company:

ProEthic

Narcotic analgesic (opioid + NSAID)

Hydrocodone bitartrate 5mg, ibuprofen 200mg; tabs.

Ibudone 10/200

Hydrocodone bitartrate 10mg, ibuprofen 200mg; tabs.

Short term (generally less than 10 days) management of acute pain.

Ibudone combines the opioid analgesic, hydrocodone, with the non-steroidal antiinflammatory drug (NSAID), ibuprofen. Hydrocodone is a semi-synthetic codeine derivative with analgesic, antitussive, and CNS effects. Ibuprofen is an antiinflammatory agent with antipyretic and analgesic effects as well.

This product is indicated only for the treatment of acute pain; it is not indicated for treating chronic conditions such as arthritis.

Hydrocodone and ibuprofen tablets were shown to be more effective than placebo and each of the individual components in the treatment of postsurgical pain. In a clinical trial involving 940 patients who had undergone abdominal, gynecological, or orthopedic surgery, single doses of one or two tablets were evaluated. The two-tablet dose was not found to be superior to the one-tablet dose.

Individualize; use lowest effective dose for shortest time. ≥16yrs: 1 tab every 4–6 hours as needed; max 5 tabs/day.

<16yrs: not recommended.

Aspirin allergy. Coronary artery bypass graft surgery. 3rd trimester pregnancy.

Advanced renal disease: not recommended. Head injury. Increased intracranial pressure. Acute abdomen. Peptic ulcer. History of upper GI disease. Impaired renal, hepatic, thyroid, pulmonary, or adrenocortical function. GI or GU obstruction. Asthma. Edema. Hypertension. Heart failure. Bleeding disorders. Monitor BP, blood, and hepatic and renal function. Dehydration. Post-op (may suppress cough reflex). Drug abusers. Discontinue if hepatic dysfunction occurs. Elderly. Debilitated. Pregnancy (Cat.C). Labor & delivery, nursing mothers: not recommended.

See Contraindications. Avoid aspirin. Alcohol, other CNS depressants potentiated. May potentiate, or be potentiated by, MAOIs (not recommended) or tricyclic antidepressants, skeletal muscle relaxants. Increases serum lithium levels. May reduce efficacy of, and increase risk of renal failure with, ACEIs, diuretics. May increase bleeding with anticoagulants. Paralytic ileus may occur with anticholinergics. May increase lithium, methotrexate toxicity. Corticosteroids increase risk of GI bleed.

Headache, CNS depression, dizziness, GI upset/bleed, constipation, rash (discontinue if occurs), respiratory depression, anemia, mood changes, confusion, anaphylaxis; aseptic meningitis (rare); others. See literature re: risk of cardiovascular events.

Tabs—100

3/14/08