Product: Ibudone 5/200

Company: ProEthic CIII

Pharmacologic class:
Narcotic analgesic (opioid + nonsteroidal anti-inflammatory drug [NSAID])

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Active ingredients: Hydrocodone bitartrate 5 mg, ibuprofen 200 mg; tabs.
ALSO: Ibudone 10/200

Active ingredients: Hydrocodone bitartrate 10 mg, ibuprofen 200 mg; tabs.

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

Pharmacology: Ibudone combines the opioid analgesic, hydrocodone, with the NSAID ibuprofen.

Hydrocodone is a semi-synthetic codeine derivative with analgesic, antitussive, and central nervous system (CNS) effects. The precise mechanism of action of hydrocodone and other opioids is unknown, although it is believed to relate to the existence of opiate receptors in the CNS.

Ibuprofen is an anti-inflammatory agent that possesses antipyretic and analgesic properties. Its mechanism of action, like that of other NSAIDs, is not completely understood but may be related to inhibition of cyclooxygenase activity and prostaglandin synthesis.

Clinical trials:
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, gynecologic, 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.

Adults: Individualize; use lowest effective dose for shortest time. >16 years: 1 tab every four to six hours as needed; maximum 5 tabs/day.

Children: <16years: not recommended.

Contraindications: Aspirin allergy. Coronary artery bypass graft surgery. Third- 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 genitourinary 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.

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

Adverse reactions: 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.

How supplied: Tabs—100

For more information, call 334.288.1288.