IMPORTANT SAFETY INFORMATION:
Carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) is indicated for the short-term (generally less than 10 days) management of acute pain. It is not indicated for the treatment of conditions such as osteoarthritis or rheumatoid arthritis. REPREXAIN™ should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). Serious gastrointestinal toxicity, such as inflammation, bleeding, ulceration and perforation of the stomach, small intestine, or large intestine, with or without warning symptoms, can occur in patients taking NSAIDs. NSAIDs have been associated with an increase in cardiovascular adverse events. The most commonly reported side effects with REPREXAIN™ include headache, nausea, dizziness, dyspepsia, somnolence, and constipation. Hydrocodone may impair mental and/or physical abilities when ingested with alcohol and other CNS depressants. REPREXAIN™ tablets should be used with caution in elderly or debilitated patients, and in those patients with severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy, or urethral stricture.
Misuse, Abuse and Diversion of Opioids: REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) contains hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion.
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