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FDA approves Apadaz (benzhydrocodone and acetaminophen) for the short-term management of acute pain. It contains an opioid agonist and acetaminophen and is indicated for the short-term (not more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Apadaz for use in patients for whom alternative treatment options have not been or are not expected tolerated, or have not provided adequate analgesia, or are not expected to provide adequate analgesia.
Apadaz is contraindicated in patients with: significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment; known or suspected gastrointestinal obstruction, including paralytic ileus; and hypersensitivity to hydrocodone or acetaminophen.
Apadaz contains benzhydrocodone, a Schedule II controlled substance. Apadaz can be abused and is subject to misuse, addiction, and criminal diversion. Potential risks associated with Apadaz include addiction, abuse, and misuse, life-threatening respiratory depression, neonatal opioid withdrawal syndrome, risks of concomitant use or discontinuation of cytochrome P450 CYP3A4 inhibitors and inducers, acetaminophen hepatoxicity risks from concomitant use with benzodiazepines or other CNS depressants.
Others are risk of life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients, adrenal insufficiency, severe hypotension, serious skin reactions, risks of use in patients with increased intracranial pressure, brain tumors, head injury, or impaired consciousness, hypersensitivity/anaphylaxis, risks of use in patients with gastrointestinal conditions, risk of use in patients with seizure disorders, and withdrawal, risks of driving and operating machinery.
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