January 9, 2019

FDA Approves Two New Strengths of Apadaz

The FDA has approved two new strengths of Apadaz (benzhydrocodone and acetaminophen) oral tablets for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Originally approved in February of 2018, Apadaz contains benzhydrocodone, a prodrug of the opioid agonist hydrocodone, meaning that while the ingredient is initially inactive, it is converted to active hydrocodone by enzymes in the intestinal tract.

Apadaz was initially approved as a 6.12mg/325mg immediate-release tablet. These new approvals are for 4.08mg/325mg and 8.16mg/325mg.

According to FDA-approved labels, like all other opioids, Apadaz comes with the risks of addiction, abuse, and misuse, even at recommended doses. As an opioid, Apadaz should not be combined with benzodiazepines or other central nervous system (CNS) depressants, and Apadaz also comes with contraindications for significant respiratory depression, acute or severe bronchial asthma, and other breathing conditions, as opioids can cause life-threatening respiratory depression. Common adverse reactions include nausea, somnolence, vomiting, constipation, pruritus, dizziness, and headache.

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