March 10, 2018

FDA Approves New Opioid Prodrug, Apadaz

The FDA has approved 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.

The following language is extracted from the FDA label for Apadaz:

The ingredient benzhydrocodone is a prodrug of the opioid agonist hydrocodone, meaning that while the ingredient is initially inactive, is it converted to active hydrocodone by enzymes in the intestinal tract.

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. Initial treatment of Apadaz is suggested at one or two tablets every 4-6 hours as needed for pain, with no more than 12 tablets in a 24-hour period.

For more information, please see the FDA approved label.

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