Benzhydrocodone

What it is used for

Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration reserve APADAZ for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:

• Have not been tolerated or are not expected to be tolerated,
• Have not provided adequate analgesia or are not expected to provide adequate analgesia.

APADAZ should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

Side effects, and when to stop

The following serious adverse reactions are described, or described in greater detail, in other sections:

• Addiction, Abuse, and Misuse
• Life-Threatening Respiratory Depression
• Interactions with Benzodiazepines and other CNS Depressants
• Neonatal Opioid Withdrawal Syndrome
• Hepatotoxicity
• Opioid-Induced Hyperalgesia and Allodynia
• Adrenal Insufficiency
• Severe Hypotension
• Serious Skin Reactions
• Gastrointestinal Adverse Reactions
• Anaphylaxis and Other Hypersensitivity Reactions
• Seizures
• Withdrawal

Who should not take it

APADAZ is contraindicated in patients with:

• Significant respiratory depression
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Known or suspected gastrointestinal obstruction, including paralytic ileus
• Hypersensitivity to hydrocodone or acetaminophen, or any other component of this product (e.g., anaphylaxis)