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Outline
What is the generic name?
HYDROCODONE BITARTRATE
What is the Trade Name for HYDROCODONE BITARTRATE?
Hydrocodone Bitartrate
What are the Indications for HYDROCODONE BITARTRATE?
- 1 INDICATIONS AND USAGE Hydrocodone bitartrate extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions ( 5.1 )] , reserve hydrocodone bitartrate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Hydrocodone bitartrate extended-release tablets are not indicated as an as-needed (prn) analgesic. Hydrocodone bitartrate extended-release tablets are an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydrocodone bitartrate extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 ) Hydrocodone bitartrate extended-release tablets are not indicated as an as-needed (prn) analgesic. ( 1 )
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References: https://open.fda.gov/
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