What is the generic name?

TRAMADOL HYDROCHLORIDE

What is the Trade Name for TRAMADOL HYDROCHLORIDE?

Tramadol Hydrochloride Extended-Release

What are the Indications for TRAMADOL HYDROCHLORIDE?

• 1 INDICATIONS AND USAGE Tramadol Hydrochloride Extended-Release Capsules 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. Tramadol Hydrochloride Extended-Release Capsules 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 Tramadol Hydrochloride Extended-Release Capsules 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 ) Tramadol Hydrochloride Extended-Release Capsules are not indicated as an as-needed (prn) analgesic. ( 1 ) Limitation 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/long-acting opioid formulations [ see Warnings and Precautions (5.1) ], reserve Tramadol Hydrochloride Extended-Release Capsules 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. Tramadol Hydrochloride Extended-Release Capsules are not indicated as an as-needed (prn) analgesic.

References: https://open.fda.gov/