tramadol hydrochloride

FDA Drug Profile — tramadol hydrochloride, ConZip, Tramadol Hydrochloride, Tramadol Hydrochloride Extended-Release

Drug Details

Generic Name
tramadol hydrochloride
Brand Names
tramadol hydrochloride, ConZip, Tramadol Hydrochloride, Tramadol Hydrochloride Extended-Release
Application Number
ANDA202075
Sponsor
Proficient Rx LP
NDC Codes
20
Dosage Forms
TABLET, CAPSULE, EXTENDED RELEASE, SOLUTION, CAPSULE
Routes
ORAL
Active Ingredients
TRAMADOL HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Tramadol hydrochloride tablets, USP are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1) ] , reserve tramadol hydrochloride tablets 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. Tramadol hydrochloride tablets is an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate ( 1 ). Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses ( 5.1 ), reserve tramadol hydrochloride tablets 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.