tramadol hydrochloride

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

Drug Details

Generic Name
tramadol hydrochloride
Brand Names
tramadol hydrochloride, Tramadol Hydrochloride Extended-Release, ConZip, Tramadol Hydrochloride
Application Number
ANDA202075
Sponsor
NuCare Pharmaceuticals,Inc.
NDC Codes
24
Dosage Forms
TABLET, CAPSULE, CAPSULE, EXTENDED RELEASE, SOLUTION
Routes
ORAL
Active Ingredients
TRAMADOL HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE CONZIP is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. CONZIP is an opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including CONZIP, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 , 5.1 ) CONZIP is not indicated as an as-needed (prn) analgesic. ( 1 ) Limitation of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1) ] , reserve opioid analgesics, including CONZIP, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. CONZIP is not indicated as an as-needed (prn) analgesic.