Tramadol HCL ER
Drug Details
- Generic Name
- Tramadol HCL ER
- Brand Names
- Tramadol HCL ER
- Application Number
- ANDA200503
- Sponsor
- Direct_Rx
- NDC Codes
- 1
- Dosage Forms
- TABLET, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- TRAMADOL HYDROCHLORIDE
Indications and Usage
Tramadol hydrochloride extended-release tablet is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosages or duration, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride 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. Tramadol hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.