tramadol hydrochloride tablet film coated

1 INDICATIONS AND USAGE Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. L imitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosages or duration [see Warnings and Precautions ( 5.1 )] , reserve tramadol hydrochloride for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 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 should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. Tramadol hydrochloride 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 ). L i m itations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve tramadol hydrochloride for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated or are not expected to be tolerated, ( 1 ) Have not provided adequate analgesia, or are not expected to provide adequate analgesia ( 1 ) Tramadol hydrochloride should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

zydus pharmaceuticals (usa) inc.

FDA Reported Adverse Reactions
[1] dependence    [2] drug ineffective    [3] nausea    [4] off label use    [5] pain    [6] dyspnoea    [7] overdose    [8] vomiting    [9] fatigue    [10] diarrhoea