12/2016
Indications and Usage (1) 12/2016
Dosage and Administration (2) 12/2016
Contraindications (4) 12/2016
Warnings and Precautions (5) 12/2016
INDICATIONS AND USAGE
Tramadol hydrochloride and acetaminophen tablets are a combination of tramadol hydrochloride, an opioid agonist, and acetaminophen, and are indicated for the management of acute pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)
Limitations of Use (1)
Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve tramadol hydrochloride and acetaminophen 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.
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. (2.1)
Initiate treatment with two tablets every 4 to 6 hours as needed for pain relief; maximum of 8 tablets per day. (2.2)
Do not use with other acetaminophen- or tramadol-containing products. (2, 5.17)
Severe Renal Impairment: Do not exceed 2 tablets every 12 hours. (2.3)
Do not stop tramadol hydrochloride and acetaminophen tablets abruptly in a physically dependent patient. (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: tramadol hydrochloride 37.5 mg and acetaminophen 325 mg. (3)
CONTRAINDICATION |
