Generic name: tramadol hydrochloride 37.5mg, acetaminophen 325mg
Dosage form: tablet, coated
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Important Dosage and Administration Instructions
- ULTRACET is not approved for use for more than 5 days.
- Do not exceed the recommended dose of ULTRACET. Do not co-administer ULTRACET with other tramadol or acetaminophen containing products [see Warnings and Precautions (5.17)].
- Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5.1)].
- Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)].
- Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy and following dosage increases with ULTRACET and adjust the dosage accordingly [see Warnings and Precautions (5.2)].
The initial dose of ULTRACET is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.
Dosage Modification in Patients with Renal Impairment
In patients with creatinine clearances of less than 30 mL/min, do not exceed 2 tablets every 12 hours.
Discontinuation of ULTRACET
ULTRACET is not approved for use greater than 5 days. In circumstances where physical dependence with ULTRACET is possible, use a gradual downward taper and do not stop use of ULTRACET abruptly. [see Warnings and Precautions (5.18].
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- Drug class: narcotic analgesic combinations