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Special Populations Renal The pharmacokinetics of ULTRACET in patients with renal impairment have not been studied. Based on studies using tramadol alone, excretion of tramadol and metabo-7517200 635-11-231-1 lite M1 is reduced in patients with creatinine clearance of less than 30 mL/ min, adjustment of dosing regimen in this patient population is recommended. (See DOSAGE AND ADMINISTRATION.) The total amount of tramadol and M1 removed during a 4-hour dialysis period is less than 7% of the administered dose based on studies using tramadol alone. Text Continues Below
Hepatic The pharmacokinetics and tolerability of ULTRACET in patients with impaired hepatic function has not been studied. Since tramadol and acetaminophen are both extensively metabolized by the liver, the use of ULTRACET in patients with hepatic impairment is not recommended (see PRECAUTIONS and DOSAGE AND ADMINIS-TRATION). Geriatric A population pharmacokinetic analysis of data obtained from a clinical trial in patients with chronic pain treated with ULTRACET which included 55 patients between 65 and 75 years of age and 19 patients over 75 years of age, showed no significant changes in pharmacoki-netics of tramadol and acetaminophen in elderly patients with normal renal and hepatic function (see PRECAU-TIONS, Geriatric Use). Gender Tramadol clearance was 20% higher in female subjects compared to males on four phase I studies of ULTRACET in 50 male and 34 female healthy subjects. The clinical significance of this difference is unknown. Pediatric Pharmacokinetics of ULTRACET Tablets have not been studied in pediatric patients below 16 years of age. Clinical Studies Single Dose Studies for Treatment of Acute Pain In pivotal single-dose studies in acute pain, two tablets of ULTRACET administered to patients with pain following oral surgical procedures provided greater relief than placebo or either of the individual components given at the same dose. The onset of pain relief after ULTRACET was faster than tramadol alone. Onset of analgesia oc-curred in less than one hour. The duration of pain relief after ULTRACET was longer than acetaminophen alone. Analgesia was generally comparable to that of the comparator, ibuprofen. Page: << Prev | 1 | 2 | 3 | 4 | 5
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