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Ultracet This page contains drug information on Ultracet. The information provided includes the following: what is Ultracet ACETAMINOPHEN; TRAMADOL (Ultracet(reg)) is a combination analgesic that is used to relieve moderate, acute pain such as pain following surgical procedures, including dental surgery. Acetaminophen; tramadol may be used for other types of pain as determined by your health care provider. Generic acetaminophen; tramadol tablets are not yet available.Ultracet
What is the most important information I should know about Ultracet? ULTRACET tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen and are light yellow in color. Inactive ingredients in the tablet are powdered cellulose, pregelatinized corn starch, sodium starch glycolate, starch, purified water, magnesium stearate, OPADRY® Light Yellow, and carnauba wax. The absolute bioavailability of tramadol from ULTRACET tablets has not been determined. Tramadol hydrochloride has a mean absolute bioavailability of approximately 75% following administration of a single 100 mg oral dose of ULTRAM® tablets. The mean peak plasma concentration of racemic tramadol and M1 after administration of two ULTRACET tablets occurs at approximately two and three hours, respectively, post-dose.
What is Ultracet? When ULTRACET was administered with food, the time to peak plasma concentration was delayed for approximately 35 minutes for tramadol and almost one hour for acetaminophen. However, peak plasma concentration or the extent of absorption of either tramadol or acetaminophen were not affected. The clinical significance of this difference is unknown.
What should I discuss with my healthcare provider before taking Ultracet? The pharmacokinetics of ULTRACET® in patients with renal impairment have not been studied. Based on studies using tramadol alone, excretion of tramadol and metabolite 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. 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 ADMINISTRATION ).
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