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Drug DescriptionSide Effects & Drug InteractionsWarnings & PrecautionsAdditional Info
Clinical PharmacologyOverdosage & ContraindicationsIndications & DosagePatient Info

Ultracet

[Tramadol/Acetaminophen]

Pediatric Use

The safety and effectiveness of ULTRACET has not been studied in the pediatric population.

Geriatric Use

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In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function; of con-comitant disease and multiple drug therapy.

Acute Abdominal Conditions

The administration of ULTRACET may complicate the clinical assessment of patients with acute abdominal conditions.

Use in Renal Disease

ULTRACET has not been studied in patients with im-paired renal function. Experience with tramadol suggest that impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabo-lite, M1. In patients with creatinine clearances of less than 30 mL/ min, it is recommended that the dosing in-terval of ULTRACET be increased not to exceed 2 tablets every 12 hours.

Use in Hepatic Disease

ULTRACET has not been studied in patients with im-paired hepatic function. The use of ULTRACET in patients with hepatic impairment is not recommended (see WARNINGS, Use With Alcohol).

Information for Patients

° ULTRACET may impair mental or physical abilities
required for the performance of potentially hazardous tasks such as driving a car or operating machinery.

° ULTRACET should not be taken with alcohol con-taining beverages.

° The patient should be instructed not to take ULTRACET in combination with other tramadol or acetaminophen-containing products, including over-the-counter prepa-rations.

° ULTRACET should be used with caution when taking medications such as tranquilizers, hypnotics or other opiate containing analgesics.

° The patient should be instructed to inform the physi-cian if they are pregnant, think they might become pregnant, or are trying to become pregnant (see PRE-CAUTIONS, Labor and Delivery).

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