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Ultracet

[Tramadol/Acetaminophen]

Interaction With Central Nervous System (CNS) Depressants

ULTRACET should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hyp-notics. Tramadol increases the risk of CNS and respi-ratory depression in these patients.

Increased Intracranial Pressure or Head Trauma

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ULTRACET should be used with caution in patients with increased intracranial pressure or head injury. The res-piratory depressant effects of opioids include carbon diox-ide retention and secondary elevation of cerebrospinal fluid pressure and may be markedly exaggerated in these patients. Additionally, pupillary changes (miosis) from tramadol may obscure the existence, extent, or course of intracranial pathology. Clinicians should also maintain a high index of suspicion for adverse drug re-action when evaluating altered mental status in these patients if they are receiving ULTRACET (see Respiratory Depression).

Use in Ambulatory Patients

Tramadol may impair the mental and or physical abili-ties required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using this drug should be cautioned accordingly. Use With MAO Inhibitors and Serotonin Re-uptake Inhibitors

Use ULTRACET with great caution in patients taking monoamine oxidase inhibitors. Animal studies have shown increased deaths with combined administration of MAO inhibitors and tramadol. Concomitant use of tramadol with MAO inhibitors or SSRI's increases the risk of adverse events, including seizure and serotonin syndrome.

Use With Alcohol

ULTRACET should not be used concomitantly with alcohol consumption. The use of ULTRACET in patients with liver disease is not recommended.

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