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Ultracet

[Tramadol/Acetaminophen]

Other events which have been reported with the use of tramadol products and for which a causal association has not been determined include: vasodilation, ortho-static hypotension, myocardial ischemia, pulmonary edema, allergic reactions (including anaphylaxis and urticaria, Stevens-Johnson syndrome/ TENS), cognitive dysfunction, difficulty concentrating, depression, suicidal tendency, hepatitis liver failure and gastrointestinal bleeding. Reported laboratory abnormalities included elevated creatinine and liver function tests.

Serotonin syndrome (whose symptoms may include mental status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis, seizures and coma) has been reported with tramadol when used concomitantly with other sero-tonergic agents such as SSRIs and MAOIs.
Other clinically significant adverse experiences previously reported with acetaminophen.

Allergic reactions (primarily skin rash) or reports of hyper-sensitivity secondary to acetaminophen are rare and generally controlled by discontinuation of the drug and, when necessary, symptomatic treatment.

Text Continues Below



Drug Interactions

In vitro studies indicate that tramadol is unlikely to in-hibit the CYP3A4-mediated metabolism of other drugs when tramadol is administered concomitantly at thera-peutic doses. Tramadol does not appear to induce its own metabolism in humans, since observed maximal plasma concentrations after multiple oral doses are higher than expected based on single-dose data. Tramadol is a mild inducer of selected drug metabolism pathways measured in animals.

Use With Carbamazepine

Patients taking carbamazepine may have a signifi-cantly reduced analgesic effect of tramadol. Because carbamazepine increases tramadol metabolism and because of the seizure risk associated with tramadol, concomitant administration of ULTRACET and carba-mazepine is not recommended.

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