Ultracet

[Tramadol/Acetaminophen]

Warnings & Precautions
WARNINGS

Seizure Risk

Seizures have been reported in patients receiving tramadol within the recommended dosage range. Spontaneous post-marketing reports indicate that seizure risk is increased with doses of tramadol above the recommended range. Concomitant use of tramadol increases the seizure risk in patients taking:

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° Selective serotonin reuptake inhibitors (SSRI antidepressants or anoretics),

° Tricyclic antidepressants (TCAs), and other tricyclic compounds (e. g., cyclobenzaprine, promethazine, etc.), or

° Other opioids.

Administration of tramadol may enhance the seizure risk in patients taking:

° MAO inhibitors (see also WARNINGS Ð Use with MAO Inhibitors),

° Neuroleptics, or

° Other drugs that reduce the seizure threshold.
Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections). In tramadol overdose, naloxone administration may increase the risk of seizure.

Anaphylactoid Reactions

Serious and rarely fatal anaphylactoid reactions havebeen reported in patients receiving therapy with tram-adol. When these events do occur it is often following the first dose. Other reported allergic reactions include pruritus, hives, bronchospasm, angioedema, toxic epi-dermal necrolysis and Stevens-Johnson syndrome. Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive ULTRACET (see CONTRA-INDICATIONS).

Respiratory Depression

Administer ULTRACET cautiously in patients at risk for respiratory depression. In these patients, alternative non-opioid analgesics should be considered. When large doses of tramadol are administered with anesthetic medications or alcohol, respiratory depression may re-sult. Respiratory depression should be treated as an over-dose. If naloxone is to be administered, use cautiously because it may precipitate seizures (see WARNINGS, Seizure Risk and OVERDOSAGE).

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