Ultram

[Tramadol]

Warnings & Precautions
WARNINGS

Seizure Risk

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

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

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

° Other opioids.
Administration of ULTRAM 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 ULTRAM overdose, naloxone administration may increase the risk of seizure. Anaphylactoid Reactions Serious and rarely fatal anaphylactoid reactions have been reported in patients receiving therapy with ULTRAM.

When these events do occur it is often following the first dose. Other reported allergic reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal 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 ULTRAM (see CONTRAINDICATIONS).

Respiratory Depression

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

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