INDICATION

ULTRAM® ER (tramadol HCl) Extended-Release Tablets are indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

IMPORTANT SAFETY INFORMATION

ULTRAM ER is contraindicated in any situation where opioids are contraindicated, including a history of anaphylactoid reactions to opioids, and in patients who have previously demonstrated hypersensitivity to tramadol.

ULTRAM ER must be swallowed whole and must not be chewed, crushed, or split. Chewing, crushing, or splitting the tablet will result in the uncontrolled delivery of the opioid and could result in overdose and death. This risk is increased with concurrent abuse of alcohol and other substances. Tramadol, like other opioids used in analgesia, can be abused.

Seizures have been reported in patients receiving tramadol. The risk of seizure is increased with doses of tramadol above the recommended range.
Concomitant use of tramadol increases the seizure risk in patients taking tricyclic antidepressants, selective serotonin reuptake inhibitors, or other opioids.
Tramadol may enhance the seizure risk in patients taking 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).

Do not prescribe ULTRAM ER for patients who are suicidal or addiction-prone. ULTRAM ER 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, antidepressants or sedative hypnotics. ULTRAM ER increases the risk of CNS and respiratory depression in these patients.

Administer ULTRAM ER cautiously in patients at risk for respiratory depression. In these patients nonopioid analgesics should be considered. When large doses of tramadol 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 precipitate seizures.

Use ULTRAM ER cautiously in patients over 65 years of age due to the greater frequency of adverse events observed in this population.

ULTRAM ER should not be used in patients with severe renal (CrCl <30 mL/min) or hepatic (Child-Pugh Class C) impairment.

In clinical trials, the most frequently reported side effects in patients receiving ULTRAM ER and placebo, respectively, were dizziness (not vertigo, 15.9%-22.5% vs 6.9%), nausea (15.1%-25.5% vs 7.9%), constipation (12.2%-21.3% vs 4.2%), somnolence (7.3%-11.3% vs 1.7%), and flushing (7.7%-10.0% vs 4.4%).

ULTRAM ER should not be administered at a dose exceeding 300 mg per day.

Please see full US Prescribing Information.

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