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. Serious anaphylactic reaction can occur even if patients have never taken 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, tramadol hydrochloride and acetamin. 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 is contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, , opioids or psychotropic drugs. ULTRAM® ER increases the risk of central nervous system and respiratory depression in these patients. ULTRAM® ER should be used with caution in patients with increased intracranial pressure or head injury, tramadol hydrochloride and acetamin. If naloxone is to be administered, use cautiously because it may precipitate seizures. ULTRAM® ER should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, tramadol hydrochloride and acetamin, anesthetic agents, , narcotics, phenothiazines, tranquilizers, tramadol hydrochloride and acetamin, antidepressants or sedative hypnotics. The development of a potentially life-threatening serotonin syndrome may occur with tramadol, particularly when combined with serotonergic drugs such as SSRISs, SNRIs, TCAs, MAOIs, triptans, tramadol hydrochloride and acetamin, drugs that alter metabolism of serotonin and drugs that alter metabolism of tramadol (CYP2D6 and CYP3A4 inhibitors). When combined treatment with these drugs is clinically warranted, patients should be closely observed for signs and symptoms of serotonin syndrome such as mental status changes, autonomic instability, neuromuscular aberrations, and/or gastrointestinal symptoms, especially during treatment initiation and dosage escalation. Patients with serotonin syndrome require immediate medical attention. Administer ULTRAM® ER cautiously in patients at risk for respiratory depression. In these patients non-opioid 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. Use ULTRAM® ER cautiously in patients over 65 years of age due to the greater frequency of adverse events observed in this population, tramadol hydrochloride and acetamin. 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, tramadol hydrochloride and acetamin, 15.9%-22.5% vs 6.9%), nausea (15.1%-25.5% vs 7.9%), tramadol hydrochloride and acetamin, constipation (12.2%-21.3% vs 4.2%), , headache (11.5%-15.5% vs 10.6%), and somnolence (7.3%-11.3% vs 1.7%) ULTRAM® ER should not be administered at a dose exceeding 300 mg per day. Taking more than the recommended dose of ULTRAM® ER, tramadol hydrochloride and acetamin, alone or in combination with alcohol or medications such as tranquilizers, hypnotics or other opioids, can cause respiratory depression, , seizures, overdose and possibly death. These risks exist at all dosage levels.
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