Ultram ER

Ultram ER (tramadol HCl) is the first extended release tramadol product approved in the United States for relief of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. Ultram ER is available in once-daily dosage strengths of 100 mg, 200 mg and 300 mg tablets.

The U. S. Food and Drug Administration (FDA) approved Ultram ER in September 2005 based on clinical and safety data obtained from four well- controlled clinical trials. More than 3,000 patients have been treated with Ultram ER in clinical trials.

Tramadol is a non-scheduled centrally-acting synthetic opioid analgesic that has been used in the treatment of moderate to moderately severe pain since its introduction in the United States in 1995. Ultram ER uses Biovail’s innovative Smartcoat(TM) technology* to produce an extended-release tablet that provides appropriate patients effective pain control over a 24-hour period in a convenient once-daily form of tramadol. In contrast, patients may need to take immediate release tramadol tablets every 4-6 hours for pain relief.

Ultram ER is contraindicated in any situation where opioids are contraindicated, including in those patients with a history of anaphylactoid reactions to opioids.

Seizures have been reported in patients receiving tramadol. The risk of seizure is increased with doses of tramadol above the recommended range and in patients taking certain medications such as tricyclic antidepressants, selective serotonin reuptake inhibitors or opioids. Administration of tramadol may enhance the seizure risk in patients taking MAO inhibitors, neuroleptics, other drugs that reduce the seizure threshold, or 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).

Tramadol, like other opioids used in analgesia, can be abused. Ultram ER should not be used in patients who are suicidal or addiction-prone, or taken with alcohol-containing beverages.

In clinical trials the most frequently reported side effects associated with Ultram ER were dizziness, nausea, constipation, somnolence, and flushing.

Ultram ER Extended-Release Tablets are intended for oral use only and should be swallowed whole. The tablets should not be chewed, crushed, or split.

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

On the Net

ortho-mcneil.com
ultram-er.com/
Ultram description on medicinenet.com
Ultram description on opioids.com

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