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ULTRAM® ER is 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

Do not take ULTRAM® ER if you have had an allergic reaction to tramadol, codeine, or other opioids in the past.

ULTRAM® ER tablets must be swallowed whole. Do not chew, crush or split the tablet before swallowing. This can lead to overdose and possible serious injury including death. Use of alcohol should be avoided when taking ULTRAM® ER.

The maximum daily dose of ULTRAM® ER is 300 mg. Do not change your dose or stop taking ULTRAM® ER without talking with your doctor first.

Talk with your doctor about all the medications you are taking. These may include antidepressants, tranquilizers, hypnotics or other opioid pain medicines. ULTRAM® ER may impair your ability to perform potentially hazardous tasks, such as driving a car or operating machinery.

Seizures have been reported in people taking tramadol, the medicine in ULTRAM® ER. The risk of seizures is increased with doses of tramadol above the recommended range. Use of tramadol increases the risk of seizures in people taking antidepressants, other opioids, or other drugs that can cause seizures. Risk of convulsions may also increase in people with epilepsy or a history of seizures.

ULTRAM® ER may be associated with a potentially life-threatening condition when taken together with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs) (classes of drugs for depression or other disorders), triptans, lithium, or St. John's Wort.  Some common SSRIs are Paxil® (paroxetine), Prozac®/Sarafem® (fluoxetine), and Zoloft® (sertraline). Some common SNRIs are Cymbalta® (duloxetine) and Effexor® (venlafaxine).  Some common triptans are Axert® (almotriptan), Imitrex® (sumatriptan), and Relpax® (eletriptan).

If you experience symptoms such as restlessness, hallucinations, loss of coordination, fast heartbeat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea, contact your doctor immediately.

ULTRAM® ER, like other opioids, can be abused or cause dependence. People who are suicidal or have a history of drug addiction should not take ULTRAM® ER. Do not take more than the recommended dose of ULTRAM® ER. Taking more than the recommended dose of ULTRAM® ER, alone or in combination with alcohol or medications such as tranquilizers, hypnotics or other opioids, can cause respiratory depression, seizures, overdose and possibly death.

Tell your doctor about all your medical conditions and if you are pregnant, think you might be pregnant or are trying to become pregnant.

The most common side effects reported with ULTRAM® ER were dizziness, nausea, constipation, headache, and drowsiness.

Paxil and Imitrex are registered trademarks of GlaxoSmithKline. Prozac and Cymbalta are registered trademarks of Eli Lilly.  Sarafem is a registered trademark of Warner Chilcott.  Zoloft and Relpax are registered trademarks of Pfizer, Inc. Effexor is a registered trademark of Wyeth. Axert is a registered trademark of Almirall Prodesfarma.

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This site is published by Ortho-McNeil-Janssen Pharmaceuticals, Inc, which is solely responsible for its contents. This information is intended for the use of our customers, patients and healthcare professionals in the United States only.

ORTHO-McNEIL recognizes that the Internet is a global communications medium; however, laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The prescribing information included here may not be appropriate for use outside of the United States. Capitalized product names are trademarks of Ortho-McNeil-Janssen Pharmaceuticals, Inc. This page was last modified on Mar 29 2008 at 08:47:07 EDT .