Legal Statement| Privacy Policy


ULTRAM® ER (tramadol HCl) Extended-Release Tablets For Chronic Pain
Home 
About ULTRAM ER 

How It Works 

How to Take it  

The Right Dose 

About Chronic Pain 

Chronic Osteoarthritis Pain 

Chronic Back Pain 

Fibromyalgia Pain 

Myofascial Pain 

Neuropathic Pain 

Managing Your Chronic Pain

Exercise 

Behavior 

Other Tips 

Relapses 

Symptom Tracker 

Talking to Your Doctor 

Doctor Checklist 

News & Events
 
Important Safety Information
 
Full Product Information
 
For Healthcare Professionals
 

On behalf of Biovail Corporation (manufacturer of ULTRAM® ER), PriCara®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. is voluntarily recalling certain lots of ULTRAM® ER. For more information,
click here.




Chronic Pain Information

About Chronic Pain

Fibromyalgia Pain

Fibromyalgia is a syndrome (not a disease) in which there is chronic, widespread pain in the muscles, ligaments and tendons. It is recognized as one of 2 common muscle pain conditions, the other being myofascial pain syndrome.


People who suffer with fibromyalgia often experience fatigue and at least 11 of 18 possible tender points - places on the body where slight pressure causes pain. It can, however, be a difficult condition to diagnose. Fibromyalgia is, above all else, a chronic muscular pain syndrome, but it is associated with a number of other symptoms that include:

  • Sleep disturbance
  • Headache
  • Morning stiffness
  • Irritable bowel syndrome (IBS)
  • Interstitial cystitis (IC)
  • Difficult or painful sexual intercourse
  • Mood disturbance

Some statistics about fibromyalgia pain:

  • For unknown reasons, between 80% and 90% of those diagnosed with fibromyalgia are women; however, men and children also can be affected. [As stated by the National Institutes of Health (NIH).]
  • According to the American Academy of Family Physicians, women diagnosed with fibromyalgia are typically 20 to 50 years of age.
  • Symptoms decrease with age, and older patients tend to have less pain, depression, illness impact and better sleep.

What causes fibromyalgia?

Doctors don't actually know what causes fibromyalgia. One theory, called "central sensitization," states that people with fibromyalgia have a lower threshold for pain as a result of increased sensitivity in the brain to pain signals. So pressure on a spot of the body that wouldn't hurt someone without fibromyalgia could be extremely painful to someone with it.

Other beliefs as to the cause of fibromyalgia include:

  • Sleep disturbances
  • Injury or trauma
  • Infection
  • Abnormalities of certain parts of the nervous system
  • Changes in muscle metabolism
  • Psychological stress
  • Hormonal changes

How is fibromyalgia pain treated?

Despite the increase in recognition of fibromyalgia, treatment still remains challenging.


Fortunately, fibromyalgia isn't progressive or life-threatening. Treatments and self-care can improve fibromyalgia pain. Probably the single most important and effective therapy is aerobic exercise, which can be especially helpful in combination with medication, cognitive behavior therapy or other pain treatments such as acupuncture, biofeedback and hypnosis.


NOTE: ULTRAM® ER has never been studied in specific fibromyalgia patients.


If you think you may suffer from pain due to fibromyalgia, ask your doctor if ULTRAM® ER could be the right course of treatment for you.



Print this page | Tell a friend | Glossary | Site map | Contact us


ULTRAM® ER is used to manage moderate to moderately severe chronic pain in adults who need to be treated around the clock for 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. Do not take ULTRAM® ER in any situation where opioids should not be used, including acute intoxication with alcohol, hypnotics, narcotics, centrally acting analgesics, opioids, or psychotropic drugs. ULTRAM® ER may worsen central nervous system and respiratory depression.


Seizures have been reported in people taking tramadol, the active ingredient in ULTRAM® ER, at recommended doses. 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, a history of seizures, or a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, and central nervous system infections).


People who are suicidal or have a history of addiction should not take ULTRAM® ER. Use of alcohol should be avoided when taking ULTRAM® ER. Do not take more than the recommended dose of ULTRAM® ER.


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). Symptoms of Serotonin Syndrome can include mental-state changes such as agitation, hallucinations, and coma. Symptoms can also include autonomic instability (e.g. fast heartbeat, fluctuating blood pressure, increased body temperature), neuromuscular aberrations (e.g. overactive reflexes, incoordination), and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea).


Serious and rarely fatal anaphylactic (allergic) reactions can occur, even if you have never taken tramadol.


Taking 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. Taking certain medications together can increase the risk of respiratory and central nervous system depression. These medications may include alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers, or sedative hypnotics.


Before taking ULTRAM® ER, you should inform your doctor if you have been diagnosed with increased intracranial pressure or have had a head injury.


ULTRAM® ER may impair your ability to perform potentially hazardous tasks, such as driving a car or operating machinery.


Talk with your doctor about all medications you are taking. These may include antidepressants, tranquilizers, hypnotics, or other opioid pain medicines. 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, or diarrhea, contact your doctor immediately.


Do not change your dose or stop taking ULTRAM® ER without talking with your doctor first as you may experience withdrawal symptoms.


ULTRAM® ER can be abused or cause dependence. 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. You should not use ULTRAM® ER if you have severe renal impairment.


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


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


Please talk to your healthcare professional for more information or if you have further questions about ULTRAM® ER. You can also call the Ortho-McNeil-Janssen Scientific Affairs, LLC, Customer Communications Center at 1-800-526-7736 for more information. In addition, please visit www.ultram-er.com for full Prescribing Information.


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.


Please see full US Prescribing Information.


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

© Ortho-McNeil-Janssen Pharmaceuticals, Inc. 2008-2010. All rights reserved. Your use of the information on this site is subject to the terms of our Legal Statement. Please see our Privacy Policy.

This site is published by PriCara®, Division of 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.


PriCara® 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 PriCara®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

This page was last modified on May 28 2010 at 16:08:50 EDT.


ULTRAM® ER (tramadol HCl) Extended-Release Tablets For Chronic Pain PriCara®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc