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

About Chronic Pain

Chronic Osteoarthritis Pain

Osteoarthritis is the most common form of arthritis.

The National Institutes of Health (NIH) defines osteoarthritis as a joint disease that mostly affects cartilage. Cartilage is the slippery tissue that covers the ends of bones in a joint. Healthy cartilage allows bones to glide over each other. It also helps absorb the shock of movement.

With osteoarthritis, the top layer of cartilage wears away - causing the bones underneath the cartilage to rub together. This rubbing can cause pain, swelling, and loss of motion. Over time, the joint may lose its shape, and bone spurs may grow on the edges of the joint. Sometimes bits of bone or cartilage can break off and float inside the joint space, causing more pain and damage.

If you think you may suffer from chronic osteoarthritis pain, ask your doctor if ULTRAM® ER is the right course of treatment for you.


Some statistics about osteoarthritis pain:

According to the NIH,

  • Osteoarthritis affects nearly 21 million people in America age 25 and older.
  • By the age of 65, half of the population shows signs of having osteoarthritis in at least one joint.
  • After the age of 45, women are more affected by osteoarthritis than men.

What causes osteoarthritis?

The cause of osteoarthritis is unknown, but may be caused by factors, such as:

  • Being overweight
  • Getting older
  • Joint injury
  • Genetic defects in joints or cartilage
  • Stresses on the joints from certain activities

Osteoarthritis warning signs.

The most common symptoms of osteoarthritis are:

  • Joint stiffness after sitting or laying down for a long time
  • Swelling or tenderness in one or more joints
  • A crunching feeling, or the sound of bones rubbing together

How is osteoarthritis pain treated?

Osteoarthritis pain treatment plans can involve:

  • Exercise
  • Heat or cold packs
  • Medication

How Osteoarthritis may affect your body

There are a few joints where one might experience chronic osteoarthritis pain. Learn a little more about some here.


Knee
Hip

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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. 2008-2009. 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 Feb 10 2010 at 02:22:46 EST.


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