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


Glossary

A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z

 

Acetaminophen: A drug used to reduce pain and fever.

 

Acute Pain: Acute pain is the normal, predicted psychological response to a noxious chemical, thermal or mechanical stimulus and typically is associated with invasive procedures, trauma and disease. It is generally time-limited.

 

Addiction: Addiction is a primary, chronic, neurobiological disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include the following: impaired control over drug use, craving, compulsive use, and continued use despite harm. Physical dependence and tolerance are normal physiological consequences of extended opioid therapy for pain and are not the same as addiction.

 

Analgesic: A compound that relieves pain by altering perception of stimuli without producing loss of sensation or loss of consciousness.

 

Anti-inflammatory: A compound, such as aspirin, that reduces inflammation.

 

Arthritis: Inflammation of the joint.

 

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Biofeedback: A training technique that allows a person to gain some voluntary control over involuntary body functions, such as muscle tension that can cause pain.

 

Cartilage: A connective tissue characterized by its firm consistency, found primarily in the joints.

 

Central Nervous System (CNS): The system that is made up of the brain and the spinal cord.

 

Chronic Pain: Chronic pain is a state in which pain persists beyond the usual course of an acute disease or healing of an injury, or that may or may not be associated with an acute or chronic pathologic process that continuous or intermittent pain over months or years.

 

Connective Tissue: The tissue that forms the supporting framework of the body.

 

COX-2 Inhibitor: Cyclooxygenase-2 inhibitor. A type of non-steroidal anti-inflammatory drug used to relieve the pain and inflammation.

 

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Dependence: Addiction to a drug.

 

Fibromyalgia: A chronic disorder characterized by widespread pain, tenderness and stiffness of muscles and associated connective tissue structures, and is typically accompanied by fatigue, headache and sleep disturbances.

 

Flare-up: A sudden increase in pain.

 

Inflammation: The body’s natural chemical reaction in response to an injury or abnormal stimulation caused by an injury, irritation or infection; usually characterized by heat, swelling, redness and pain.

 

Interstitial cystitis (IC): A chronic condition characterized by painful inflammation of the lining of the bladder wall.

 

Joint: In the body, where two or more bones join, such as the elbow or knee.

 

Ligament: A band or sheet of fibrous tissue connecting two or more bones, cartilages, or other structures.

 

Massage: A method of manipulation of the body by rubbing, pinching, kneading, tapping, etc.

 

Monoamine Oxidase Inhibitor (MAOI): A class of medications that are used for depression.

 

Myofascial Pain: A chronic form of muscle pain, centering around sensitive areas called trigger points.

 

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Neuropathic Pain: Chronic, shock-like pain that occurs once there is damage to the nervous system (the nerves, spinal cord or brain).

 

NSAID (Non-Steroidal Anti-inflammatory Drug): A drug that has analgesic, anti-inflammatory actions. NSAIDs are used to treat acute and chronic pain, including the pain of injuries and arthritis; to reduce inflammation; and to prevent complications in serious illness.

 

Opiate: A drug containing or derived from opium and tending to induce sleep and alleviate pain.

 

Opioid: Natural and semi-synthetic derivatives opium poppy, as well as synthetic components not derived from opium.

 

Orthopedics: The branch of medical science that deals with prevention or correction of disorders involving the skeleton, joints, muscles and other supporting structures, such as ligaments and cartilage.

 

Osteoarthritis: A type of arthritis marked by progressive cartilage deterioration in joints.

 

Osteoporosis: A condition that causes weak, porous bones.

 

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Pain: An unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.

 

Physical Dependence: Physical dependence is a state of adaptation that is manifested by drug class-specific signs and symptoms that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. Physical dependency, by itself, does not equate with addiction.

 

Physical Therapy: The health profession concerned with promotion of health, prevention of physical disabilities, evaluation and rehabilitation of people disabled by pain, disease or injury, and treatment by physical therapeutic measures.

 

Pseudoaddiction: The iatrogenic syndrome resulting from the misinterpretation of relief seeking behaviors as though they are drug-seeking behaviors that are commonly seen with addiction. The relief seeking behaviors resolve upon institution of effective analgesic therapy.

 

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Relaxation Technique: A method used to reduce tension in the muscles.

 

Serotonin Norepinephrine Reuptake Inhibitor (SNRI): A class of medications that are used for depression.

 

Serotonin Reuptake Inhibitor (SSRI): A class of medications that are used for depression.

 

Substance Abuse: Substance abuse is the use of any substance(s) for non-therapeutic purposes or use of medication for purposes other than those for which it is prescribed.

 

Tendon: A band of tough, inelastic fibrous tissue connecting a muscle with its bony attachment.

 

Tolerance: Tolerance is a psychologic state resulting from regular use of a drug in which an increased dosage is needed to produce a specific effect, or a reduced effect is observed with a constant dose over time. Tolerance may or may not be evident during opioid treatment and does not equate with addiction.

 

Tramadol: The medicine in ULTRAM® ER. A synthetic opioid analgesic administered orally to treat moderate to moderately severe pain.

 

Transcutaneous Electric Nerve Stimulation (TENS): The application of mild electrical stimulation to skin electrodes placed over a painful area. It alleviates pain by interfering with transmission of painful stimuli.

 

Tricyclic antidepressant (TCA): A class of medications that are used for depression.

 

Vertebrae: Segments of the spinal column; in humans, there are usually 33 vertebrae: 7 cervical, 12 thoracic, 5 lumbar, 5 sacral (fused into one bone, the sacrum), and 4 coccygeal (fused into one bone, the coccyx).

 

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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. 2008-2010. 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 16:13:49 EDT.


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