New, Once Daily Medicine Available for Treatment for Moderate to Moderately Severe Chronic Pain in Adults
Posted on: Wednesday, 12 July 2006, 12:00 CDT
NEW YORK, July 12 /PRNewswire/ -- STORY INFORMATION:
SUGGESTED ANCHOR LEAD: CHRONIC PAIN AFFECTS A LARGE SEGMENT OF THE AMERICAN POPULATION AND FOR INDIVIDUALS SUFFERING WITH CHRONIC PAIN, MORE THAN 3 IN 5 HAVE BEEN IN PAIN FOR MORE THAN A YEAR.
SCRIPT: THIS IS YOUR HEALTHY MINUTE.
MORE THAN 50 MILLION AMERICANS SUFFER FROM PERSISTENT, CHRONIC PAIN. ACCORDING TO THE AMERICAN PAIN FOUNDATION, CHRONIC PAIN IS A SYMPTOM THAT ADVERSELY AFFECTS THE QUALITY OF LIFE FOR PEOPLE DEALING WITH PAIN - BOTH IN TERMS OF THEIR DAY-TO-DAY ACTIVITIES AND THEIR EMOTIONAL WELL-BEING.
A NEW ONCE-A-DAY PRESCRIPTION MEDICINE-ULTRAM(R) ER (TRAMADOL HCL) EXTENDED-RELEASE TABLETS-IS NOW AVAILABLE FOR MANAGEMENT OF MODERATE TO MODERATELY SEVERE CHRONIC PAIN IN ADULTS WHO NEED AROUND-THE-CLOCK PAIN TREATMENT FOR AN EXTENDED PERIOD OF TIME.
DR. ZORBA PASTER CLINICAL PROFESSOR OF FAMILY MEDICINE, UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH:
"Chronic pain affects a large segment of the American population, often requiring physician treatment for persistent pain. ULTRAM ER is an important new option, providing once-a-day dosing, for adults who suffer from moderate to moderately severe chronic pain, and for the physicians who treat them."
WHEN TREATING CHRONIC PAIN, IT IS IMPORTANT FOR PATIENTS TO HAVE A DISCUSSION WITH THEIR PHYSICIAN ABOUT THEIR INDIVIDUAL NEEDS.
FOR MORE ABOUT ULTRAM ER, TALK TO YOUR DOCTOR OR VISIT ULTRAM-ER.COM Important Safety Information
ULTRAM ER is contraindicated in any situation where opioids are contraindicated, including a history of anaphylactoid reactions to opioids, and in patients who have previously demonstrated hypersensitivity to tramadol.
ULTRAM ER must be swallowed whole and must not be chewed, crushed, or split. Chewing, crushing, or splitting the tablet will result in the uncontrolled delivery of the opioid and could result in overdose and death. This risk is increased with concurrent abuse of alcohol and other substances. Tramadol, like other opioids used in analgesia, can be abused.
Seizures have been reported in patients receiving tramadol. The risk of seizure is increased with doses of tramadol above the recommended range.
Concomitant use of tramadol increases the seizure risk in patients taking tricyclic antidepressants, selective serotonin reuptake inhibitors, or other opioids.
Tramadol may enhance the seizure risk in patients taking MAO inhibitors, neuroleptics, or other drugs that reduce the seizure threshold.
Risk of convulsions may also increase 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).
Do not prescribe ULTRAM ER for patients who are suicidal or addiction-prone.
ULTRAM ER should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers, antidepressants or sedative hypnotics. ULTRAM ER increases the risk of CNS and respiratory depression in these patients.
Administer ULTRAM ER cautiously in patients at risk for respiratory depression. In these patients nonopioid analgesics should be considered. When large doses of tramadol are administered with anesthetic medications or alcohol, respiratory depression may result. Respiratory depression should be treated as an overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures.
Use ULTRAM ER cautiously in patients over 65 years of age due to the greater frequency of adverse events observed in this population.
ULTRAM ER should not be used in patients with severe renal (CrCl <30 mL/min) or hepatic (Child-Pugh Class C) impairment.
In clinical trials, the most frequently reported side effects in patients receiving ULTRAM ER and placebo, respectively, were dizziness (not vertigo, 15.9%-22.5% vs 6.9%), nausea (15.1%-25.5% vs 7.9%), constipation (12.2%-21.3% vs 4.2%), somnolence (7.3%-11.3% vs 1.7%), and flushing (7.7%-10.0% vs 4.4%).
ULTRAM ER should not be administered at a dose exceeding 300 mg per day.
AUDIO PROVIDED BY: Ortho-McNeil, Inc.
Audio: http://www.prnewswire.com/broadcast/24620/consumer.html
Ortho-McNeil, Inc.
CONTACT: FOR STORY INFORMATION, PLEASE CALL: MultiVu Media Relations,1-800-653-5313, EXT. 3 OR EMAIL RADIO@MULTIVU.COM
Web site: http://www.ultram-er.com/
Source: PRNewswire
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