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Official Information About Ultram
About ULTRAM®
(tramadol
hydrochloride tablets)
What
ULTRAM® is
What ULTRAM® is NOT
Dosage
Warnings
Side Effects
What ULTRAM®
is
ULTRAM® (tramadol hydrochloride tablets) is a prescription medication
indicated for the management of moderate to moderately severe pain. ULTRAM
received U.S. Food and Drug Administration (FDA) approval in March 1995.
Tramadol has been prescribed in more than 55 million patients worldwide and
ULTRAM has been prescribed in more than 21 million patients in the United
States. See What is ULTRAM®
and How Does It Work? in the Frequently Asked Question section for more
information.
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What ULTRAM®
is NOT
ULTRAM is a centrally acting synthetic analgesic, not a non-steroidal
anti-inflammatory drug (NSAID). ULTRAM has no anti-inflammatory activity and no
potential for prostaglandin-mediated side effects. Unlike NSAIDs, ULTRAM does
not have the potential to compromise the efficacy of certain antihypertensive
agents (diuretics, beta blockers, and ACE-inhibitors). See
What is ULTRAM® and How
Does It Work? in the Frequently Asked Question section for more information.
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Dosage and
Administration—Adults (17 years of age and over)
For patients with moderate to moderately severe chronic pain not requiring rapid
onset of analgesic effect, the tolerability of ULTRAM can be improved by
initiating therapy with the following titration regimen: ULTRAM should be
started at 25 mg/day qAM and titrated in 25 mg increments as separate doses
every 3 days to reach 100 mg/day (25 mg q.i.d.). Thereafter the total daily dose
may be increased by 50 mg as tolerated every 3 days to reach 200 mg/day (50 mg
q.i.d.). After titration, ULTRAM 50 to 100 mg can be administered as needed for
pain relief every 4 to 6 hours not to exceed 400 mg/day.
For the subset of patients
for whom rapid onset of analgesic effect is required and for whom the benefits
outweigh the risk of discontinuation due to adverse events associated with
higher initial doses, ULTRAM 50 mg to 100 mg can be administered as needed for
pain relief every four to six hours, not to exceed 400 mg per day. See
How Should I Take ULTRAM®?
in the Frequently Asked Questions section for more information.
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Warnings
Seizures have been reported in-patients receiving ULTRAM. The risk of seizures
is increased with doses of ULTRAM above the recommended range. ULTRAM increases
the seizure risk in patients taking certain medications (e.g. tricyclic
antidepressants, selective serotonin reuptake inhibitors, opioids) and may
enhance the seizure risk in patients taking MAO inhibitors, neuroleptics, or
other drugs that reduce the seizure threshold or in patients with a medical
history that may suggest increased risk of seizure. Please see full U.S.
Prescribing Information. See Who
Should Not Take ULTRAM®? and
Can I Take ULTRAM®
Along With Other Medications? in the Frequently Asked Question section for
more information.
Patients with a history of severe, life-threatening allergic (anaphylactoid) reactions to codeine and other opioids may be at risk and therefore should not receive ULTRAM.
Cases of abuse and
dependence on ULTRAM have been reported. ULTRAM should not be used in opioid-dependent
patients. Since ULTRAM can reinitiate physical dependence, it is not recommended
for patients with a tendency to drug abuse, a history of drug dependence, or
chronically using opioids.
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Side Effects
The most frequently reported side effects experienced with ULTRAM were
constipation, nausea, dizziness, headache, somnolence, and vomiting. See
Does ULTRAM® Have Side Effects?
in the Frequently Asked Question section for more information.
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Ortho-McNeil Pharmaceutical
1998-2003. All rights reserved.
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Frequently Asked
Questions
What is ULTRAM® and How Does It Work?
What is ULTRAM® and How Does It Work?
Who Should Not Take ULTRAM®? Additionally, anyone who has had an allergic-type reaction to either ULTRAM or any product containing an opioid medicine (like Tylenol®* with Codeine) should not take ULTRAM. Talk with your doctor if you may be pregnant, or are trying to become pregnant, before using ULTRAM or any other medicine. Safe use during pregnancy has not been established. As with all prescription medicines, you should not share your ULTRAM tablets with anyone else. Also, you should not take medicines that have not been prescribed specifically for you. All prescription
medicines should be taken under the medical supervision of your doctor.
Why Has My Doctor Prescribed ULTRAM for Me?
Can I Take ULTRAM® Along with Other Medications?
Can I Take ULTRAM® And Drink Alchohol?
Does ULTRAM® Have Side Effects? ULTRAM may impair your ability to drive a car or operate machinery. Seizures have been reported in patients taking ULTRAM. The risk of seizures is increased with doses of ULTRAM above the recommended range. You should not take more than 400 mg of ULTRAM (eight 50 mg tablets) per day. ULTRAM increases the risk of seizures in patients taking certain medications for other medical conditions (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, or opioids). ULTRAM may enhance the seizure risk in patients taking MAO inhibitors, neuroleptics, or other drugs that reduce the seizure threshold or 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). Patients with a
history of severe, life-threatening allergic (anaphylactoid) reactions to
codeine and other opioids may be at increased risk and therefore should not
receive ULTRAM.
How Should I Take ULTRAM®?
How Should ULTRAM® Be Stored?
Why Is Chronic Pain So Hard to Treat?
If you are like most
people who have a chronic painful condition, your pain just won't go away
and may actually make it hard for you to lead your life as you would like
to.
What Else Might I Do to Manage My Pain? What You Can Do:
Talk with Your Doctor About:
Be sure to ask your
doctor about the types of non-drug pain management techniques that might
work for you. You can also ask for referrals to specific providers of these
services. |
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You can reach Karl Loren at www.PainStudy.com by mail at 1831 N. Bel Aire Drive, Burbank, CA 91504. Within the US and Canada, use the toll free number: (800) 523-4521, the local number: (818) 558-1799, the FAX: (818) 558-7299, eMail to karl@painstudy.com
Copyright © May 20, 2008 6:26 AM by Karl Loren on behalf of Vibrant Life, ALL RIGHTS RESERVED. Permission is granted for non-commercial downloading, copying, distribution or redistribution on two conditions: One, that some form of copyright notice is included in every copy distributed or copied, showing the copyright belonging to Vibrant Life, Burbank, CA, at www.oralchelation.com . The second condition is that the material is not to be used for any purpose contrary to the purposes and objectives of this site. This permission does not extend to materials on this site which are copyrighted by others.