ULTRAM SUMMARY
ULTRAM® (tramadol hydrochloride tablets) is a centrally acting analgesic.
ULTRAM is indicated for the management of moderate to moderately severe pain in adults.
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NEWS HIGHLIGHTSMedia Articles Related to Ultram (Tramadol)
62-Year-Old Man Becomes First Patient In China Implanted With Rechargeable Neurostimulator For Chronic Pain
Source: Health News from Medical News Today [2009.11.19]
St. Jude Medical, Inc. (NYSE:STJ) announced that a 62-year-old man from Shenzhen, Guangdong province has become the first patient in China to be implanted with the Eon™ neurostimulator, a rechargeable device used to help manage chronic pain. Despite prior back surgeries, the patient suffered from chronic back pain for more than a decade.
Common Pain Relief Medication May Encourage Cancer Growth
Source: Cancer / Oncology News From Medical News Today [2009.11.19]
Although morphine has been the gold-standard treatment for postoperative and chronic cancer pain for two centuries, a growing body of evidence is showing that opiate-based painkillers can stimulate the growth and spread of cancer cells. Two new studies advance that argument and demonstrate how shielding lung cancer cells from opiates reduces cell proliferation, invasion and migration in both cell-culture and mouse models.
CNSBio Inc. To Present Latest Clinical Trial Data For CNSB015 At Neuropathic Pain Conference In San Francisco
Source: Clinical Trials / Drug Trials News From Medical News Today [2009.11.19]
CNSBio Inc. will present recent Phase IIa proof-of-concept clinical trial data for CNSB015, an orally administered potassium channel modulator used in combination with opioids for the treatment of neuropathic pain, at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain on November 20-21, 2009 in San Francisco, CA. Dr.
Transplanting People's Own Stem Cells Into Heart Lessens Pain, Improves Ability To Walk
Source: Clinical Trials / Drug Trials News From Medical News Today [2009.11.19]
The largest national stem cell study for heart disease showed the first evidence that transplanting a potent form of adult stem cells into the heart muscle of subjects with severe angina results in less pain and an improved ability to walk. The transplant subjects also experienced fewer deaths than those who didn't receive stem cells.
FDA Approves New Drug For Pain That Persists After Shingles
Source: Dermatology News From Medical News Today [2009.11.18]
The US Food and Drug Administration (FDA) announced yesterday that it has approved Qutenza (capsaicin) 8% patch for the treatment of post-herpetic neuralgia (PHN), an often excruciating pain that can persist for weeks, months and even years in 10 to 15 per cent of people who get shingles. The medicated skin patch, which is made by Lohmann Therapie-Systems AD of Andernach, Germany and distributed in the US by NeurogesX Inc.
Published Studies Related to Ultram (Tramadol)
Effects of tramadol on the minimum alveolar concentration of sevoflurane in dogs. [2009.07]
OBJECTIVE: To evaluate the effect of tramadol on sevoflurane minimum alveolar concentration (MAC(SEVO)) in dogs. It was hypothesized that tramadol would dose-dependently decrease MAC(SEVO).CONCLUSION AND CLINICAL RELEVANCE: Tramadol significantly reduced MAC(SEVO) but this was not dose dependent at the doses studied.
Pharmacokinetics of tramadol and its major metabolites following rectal and intravenous administration in dogs. [2009.06]
AIM: To compare the rectal and I/V administration of tramadol in dogs, to assess both its pharmacokinetic properties and absolute bioavailability... CONCLUSIONS: After rectal administration of tramadol suppositories, absorption of the active ingredient was rapid, but its metabolism quickly transformed the parent drug to high levels of M2 and M5. CLINICAL RELEVANCE: In the dog, rectal pharmaceutical formulation of tramadol would have a different pharmacokinetic behaviour than in humans.
Significance of the biopharmaceutical properties of tramadol sustained-release formulations for chrono-pharmacologically optimized treatment of pain from various sources. [2009.06]
Tramadol is currently one of the most frequently used opioid analgesics in the world. OBJECTIVE: The objective of this study was to investigate the rate and extent of tramadol bioavailability following evening versus morning intake of an extended-release pellet system designed for once daily administration. Moreover, the suitability of the preparation for chrono-adjusted pharmacotherapy was to be investigated... CONCLUSIONS: Bioavailability of the extended-release tramadol capsules for once daily administration is not affected by the time-point of administration. Total and maximum exposure of the product was bioequivalent after intake in the morning and at night. Thus, the time-point of administration may be adjusted to the patient's needs without any significant change in the in-vivo performance.
Comparison of analgesic effect of tramadol alone and a combination of tramadol and paracetamol in day-care laparoscopic surgery. [2009.06]
BACKGROUND AND OBJECTIVE: To compare the analgesic efficacy of tramadol alone (1.5 mg kg(-1)) with a tramadol (1 mg kg(-1)) and paracetamol combination in day-care laparoscopic patients... CONCLUSION: We conclude that reducing the dose of tramadol to 1 mg kg(-1) and combining it with paracetamol 1 g orally decreased the incidence of side effects of tramadol without reducing analgesic efficacy.
Analgesic efficacy of perioperative use of vedaprofen, tramadol or their combination in cats undergoing ovariohysterectomy. [2009.06]
The analgesic efficacy of tramadol and/or vedaprofen was evaluated in cats submitted for elective ovariohysterectomy, using a randomised double blind placebo controlled design. Forty adult female cats (3.0+/-0.32kg; 1.8+/-0.7 years) were distributed into four groups... This work also provides evidence for the benefits of analgesia for up to 3 days following ovariohysterectomy.
Clinical Trials Related to Ultram (Tramadol)
A Comparison of the Effectiveness and Safety of ULTRACET® (Tramadol Hydrochloride/Acetaminophen) Versus ULTRAM® (Tramadol Hydrochloride) Versus Placebo in Patients With Pain After Oral Surgery [Completed]
The purpose of this study is to explore the pain-relieving effects and safety of two
analgesic treatment regimens as compared to placebo in patients experiencing pain after oral
surgery. Tramadol hydrochloride/acetaminophen is approved to treat acute pain. This study
will evaluate the effectiveness and safety of tramadol hydrochloride/acetaminophen compared
with tramadol hydrochloride alone compared with placebo as a pain medication in the treatment
of pain following oral surgery.
CYTRAM (Cytochrome P450, Tramadol) [Not yet recruiting]
Many methods to detect CYP2D6 poor metabolizers have been validated. Some of them are based
on phenotyping (metabolism of dextromethorphan or debrisoquine) and some others on
genotyping. Up to now, CYP2D6 pharmacogenetics has been restricted to the field of research,
in spite of poor metabolizer profile concerns 5 to 10 % of caucasian population.
Nevertheless, the polymorphism of CYP2D6 is responsible for the metabolism of many drugs,
particulary of two opioids involved in pain management: codeine and tramadol, their
metabolites representing the most effective part of the drug effect. So prescribing codeine
or tramadol in a patient poor metabolizer for the CYP2D6 is likely to be ineffective in pain
management.
O-demethyl-tramadol, the metabolite of tramadol via CYP2D6, is important to consider because
its analgesic effect is 2 to 4 times more potent than tramadol.
The investigators propose to phenotype CYP2D6 in post-operative patients treated by tramadol
by monitoring seric concentrations of O-demethyl tramadol and tramadol to make a ratio in
comparision with genotype, and to find a threeshold to determine poor metabolizers. As
already described, genotyping CYP2D6 will use a rapid detection method of the alleles
implicated in poor metabolizer status (CYP2D6*3, *4, *5 et *6) in a caucasian population.
Sampling will be executed at two times (H24 and H48 after surgery) and only with blood
(three EDTA tubes) during the post-operative monitoring of the patients. This study is
likely to include 320 post-operative patients treated with intravenous tramadol during one
year in three university hospitals centers (CHU of Caen, Créteil and Rouen).
The first aim of this study is the validation of monitoring seric concentrations of
O-demethyl-tramadol and tramadol to make the ratio in order to detect CYP2D6 poor
metabolizers in therapeutic situation, comparing the result with genotyping. The finding of
a poor metabolizer status in a patient will make the choice of antalgic drugs easier,
avoiding tramadol and codeine. The final objective of this research is to be able to
determine the CYP2D6 phenotype in a patient treated by tramadol without a good analgesia. By
a single take of blood and a rapid response, this method should be liked to improve pain
managment. Furthermore, CYP2D6 phenotyping is interesting for the patient because many other
drugs depend on this way of metabolism.
Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain. [Completed]
This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for
patients with chronic low back pain, when administered over a 6-week period.
The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects [Recruiting]
Escitalopram will be given to a panel of 16 healthy subject for 9 days. On the ninth day a
single dose of tramadol is administered to the subjects and pharmacokinetic(PK) and
pharmacodynamic(PD) measurements are done for the next 24 hours.
It is stated that escitalopram is only a weak inhibitor of CYP2D6 and therefore no effect is
seen in Pk or PK of tramadol
Comparison of Tramadol Orally Versus an Optimized Dose of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery [Recruiting]
The purpose of this study is to compare the administration of 1 unit dose of 50 mg tramadol
perorally given in 3 unit dosages versus tramadol IV given in 3 unit dosage of 35 mg during
the first 6 hours postoperatively and to investigate the time course and accuracy of pain
relief versus the onset and duration of side effects. The first unit dose will be
administered at arrival at the PACU when a Visual Analogue Pain (VAS) score of more than 3
is reached. The second and third unit dose will be administered after 1 and 2 hours,
respectively, when a VAS of more than 3 is observed.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 6 ratings/reviews, Ultram has an overall score of 7.67. The effectiveness score is 7.33 and the side effect score is 7.33. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Ultram review by 55 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | arthritis pain |
| Dosage & duration: | | 100 mg taken twice a day for the period of 2 years now |
| Other conditions: | | menopause |
| Other drugs taken: | | hormone replacement therapy | | |
Reported Results |
| Benefits: | | I stayed loose and limber throughout the day. Didn't end up limping at the end of the day or after a 30 min car ride. It made me feel like I was in my 30's again instead of my 50's. It enables me to do yoga moves which I could not do because of the pain. It's changed my life. None of the side effects that narcotic pain relievers give. No tiredness or spaciness |
| Side effects: | | At first, it caused itching, but now I don't have that. If I take it close to bedtime, I can't sleep. |
| Comments: | | two 50 mg tabs twice a day. Usually at 0900 and 1700 |
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| | Ultram review by 62 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | hand pain |
| Dosage & duration: | | 100 mg q 12 hours taken daily when having bouts of pain for the period of Off and on for last ten years |
| Other conditions: | | premenopause- menopause |
| Other drugs taken: | | celebrex occasionally, Motrin occasionally | | |
Reported Results |
| Benefits: | | Since I tried to avoid the GI effect of Motrin, or celebrex if used too long, the tramadol seemed a good alterntive. I took it in the morning, and it generally seemed to energize me enough so that I stayed active, and if it didn't relieve the pain, It seemed to keep me from thinking about it and I remained busy. |
| Side effects: | | I did find that if I took it in the late afternoon, I really couldn't sleep at night, mymind raed and I felt unsettled. It reduced my appetite a bit, ad I would work without eating, or drinking. Had to remind myself to eat. |
| Comments: | | I have degenerative joint desease in both my hands. Took the standrd painkillers, not narcotics, but asa, tylenol, motrin, and then Celebrex. The best was celebrex, but there is a danger with taking it long term. Ultram ws prescribed at first as 50mg twice a day. This wasn't at all effective. So we upped the dose, and this worked well, except not at night. Since then I hae had boththumb joints replaced, and althoughI still have a prescription for the Ultram, I rarely use it... sometimes for back aches. Someone once told me it is an opiate derivative. If so, it does not seem to have an addictive quality, or any withdrawal symptoms, at least not the way I have used it. |
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| | Ultram review by 60 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Arthritis |
| Dosage & duration: | | 50 MG taken 2 times a day for the period of 2 years |
| Other conditions: | | Diabetes |
| Other drugs taken: | | Metformin & Glyberide | | |
Reported Results |
| Benefits: | | Arthritis Med/Tramadol HLC Only helps a little with Arthritis Pain. Keeps it down to a dull roar!
Diabetes Meds,Helped lower Blood Levels. Kept A1c under 7%. Made it safe to live a normal life by keeping Blood Sugar under control. Helped keep Disease & Diabetes out of Eyes. Help Kidneys function normal. |
| Side effects: | | Arthritis Med/Tramadol HLC causes slight dizziness! I also have to take 500 MG of Tylenol 3 times a day. to help with the pain. As the Tramadol HLC is not enough. Vioxx worked better! I can't take Nsaids as i am Allergic to Aspirin.
Diabetes Meds make Blood Sugar level drop Between Breakfast & Lunch. Fast! Because I/Patient am almost in the Pre/Boaderline Diabetes Stage. |
| Comments: | | 50 MG Tramadol 2 times a day.Tylenol 500 MG 3 times a day for the Arthritis pain. Neither really help much to get rid of the pain.
500 MG Metformin 3 times a day.Glyberide 1.25 MG 1 time a day for the Diabetes.I have done well on the Meds as far as keeping Diabetes under control. |
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Page last updated: 2009-11-19
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