ULTRACET SUMMARY
ULTRACET™ (37.5 mg tramadol hydrochloride/325 mg acetaminophen tablets) combines two analgesics, tramadol and acetaminophen.
ULTRACET is indicated for the short-term (five days or less) management of acute pain.
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NEWS HIGHLIGHTSMedia Articles Related to Ultracet (Tramadol / Acetaminophen)
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 Ultracet (Tramadol / Acetaminophen)
Ultra low-dose naloxone and tramadol/acetaminophen in elderly patients undergoing joint replacement surgery: a pilot study. [2009.03]
OBJECTIVE: A pilot study was conducted to assess whether both the rationale and feasibility exist for future randomized clinical trials to evaluate the combined use of naloxone infusion and tramadol/acetaminophen as opioid-sparing drugs in elderly patients undergoing lower extremity joint replacement surgery... CONCLUSION: Consequently, a randomized, double-blinded clinical trial comparing standard therapy versus standard therapy plus these two drugs seems warranted. In such a trial, it would require approximately 20 subjects per treatment arm to detect a 80% decrease in morphine use.
A 2-week, multicenter, randomized, double-blind, double-dummy, add-on study of the effects of titration on tolerability of tramadol/acetaminophen combination tablet in Korean adults with knee osteoarthritis pain. [2007.07]
BACKGROUND: Combined tramadol/acetaminophen is used to treat pain related to osteoarthritis. However, adverse events (AEs) leading to discontinuation can occur. Dose titration may decrease the risk for AEs. OBJECTIVE: The aim of this study was to assess the effect of tramadol/acetaminophen titration on the development of AEs leading to treatment discontinuation in patients with knee osteoarthritis... CONCLUSIONS: In this population of Korean patients with knee osteoarthritis pain managed with a stable dose of NSAIDs, titration of tramadol/acetaminophen over 12 days was associated with improved tolerability and a significantly lower discontinuation rate compared with nontitration. Both regimens significantly reduced from baseline associated with osteoarthritis.
Tramadol/acetaminophen or hydrocodone/acetaminophen for the treatment of ankle sprain: a randomized, placebo-controlled trial. [2007.04]
STUDY OBJECTIVE: This randomized, multicenter study compares the analgesic efficacy and safety of tramadol/acetaminophen versus hydrocodone/acetaminophen versus placebo for the treatment of acute musculoskeletal pain caused by ankle sprain... CONCLUSION: One or 2 capsules of 37.5 mg tramadol/325 mg acetaminophen and 1 capsule of 7.5 mg hydrocodone/650 mg acetaminophen were well tolerated, had comparable clinical utility, and were more effective than placebo in the management of acute musculoskeletal pain caused by ankle sprain.
Tramadol/Acetaminophen or Hydrocodone/Acetaminophen for the Treatment of Ankle Sprain: A Randomized, Placebo-Controlled Trial. [2006.11.17]
STUDY OBJECTIVE: This randomized, multicenter study compares the analgesic efficacy and safety of tramadol/acetaminophen versus hydrocodone/acetaminophen versus placebo for the treatment of acute musculoskeletal pain caused by ankle sprain... CONCLUSION: One or 2 capsules of 37.5 mg tramadol/325 mg acetaminophen and 1 capsule of 7.5 mg hydrocodone/650 mg acetaminophen were well tolerated, had comparable clinical utility, and were more effective than placebo in the management of acute musculoskeletal pain caused by ankle sprain.
Combination of oral tramadol, acetaminophen and 1% lidocaine induced periprostatic nerve block for pain control during transrectal ultrasound guided biopsy of the prostate: a prospective, randomized, controlled trial. [2006.10]
PURPOSE: Prostate biopsy for diagnosing cancer can be painful. Tramadol is a centrally acting analgesic used to treat many pain disorders. We determined whether administering oral tramadol and acetaminophen combined with 1% lidocaine induced periprostatic nerve block would significantly decrease the pain experienced by patients during standard 10-core transrectal ultrasound guided needle biopsy of the prostate... CONCLUSIONS: Administering 75 mg tramadol/650 mg acetaminophen orally with periprostatic 1% lidocaine before transrectal ultrasound guided prostate biopsy is a safe, easy and effective method of controlling pain during the biopsy procedure.
Clinical Trials Related to Ultracet (Tramadol / Acetaminophen)
A Study to Evaluate the Clinical Benefits of Tramadol/Acetaminophen (Ultracet) Versus Diclofenac in the Treatment of Pain in Patients With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-Rheumatic Drugs (DMARDs) [Not yet recruiting]
The purpose of the study is to investigate the clinical benefit of Tramadol/Acetaminophen
(Ultracet) vs. NSAID (Diclofenac 50 mg) in the treatment of pain in patients with ankylosing
spondylitis receiving stable treatment of disease modifying anti-rheumatic drugs (DMARDs).
A Study to Evaluate the Effect of Analgesics on a Walking Model of Knee Pain [Recruiting]
This study will evaluate a walking model of osteoarthritis for use in testing of new
therapeutic agents.
Tramadol/Acetaminophen(Ultracet) AS Add-on Therapy in the Treatment of Patients With Ankylosing Spondylitis [Not yet recruiting]
Ankylosing spondylitis (AS) is a chronic inflammatory arthritis causing back pain,
peripheral arthritis and enthesitis due to genetic background and autoimmunity. Patients
with ankylosing spondylitis usually suffered from chronic pain over spine and peripheral
joints since their second or third decades. It may also cause severe social and
psychological burden to patients and their family.
Exercise and non-steroid anti-inflammatory drugs (NSAID) are the standard first-line
treatments for AS（1）. Only 50% of patients with AS reach the ASAS response criteria（2） in
clinical trials. Patients with severe disease activity should be put on disease-modifying
anti-rheumatic drugs (DMARD), such as sulfasalazine（3） and anti-TNF biological agents.
Add-on of acetaminophen and low dose anti-depressant （4）can slightly improve the response
rate. However, there is no data if tramadol or ultracet can benefit AS.
Tramadol 37. 5 mg/APAP 325 mg combination tablets (ULTRACET®) were effective and safe as
addon therapy with COX-2 NSAID for treatment of osteoarthritis (5) and chronic low back
pain (6).There is no clinical trial regarding tramadol usage in chronic inflammatory
arthritis such as rheumatoid arthritis (RA) or ankylosing spondylitis. It would be important
to do a pilot clinical trial on add-on effect of tramadol to NSAID in patients with AS or
RA.
This Open-Label Study Will Evaluate the Analgesic Effectiveness and Safety Measurement of Tramadol HCl/Acetaminophen in the Treatment of Pain for Fibromyalgia. [Not yet recruiting]
The purpose of the study is to evaluate the analgesic effectiveness and safety measurement of
Ultracet in the treatment of pain for fibromyalgia. This is a multicenter, single arm study.
Patients receiving antidepressants, cyclobenzaprine or anti-epileptic drugs for pain prior to
entering this study, must discontinue these medications at least three weeks before entering
the Treatment Phase.
Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions [Completed]
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 3 ratings/reviews, Ultracet has an overall score of 5.33. The effectiveness score is 6 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst.
| | Ultracet review by 51 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | chronic pain from disk hernia in cervical spine |
| Dosage & duration: | | 50mg taken 2-4 times a day for the period of 6 months |
| Other conditions: | | none |
| Other drugs taken: | | Skelaxin | | |
Reported Results |
| Benefits: | | enabled me to manage pain without being on narcotics. I did not experience a spacey out of touch feeling as I did when taking vicodin. It did make me a bit sleepy for the first couple of hours after dosing |
| Side effects: | | mild sleepyness |
| Comments: | | on drug to control pain prior to surgical correction of a herniated cervical disk and for post op pain |
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| | Ultracet review by 49 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Tooth Infection |
| Dosage & duration: | | 2 tablets 4-6 hrs taken every 4 hrs for pain for the period of 3 Days |
| Other conditions: | | None |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | There were no benefits to this treatment. |
| Side effects: | | I had a tooth infected went to the dentist for exam and antibotics, and he gave me Tramadol. I took it from 10/14/2008 to 10/16/2008 early am every 4 to 6 hrs 2 pills for pain. I woke up Thursday around 2 am took 2 more as prescribed was unable to walk due to muscle spasms. I could not go to the bathroom due to pain just made the barrel by the bed and crawled back in the bed stopped taking the pain pills after this. My Husband took me to the Doctors office carefully assisting me as I could not walk. I was paralized with extreme severe pain. He made a make shift ambulance out of a ford escort in the back making a bed and I crawled carefully in pain and laid there. The Physician office told me go to the Emg. room St Michaels Hospital. I was unable to get out of the back of the car. With assistance it took a good while to get me out and to lean on a wheelchair to try and walk with constant spasms and pain. I finally got to a bed in the emergency room and laid on my side. In less than 1 hour I had 2 shots in my rear and one in my arm informing I was having severe adverse reactions to the meds. They went from the top of my shoulders, down my back, to my stomach and legs. This was worse than having a baby and I had 3. I am still laid up today and have had a leave of absence due that I am unable to walk or sit at present. I am very upset at the slow process and the information on side affects do not talk about these adverse affects. My physician took blood and urine samples for a possible muscle problem that this adverse reaction can cause. Waiting for the results. |
| Comments: | | Take 2 pills every 4 to 6 hrs. for pain. Not to exceed 8 pills |
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| | Ultracet review by 49 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Tooth Infection |
| Dosage & duration: | | 2 tablets 4-6 hrs taken every 4 hrs for pain for the period of 3 Days |
| Other conditions: | | None |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | There were no benefits to this treatment. |
| Side effects: | | I had a tooth infected went to the dentist for exam and antibotics, and he gave me Tramadol. I took it from 10/14/2008 to 10/16/2008 early am every 4 to 6 hrs 2 pills for pain. I woke up Thursday around 2 am took 2 more as prescribed was unable to walk due to muscle spasms. I could not go to the bathroom due to pain just made the barrel by the bed and crawled back in the bed stopped taking the pain pills after this. My Husband took me to the Doctors office carefully assisting me as I could not walk. I was paralized with extreme severe pain. He made a make shift ambulance out of a ford escort in the back making a bed and I crawled carefully in pain and laid there. The Physician office told me go to the Emg. room St Michaels Hospital. I was unable to get out of the back of the car. With assistance it took a good while to get me out and to lean on a wheelchair to try and walk with constant spasms and pain. I finally got to a bed in the emergency room and laid on my side. In less than 1 hour I had 2 shots in my rear and one in my arm informing I was having severe adverse reactions to the meds. They went from the top of my shoulders, down my back, to my stomach and legs. This was worse than having a baby and I had 3. I am still laid up today and have had a leave of absence due that I am unable to walk or sit at present. I am very upset at the slow process and the information on side affects do not talk about these adverse affects. My physician took blood and urine samples for a possible muscle problem that this adverse reaction can cause. Waiting for the results. |
| Comments: | | Take 2 pills every 4 to 6 hrs. for pain. Not to exceed 8 pills |
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Page last updated: 2009-11-19
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