Ultracet (Tramadol Hydrochloride / Acetaminophen) - Summary

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.

See all indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Ultracet (Tramadol / Acetaminophen)

Addex: ADX71943 Demonstrates Analgesic Effects In Pain Models
Source: Health News from Medical News Today [2010.02.08]
Addex Pharmaceuticals / Addex: ADX71943 Demonstrates Analgesic Effects in Pain Models processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement. Addex Pharmaceuticals (SWISS: ADXN), the allosteric modulation company, announced today that ADX71943 has demonstrated statistically significant analgesic-like effects in three preclinical models of pain...

AAPM: Spine Stimulation Leads to Durable Pain Relief (CME/CE)
Source: MedPage Today Neurology [2010.02.07]
SAN ANTONIO (MedPage Today) -- Spinal cord stimulation provided durable pain relief for patients with complex regional pain syndrome but did not halt progression, a retrospective analysis of a small clinical series showed.

AAPM: Facet Graft Quells Refractory Back Pain (CME/CE)
Source: MedPage Today Neurology [2010.02.07]
SAN ANTONIO (MedPage Today) -- Minimally invasive facet arthrodesis significantly reduced pain and improved physical function for one year in patients with medically refractory facet arthropathy, according to data from a prospective clinical series.

Minimally Invasive Spine Surgery And Spinal Cord Stimulation Show Promise In Alleviating Back Pain
Source: Clinical Trials / Drug Trials News From Medical News Today [2010.02.05]
Results from the first prospective study of minimally invasive facet arthrodesis and long-term data on spinal cord stimulation demonstrate the viability of these options to achieve pain relief in patients with various back pain conditions. The studies were presented at the American Academy of Pain Medicine's 26th Annual Meeting in San Antonio, TX...

New, Targeted Pain Medicine Delivery Systems May Reduce Costs Long Term; Cost To Treat Pain Varies Significantly By Chronic Pain Condition
Source: Clinical Trials / Drug Trials News From Medical News Today [2010.02.05]
Estimates of pain care treatment costs exceed $1 billion annually in the United States. Today at the American Academy of Pain Medicine's 26th Annual Meeting two abstracts looked at the issue. One evaluated intrathecal drug delivery (a targeted medicine delivery system) that could save costs over time. The other analyzed the differences between the costs of treatment for chronic pain treatments...

more news >>

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.

more studies >>

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]

more trials >>

PATIENT REVIEWS / RATINGS / COMMENTS

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

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

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