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Ultracet (Tramadol Hydrochloride / Acetaminophen) - Summary

 
 



HEPATOTOXICITY

ULTRACET® contains tramadol HCl and acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product (see WARNINGS).

 

ULTRACET SUMMARY

ULTRACET® (tramadol hydrochloride/acetaminophen) Tablets combines two analgesics, tramadol 37.5 mg and acetaminophen 325 mg.

ULTRACET® is indicated for the short-term (five days or less) management of acute pain.


See all Ultracet indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Ultracet (Tramadol / Acetaminophen)

DPP-4 Inhibitors Can Cause Severe Joint Pain, FDA Says
Source: Medscape Diabetes & Endocrinology Headlines [2015.08.28]
However, the pain associated with dipeptidyl peptidase-4 inhibitors for type 2 diabetes goes away once patients stop taking the medicine, according to the agency.
News Alerts

Group Offers Guidelines to Lessen Vaccination Pain
Source: Medscape Pediatrics Headlines [2015.08.28]
Clinicians can shuffle the order of vaccine injections, leverage the calming influence of parents and breast-feeding, and routinely apply topical anesthetic to ease vaccination pain for patients.
Medscape Medical News

DPP-4 Inhibitors Linked to Severe Joint Pain, FDA Warns
Source: MedPageToday.com - medical news plus CME for physicians [2015.08.28]
(MedPage Today) -- The agency has identified 33 cases since 2006

Low Back Pain and GI Symptoms on the Swiss Alps
Source: Medscape Gastroenterology Headlines [2015.08.26]
Dr Paget discusses a recent patient of his who presented with a 5-year history of recurrent severe low back pain and gastrointestinal symptoms.
Medscape Rheumatology

Is There Sex After Low Back Pain?
Source: Medscape Orthopaedics Headlines [2015.08.26]
For many people with low back pain, sex is excruciating. But the recommended position for the past 25 years--'side-lying' (ie, 'spooning')--is contraindicated by two new biomechanical studies.
Medscape Orthopedics

more news >>

Published Studies Related to Ultracet (Tramadol / Acetaminophen)

Pharmacokinetics of extended-release versus conventional tramadol/acetaminophen fixed-dose combination tablets: an open-label, 2-treatment, multiple-dose, randomized-sequence crossover study in healthy korean male volunteers. [2011.06]
BACKGROUND: A fixed-dose combination tablet of tramadol/acetaminophen exhibits both rapid and sustained analgesic effects due to different pharmacologic activities. To prolong analgesia and improve patient convenience, an extended-release (ER) tablet of this agent has been developed. OBJECTIVE: The aim of this study was to explore the pharmacokinetic profiles of the new ER tramadol/acetaminophen fixed-dose combination and compare them with those of a conventional immediate-release (IR) formulation after multiple dosing as a Phase I clinical exploratory trial... CONCLUSIONS: The ER formulation displayed a similar AUC(0-12,ss) to that of the IR formulation for tramadol and acetaminophen. Copyright (c) 2011 Elsevier HS Journals, Inc. All rights reserved.

Comparison of efficacy and effectiveness between ULTRACET and tramadol/acetaminophen in acute postoperative pain after upper extremity surgery. [2010.07]
OBJECTIVE: To compare the efficacy and effectiveness between ULTRACE, a new analgesic combination of tramadol/ acetaminophen, and tramadol/acetaminophen for acute postoperative pain after upper extremity surgery... CONCLUSION: ULTRACET has more efficacy and fewer side effects when compared with tramadol and acetaminophen in acute postoperative pain surgery.

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.

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Clinical Trials Related to Ultracet (Tramadol / Acetaminophen)

A Study to Assess the Bioequivalence of a New ULTRACET Extended Release (ER) Tablet With Respect to a Marketed ULTRACET ER Tablet Under Fasted Condition [Completed]
The purpose of this study is to evaluate the bioequivalence of a newly developed ULTRACET extended-release (ER) tablet of tramadol hydrochloride and acetaminophen, to the current marketed ULTRACET ER tablet, in healthy participants under fasted condition.

A Study to Evaluate the Effect of Analgesics on a Walking Model of Knee Pain (0000-105)(COMPLETED) [Completed]
This study will evaluate a walking model of osteoarthritis for use in testing of new therapeutic agents. The primary hypothesis is that participants treated with Naproxen or Ultracet will have lower Pain Intensity (PI) than those treated with Placebo during self-paced walks on Day 3 of treatment.

Tramadol/Acetaminophen(Ultracet) AS add-on Therapy in the Treatment of Patients With Ankylosing Spondylitis [Completed]
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.

A Comparative Bioavailability/Food Effect Study of Immediate-Release and Extended-Release Tramadol HCl/Acetaminophen Combination Products Following Single-Dose and Multiple-Dose Administration in Healthy Adult Volunteers [Completed]
The objectives of this two-part study were to compare the single-dose and multiple-dose pharmacokinetics of extended release and immediate-release fixed combination formulations containing tramadol-HCl/acetaminophen and to evaluate the effect of food on the extended-release formulation.

A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions [Completed]
This study will compare the relative bioavailability of hydrocodone, acetaminophen, and promethazine in CL-108 (hydrocodone 7. 5mg/ acetaminophen 325 mg/ promethazine 12. 5 mg) manufactured by Charleston Laboratories, Inc. to hydrocodone in Vicoprofen (hydrocodone 7. 5 mg /ibuprofen 200 mg), promethazine 12. 5 mg, and acetaminophen in Ultracet (tramadol HCl 37. 5 mg/acetaminophen 325 mg) under fasted and fed conditions.

more trials >>

Reports of Suspected Ultracet (Tramadol / Acetaminophen) Side Effects

Dizziness (13)Vomiting (7)Fall (5)Rhabdomyolysis (4)Drug Ineffective (4)Somnolence (4)Loss of Consciousness (4)Delirium (4)Hypercreatininaemia (3)Unresponsive TO Stimuli (3)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 5 ratings/reviews, Ultracet has an overall score of 6.20. The effectiveness score is 7.20 and the side effect score is 6.80. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Ultracet review by 61 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Fibromyalgia
Dosage & duration:   50 MG taken 2 / day for the period of 6 YEARS - ONGOING
Other conditions:   DIABETES
Other drugs taken:   CYMBALATA
  
Reported Results
Benefits:   I WAS LIVING WITH PAIN IN MOST OF THE MAJOR MUSCLE GROUPS OF MY BODY. IT HAD GOTTEN TO THE POINT OF HAVING TO HAVE HELP TO GET OUT OF BED. WHEN THERE WAS A FLARE-UP I HAD TO GO TO BED. TRAMADOL HCL COMBINED WITH CYMBALATA REDUCED MY PAIN BY ABOUT 85%! MADE MY LIFE LIVABLE AGAIN. I'M THANKFUL THAT I HUNG IN THROUGH THE SIDE EFFECTS OF CYMBALATA. IT TOOK OVER A YEAR TO FIND THE RIGHT COMBINATION OF DRUGS AND I'M THANKFUL THAT FINALLY DID.
Side effects:   CYMBALATA SIDE EFFECTS: VIVID NON-STOP DREAMS FOR ABOUT A YEAR, AND SLIGHT NAUSEA AND SLEEPINESS FOR SEVERAL WEEKS. THE EXCESS DREAMING FINALLY STOPPED AND THE COMBINATION OF THE 2 DRUGS HAS BEEN WORKING MIRACLES FOR ME EVER SINCE. MOST PEOPLE GIVE UP ON CYMBALTA BUT I WAS DESPARATE. MOST OF THE SIDE EFFECTS DO GO AWAY AS I SAID IN ABOUT 2 WEEKS EXCEPT FOR THE DREAMING.
Comments:   NO DETAILS REALLY, JUST TAKE PILLS AS PRESCRIBED, TRAMADOL 2 A DAY AND CYMBALATA 2 A DAY. I CAN ADD A TRAMADOL IF I AM HAVING A FLAREUP. I'M LEADING A PRETTY NORMAL LIFE. I DON'T HAVE AS MUCH ENERGY AS I WOULD LIKE BUT I SURE HAVE A LOT LESS PAIN.

 

Ultracet review by 62 year old male patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   herniated disk in my lower back
Dosage & duration:   1 tablet taken 2 times a day for the period of over a year
Other conditions:   high blood pressure
Other drugs taken:   benicar, quintrpill
  
Reported Results
Benefits:   reduces pain
Side effects:   constipation, high feeling, loss of mental skills. I had a minor operation on my foot and sufered a servere reaction to the anesthesia. they could not wake me up for 2 days. during this time i also had seizures.
Comments:   i began using this medication for back pain over a year ago.

 

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

See all Ultracet reviews / ratings >>

Page last updated: 2015-08-28

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