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Tramadol and Acetaminophen (Tramadol Hydrochloride / Acetaminophen) - Summary

 
 



HEPATOTOXICITY



Tramadol hydrochloride and acetaminophen tablets contain 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).

 

SUMMARY


Tramadol hydrochloride and acetaminophen tablets USP combines two analgesics, tramadol 37.5 mg and acetaminophen 325 mg.

The chemical name for tramadol hydrochloride is (±) cis -2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride.

Tramadol hydrochloride and acetaminophen tablets USP are indicated for the short-term (five days or less) management of acute pain.


See all Tramadol and Acetaminophen indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Tramadol and Acetaminophen (Tramadol / Acetaminophen)

Medical News Today: Meditation shown to reduce pain during breast cancer biopsy
Source: Featured Health News from Medical News Today [2016.02.04]
Though undergoing a breast biopsy is anything but relaxing, a new study shows that patients who meditate during the procedure experience less pain, anxiety and fatigue.

Why is calcific tendinitis so painful?
Source: Bones / Orthopedics News From Medical News Today [2016.02.04]
Calcific tendinitis of the shoulder, typically characterized by calcium deposits on the rotator cuff, is an extremely painful condition that can severely impair movement and life quality.

Meditation shown to reduce pain during breast cancer biopsy
Source: Breast Cancer News From Medical News Today [2016.02.04]
Though undergoing a breast biopsy is anything but relaxing, a new study shows that patients who meditate during the procedure experience less pain, anxiety and fatigue.

Energy from cellphone towers amplify pain in amputees, UT Dallas study finds
Source: Neurology / Neuroscience News From Medical News Today [2016.02.04]
For years, retired Maj. David Underwood has noticed that whenever he drove under power lines and around other electromagnetic fields, he would feel a buzz in what remained of his arm.

New hand-held emergency pain relief inhaler launched in the UK
Source: Pain / Anesthetics News From Medical News Today [2016.02.04]
Galen Ltd. has announced that Penthrox®, a new, hand-held inhaler, which brings rapid pain relief to adult trauma patients1, is now available in the UK.

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Published Studies Related to Tramadol and Acetaminophen (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.

A single blind controlled comparison of tramadol/paracetamol combination and paracetamol in hand and foot surgery. A prospective study. [2011.03]
The objective of this study was to compare the efficacy and effectiveness between an analgesic combination of tramadol/paracetamol (37.5+325 mg), and paracetamol monotherapy (1000 mg) for acute postoperative pain after hand and foot surgery. The study design was a single blind randomized controlled trial...

Effects of clonidine as premedication on plasma renin activity, serum and urine electrolytes and body fluids in general anesthesia. A randomized double blind placebo controlled clinical trial. [2011.02]
CONCLUSION: This study suggested that clonidine is a safe premedication drug in anesthesia and does not change the serum electrolytes level.

Analgesia with paracetamol/tramadol vs. paracetamol/codeine in one day-surgery: a randomized open study. [2011.02]
OBJECTIVES: The analgesic efficacy of two fixed combinations of tramadol/paracetamol (TP 37.5/325 mg) and codeine/paracetamol (CP 30/500 mg) was compared in 122 patients undergoing one-day surgical procedures (hallux valgus, haemorrhoidectomy, varicectomy and inguinal hernia repair), randomly treated with TP 37.5/325 mg or CP 30/500 mg one tablet after surgery ended, followed by one tablet four times daily for 48 hours... CONCLUSIONS: We conclude that a fixed association of tramadol/paracetamol is a valuable and safe tool for pain management in day hospital surgery, especially whenever any effort is done to reduce the time for hospitalization.

The efficacy of intravenous paracetamol versus tramadol for postoperative analgesia after adenotonsillectomy in children. [2011.02]
STUDY OBJECTIVE: To evaluate the efficacy and the quality of recovery with intravenous (IV) paracetamol versus tramadol for postoperative analgesia after adenotonsillectomy in children... CONCLUSIONS: The IV formulation of paracetamol was associated with similar analgesic properties and early recovery to that of IV tramadol after adenotonsillectomy in children. Copyright (c) 2011 Elsevier Inc. All rights reserved.

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Clinical Trials Related to Tramadol and Acetaminophen (Tramadol / Acetaminophen)

A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy [Completed]
Tonsillectomy is the most common pediatric surgical procedure performed in the US. The postoperative period can be particularly painful. Codeine (usually in mixed formulation with acetaminophen) is the most commonly prescribed opioid in the US. However, evolving data questions its ability to provide optimal pain relief, while avoiding side effects, especially in the postoperative setting. Tramadol may be a better option for children in the postoperative setting due to its well-documented analgesic properties, low potential for side effects, and excellent safety profile. Seventy-two children scheduled to undergo tonsillectomy (with or without adenoidectomy) at Children's will be invited to participate in a randomized, prospective, double-blinded study to evaluate the efficacy and side effects of codeine with acetaminophen versus tramadol. Using a 10-day take-home diary, caregivers will be asked to record daily information about their child's postoperative pain and other core outcomes and domains as recommended in the recent consensus statement put forth by the Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) (McGrath et al., 2008). This study will offer new information regarding the efficacy and side effects associated with tramadol as compared with codeine/acetaminophen (the current practice standard) in a pediatric population. Hypotheses H1: Children who receive scheduled tramadol following tonsillectomy will report better pain control than children who receive scheduled codeine/acetaminophen. H2: Children who receive scheduled tramadol following tonsillectomy will report fewer side effects than children who receive scheduled codeine/acetaminophen.

Postoperative Tramadol/Gabapentin/Ibuprofen Versus Tramadol/Placebo/Ibuprofen [Recruiting]
Tonsillectomy is the most common pediatric surgical procedure performed in the US, with over 530,000 procedures performed annually in children under 15 years (Baugh et al., 2011). The postoperative period can be particularly painful. A recent clinical consensus acknowledges there is no standard analgesic protocol, and calls for further research comparing postoperative pain medications (Baugh et al., 2011). Tramadol was found to be as effective as codeine with few reported side effects in a recent double-blinded, controlled trial conducted by the investigators at Children's Hospitals and Clinics (CHC), and it is currently being prescribed in the postoperative setting. However, despite its effectiveness for pain control, there were some children that continued to report pain during the 10-day follow-up period. In response, the investigators will conduct a randomized, double-blinded controlled trial to determine whether or not adding scheduled gabapentin to a scheduled tramadol + "as needed" (PRN) ibuprofen regimen provides better pain control than tramadol + ibuprofen PRN alone during the post-tonsillectomy period. Using a 10-day take-home diary, caregivers will be asked to record daily information about their child's postoperative pain and other core outcomes and domains as recommended in the recent consensus statement put forth by the Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) (McGrath et al., 2008). This study will offer new information regarding the efficacy and side effects associated with adding scheduled gabapentin to a postoperative pain management protocol in a pediatric population.

A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers [Completed]
The purpose of this study is to determine the safety and tolerability profile of tramadol hydrochloride (HCl) given as oral doses every 6 hours, within the range of dosages supported by currently available toxicology and clinical data (200 mg to 600 mg per day).

Evaluation of the Role of Tramadol 50mg as an Analgesic During Outpatient Hysteroscopy [Completed]

PK PD of the Enantiomers of Tramadol and O-desmethyltramadol in Elderly and Young Subjects [Completed]
This study evaluates the pharmacokinetics and pharmacodynamics of the enantiomers of tramadol and O-desmethyltramadol (ODM) in generally healthy young and elderly adults. Using a randomised, double-blind, crossover design, participants were administered a single 200mg tramadol extended-release tablet and placebo.

more trials >>


Page last updated: 2016-02-04

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