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Ryzolt (Tramadol Hydrochloride) - Summary

 
 



RYZOLT SUMMARY

RYZOLT (tramadol hydrochloride extended-release tablets) is a centrally acting analgesic composed of a dual-matrix delivery system with both immediate-release and extended-release characteristics.

RYZOLT® is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.


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NEWS HIGHLIGHTS

Media Articles Related to Ryzolt (Tramadol)

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

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Published Studies Related to Ryzolt (Tramadol)

Does the addition of tramadol and ketamine to ropivacaine prolong the axillary brachial plexus block? [2014]
ropivacaine in brachial plexus anesthesia... CONCLUSION: We conclude that when added to brachial plexus analgesia at a dose of

Efficacy of extended-release tramadol for treatment of prescription opioid withdrawal: a two-phase randomized controlled trial. [2013]
whether cessation of ER tramadol produces opioid withdrawal... CONCLUSIONS: ER tramadol 200mg modestly attenuated opioid withdrawal. Mild opioid

Comparison of the analgesic effects of oral tramadol and naproxen sodium on pain relief during IUD insertion. [2012]
on pain during insertion of an intrauterine device (IUD)... CONCLUSION: Prophylactic analgesia using 50 mg tramadol and 550 mg naproxen,

Tramadol versus methadone for treatment of opiate withdrawal: a double-blind, randomized, clinical trial. [2012]
The aim of this study was to compare the efficacy and safety of tramadol versus methadone for treatment of opiate withdrawal. Seventy patients randomly were assigned in two groups to receive either prescribed methadone (60 mg/day) or tramadol (600 mg/day)... Tramadol may be as effective as methadone in the control of withdrawal and could be considered as a potential substitute for methadone to manage opioids withdrawal.

Comparison of peritonsillar infiltration effects of ketamine and tramadol on post tonsillectomy pain: a double-blinded randomized placebo-controlled clinical trial. [2012]
on post tonsillectomy pain and compare the side effects... CONCLUSION: Preoperative peritonsillar infiltration of tramadol can decrease

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Clinical Trials Related to Ryzolt (Tramadol)

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 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.

The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects [Completed]
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

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).

CYTRAM (Cytochrome P450, Tramadol) [Completed]
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, particularly 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 comparison with genotype, and to find a threshold 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, Creteil 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 analgesic 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 management. Furthermore, CYP2D6 phenotyping is interesting for the patient because many other drugs depend on this way of metabolism.

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Page last updated: 2015-08-28

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