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Capital and Codeine (Acetaminophen / Codeine Phosphate) - Summary

 
 



SUMMARY

CAPITAL® AND CODEINE ORAL SUSPENSION (Acetaminophen and codeine phosphate oral suspension) is pharmacologically classified as an analgesic. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic.

CAPITAL® AND CODEINE ORAL SUSPENSION (Acetaminophen and codeine phosphate oral suspension) is indicated for the relief of mild to moderate pain.


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NEWS HIGHLIGHTS

Media Articles Related to Capital and Codeine (Acetaminophen / Codeine)

Tackling inflammatory pain
Source: Immune System / Vaccines News From Medical News Today [2014.08.29]
Pain from inflammation sidelines thousands of Americans each year. Many face a tough choice: deal with the pain, take a potentially addictive opioid or use a nonsteroidal anti-inflammatory drug that...

'Doctor-Shopping' for Painkillers Common After Broken-Bone Surgery, Study Finds
Source: MedicineNet Chronic Pain Specialty [2014.08.29]
Title: 'Doctor-Shopping' for Painkillers Common After Broken-Bone Surgery, Study Finds
Category: Health News
Created: 8/29/2014 9:35:00 AM
Last Editorial Review: 8/29/2014 12:00:00 AM

Iroko Pharmaceuticals gains FDA approval of ZORVOLEX® for management of osteoarthritis pain
Source: Arthritis / Rheumatology News From Medical News Today [2014.08.28]
Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, has announced the United States Food and Drug Administration (FDA) has...

States that legalize medical marijuana 'have fewer deaths from opioid painkillers'
Source: Alcohol / Addiction / Illegal Drugs News From Medical News Today [2014.08.26]
Annual deaths from prescription painkillers are, on average, 25% lower in states that legalize medical marijuana, according to a new study from Johns Hopkins researchers.

The effect of serotonin on sensitivity to pain
Source: Depression News From Medical News Today [2014.08.26]
In a study published in the scientific journal PLoS One, researchers at the Champalimaud Neuroscience Programme establish the effect of serotonin on sensitivity to pain using a combination of...

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Published Studies Related to Capital and Codeine (Acetaminophen / Codeine)

Economic evaluation of controlled-release oxycodone vs oxycodone-acetaminophen for osteoarthritis pain of the hip or knee. [2006.04]
OBJECTIVE: To examine, in routine practice, the effectiveness and cost-effectiveness of oxycodone (OxyContin) compared with standard therapy for osteoarthritis pain. STUDY DESIGN: Open-label active-controlled randomized naturalistic 4-month study of oxycodone vs a combination of oxycodone-acetaminophen (Percocet)... CONCLUSIONS: From the societal perspective, oxycodone was more effective and less costly than oxycodone-acetaminophen. From the healthcare perspective, oxycodone (compared with generic oxycodone-acetaminophen) fell within the acceptable range of cost-effectiveness between 50,000 US dollars and 100,000 US dollars per QALY gained.

Analgesic efficacy of rofecoxib compared with codeine/acetaminophen using a model of acute dental pain. [2005.10]
OBJECTIVE: To determine analgesic efficacy of a single oral dose of rofecoxib 50 mg compared with acetaminophen/codeine 600/60 mg, we conducted a double-blind, randomized, placebo- and active-comparator-controlled, parallel-group study... CONCLUSION: Rofecoxib provided superior analgesic efficacy compared with codeine/acetaminophen with fewer gastrointestinal and nervous system adverse events.

Comparison of ibuprofen and acetaminophen with codeine following cosmetic facial surgery. [2009.10]
OBJECTIVES: To compare the efficacy and side effects of ibuprofen and acetaminophen with codeine when given postoperatively following cosmetic facial surgery and to assess whether bruising is worse or the incidence of hematoma is greater when ibuprofen is taken postoperatively. DESIGN: Prospective, double-blind, randomized trial. SETTING: Accredited outpatient surgery centre... CONCLUSIONS: Ibuprofen 400 mg is as effective as acetaminophen/codeine 600/60 mg for pain relief following cosmetic facial surgery. Ibuprofen is better tolerated, with fewer side effects, than acetaminophen with codeine. Ibuprofen given postoperatively does not result in increased bruising or increased incidence of hematoma.

Codeine-acetaminophen versus nonsteroidal anti-inflammatory drugs in the treatment of post-abdominal surgery pain: a systematic review of randomized trials. [2009.08]
BACKGROUND: Cesarean section, episiotomy, and third and perineal tears are associated with significant tissue damage, causing pain in the immediate postpartum period. The current standard in North America is to prescribe oral acetaminophen/codeine (A + C) for postpartum pain. Codeine has opioid-related adverse effects and may not be safe during breastfeeding in the postpartum period for all neonates. Nonsteroidal anti-inflammatory drugs (NSAIDs) are devoid of opioid-related adverse effects and could be a possible alternative for analgesia in postpartum pain. The objective of this systematic review was to compare the analgesic effect and safety profile of acetaminophen/codeine (A + C) with NSAIDs in the management of pain after laparotomy... CONCLUSIONS: None of the studies found A + C to be superior to NSAIDs in controlling postlaparotomy pain. NSAIDs appear to be an equipotent alternative in the treatment of postlaparotomy pain. Four of the 9 studies reported less adverse effects in the NSAID group. There appears to be an overall better risk/benefit ratio for the use of NSAIDs for postpartum pain.

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Clinical Trials Related to Capital and Codeine (Acetaminophen / Codeine)

Evaluation of Skeletal Maturity for Slipped Capital Femoral Epiphysis [Recruiting]
This study is being done for two reasons: 1) to evaluate growth problems in the hip in patients with Slipped Capital Femoral Epiphysis (SCFE) as they continue to grow into adults, and 2) to help doctors determine which patients are at risk for developing a SCFE on their opposite hip. Studies show that up to 60% of patients with a SCFE will go on to develop a SCFE on their other side. Being able to better determine which patients are at risk for developing a SCFE on the other side will help physicians better monitor patients with a history of a SCFE and perhaps treat them before they develop a SCFE on the opposite side. By studying the growth centers seen on X-rays of your child's legs and elbow, the investigators may be able to better predict which children with a SCFE are at risk for developing a SCFE on their opposite hip and potential growth problems as they continue to grow.

Carvedilol Post-intervention Long-term Administration in Large-scale Trial [Recruiting]
The purpose of this study is to evaluate whether beta-blocker therapy improves 6-year clinical outcomes in patients with ST-segment elevation acute myocardial infarction and preserved left ventricular ejection fraction after primary percutaneous coronary intervention.

A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy [Recruiting]
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.

Fibrinogen Concentrate as Initial Treatment for Postpartum Haemorrhage: A Randomised Clinically Controlled Trial [Recruiting]
Severe maternal bleeding is a serious complication of birth and causes 125. 000 deaths worldwide each year. The investigators aim to investigate if early treatment with fibrinogen concentrate versus saline can reduce the incidence of blood transfusion in women with postpartum haemorrhage.

A low level of fibrinogen has been associated with increased blood loss and transfusion requirements in different clinical settings including obstetrical bleeding. Early up-front treatment with fibrinogen may reduce incidence of transfusion by securing optimal haemostatic capacity in women with postpartum haemorrhage.

The investigators plan to enrol 245 patients on four hospitals in the Capital Region of Denmark during a two year period.

As safety measure the investigators plan to use TEGĀ®/Functional Fibrinogen/Rapid-TEG as haemostatic monitoring of all participants during the trial: Baseline test is taken at inclusion before administration of fibrinogen concentrate/placebo. Further tests are taken immediately after intervention, 4 hours and 24 hours after. Baseline test is blinded to the

providers of treatment - the rest is clinically available.

Short-Term Prognosis Evaluation of Transient Ischemic Attack Patients Using ABCD2 Score [Recruiting]
The purpose of this study is to determine whether the ABCD2 score can be used in patients with transient ischemic attack, admitted to Beijing anzhen hospital, to evaluate the prognosis, risk factor of those patients.

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Page last updated: 2014-08-29

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