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Capital and Codeine (Acetaminophen / Codeine Phosphate) - Summary


WARNING: Hepatotoxicity

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 4000 milligrams per day, and often involve more than one acetaminophen containing product.

WARNING: Death Related to Ultra-Rapid Metabolism of Codeine to Morphine

Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism.



CAPITAL® AND CODEINE ORAL SUSPENSION (Acetaminophen and codeine phosphate oral suspension) is pharmacologically classified as an analgesic.

CAPITAL® AND CODEINE ORAL SUSPENSION is indicated for the relief of mild to moderate pain.

See all Capital and Codeine indications & dosage >>


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

Hepatocyte Growth Factor Shows Benefit for Diabetic Pain
Source: Medscape NeurologyHeadlines [2015.10.09]
The nonviral gene therapy shows higher efficacy in pain relief among patients not taking pregabalin or gabapentin.
Medscape Medical News

Combined Stimulation Improves Pain, Not Outcome, in Migraine
Source: Medscape NeurologyHeadlines [2015.10.09]
Combined stimulation alleviated pain for patients with chronic migraine but did not improve long-term functional outcomes, a new study shows.
Medscape Medical News

Long-term opioid therapy relieves chronic pain in only 20% of women
Source: Pain / Anesthetics News From Medical News Today [2015.10.09]
Women, and especially younger women, are much less likely than men to have good relief of chronic, non-cancer pain with long-term opioid use, with only one in five women reporting low levels of...

CardioBrief: Test May Allow Early Discharge of Chest Pain Patients (CME/CE)
Source: MedPage Today Cardiovascular [2015.10.09]
(MedPage Today) -- High-sensitivity cardiac troponin has "excellent" performance in Scottish study

Medical News Today: Exercise before pregnancy reduces risk of pelvic girdle pain
Source: Featured Health News from Medical News Today [2015.10.08]
Pelvic girdle pain is a common problem during pregnancy; new research shows that exercise before pregnancy can reduce the incidence of this pain.

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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.

Utility of a Smart Phone Application in Assessing Radial Artery Patency - the CAPITAL iRADIAL Study [Recruiting]
Accessing the arteries of the heart through the blood vessels of the wrist is becoming increasingly popular. By obtaining access via the artery in the arm as opposed to the groin, there is less risk of complications and improved patient satisfaction. However, using the wrist can cause blockage of the artery after the procedure. If there is too little blood flow from a second artery that supplies the hand, this could result in significant injury. Therefore, it is important to test these blood vessels in the wrist prior to having this procedure. The best way to evaluate these arteries involves the use of ultrasounds but this takes a long time and is expensive. Therefore, the artery is usually evaluated with a clinical test known as the modified Allen's test, which relies on the doctor watching the flushing of the hand during compression of the artery. Currently smart phones with cameras are able to assess blood flow by passing light through the skin and watching differences in brightness. This may be a better way to assess the arteries in the hand as it is less subjective than simply watching the flushing of the hand. This study aims to assess the ability of an iPhone application in determining whether there is sufficient blood flow through the arteries of the wrist and comparing it to the clinical test commonly used.

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.

Saving Brain in Uganda and Burkina Faso [Enrolling by invitation]
The study will estimate the effect of peer-counseling for exclusive breast feeding (EBF) in the first 6 months of life on cognition and other determinants of human capital formation including behavioral and emotional status; school readiness and attainment; health status; fine and gross motor skills; physical growth; and household economic status.

Fibrinogen Concentrate as Initial Treatment for Postpartum Haemorrhage: A Randomised Clinically Controlled Trial [Completed]
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 TEG®/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.

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Page last updated: 2015-10-09

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