CODRIX SUMMARY
CODRIX™ (Acetaminophen and Codeine Phosphate Tablets, USP)
Acetaminophen and codeine is supplied in tablet form for oral administration.
Acetaminophen, 4'-hydroxyacetanalide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic.
Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive.
Each tablet contains:
Acetaminophen 500 mg
Codeine phosphate 15 mg
CODRIX™ is indicated for the relief of mild to moderately severe pain.
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NEWS HIGHLIGHTSMedia Articles Related to Codrix (Acetaminophen / Codeine)
Ibuprofen Bests Acetaminophen/Codeine for Kids' Broken Arms (CME/CE) Source: MedPage Today Emergency Medicine [2009.08.19] Children treated for arm fractures reported that ibuprofen killed the pain as effectively as a combination of codeine and acetaminophen (Tylenol 3), with fewer adverse effects in a randomized trial.
Yoga May Be Effective For Chronic Low Back Pain In Minority Populations Source: Health News from Medical News Today [2009.11.05] Researchers from Boston University School of Medicine (BUSM) and Boston Medical Center found that yoga may be more effective than standard treatment for reducing chronic low back pain in minority populations. This study appears in the November issue of Alternative Therapies in Health and Medicine.



Radiation Therapy Technique Successfully Treats Pain In Patients With Advanced Cancer Source: Cancer / Oncology News From Medical News Today [2009.11.05] Stereotactic radiosurgery (SRS), a radiation therapy procedure pioneered at the University of Pittsburgh Cancer Institute (UPCI) that precisely delivers a large dose of radiation to tumors, effectively controls pain in patients with cancer that has spread to the spine, according to researchers from UPCI. The results of the research were presented this week during the American Society for Radiation Oncology (ASTRO) annual meeting in Chicago, being held November 1 - 5, 2009.
Common Pain Relievers May Dilute Power Of Flu Shots Source: Biology / Biochemistry News From Medical News Today [2009.11.04] With flu vaccination season in full swing, research from the University of Rochester Medical Center cautions that use of many common pain killers -- Advil, Tylenol, aspirin -- at the time of injection may blunt the effect of the shot and have a negative effect on the immune system. Richard P. Phipps, Ph.D.
Cancer, Pain Relief And Immunity Research Supported By ARC Source: Breast Cancer News From Medical News Today [2009.11.04] Research at the Walter and Eliza Hall Institute into the genes involved in breast cancer development, new drugs for chronic pain, and the proteins involved in inflammatory diseases has received funding in this year's round of Australian Research Council (ARC) Discovery Project grants. Seven projects proposed by institute researchers have received ARC support.
Published Studies Related to Codrix (Acetaminophen / Codeine)
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.
A randomized, double-blind, parallel-group study comparing the analgesic effect of etoricoxib to placebo, naproxen sodium, and acetaminophen with codeine using the dental impaction pain model. [2004.05] OBJECTIVE: To compare the overall analgesic effect, including time to onset, peak and duration of effect for etoricoxib 120 mg, a new COX-2 selective inhibitor, in patients with acute pain to that of placebo. Naproxen sodium 550 mg and acetaminophen/codeine 600/60 mg were the active comparators.Etoricoxib was generally well tolerated.
Tramadol suppositories are less suitable for post-operative pain relief than rectal acetaminophen/codeine. [1999.07] The suitability of tramadol suppositories for inclusion in our hospital formulary for the treatment of mild to moderate post-operative pain was evaluated. In an open randomized trial, rectal tramadol was compared with our standard treatment acetaminophen/codeine suppositories...
The analgesic efficacy of flurbiprofen compared to acetaminophen with codeine. [1991] In a single-dose, parallel group, randomized block treatment allocation study, the relative analgesic efficacy of flurbiprofen, a nonsteroidal antiinflammatory drug, was compared to acetaminophen 650 mg with codeine 60 mg, zomepirac sodium 100 mg, and placebo... The results of this study support previous work on flurbiprofen.
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.
Clinical Trials Related to Codrix (Acetaminophen / Codeine)
Comparison of Acetaminophen With Codeine and Ibuprofen for Children With Injuries [Completed]
We compared the pain relief of acetaminophen with codeine versus ibuprofen for children ages
5-18 years who came to the Pediatric Emergency Department with injuries to their arms or
legs.
Acute Pediatric Fracture Analgesia Study [Completed]
A clinical trial comparing ibuprofen and acetaminophen with codeine for children after
discharge from the emergency department. We hypothesize that Ibuprofen will provide 20% more
effective analgesia compared to acetaminophen with codeine in children with uncomplicated
forearm fractures.
Chiropractic Care, Medication, and Self-Care for Neck Pain
This study will compare the effectiveness of chiropractic care, medications, and self-care on
neck pain, a very common condition. The broad, long-term objective of this study is to
identify effective therapies for neck pain sufferers and to increase understanding of neck
pain conditions.
SB-705498 Dental Pain Study After Tooth Extraction
This clinical trial is a multi centre, randomised, single-blind, parallel group,
placebo-controlled, single oral dose study with a positive control arm. Patients previously
scheduled for 3rd molar tooth extraction, who are otherwise healthy, will be recruited. Upon
completion of surgery, e. g. prior to established pain, patients will be randomised to
treatment (SB-706598, placebo or co-codamol) and dosed with the study medication
Rofecoxib to Prevent Pain After Third Molar (Wisdom Tooth) Extraction [Completed]
This study will evaluate the ability of a new non-steroidal anti-inflammatory drug (NSAID)
called rofecoxib to prevent pain following third molar (wisdom tooth) extraction. The Food
and Drug Administration approved rofecoxib in 1999 to treat the symptoms of arthritis,
menstrual cramps, and pain.
Healthy normal volunteers between 16 and 35 years of age in general good health who require
third molar (wisdom tooth) extraction may be eligible for this study. Candidates will be
screened with a medical history and oral examination, including dental x-rays as needed to
confirm the need for third molar removal.
Participants will have all four wisdom teeth extracted, and a biopsy (removal of a small
piece of tissue) will be taken from the inside of the cheek around the area behind the lower
wisdom tooth. On the morning of surgery, patients will be given a dose of either the standard
anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or rofecoxib, or a placebo (a pill
with no active ingredient). Before surgery, they will be given a local anesthetic (lidocaine)
in the mouth and a sedative (midazolam) through an arm vein.
After the surgery, patients will remain in the clinic for up to 4 hours to monitor pain and
the effects of the drug. Patients will complete pain questionnaires. Patients whose pain is
unrelieved an hour after surgery may request and receive morphine intravenously (through a
vein). After 4 hours, patients will be discharged with additional pain medicines (Tylenol
with codeine and the study drug) and instructions for their use. They will also be given a
pain diary to record pain ratings and medications taken at home. A clinic staff member will
telephone patients at home the morning after surgery to ensure they are rating their pain
intensity at the proper time and are taking their medications as instructed.
Patients will return to the clinic 48 hours after surgery with the pain diary and pain
relievers. At this visit, another biopsy will be taken under local anesthetic.
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