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)
Opiate Painkillers May Encourage Spread Of Cancer
Source: Health News from Medical News Today [2009.11.23]
New research from the US adds weight to the growing body of evidence that opiate-based painkillers like morphine, which has been used to treat postoperative and chronic cancer pain for two hundred years, encourage cancer cells to grow and spread.
62-Year-Old Man Becomes First Patient In China Implanted With Rechargeable Neurostimulator For Chronic Pain
Source: Medical Devices / Diagnostics News From Medical News Today [2009.11.19]
St. Jude Medical, Inc. (NYSE:STJ) announced that a 62-year-old man from Shenzhen, Guangdong province has become the first patient in China to be implanted with the Eon™ neurostimulator, a rechargeable device used to help manage chronic pain. Despite prior back surgeries, the patient suffered from chronic back pain for more than a decade.
CNSBio Inc. To Present Latest Clinical Trial Data For CNSB015 At Neuropathic Pain Conference In San Francisco
Source: Pain / Anesthetics News From Medical News Today [2009.11.19]
CNSBio Inc. will present recent Phase IIa proof-of-concept clinical trial data for CNSB015, an orally administered potassium channel modulator used in combination with opioids for the treatment of neuropathic pain, at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain on November 20-21, 2009 in San Francisco, CA. Dr.
Common Pain Relief Medication May Encourage Cancer Growth
Source: Pain / Anesthetics News From Medical News Today [2009.11.19]
Although morphine has been the gold-standard treatment for postoperative and chronic cancer pain for two centuries, a growing body of evidence is showing that opiate-based painkillers can stimulate the growth and spread of cancer cells. Two new studies advance that argument and demonstrate how shielding lung cancer cells from opiates reduces cell proliferation, invasion and migration in both cell-culture and mouse models.
Transplanting People's Own Stem Cells Into Heart Lessens Pain, Improves Ability To Walk
Source: Pain / Anesthetics News From Medical News Today [2009.11.19]
The largest national stem cell study for heart disease showed the first evidence that transplanting a potent form of adult stem cells into the heart muscle of subjects with severe angina results in less pain and an improved ability to walk. The transplant subjects also experienced fewer deaths than those who didn't receive stem cells.
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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