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)
NSAID Prescriptions for Pain 'Out of Control' Source: Medscape Medical News Headlines [2013.06.15] An increasing number of patients with heart disease and cardiovascular risk factors are prescribed nonsteroidal anti-inflammatory drugs rather than safer alternatives, warn researchers. Medscape Medical News
EU regulator advises caution on painkiller diclofenac Source: Yahoo! Health News [2013.06.14] LONDON (Reuters) - Europe's drugs agency warned on Friday that use of the common painkiller diclofenac, especially in high doses, carries extra heart attack risks which should be taken into consideration by doctors prescribing the drug. While ...
Steroid Injections for Back Pain Linked to Spinal Fracture Risk Source: MedicineNet Low Back Pain Specialty [2013.06.14] Title: Steroid Injections for Back Pain Linked to Spinal Fracture Risk Category: Health News Created: 6/14/2013 10:35:00 AM Last Editorial Review: 6/14/2013 12:00:00 AM
Cardiac MRI Use Reduces Adverse Events For Patients With Acute Chest Pain Source: Cardiovascular / Cardiology News From Medical News Today [2013.06.13] Wake Forest Baptist Medical Center doctors have found that using stress cardiac magnetic resonance (CMR) imaging in an Emergency Department observation unit to care for patients with acute chest pain is a win-win - for the patient and the institution. In a small, single-center clinical trial, Chadwick Miller, M.D., M.S...
Scant data on seizure drugs for women's genital pain Source: Yahoo! Health News [2013.06.13] By Kerry Grens NEW YORK (Reuters Health) - Although doctors sometimes prescribe anti-seizure drugs to treat chronic pain in the vulva, just a handful of low-quality studies have examined the drugs' effects, according to a new review. Based on ...
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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