SUMMARY
ACETAMINOPHEN AND
CODEINE PHOSPHATE TABLETS, USP
300 mg/15 mg
Acetaminophen and codeine is supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic.
Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.
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NEWS HIGHLIGHTSMedia Articles Related to Acetaminophen with Codeine (Codeine / Acetaminophen)
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 Acetaminophen with Codeine (Codeine / Acetaminophen)
A randomized clinical trial of ibuprofen versus acetaminophen with codeine for acute pediatric arm fracture pain. [2009.10]
STUDY OBJECTIVE: We compare the treatment of pain in children with arm fractures by ibuprofen 10 mg/kg versus acetaminophen with codeine 1 mg/kg/dose (codeine component)... CONCLUSION: Ibuprofen was at least as effective as acetaminophen with codeine for outpatient analgesia for children with arm fractures. There was no significant difference in analgesic failure or pain scores, but children receiving ibuprofen had better functional outcomes. Children receiving ibuprofen had significantly fewer adverse effects, and both children and parents were more satisfied with ibuprofen. Ibuprofen is preferable to acetaminophen with codeine for outpatient treatment of children with uncomplicated arm fractures.
O-demethylation of codeine to morphine inhibited by low-dose levomepromazine. [2009.08]
PURPOSE: Codeine/paracetamol (C/P) and levomepromazine (L) are frequently co-administered for the treatment of acute back pain, but the efficacy/effectiveness of this combination drug therapy has not been evaluated. The demethylation of codeine to morphine is catalyzed by the polymorphic enzyme cytochrome P450 2D6 (CYP2D6), of which levomepromazine (methotrimeprazine) is a known inhibitor. The aim of this study was to investigate whether low-dose levomepromazine inhibits the formation of morphine from codeine in a patient population of homozygous extensive (EM) and heterozygous extensive (HEM) metabolizers of CYP2D6... CONCLUSIONS: Our study revealed significant inhibition in the O-demethylation of codeine to morphine in homozygous EM of CYP2D6 treated with low-dose levomepromazine and codeine/paracetamol, compared to treatment with codeine/paracetamol only. No significant difference could be detected in HEM or in the mixed and heterogenous group of EM/HEM. In patients prescribed this drug combination, the amount of morphine generated by the O-demethylation of codeine may be insufficient for effective pain relief. The therapeutic effect of codeine in the treatment of acute back pain should be assessed with and without levomepromazine.
Effect of delayed activated charcoal on acetaminophen concentration after simulated overdose of oxycodone and acetaminophen. [2009.02]
OBJECTIVE: To determine the effect of activated charcoal (AC) on acetaminophen (APAP) absorption kinetics when administered at 1, 2, or 3 h after combined oral overdose with oxycodone... CONCLUSION: The effect of AC rapidly declines between 1 and 3 h after combined oral overdose of APAP and oxycodone. AC is unlikely to be beneficial at or beyond 2 h after an overdose of acetaminophen and oxycodone.
Subjective, psychomotor, and physiological effects profile of hydrocodone/acetaminophen and oxycodone/acetaminophen combination products. [2008.05]
OBJECTIVES: To compare within the same individuals two typically prescribed doses of hydrocodone/acetaminophen and oxycodone/acetaminophen products for their subjective, psychomotor, and physiological effects in healthy volunteers... CONCLUSIONS: The results of this study, albeit in pain-free individuals, may inform physicians who prescribe, and pharmacists who dispense, two widely prescribed opioid/acetaminophen combination products on how patients might be feeling from the drugs. Patients prescribed either of the two opioid/acetaminophen combination products may experience a number of subjective effects, including effects that would contraindicate certain activities, and they should be cautioned accordingly. However, this study documented rather large differences in magnitude of subjective effects between 10 mg oxycodone/650 mg acetaminophen and placebo, and physicians and pharmacists, and ultimately patients, should be aware of these differences.
A randomized controlled trial comparing acetaminophen plus ibuprofen versus acetaminophen plus codeine plus caffeine after outpatient general surgery. [2008.03]
BACKGROUND: Narcotics are used extensively in outpatient general surgery but are often poorly tolerated with variable efficacy. Acetaminophen combined with NSAIDs is a possible alternative. The objective of this study was to compare the efficacy of acetaminophen, codeine, and caffeine (Tylenol No. 3) with acetaminophen and ibuprofen for management of pain after outpatient general surgery procedures... CONCLUSIONS: When compared with Tylenol No. 3, AcIBU was not an inferior analgesic and was associated with fewer side effects and higher patient satisfaction. AcIBU is an effective, low-cost, and safe alternative to codeine-based narcotic analgesia for outpatient general surgery procedures.
Clinical Trials Related to Acetaminophen with Codeine (Codeine / Acetaminophen)
Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days [Completed]
Acetaminophen is commonly used to treat fever or pain. Your body clears acetaminophen by
processing it in the liver. During the processing, some of the acetaminophen may bind to
proteins in the liver. The protein-acetaminophen product is called an "adduct". After a large
acetaminophen overdose, the liver has to process a lot of acetaminophen, so large amounts of
adducts are formed. However, we have found that lower levels may be formed even when people
take recommended doses. The purpose of this study is to measure the amount of adducts formed
when healthy people who do not drink alcohol take normal doses of acetaminophen for 10 days.
A Study of the Efficacy and Safety of Tramadol HCl/Acetaminophen, Hydrocodone Bitartrate/Acetaminophen and Placebo in Patients With Pain From an Ankle Sprain With a Partial Torn Ligament [Completed]
The purpose of this study is to explore the pain-relieving effects and safety of two
analgesic treatment regimens as compared to placebo in patients experiencing acute
musculoskeletal pain. Patients who are experiencing at least moderate acute musculoskeletal
pain from an ankle sprain severe enough to require prescription pain relief medication will
be randomized to receive either tramadol HCl/acetaminophen, hydrocodone
bitartrate/acetaminophen or placebo.
Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an Intravenous (i.v.) Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-Menopausal Women With Low Bone Mass [Completed]
This study will evaluate the efficacy of acetaminophen or fluvastatin in reducing the rate of
occurrence and the severity of post dose symptoms that may occur during the 3 day period
following a zoledronic acid infusion in post menopausal women with low bone mass.
The Effects of Aspirin and Acetaminophen on the Stomach in Healthy Volunteers [Completed]
Aspirin is a medication commonly used to relieve minor pains. Aspirin has also been used to
prevent heart attacks and strokes. Aspirin, however, can also cause damage to the stomach
and/or intestinal lining leading to the development of erosions ("small sores") and/or ulcers
("large sores"). Erosions may cause bleeding ("bleeding ulcers") and/or perforations ("holes
in the stomach"). Acetaminophen, often referred by the brand name, Tylenol, is also used to
treat minor pains but is not commonly recognized to cause damage to the stomach lining.
Many patients often take both of these medications together. While the effects on the
stomach lining of each medication, when used alone, are known, the effects of both
medications, when used together, are not.
The purpose of this study is to show whether or not the collective effects of both aspirin
and acetaminophen, when used together, increase the damage on the stomach lining when
compared to either medication alone.
A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery [Completed]
Increasingly in general surgery, the investigators are conducting outpatient day surgery.
Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America.
These patients all require some form of analgesia which can be taken at home in the first few
days after the surgery. The current standard at the investigators' centre and many others in
the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or
oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as
oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication
(Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects,
and may not provide effective pain relief. In the investigators' experience, non-steroidal
anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic
regimen.
Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain
medication. They hope to show that a combination of ibuprofen and acetaminophen is better for
pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a
safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of
surgeons are old habits, it will require a very convincing argument to get them to change
their practices. A randomized controlled trial comparing these two regimens, the
investigators hope, would be a powerful enough argument.
The hypothesis of this study, therefore, is that the pain control provided by a combination
of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to
Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day).
This study will attempt to enroll 150 patients in total. Eligible patients will be identified
by their attending surgeon and contacted by study personnel. Patients who enroll in the study
will undergo their surgery in the usual manner. After the surgery, in the recovery room, once
they are ready to go home, they will be randomized to receive combination A or B and be given
a week's worth of pain medication. They will then go home and take this medication as
directed. They will record their pain intensity and pain relief once per day using a diary
provided in the study package. One week after their surgery, they will return to the hospital
clinic and be seen by the study nurse. They will hand over the diary and any unused
medication. They will also be asked several questions regarding their overall satisfaction,
incidence of side effects, and how long until they were pain free.
The risks of participating in this study are minimal from the risks inherent to the
procedures and medications the patients would receive within the standard of care. Ibuprofen
is a commonly used NSAID which is widely available over the counter and has an established
safety profile. The most common adverse effects of ibuprofen and other NSAIDs are
gastrointestinal bleeding and ulceration. Other less common adverse effects include
nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive
dysfunction. The investigators' patients will be selected to exclude those most at risk for
these complications (see exclusion criteria). Acetaminophen has few side effects, with no
adverse effects on platelet function and no evidence of gastric irritation.
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Page last updated: 2009-11-23
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