Tylenol with Codeine (Codeine / Acetaminophen) - Summary

SUMMARY

TYLENOL with Codeine (acetaminophen and codeine phosphate tablets and oral solution USP) combine the analgesic effects of a centrally acting analgesic, codeine, with a peripherally acting analgesic, acetaminophen.

TYLENOL with Codeine tablets (acetaminophen and codeine phosphate tablets) are indicated for the relief of mild to moderately severe pain.

TYLENOL with Codeine elixir (acetaminophen and codeine phosphate oral solution USP) is indicated for the relief of mild to moderate pain.

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NEWS HIGHLIGHTS

Published Studies Related to Tylenol with Codeine (Codeine / Acetaminophen)

A randomized controlled trial comparing acetaminophen, acetaminophen and ibuprofen, and acetaminophen and codeine for postoperative pain relief after Mohs surgery and cutaneous reconstruction. [2011.07]
BACKGROUND: There are no population-based data comparing analgesics after Mohs micrographic surgery (MMS) and reconstruction. OBJECTIVE To compare the efficacy in pain management of three analgesic combinations... CONCLUSIONS: The combination of Ac+Ib is superior to Ac alone or Ac+Co in controlling postoperative pain after MMS and cutaneous reconstruction. (c) 2011 by the American Society for Dermatologic Surgery, Inc.

Analgesia with paracetamol/tramadol vs. paracetamol/codeine in one day-surgery: a randomized open study. [2011.02]
OBJECTIVES: The analgesic efficacy of two fixed combinations of tramadol/paracetamol (TP 37.5/325 mg) and codeine/paracetamol (CP 30/500 mg) was compared in 122 patients undergoing one-day surgical procedures (hallux valgus, haemorrhoidectomy, varicectomy and inguinal hernia repair), randomly treated with TP 37.5/325 mg or CP 30/500 mg one tablet after surgery ended, followed by one tablet four times daily for 48 hours... CONCLUSIONS: We conclude that a fixed association of tramadol/paracetamol is a valuable and safe tool for pain management in day hospital surgery, especially whenever any effort is done to reduce the time for hospitalization.

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.

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.

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Clinical Trials Related to Tylenol 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 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.

Acetaminophen-Protein Adduct Resolution [Recruiting]
The purpose of this study is to better understand the pharmacokinetics of acetaminophen and further clinical interpretations of laboratory results that confirm the presence of acetaminophen-cys adducts. This study will determine how long adducts persist in serum after a therapeutic course of acetaminophen as taken in a previous study (COMIRB 06-1265). Subjects will be asked to complete three study visits, each three days apart, following termination of COMIRB 06-1265. Each study visit will include collection of blood samples for batch testing of aminotransferase, serum acetaminophen and protein adducts. No interventions are planned.

Pharmacokinetics, -Dynamics and Safety of Intravenous Paracetamol in Neonates [Recruiting]
The purpose of this study is triple, i. e. document single dose pharmacokinetics and

- dynamics of intravenous paracetamol in preterm and term neonates after a loading dose (20

mg/kg iv bolus paracetamol), document multiple dose pharmacokinetics and - dynamics of

intravenous paracetamol in preterm and term neonates, based on the daily doses routinely used within the neonatal intensive care unit and as reported in literature. Finally, document safety of single and repeated dose of intravenous paracetamol in preterm and term neonates.

Aminotransferase Trends During Prolonged Acetaminophen Dosing [Recruiting]
The objective of this study is to monitor liver function tests (blood levels of an indicator of liver function) of healthy people taking the maximum labeled daily dose of acetaminophen compared to people taking placebo for 16 to 40 days. Those people that continue to have normal liver tests after 16 days will have completed their part of the study. People that develop abnormal liver function tests will continue taking acetaminophen or placebo, and have their liver tests monitored closely for up to an additional 24 days. This is to (1) make sure these tests return to normal and (2) determine when these tests return to normal while still taking acetaminophen or placebo. If at any time the liver tests indicate anything more than a minor increase, you would be immediately told to stop taking the study drug.

Secondary objective is to determine the proportion of subjects that have detectable acetaminophen-protein adducts after daily dosing.

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PATIENT REVIEWS / RATINGS / COMMENTS

Tylenol with Codeine review by 48 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		pain after minor surgery
Dosage & duration:		one or two every 4 to 6 hrs (dosage frequency: one dose) for the period of one dose
Other conditions:		recovery from vein surgery
Other drugs taken:		none
		Reported Results
Benefits:		Due to extensive varicose veins, I was in pain, especially when standing. They were physically embarassing and I could not even wear sheer pantyhose. The surgery would eliminate pain and the ugliness. I was told to take the drug before surgery to minimize swelling and to minimize pain. I do not like to introduce drugs into my body unless an emergency so I did not take it before the surgery, instead opting for Bromelain enzyme, ginger and tumeric to reduce swelling.
Side effects:		The side effects after the surgery were swelling and pain and possibly infection at the incision sites. About 10 hours post surgery, the pain became unbearable, and I decided to take one dose of acetaminophen w/codeine #3. When I got up a couple of hours later to go and use the bathroom, I passed out in the bathroom. Lucky for me, my husband was nearby.
Comments:		I had a large vein stripped from my thigh and smaller ones in the leg, due to pain and discomfort I had been experiencing. It was an outpatient procedure that lasted about 2 hours.