HEPATOTOXICITY
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product (see WARNINGS).
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SUMMARY
TYLENOL® with Codeine (acetaminophen and codeine phosphate) is supplied in tablet form for oral administration.
TYLENOL® with Codeine (acetaminophen and codeine phosphate) Tablets are indicated for the relief of mild to moderately severe pain.
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NEWS HIGHLIGHTS
Published Studies Related to Tylenol with Codeine (Codeine / Acetaminophen)
Randomized clinical trial of hydrocodone/acetaminophen versus
codeine/acetaminophen in the treatment of acute extremity pain after emergency
department discharge. [2014]
(DEA) Schedule III narcotics... CONCLUSIONS: Both medications decreased NRS pain scores by approximately 50%.
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.
Clinical Trials Related to Tylenol with Codeine (Codeine / Acetaminophen)
Equality Study of Ofirmev vs Oral Acetaminophen [Not yet recruiting]
Acetaminophen (Tylenol) is a drug that is used commonly for relief of mild to moderate pain.
It is found in many pain medicines that people take after having surgery. Narcotics are
other drugs also used for pain (examples of narcotics are morphine and related pain
medications). Medical science knows for a fact that acetaminophen works well when taken
with narcotics for moderate to severe pain. Recently, acetaminophen has become available
in an intravenous (IV) form called Ofirmev®. The IV form means that acetaminophen can be
given into a vein. The benefits of getting medicine from an IV include:
- making the medicine work quickly
- less medicine having to pass through the liver to be changed into a form that your body
can process The investigators know that acetaminophen is helpful for pain relief at the
time of surgery and after surgery. Acetaminophen is a very popular drug in outpatient
surgery for pain control when patients go home. The patient's surgeon uses it to
control pain after surgery at home in the form of Lortab or Percocet (Lortab and
Percocet also have a narcotic medicine that mixes with acetaminophen). Also, currently
at Surgicare, some anesthesiologists give intravenous acetaminophen while the patient
is waiting to go to surgery. The investigators currently do not give any patient
acetaminophen by mouth BEFORE surgery. However, since the addition of the IV form to
the drug market, there has been interest to see if the oral form is just as good or
better in reducing pain after surgery. This is why we are asking patients to join our
study. The goal of this study is to find out if the oral form (by mouth) or the IV
form (given into a vein) of acetaminophen controls pain after surgery better.
Protective Effects of Propylene Glycol in Daily Acetaminophen Dosing [Recruiting]
A purpose of this protocol is to is to compare the metabolites of the toxic bioactivating
pathway after acetaminophen alone or acetaminophen followed by Propylene Glycol (PG) and to
determine if it prevents the formation of the toxic metabolites of acetaminophen.
Effect on Acetaminophen Metabolism by Liquid Formulations [Completed]
The purpose of this study is to determine whether excipients in the liquid formulation of
acetaminophen prevent the formation of the toxic metabolites of acetaminophen.
A Randomized Crossover Study to Determine the Pharmacokinetics of Intranasally Administered Acetaminophen in Healthy Adults [Withdrawn]
This study is being done to determine the systemic absorption of nasally inhaled
acetaminophen (Tylenol®) versus orally ingested acetaminophen by comparing the serum drug
concentrations of the two groups obtained at various times after study drug administration.
Analgesic Effect of Paracetamol, Paracetamol + Codeine, Ibuprofen and Their Combination [Recruiting]
The purpose of this study is to determine whether the combination of paracetamol
(acetaminophen) and other NSAIDs with or without weak opioids can give synergistic analgesic
effect.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Tylenol with Codeine has an overall score of 1. The effectiveness score is 8 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst.
| | 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. |
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Page last updated: 2014-11-30
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