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Hydrocodone and Acetaminophen (Hydrocodone Bitartrate / Acetaminophen) - Summary

 
 



WARNING

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 4000 milligrams per day, and often involve more than one acetaminophen-containing product.

 

SUMMARY

Hydrocodone Bitartrate and Acetaminophen Tablets are supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive. Acetaminophen is a non-opiate, non-salicylate analgesic and antipyretic.

Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.


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NEWS HIGHLIGHTS

Published Studies Related to Hydrocodone and Acetaminophen (Hydrocodone / 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 clinical trial of the efficacy of scheduled dosing of acetaminophen and hydrocodone for the management of postoperative pain in children after tonsillectomy. [2010.02]
OBJECTIVES: To determine the effectiveness of around-the-clock (ATC) analgesic administration, with or without nurse coaching, compared with standard care with as needed (PRN) dosing in children undergoing outpatient tonsillectomy. METHODS: Children 6 to 15 years of age were randomized to receive acetaminophen and hydrocodone (167 mg/2.5 mg/5 mL) for 3 days after surgery: Group A (N=39)-every 4 hours PRN, with standard postoperative instructions; Group B (N=34)-every 4 hours ATC, with standard postoperative instructions, without nurse coaching; and Group C (N=40)-every 4 hours ATC, with standard postoperative instructions, with coaching...

A randomized clinical trial of the efficacy of scheduled dosing of acetaminophen and hydrocodone for the management of postoperative pain in children after tonsillectomy. [2010]
OBJECTIVES: To determine the effectiveness of around-the-clock (ATC) analgesic administration, with or without nurse coaching, compared with standard care with as needed (PRN) dosing in children undergoing outpatient tonsillectomy. METHODS: Children 6 to 15 years of age were randomized to receive acetaminophen and hydrocodone (167 mg/2.5 mg/5 mL) for 3 days after surgery: Group A (N=39)-every 4 hours PRN, with standard postoperative instructions; Group B (N=34)-every 4 hours ATC, with standard postoperative instructions, without nurse coaching; and Group C (N=40)-every 4 hours ATC, with standard postoperative instructions, with coaching...

Within-subject comparison of the psychopharmacological profiles of oral hydrocodone and oxycodone combination products in non-drug-abusing volunteers. [2009.04.01]
BACKGROUND: Non-medical use and abuse of prescription opioids is a significant problem in the United States. Little attention has been paid to assessing the relative psychopharmacological profile (including abuse liability-related effects) of specific prescription opioids. The purpose of this study was to directly compare the psychopharmacological profile of two widely prescribed and abused oral opioid combination products within the same subject... CONCLUSIONS: Consistent with a recent study published in this journal using identical doses of HYD and OXY (without ACET) in prescription opioid abusers (Walsh, S.L., Nuzzo, P.A., Lofwall, M.R., Holtman Jr., J.R., 2008. The relative abuse liability of oral oxycodone, hydrocodone and hydromorphone assessed in prescription drug abusers. Drug Alcohol Depend. 198, 191-202), we found little difference in the pharmacodynamic effects of HYD/ACET and OXY/ACET in non-drug-abusing volunteers.

Hydrocodone/acetaminophen and tramadol chlorhydrate combination tablets for the management of chronic cancer pain: a double-blind comparative trial. [2008.01]
OBJETIVES: The purpose of this study was to compare the analgesic efficacy and tolerability of opioids hydrocodone and tramadol in the relief of cancer pain... CONCLUSIONS: There was no superior analgesic efficacy with the administration of hydrocodone/acetaminophen when compared to patients receiving tramadol in the relief of cancer pain. Tramadol produced more mild side effects than hydrocodone.

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Clinical Trials Related to Hydrocodone and Acetaminophen (Hydrocodone / Acetaminophen)

Single Dose Pharmacokinetics of Egalet� Hydrocodone [Completed]

Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients [Completed]
Objective is to evaluate the pharmacokinetics profile of hydrocodone's metabolite hydromorphone in patients who are taking hydrocodone on a routine basis for more than 3 months for chronic pain and correlate hydromorphone levels to their hydrocodone usage.

Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction [Completed]
The purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen compared to placebo in moderate to severe pain following molar extraction.

A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR) in Subjects With Acute Pain Following Bunionectomy [Completed]
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended-Release Hydrocodone/Acetaminophen compared to placebo over a 48 hour dosing period in patients who have had bunionectomy surgery and to assess the safety of the drug for 7 days after patients are discharged from the hospital.

A Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery [Completed]
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of Extended Release Hydrocodone/Acetaminophen with placebo over a 48 hour dosing period in patients who have had bunionectomy surgery, and to assess the safety of the drug for 7 days after patients are discharged from the hospital.

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PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Hydrocodone and Acetaminophen has an overall score of 9. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
 

Hydrocodone and Acetaminophen review by 54 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   cervical spondylosis
Dosage & duration:   7.5-325 every 6 hrs. (dosage frequency: as directed) for the period of 4 weeks
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   Drug offers reliable pain relief with little negative side affects. Pain in neck, left shoulder, arm and hand. Numbness in hand and fingers. Did not experience any nausea, dizziness.
Side effects:   Loss of appetite, drowsiness, sleepiness.
Comments:   Cervical spondylosis. Attempted to treat conservatively with chiropractics, including stimulation therapy, traction, cold therapy and medication. Surgery required to fuse C5,6,7. Peruneural root cyst C6. Inoperable.

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Page last updated: 2014-11-30

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