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Hydrocodone and Acetaminophen (Hydrocodone Bitartrate / Acetaminophen) - Summary

 
 



SUMMARY

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP
10 mg/650 mg

Each tablet, for oral administration, contains hydrocodone bitartrate (WARNING: May be habit forming) and acetaminophen in the following strengths:

Hydrocodone bitartrate, USP - 7.5 mg
Acetaminophen, USP - 500 mg

Hydrocodone bitartrate, USP - 7.5 mg
Acetaminophen, USP - 650 mg

Hydrocodone bitartrate, USP - 10 mg
Acetaminophen, USP - 650 mg

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


See all Hydrocodone and Acetaminophen indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Hydrocodone and Acetaminophen (Hydrocodone / Acetaminophen)

Human Abuse Liability (HAL) data released for investigational MNK-155, an extended-release hydrocodone/acetaminophen combination
Source: Alcohol / Addiction / Illegal Drugs News From Medical News Today [2014.09.09]
Mallinckrodt has reported data from a Human Abuse Liability (HAL) study in which both intact and crushed MNK-155 showed lower subjective abuse-related effects than an immediate-release hydrocodone...

MNK-155, an extended-release hydrocodone/acetaminophen combination, shows efficacy in Phase 3 acute pain trial
Source: Clinical Trials / Drug Trials News From Medical News Today [2014.09.09]
Mallinckrodt has reported that a Phase 3 efficacy trial of investigational MNK-155 met the study's primary endpoint of improved pain scores vs.

more news >>

Published Studies Related to Hydrocodone and Acetaminophen (Hydrocodone / Acetaminophen)

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.

Tramadol/acetaminophen or hydrocodone/acetaminophen for the treatment of ankle sprain: a randomized, placebo-controlled trial. [2007.04]
STUDY OBJECTIVE: This randomized, multicenter study compares the analgesic efficacy and safety of tramadol/acetaminophen versus hydrocodone/acetaminophen versus placebo for the treatment of acute musculoskeletal pain caused by ankle sprain... CONCLUSION: One or 2 capsules of 37.5 mg tramadol/325 mg acetaminophen and 1 capsule of 7.5 mg hydrocodone/650 mg acetaminophen were well tolerated, had comparable clinical utility, and were more effective than placebo in the management of acute musculoskeletal pain caused by ankle sprain.

more studies >>

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

A Study to Evaluate the Pharmacokinetics of the Hydrocodone Extended-Release Tablet (CEP-33237) in Subjects With Normal Hepatic Function and Subjects With Moderate Hepatic Impairment [Recruiting]
The purpose of this study is:

1. To assess the pharmacokinetics of the hydrocodone bitartrate extended-release tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic function.

2. To assess the safety and tolerability of the hydrocodone bitartrate extended-release tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic function.

Hydrocodone For Pain Control in First Trimester Surgical Abortion [Recruiting]
The purpose of this study is to determine whether preoperatively administered hydrocodone/acetaminophen (HC/APAP) reduces pain during a first trimester surgical abortion.

Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time [Recruiting]
The primary objective of this study is to evaluate efficacy of hydrocodone extended-release tablets compared with placebo in alleviating moderate to severe pain in patients with osteoarthritis or low back pain as assessed by the weekly Average Pain Intensity (API) at week 12.

Pharmacokinetics and Bioequivalence of Vycavert (10 mg Hydrocodone Bitartrate/325 mg Acetaminophen) Compared to the Reference Drug Norco [Recruiting]
This study aims to determine whether the hydrocodone and acetaminophen exposures following oral dosing of Vycavert are comparable to those following oral dosing of Norco.

Long-term Safety of Once-daily Hydrocodone Bitartrate (HYD) Tablets For Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain [Recruiting]
The primary objective of this study is to characterize the long-term safety of Hydrocodone Bitartrate (HYD) tablets 20 to 120 mg once-daily in subjects with chronic nonmalignant and nonneuropathic pain.

more trials >>


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.

See all Hydrocodone and Acetaminophen reviews / ratings >>

Page last updated: 2014-09-09

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