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Zydone (Hydrocodone Bitartrate / Acetaminophen) - Summary

 
 



ZYDONE SUMMARY

ZYDONE®

ZYDONE (hydrocodone bitartrate and acetaminophen tablets) for oral administration, contain hydrocodone bitartrate, an opioid analgesic, and acetaminophen.

ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is indicated for the relief of moderate to moderately severe pain.


See all Zydone indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Zydone (Hydrocodone / Acetaminophen)

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.

Tramadol/Acetaminophen or Hydrocodone/Acetaminophen for the Treatment of Ankle Sprain: A Randomized, Placebo-Controlled Trial. [2006.11.17]
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.

Rofecoxib versus hydrocodone/acetaminophen for postoperative analgesia in functional endoscopic sinus surgery. [2006.04]
OBJECTIVES/HYPOTHESIS: Functional endoscopic sinus surgery (FESS) is less invasive and more tissue sparing than extirpative techniques, with an assumed benefit of diminished postoperative pain. Oral opioids are commonly prescribed after sinus surgery but are associated with adverse effects, including gastrointestinal and neurologic symptoms. Nonopioid analgesics have been suggested to offer similar pain control efficacy with fewer adverse effects. STUDY DESIGN: To investigate postoperative analgesia in FESS, a prospective randomized, double-blinded comparison of hydrocodone/acetaminophen 7.5/750 mg (an opioidderivative) with rofecoxib 50 mg (a cyclooxygenase-2 inhibitor) was performed... CONCLUSIONS: The use of nonopioid analgesics after FESS may provide similar pain control to oral opioids.

Profiling the subjective, psychomotor, and physiological effects of a hydrocodone/acetaminophen product in recreational drug users. [2005.06.01]
BACKGROUND: Hydrocodone (HYD) is a mu opioid agonist. Hydrocodone/acetaminophen HYD/ACET compounds are both widely prescribed and abused prescription painkillers in the United States. In the present study, we profiled the subjective, psychomotor, and physiological effects of the compound. It was of particular interest to determine if HYD/ACET had abuse liability-related subjective effects in a population of recreational drug users... CONCLUSIONS: HYD/ACET produced some abuse liability-related subjective effects in recreational drug users, which is consistent with the widespread non-medical use and abuse of this product.

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Clinical Trials Related to Zydone (Hydrocodone / Acetaminophen)

A Study Comparing VicodinŽ CR and NORCOŽ to Placebo 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 and Immediate Release Hydrocodone/Acetaminophen with placebo over a 12 hour dosing period in patients who have had a bunionectomy, and to assess the safety of the drug for 7 days after patients are discharged from the hospital.

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.

A Study to Evaluate the Interaction Between VicodinŽ CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers [Completed]

Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain [Recruiting]
This is a double-blind, randomized, multiple-dose, placebo- and positive-controlled study of CL-108 (hydrocodone 7. 5 mg/APAP 325 mg, promethazine 12. 5 mg) in patients with moderate to severs pain following surgical removal of impacted third molar teeth.

A positive control ( Norco, A commercial formulation of hydrocodone 7. 5 mg/APAP 325 mg) is included to determine the anti-emetic effects of CL-108.

Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer [Recruiting]
This study will evaluate the ability of grape exosomes, given to the subject as grape powder, as an important anti-inflammatory agent to reduce the incidence of oral mucositis during radiation and chemotherapy treatment for head and neck tumors.

more trials >>


Page last updated: 2008-03-26

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