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Vicodin (Hydrocodone Bitartrate / Acetaminophen) - Summary

 
 



boxed 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.

 

VICODIN SUMMARY

Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light.

VICODIN tablets are indicated for the relief of moderate to moderately severe pain.


See all Vicodin indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Vicodin (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%.

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.

more studies >>

Clinical Trials Related to Vicodin (Hydrocodone / Acetaminophen)

A Study Comparing Vicodin® CR and NORCO® 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.

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

Comparison of Tramacet Versus Percocet in Post Surgical Patients [Not yet recruiting]
Opioid naive patients are randomized to receive either TRAMACET or PERCOCET at the time of discharge following mild to moderate pain risk surgery. The following will be assessed: 1) Brief pain inventory (BPI) for the month. 2) Post operative pain management satisfaction. 3) Whether they sought any repeat opioid prescription. 4) Whether they intend to seek repeat opioid prescription. It is expected that both groups will have similar pain outcomes but those patients in the Percocet group will be more likely to seek a second prescription.

PK and Safety Study of XARTEMISďż˝ XR (7.5 mg Oxycodone HCl/325 mg APAP) in Postsurgical Adolescent Subjects With Moderate to Severe Acute Pain [Recruiting]
Phase 4, multicenter, open-label, multiple-dose study of the pharmacokinetics (PK) and safety of XARTEMIS XR in postsurgical adolescent subjects aged 12 to 17 years with moderate to severe acute pain. The study will assess the safety of administering multiple doses of XARTEMIS XR in this population.

Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery [Enrolling by invitation]
Adequate pain relief has been a priority of the Joint Commission and is featured on national inpatient surveys such as the H-CAHPS. When considering methods for improving satisfaction with pain relief in the United States, a great deal of emphasis has been placed on opioid pain medications. Some of this emphasis on opioid pain medication is driven by the pharmaceutical industry and by advocacy groups with ties to the pharmaceutical industry. There is evidence that the "pain is the fifth vital sign" campaign of the Joint Commission led to an increased incidence of prescription of opioids, but there is less evidence of improved satisfaction with pain relief. There is some evidence of an increase in opioid-related adverse events. As the sales of opioids have tripled from 1999-2008, so has the number of deaths caused by opioid overdose; 14,800 in 2008. The number of visits to the Emergency Department for opioid overdose doubled between 2004 and 2008. Patients in other countries take far less opioid pain medication and are equally satisfied with pain relief. For instance, Lindenhovius et al. found in a retrospective study that Dutch patients take a weak (Tramadol) or no opioid pain medication after ankle fracture surgery and have comparable or better satisfaction with pain relief than American patients, most of whom take oxycodone. That study was repeated prospectively (unpublished) and confirmed that Dutch patients do not feel their pain is undertreated. A study of morphine use after a femur fracture demonstrated that American patients used far more than Vietnamese patients (30 mg/kg versus 0. 9 mg/kg), but were more dissatisfied with their pain relief. These sociological differences are striking and suggest strongly that personal factors may be the most important determinant of satisfaction with pain relief. It is our impression that most American hand surgeons give patients a prescription for an opioid pain medication after carpal tunnel release, and that is certainly true in our practice. This seems to be based primarily on the outliers, and intended to avoid confrontation with patients that desire opioids; however, most patients take little or no narcotic pain medication, and many who do use the opioids complain of the side effects—nausea and pruritis in particular. It is therefore not clear whether routine opioids is the optimal pain management strategy after carpal tunnel release. In the study of Stahl et al. from Israel, patients were prescribed acetaminophen rather than opioids after carpal tunnel release and only 20 of 50 patients used acetaminophen; 30 patients did not use acetaminophen or other pain medication at all after the operation. Our aim is to determine if there is a difference in satisfaction with pain relief between patients advised to take opioids compared to patients advised to use over the counter acetaminophen after carpal tunnel release under local anesthesia. A secondary aim is to determine if personal factors account for more of the variability in satisfaction with pain relief than opioid strategy.

more trials >>

Reports of Suspected Vicodin (Hydrocodone / Acetaminophen) Side Effects

Vomiting (59)Drug Ineffective (56)Nausea (54)Drug Hypersensitivity (44)Pain (31)Headache (28)Constipation (28)Dizziness (28)Insomnia (28)Feeling Abnormal (24)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 23 ratings/reviews, Vicodin has an overall score of 6.30. The effectiveness score is 8.26 and the side effect score is 6.96. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Vicodin review by 26 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   post surgery stomach pain
Dosage & duration:   2 pills taken once for the period of one day
Other conditions:   fever
Other drugs taken:   none
  
Reported Results
Benefits:   The pain subsided very quickly with no side effects.
Side effects:   none.
Comments:   After a surgery to remove ovarian cysts, I was left with pain in my stomach and lower back. The Hydrocodone/acetaminophen pills were prescribed and were very effective in getting rid of the pain, with no side effects.

 

Vicodin review by 40 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   I got my toothpulled
Dosage & duration:   1 or 2 pills as needed taken twice for the period of 1 day
Other conditions:   None
Other drugs taken:   Antibiotics
  
Reported Results
Benefits:   I took the drug shortly after having my tooth pulled. I never noticed a great amount of pain, and contribute this to the laughing gas and novicane during the proceduce, and taking the vicadin shortly after the procedure. I took the vicadin drug twice because after several hours I started to feel pain again. It was effective in reliefing my pain.
Side effects:   After taking the drug, I became sick to my stomach. I threw up everything that I had consumed prior to the procedure. This feeling stayed with me for several hours. I initally thought I was sick, because I did not eat when I took the first dosage. I then took another dose, but this time I made myself eat a little something, (I could not eat much at this point), but it mattered not...I got sick again. I threw the rest of the presciption out.
Comments:   The prescription was given to me prior to having my tooth pulled. I never filled the prescription because I really did not notice any pain. After the procedure, I immediately went to have the prescription filled. I took the medication while I was still numb from the novicane. As the novicane wore off, and the two tablets I took wore off, I took the vicadine once again.

 

Vicodin review by 56 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   nausea, headaches, dizziness
Dosage & duration:   5 mg ????? taken as needed for pain for the period of 3 days
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   reactions over-road the benefits. I will simply say that I did not think I received benefits from this particular drug. There are other pain inhibitors that worked as well as the vicodin with out the druggy feelings and sickness.
Side effects:   headaches, nausea, druggy feelings, heaviness, just an overall sense of malaise. Felt like I was in a drug induced stupor. Very uncomfortable and unacceptable.
Comments:   to control pain after surgery

See all Vicodin reviews / ratings >>

Page last updated: 2014-11-30

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