VICOPROFEN is supplied in a fixed combination tablet form for oral administration. VICOPROFEN combines the opioid analgesic agent, hydrocodone bitartrate, with the nonsteroidal anti-inflammatory (NSAID) agent, ibuprofen.
Carefully consider the potential benefits and risks of VICOPROFEN and other treatment options before deciding to use VICOPROFEN. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
VICOPROFEN tablets are indicated for the short-term (generally less than 10 days) management of acute pain. VICOPROFEN is not indicated for the treatment of such conditions as osteoarthritis or rheumatoid arthritis.
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Published Studies Related to Vicoprofen (Hydrocodone / Ibuprofen)
Analgesic efficacy and tolerability of oxycodone 5 mg/ibuprofen 400 mg compared with those of oxycodone 5 mg/acetaminophen 325 mg and hydrocodone 7.5 mg/acetaminophen 500 mg in patients with moderate to severe postoperative pain: a randomized, double-blind, placebo-controlled, single-dose, parallel-group study in a dental pain model. [2005.04]
BACKGROUND: Combination therapy has been widely used for the clinical management of acute pain. By combining 2 drugs with different mechanisms of action, such therapy provides additive analgesic effects while reducing the risk for adverse effects. OBJECTIVE: This study compared the efficacy and tolerability of oxycodone 5 mg/ibuprofen 400 mg with those of oxycodone 5 mg/acetaminophen 325 mg, hydrocodone 7.5 mg/acetaminophen 500 mg, and placebo in a dental pain model... CONCLUSIONS: In this study in patients with moderate to severe pain after surgery to remove impacted third molars, oxycodone 5 mg/ibuprofen 400 mg provided significantly better analgesia throughout the 6-hour study compared with the other opioid/nonopioid combinations tested, and was associated with fewer adverse events.
Efficacy of ibuprofen-hydrocodone for the treatment of postoperative pain after periodontal surgery. [2004.06]
BACKGROUND: Previous studies have shown that non-steroidal anti-inflammatory drugs (NSAIDs) have significant benefits in the control of postoperative pain after periodontal or oral surgical procedures. The combination of a peripherally acting NSAID with a centrally acting opioid drug is found to be more effective. The purpose of this study was to compare an alternative combination of ibuprofen 400 mg with 5 mg of hydroxycodone to ibuprofen 400 mg used alone in the management of pain following periodontal surgery... CONCLUSION: The findings suggest that a combination analgesic preparation of ibuprofen (400 mg) with hydrocodone (5 mg) results in better pain control compared to ibuprofen used alone.
Cognitive and motor function after administration of hydrocodone bitartrate plus ibuprofen, ibuprofen alone, or placebo in healthy subjects with exercise-induced muscle damage: a randomized, repeated-dose, placebo-controlled study. [2003.03]
RATIONALE: Medications combining hydrocodone bitartrate and non-steroidal anti-inflammatory agents appear more beneficial than anti-inflammatory medications alone in treating pain and inflammation from acute soft tissue trauma, but opiate side effects may include sedation and impaired cognitive and motor performance. OBJECTIVE: Performance on complex cognitive and motor tasks was evaluated in healthy subjects with exercise-induced muscle damage who were treated with a hydrocodone-ibuprofen combination, ibuprofen alone, or placebo... CONCLUSION: Hydrocodone plus ibuprofen was not associated with deterioration in complex cognition but was related to very transitory decrements in tasks involving simple hand-eye coordination.
Combination hydrocodone and ibuprofen versus combination oxycodone and acetaminophen in the treatment of moderate or severe acute low back pain. [2002.01]
BACKGROUND: Introduced in 1997, the combination of hydrocodone and ibuprofen is the only fixed-dose combination analgesic containing an opioid and ibuprofen that has been approved by the US Food and Drug Administration. OBJECTIVE: This study compared the efficacy and tolerability of combination hydrocodone 7.5 mg and ibuprofen 200 mg (HC/IB) with those of combination oxycodone 5 mg and acetaminophen 325 mg (OX/AC) in the treatment of moderate or severe acute low back pain... CONCLUSIONS: The results of this study suggest that HC/IB and OX/AC are similarly effective and tolerable in relieving moderate or severe acute low back pain. Additional controlled longitudinal trials are necessary to evaluate the clinical utility of HC/IB in treating acute low back pain.
Dose-response effect of combination hydrocodone with ibuprofen in patients with moderate to severe postoperative pain. [2000.08]
OBJECTIVE: The objective of this study was to demonstrate a dose-response effect with 1- and 2-tablet doses of combination hydrocodone 7.5 mg with ibuprofen 200 mg and placebo in patients with moderate to severe postoperative abdominal or gynecologic pain. BACKGROUND: Hydrocodone 7.5 mg with ibuprofen 200 mg is the only approved fixed-dose combination analgesic containing an opioid and ibuprofen. Previous studies with this combination have demonstrated that the components have an additive analgesic effect as well as efficacy compared with other fixed-dose combination analgesics... CONCLUSIONS: This study demonstrated that a 2-tablet dose of hydrocodone with ibuprofen provided significantly more analgesia than a 1-tablet dose (a positive dose-response effect) and that both doses were superior to placebo.
Clinical Trials Related to Vicoprofen (Hydrocodone / Ibuprofen)
A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions [Completed]
This study will compare the relative bioavailability of hydrocodone, acetaminophen, and
promethazine in CL-108 (hydrocodone 7. 5mg/ acetaminophen 325 mg/ promethazine 12. 5 mg)
manufactured by Charleston Laboratories, Inc. to hydrocodone in Vicoprofen (hydrocodone 7. 5
mg /ibuprofen 200 mg), promethazine 12. 5 mg, and acetaminophen in Ultracet (tramadol HCl
37. 5 mg/acetaminophen 325 mg) under fasted and fed conditions.
Reports of Suspected Vicoprofen (Hydrocodone / Ibuprofen) Side Effects
Abdominal Distension (4),
Influenza Like Illness (1),
Upper Respiratory Tract Infection (1),
Pleural Effusion (1),
Emotional Disorder (1), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 1 ratings/reviews, Vicoprofen has an overall score of 7. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
Vicoprofen review by 38 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || oral infection|
|Dosage & duration:|| || 7.5/200mg taken 1 every 4 to 6 hours 3 times a day for the period of For 5 days|
|Other conditions:|| || swelling|
|Other drugs taken:|| || none|
|Benefits:|| || The benefits to the treatment was temporary relief of pain due to unknown infection in jaw area. Though no other drugs were taken to address the infection, the prescribed drug did alleviated the pain until the condition improved. Eventually a root canal was performed and I received a second prescription.|
|Side effects:|| || The only noticeable side effect was that I became drowsy when taking the drug and had to lay down throughout the day. As I was unable to work under these conditions, I did not have to perform usual task, therefore it is hard to measure what I would or would not have been able to do while taking the pain killer.|
|Comments:|| || I went to my dentist complaining of immense pain and swelling in my jaw area. An x-ray was performed and nothing could be detected. However, due to my symptoms, Hydrocodone/Ibuprofen was prescribed. I was sent home with a follow up visit scheduled. The swelling and pain decreased within a few days, I discontinued taking the drug and I was able to continue normal activities. However, approximately a week later the symptoms returns and I returned to dentist. This time the x-ray revealed a need for a root canal. I continued to use the remaining tablets until my root canal, when I received a second prescription of Hydrocodone/Ibuprofen which I only used a few of the 16 tablets prescribed. |
Page last updated: 2017-03-18