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Oruvail Extended-Release (Ketoprofen) - Summary

 



Cardiovascular Risk

• NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. (See WARNINGS).

• Orudis and Oruvail are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. (See WARNINGS).

Gastrointestinal Risk

• NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal (GI) events. (See WARNINGS).

 

SUMMARY

Orudis®
[o′′roo′dis]
(ketoprofen)
Capsules

Oruvail®
[or′ü vāl]
(ketoprofen)
Extended-Release Capsules

Ketoprofen is a nonsteroidal anti-inflammatory drug.

Carefully consider the potential benefits and risks of Orudis and Oruvail and other treatment options before deciding to use Orudis and Oruvail. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Orudis and Oruvail are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Oruvail is not recommended for treatment of acute pain because of its extended-release characteristics (see “PHARMACOKINETICS”).

Orudis is indicated for the management of pain. Orudis is also indicated for treatment of primary dysmenorrhea.


See all indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Oruvail Extended-Release (Ketoprofen)

ketoprofen None (Note: previous brand names no longer available in the US include Orudis, Oruvail)
Source: MedicineNet Ankylosing Spondylitis Specialty [2009.03.26]
Title: ketoprofen None (Note: previous brand names no longer available in the US include Orudis, Oruvail)
Category: Medications
Created: 12/31/1997
Last Editorial Review: 3/26/2009

more news >>

Published Studies Related to Oruvail Extended-Release (Ketoprofen)

A randomized, controlled clinical trial of ketoprofen for sickle-cell disease vaso-occlusive crises in adults. [2009.08.28]
Vaso-occlusive crisis (VOC) is the primary cause of hospitalization of patients with sickle-cell disease. Treatment mainly consists of intravenous morphine, which has many dose-related side effects...

Effects of ketoprofen and diclofenac potassium on blood coagulation tests after removal of third molars. [2009.04]
CONCLUSION: These results suggest that the safety of ketoprofen and diclofenac potassium is comparable to their anticoagulation effect.

Effects of combination treatment with ketoprofen 100 mg + acetaminophen 1000 mg on postoperative dental pain: a single-dose, 10-hour, randomized, double-blind, active- and placebo-controlled clinical trial. [2009.03]
BACKGROUND: A combination of analgesic drugs with different pharmacologic properties may be more effective, with fewer adverse events, than either agent used alone. OBJECTIVE: This study assessed whether the combination of acetaminophen and ketoprofen is more effective and better tolerated than either drug used alone in treating postoperative pain... CONCLUSIONS: The results from this study suggest that the combination of ketoprofen 100 mg + acetaminophen 1000 mg provided a significantly more rapid onset of analgesia than either drug given alone in the management of pain after oral surgery in this patient population. Adverse events were not significantly different between the study groups. These results support the clinical practice of combining ketoprofen with acetaminophen for the management of acute pain.

Antipyretic effect of ketoprofen. [2009.03]
OBJECTIVE: The aim of this study was to investigate the efficacy and side effect profile of ketoprofen as well as compliance with respect to the taste of the drug and compare these parameters with those of acetaminophen and ibuprofen... CONCLUSION: All three drugs were similar in terms of efficacy, adverse effects, and compliance within 48 hours of therapy. These results suggest that ketoprofen may be used for antipyresis as an alternative to acetaminophen and ibuprofen.

Efficacy and safety of piroxicam patch versus piroxicam cream in patients with lumbar osteoarthritis. A randomized, placebo-controlled study. [2009]
CONCLUSIONS: The piroxicam patch is effective in the treatment of lumbar osteoarthritis and has demonstrated to be well tolerated and it improves patients compliance. The piroxicam patch offers a comparable alternative to the marketed piroxicam cream for the treatment of lumbar osteoarthritis with the advantage of a better compliance with the once a day application of the patch compared to three daily applications for the piroxicam cream.

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Clinical Trials Related to Oruvail Extended-Release (Ketoprofen)

Study of Non Inferiority Bi-Profenid® 200mg Versus Bi-Profenid® 300mg Among Patients Presenting of the Post-Traumatic or Rheumatologic Acute Affections of the Locomotor Apparatus (BIPROPAIN) [Recruiting]
Primary objective:

To demonstrate the non-inferiority of Bi-Profenid 100 mg x 2 day versus Bi-Profenid 150 mg x 2 day in patients presenting with pain related to closed, benign, acute post-traumatic conditions of the motor system or acute, non-infectious rheumatologic conditions, by comparing, on the one hand, changes in resting pain intensity over the entire day, measured at the end of the day using a numeric scale (NS), over 5 days and, on the other hand, total intake over 5 days of concomitant analgesics.

Secondary Objectives:

- To describe concomitant analgesic treatments

- To describe the time between baseline and use of a step I, II or III analgesic

- To evaluate patients pain relief using a Likert 4-class scale (complete or substantial

relief, moderate relief slight relief and absence of relief) at D5

- To evaluate changes in intensity of pain when moving, over the entire day, measured at

the end of the day using a numeric scale, over 5 days

- To evaluate the patients overall satisfaction at the end of treatment using a 4-point

Simple Verbal Scale (SVS) (very satisfied, somewhat satisfied, somewhat unsatisfied, very unsatisfied)

- To evaluate the patients overall satisfaction at the end of the study using a 4-point

Simple Verbal Scale (EVS) (very satisfied, somewhat satisfied, somewhat unsatisfied, very unsatisfied)

- To compare the safety of the two treatments

Ketoprofen 10% Cream for Treatment of Pain Associated With Mild to Moderate Acute Tissue Injury [Recruiting]

Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee [Completed]
The purpose of the study is to evaluate the safety and effectiveness of the investigational ketoprofen patch with a controlled heating patch, compared to placebo (inactive substance) for the treatment of pain caused by osteoarthritis.

Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood [Not yet recruiting]
This is a Randomized double blind trial with the aim to estimate the effectiveness of 3 therapeutic regimes per os on migraine pain:

- metoclopramide 0,15 mg/kg + placebo

- metoclopramide 0,15 mg/Kg + ketoprofen 1 mg/kg

- ketoprofen 1 mg/Kg + placebo

Intensity of pain will be measured with linear 1-10 scale or analogic McGrath type scale every 20 min.

The main objective is the evaluation of healing times from pain in the 3 groups

Ketoprofen in Transfersome Compared to Oral Celecoxib and Placebo for Pain Associated With Osteoarthritis of the Knee [Completed]
The purpose of this study is to determine the safety and effectiveness of 110 mg ketoprofen in Transfersome applied to the skin twice daily as compared to placebo and oral celecoxib 200 mg per day for the relief of signs and symptoms of osteoarthritis of the knee for a period of six weeks.

more trials >>

Page last updated: 2009-10-20

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