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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).




[or′ü vāl]
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 Oruvail Extended-Release indications & dosage >>


Published Studies Related to Oruvail Extended-Release (Ketoprofen)

Comparing the efficacy of intravenous tenoxicam, lornoxicam, and dexketoprofen trometamol for the treatment of renal colic. [2012]
dexketoprofen trometamol-for the treatment of patients with renal colic... CONCLUSIONS: Intravenous tenoxicam, lornoxicam, and dexketoprofen are all

Postoperative analgesic efficacy of intravenous dexketoprofen in lumbar disc surgery. [2011.07]
BACKGROUND: We investigated the postoperative analgesic efficacy and effect on total tramadol consumption of intravenous dexketoprofen trometamol, a new nonsteroidal anti-inflammatory drug, in patients that had undergone lumbar disc surgery... CONCLUSION: We found that dexketoprofen was an effective analgesic for postdiscectomy pain when used alone or in addition to opioids. It is easy to administer and decreases tramadol consumption and opioid-related side effects.

Clinical evaluation of meloxicam versus ketoprofen in cats suffering from painful acute locomotor disorders. [2011.04]
The aim of this study was to evaluate the efficacy and palatability of meloxicam 0.5mg/ml oral suspension, compared to ketoprofen tablets in cats suffering from painful acute locomotor disorders. This single blinded, positively-controlled, randomised, multicentre trial involved 121 client owned cats...

[Pre-emptive ketoprofen for postoperative pain relief after urologic surgery]. [2011.01]
BACKGROUND: Effective multimodal postoperative analgesia is one of determinants of patient satisfaction after successful surgery. Following the recommendations of non-steroidal antiinflammatory agents (NSAIDs) for pre-emptive analgesia, we assessed the efficacy of ketoprofen administered before urological surgery... CONCLUSION: Pre-emptive analgesia with intravenous ketoprofen was ineffective in patients undergoing urological surgery.

[The effects of preemptive dexketoprofen use on postoperative pain relief and tramadol consumption]. [2011.01]
OBJECTIVES: In this study, the efficacy of preemptive dexketoprofen usage on postoperative pain relief and tramadol consumption was evaluated... CONCLUSION: Preemptive use of dexketoprofen reduced postoperative tramadol consumption and incidence of adverse events.

more studies >>

Clinical Trials Related to Oruvail Extended-Release (Ketoprofen)

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

Study to Assess the Efficacy and Safety of Ibuprofen 50 mg/g Gel Compared to Profenid 25mg/g Gel [Not yet recruiting]
The aim of this study is to determine that ibuprofen 50mg/g gel is effective and safety treating patients with muscle aches, joint pains or due to sprains, bruises, tendinitis or myofascial compared to Profenid 25mg/g gel.

Evaluation of Inflammatory Symptoms Reduction With Amoxicillin + Ketoprofen in Acute Pharyngeal- Tonsillitis in Pediatric Patients [Recruiting]
The purpose of this study is to evaluate the inflammatory symptoms and signs (hyperemia, edema and pain) reduction after 24 hours of treatment with ketoprofen drops when associated to amoxicillin.

Topical Intra-Oral Ketoprofen for Migraine Prevention [Recruiting]
Intra-Oral Topical Ketoprofen gel, applied to a branch of the trigeminal nerve, has been shown to prevent migraines when used once daily for 3 months in open label studies. This is a randomized, double-blind, placebo controlled phase III prevention trial to determine safety and efficacy.

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

more trials >>

Page last updated: 2013-02-10

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