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Oruvail Extended-Release (Ketoprofen) - Summary

 

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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.

NEWS HIGHLIGHTS RELATED TO ORUVAIL EXTENDED-RELEASE

Media Articles Related to Oruvail Extended-Release (Ketoprofen)

Idea AG Withdraws Its Marketing Authorisation Application For Diractin(ketoprofen), Europe
Source: Arthritis / Rheumatology News From Medical News Today [2008.07.28]

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Published Studies Related to Oruvail Extended-Release (Ketoprofen)

Evaluation of bioequivalence after oral, intramuscular, and intravenous administration of racemic ketoprofen in pigs. [2008.01]

Efficacy and safety of epicutaneous ketoprofen in Transfersome (IDEA-033) versus oral celecoxib and placebo in osteoarthritis of the knee: multicentre randomised controlled trial. [2007.09]

Intravenous ketoprofen as an adjunct to patient-controlled analgesia morphine in adolescents with thoracic surgery: a placebo controlled double-blinded study. [2007.08]

Comparison of intravenous dexketoprofen and dipyrone in acute renal colic. [2007.08]

Pilot study of relative bioavailability of two oral formulations of ketoprofen 25 mg in healthy subjects. A fast-dissolving lyophilized tablet as compared to immediate release tablet. [2007.05]

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Clinical Trials Related to Oruvail Extended-Release (Ketoprofen)

Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood [Not yet recruiting]

Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee [Completed]

Ketoprofen in Transfersome Compared to Oral Celecoxib and Placebo for Pain Associated With Osteoarthritis of the Knee [Completed]

Efficacy Safety of a Combination Thiocolchicoside+Ketoprofen Compared to Thiocolchicoside Twice a Day for 7 Days in Patients Suffering From Acute Non Specific Low Back Pain [Recruiting]

Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis [Completed]

more>>

Page last updated: 2008-07-28

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