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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)

Dexketoprofen trometamol in the acute treatment of migraine attack: a phase II, randomized, double-blind, crossover, placebo-controlled, dose optimization study. [2014]
Migraine is a disabling disease that can significantly affect a person's quality of life... Its rapid absorption rate with higher maximum plasma concentrations and shorter time to maximum values suggest that this drug is a good option for acute migraine treatment.

Comparison of the analgesic efficacy of dexketoprofen trometamol and meperidine HCl in the relief of renal colic. [2014]
In this study, the analgesic effects of dexketoprofen trometamol and meperidine hydrochloride were compared in patients diagnosed with renal colic. This study was a prospective, randomized, double-blind study... With this study, we concluded that dexketoprofen trometamol, from the nonsteroidal anti-inflammatory drug group, can be within the primary treatment options for renal colic because of better analgesic efficacy, being well tolerated by patients compared with meperidine hydrochloride.

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...

more studies >>

Clinical Trials Related to Oruvail Extended-Release (Ketoprofen)

Ketoprofen Gel vs Placebo in Low Back Pain [Recruiting]
This study aimed to analyse the analgesic effect of ketoprofen gel in patients presented with mechanical low-back pain to the emergency department.

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

Topical Intra-Oral Ketoprofen for Migraine Prevention [Completed]
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.

Ketoprofen Gel vs Placebo in Children With Ankle Sprain [Recruiting]
The aim of this study is to analyse the effect of ketoprofen gel in children presented with ankle sprain to the emergency department.

Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain [Completed]
The aim of this study is to analyse the effect of ketoprofen gel in patients presented with ankle sprain to the emergency department.

more trials >>

Page last updated: 2015-08-10

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