Generic Name: Generic abana
What is Generic Abana?
The EDGE and EDGE II studies compared the gastrointestinal tolerability of etoricoxib versus diclofenac. The EDGE study included 7,111 OA patients treated with a dose of etoricoxib 90 mg daily 1. The EDGE II study included 4,086 RA patients treated with etoricoxib 90 mg daily or diclofenac 150 mg daily for a mean period of 19.
Use of gastroprotective agents and low dose aspirin were permitted in the studies. Overall Safety: There was no significant difference between etoricoxib and diclofenac in the rate of cardiovascular thrombotic events.
Cardiorenal adverse events were observed more frequently with etoricoxib than with diclofenac, and this effect was dose-dependent see specific results below. Gastrointestinal and hepatic adverse events were observed significantly more frequently with diclofenac than etoricoxib. The incidence of adverse experiences in EDGE and EDGE II and of adverse experiences considered serious or resulting in discontinuation in the MEDAL study was higher with etoricoxib than diclofenac.
Cardiovascular safety results: The rate of confirmed thrombotic cardiovascular serious adverse events consisting of cardiac, cerebrovascular, and peripheral vascular events was comparable between etoricoxib and diclofenac, and data are summarized in the table below. There were no statistically significant differences in thrombotic event rates between etoricoxib and diclofenac across all subgroups analyzed including patient categories across a range of baseline cardiovascular risk.
As with other drugs, caution should be exercised in elderly patients see section 4. Patients with hepatic impairment Regardless of indication, in patients with mild hepatic dysfunction Child-Pugh score 5-6 a dose of 60 mg once daily should not be exceeded. In patients with moderate hepatic dysfunction Child-Pugh score 7-9regardless of indication, the dose of 30 mg once daily should not be exceeded.
The onset of the effect of the medicinal product may be faster when ARCOXIA is administered without food. This should be considered when rapid symptomatic relief is needed.
There is a further increase in the risk of gastrointestinal adverse effects gastrointestinal ulceration or other gastrointestinal complications when etoricoxib is taken concomitantly with acetylsalicylic acid even at low doses. Cardiovascular effectsClinical trials suggest that the selective COX-2 inhibitor class of drugs may be associated with a risk of thrombotic events especially myocardial infarction MI and strokerelative to placebo and some NSAIDs.
As the cardiovascular risks of etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. Patients with significant risk factors for cardiovascular events e. Therefore, under conditions of compromised renal perfusion, administration of etoricoxib may cause a reduction in prostaglandin formation and, secondarily, in renal blood flow, and thereby impair renal function.
Patients at greatest risk of this response are those with pre-existing significantly impaired renal function, uncompensated heart failure, or cirrhosis.
Monitoring of renal function in such patients should be considered. Fluid retention, oedema and hypertension As with other medicinal products known to inhibit prostaglandin synthesis, fluid retention, oedema and hypertension have been observed in patients taking etoricoxib. All Nonsteroidal Anti-inflammatory Drugs NSAIDsincluding etoricoxib, can be associated with new onset or recurrent congestive heart failure.
How should I take Generic Abana?
Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine. Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine.
Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect. The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
What should I avoid while taking Generic Abana?
This was a randomised, double blind the investigators and sponsor were blinded throughout the studyactive comparator controlled study. The institutional review board or ethics review committee at each centre approved the protocol, and all patients gave written informed consent before participation. Patients were screened and, if eligible, randomised immediately day 1according to a computer generated allocation schedule provided by the sponsor, to receive oral administration of etoricoxib 120 mg once daily or indometacin 50 mg three times daily.
Patients took one tablet of etoricoxib or placebo from bottle A once daily in the morning and one capsule of indometacin or placebo from bottle B three times daily morning, afternoon, and evening. The treatment allocation was stratified for monoarticular or polyarticular acute gout. Efficacy end points included patients' assessment of pain in the study joint primary end point and investigators' assessments of tenderness, swelling, and erythema. We also evaluated patients' and investigators' global assessments of response to treatment.
Generic Abana side effects
The results of this study indicate that etoricoxib represents an effective treatment alternative to indometacin. We thank Elliot Ehrich for invaluable contributions to the design of the study, Peter Merkel for helpful suggestions regarding the study design, and Ken Truitt for guidance during the course of the study.
We also thank Briggs Morrison, Ned Braunstein, and Barry Gertz for their helpful comments and suggestions. Contributors: HRS contributed to the design and recruitment of the study. Design: Randomised, double blind, active comparator controlled trial.
Setting: 43 outpatient study centres in 11 countries.
Common Generic Abana ide effects may include:
For the relief of gout attacks, the recommended dose is 120 mg taken once a day, which should only be used during the painful period, to a maximum of 8 days treatment.
Two randomised, double-blind, phase III trials have shown that a 60mg daily dose of etoricoxib is effective for the treatment of rheumatoid arthritis and ankylosing spondylitis, although some patients required an increased dose of 90mg daily.
Patients who have any questions or concerns should speak to their doctor or pharmacist.
The company that makes etoricoxib-containing medicines should also look into ways to investigate their safety in patients with ankylosing spondylitis in more depth, such as setting up a registry of patients taking the medicines.
Etoricoxib pronounced ee-TOR-ee-cox-ib What is in this leaflet This leaflet answers some common questions about ARCOXIA. It does not contain all the available information.
Where can I get more information?
Etoricoxib is prescribed to relieve pain and inflammation in patients with various types of arthritis.
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