Amoria

Amoria

meloxicam

Manufacturer:

Samik

Distributor:

SB Pharma
Full Prescribing Info
Contents
Meloxicam.
Description
Each capsule contains: Meloxicam 7.5 mg.
Action
Meloxicam, an oxicam derivative, is an NSAID. It is reported to be a selective inhibitor of cyclo-oxygenase-2 (COX-2).
Indications/Uses
For adult aged 16 or above: Meloxicam is used in the management of rheumatoid arthritis, for the short-term symptomatic treatment of acute exacerbations of osteoarthritis, and for the symptomatic treatment of ankylosing spondylitis. It may also be used in the treatment of juvenile idiopathic arthritis.
Dosage/Direction for Use
In the treatment of rheumatoid arthritis and ankylosing spondylitis, meloxicam is given in a usual oral dose of 15 mg daily as a single dose. Those with an increased risk of adverse reactions should be started on 7.5 mg daily. A dose of 7.5 mg daily is recommended for long-term treatment in the elderly.
In the treatment of acute exacerbations of osteoarthritis the usual oral daily dose of meloxicam is 7.5 mg, increased if necessary to a maximum of 15 mg daily given as a single dose.
Amoria Capsules 7.5 mg should be used at the lowest effective dose for shortest possible time.
Contraindications
Amoria Capsules 7.5 mg is contraindicated i) in patients with severe heart failure and ii) for the treatment of peri-operative pain in the setting of coronary artery bypass graft surgery.
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy; active, or history of recurrent peptic ulcer / haemorrhage.
Meloxicam should not be used in children aged under 16 years.
Warnings
In rare cases, Meloxicam has been associated with serious liver injury.
Special Precautions
Cardiovascular Risk: NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, 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.
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 events.
Renal Effects: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Advanced Renal Disease: No information is available from controlled clinical studies regarding the use of Amoria Capsules 7.5 mg in patients with advanced renal disease. Therefore, treatment with Amoria Capsules 7.5 mg is not recommended in these patients with advanced renal disease. If therapy must be initiated, close monitoring of the patient’s renal function is advisable.
Storage
Store below 30°C.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AC06 - meloxicam ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, oxicams.
Presentation/Packing
Form
Amoria cap 7.5 mg
Packing/Price
10 × 10's
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