Uniren/Uniren 50

Uniren/Uniren 50

diclofenac

Manufacturer:

Unison

Distributor:

Health Alliance
/
Firma Welfare Instrument
Full Prescribing Info
Contents
Diclofenac sodium.
Description
Each enteric coated tablet contains: Diclofenac sodium 25 mg.
Each enteric coated tablet contains: Diclofenac sodium 50 mg.
Indications/Uses
UNIREN is indicated for acute and chronic treatment of the signs and symptoms of rheumatoid arthritis, osteo-arthritis and ankylosing spondylitis.
Dosage/Direction for Use
Usual adult dose: 75 to 100 mg in divided doses or as prescribed by the physician.
UNIREN should be used at the lowest effective dose for shortest possible time.
Note: Diclofenac, particularly at higher doses (150 mg per day), is associated with an increased risk of serious cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events which can be fatal) that is comparable to COX-2 inhibitors. Evidence suggests that the risk may increase with the dose and duration of use. The maximum recommended daily dose of systemic Diclofenac has been reduced from 150 mg per day to 100 mg per day for all indications, excluding Diclofenac potassium preparations which allows for a 200 mg dose only on the first day of treatment for dysmenorrhea. To minimize the potential risk for an adverse cardiovascular event, the lowest effective dose should be used for the shortest possible duration.
Contraindications
UNIREN is contraindicated in patients with hypersensitivity to it and in patients with peptic ulcer.
UNIREN is contraindicated: In patients with severe heart failure and; 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/ hemorrhage.
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.
Treatment with Diclofenac is not recommended in patients with pre-existing cardiovascular disease or cerebrovascular disease, or presenting risk factors for cardiovascular disease. For these patients, treatment options other than NSAIDs, particularly COX-2 inhibitors and Diclofenac, should be considered first.
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 a NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greater risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitor, 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 UNIREN in patients with advanced renal disease. Therefore, treatment with UNIREN 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.
Note: In rare cases, Diclofenac has been associated with serious liver injury.
Use In Pregnancy & Lactation
Usage during Pregnancy: There are no adequate and well-controlled studies in pregnant women. Diclofenac should be used during pregnancy only if the benefits to the mother justify the potential risk to the fetus. Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system, use of Diclofenac during late pregnancy should be avoided.
Adverse Reactions
Gastrointestinal disorders (eg. nausea, vomiting, diarrhea), gastrointestinal bleeding.
Storage
Store at temperature not more than 30°C.
ATC Classification
M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
EC tab 25 mg x 1,000's. 50 mg x 500's.
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