FELDENE 10MG TAB
Feldene 10mg Tablet
WHAT IS FELDENE 10MG TAB?
FELDENE 10mg CAPSULES possess active ingredient piroxicam 10 mg (anhydrous).
Excipient with known effect is Lactose.
WHAT ARE THE USES OF FELDENE 10MG TAB?
- Feldene is indicated for symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis.
- Feldene is not a first line option should an NSAID be indicated. The decision to prescribe Feldene should be based on an assessment of the individual patient's overall risks.
WHAT ARE THE SIDE EFFECTS OF FELDENE 10MG TAB?
WHEN NOT TO USE FELDENE 10MG TAB?
- History of gastro-intestinal ulceration, bleeding or perforation.
- Patient history of gastrointestinal disorders that predispose to bleeding disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancers or diverticulitis.
- Patients with active peptic ulcer, inflammatory gastrointestinal disorder or gastrointestinal bleeding.
- Concomitant use with other NSAIDs, including COX-2 selective NSAIDs and acetylsalicylic acid at analgesic doses.
- Concomitant use with anticoagulants.
- History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
- Hypersensitivity to the active substance or the excipients, previous skin reaction (regardless of severity) to piroxicam, other NSAIDs and other medications.
- Patients in whom aspirin and other non-steroidal anti-inflammatory drugs induce the symptoms of asthma, nasal polyps, angioedema or urticaria.
- Severe heart failure.
- During the last trimester of pregnancy.
WHAT ARE THE PRECAUTIONS OF FELDENE 10MG TAB?
- Given that piroxicam has been shown to be associated with an increased risk of gastrointestinal complications, the need for possible combination therapy with gastro-protective agents (e.g. misoprostol or proton pump inhibitors) should be carefully considered, in particular for elderly patients.
- Elderly, frail or debilitated patients may tolerate side-effects less well and such patients should be carefully supervised. As with other NSAIDs, caution should be used in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function.
- For oral administration. To be taken preferably with or after food.
- Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
WHAT ARE THE INTERACTIONS FELDENE 10MG TAB?
Antacids: Concomitant administration of antacids had no effect on piroxicam plasma levels.
Anticoagulants: NSAIDs, including piroxicam, may enhance the effects of anticoagulants, such as warfarin. Therefore the use of piroxicam with concomitant anticoagulant such as warfarin should be avoided (see section 4.3).
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4).
Aspirin and other Non-Steroidal Anti-Inflammatory Drugs: Feldene, like other non-steroidal anti-inflammatory drugs decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined.
Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.
Ciclosporin, Tacrolimus: possible increased risk of nephrotoxicity when NSAIDs are given with ciclosporin or tacrolimus.
Cimetidine: Results of two separate studies indicate a slight but significant increase in absorption of piroxicam following cimetidine administration but no significant changes in elimination rate constants or half-life.
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
Digoxin, Digitoxin: Concurrent therapy with Feldene and digoxin, or Feldene and digitoxin, did not affect the plasma levels of either drug.
WHAT IS THE DOSE OF FELDENE 10MG TAB?
The maximum recommended daily dose is 20 mg.