PIROXICAM

The prescription of Piroxicam should be initiated by physicians with experience in the diagnostic evaluation and treatment of patients with inflammatory or degenerative rheumatic diseases. The maximum recommended daily dose is 20 mg.

Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms. The benefit and tolerability of treatment should be reviewed within 14 days. If continued treatment is considered necessary, this should be accompanied by frequent review.

g. misoprostol or proton pump inhibitors) should be carefully considered, in particular for elderly patients.

Use in elderly:

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.

Use in children:

Dosage recommendations and indications for use in children have not been established.

Administration:

Oral To be taken preferably with or after food.

Gastro-intestinal:

The most commonly-observed adverse events are gastrointestinal in nature. 4). 4) have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely. Objective evaluations of gastric mucosa appearances and intestinal blood loss show that 20mg/day of piroxicam administered either in single or divided doses is significantly less irritating to the gastro-intestinal tract than aspirin.

Peptic ulceration, perforation and gastro-intestinal bleeding in rare cases fatal, have been reported with piroxicam. Some epidemiological studies have suggested that piroxicam is associated with higher risk of gastro-intestinal adverse reactions compared with some NSAIDs, but this has not been confirmed in all studies.

2 Posology and method of administration). Long term administration of doses of 30 mg or higher carries an increased risk of gastro-intestinal side effects.

Hypersensitivity reactions:

Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis rarely, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea rarely, or (c) assorted skin disorders, rarely including rashes of various types, pruritus, urticaria, purpura, angiodema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Vasculitis and serum sickness have been rarely reported.

Cardiac:

Oedema, hypertension, and cardiac failure, have been reported in association with NSAIDs treatment. The possibility of precipitating congestive heart failure in elderly patients or those with compromised cardiac function should therefore be borne in mind.

2 and GI and cardiovascular risks below). The clinical benefit and tolerability should be re-evaluated periodically and treatment should be immediately discontinued at the first appearance of cutaneous reactions or relevant gastrointestinal events.

Gastrointestinal (GI) Effects, Risk of GI Ulceration, Bleeding, and Perforation:

NSAIDs, including Piroxicam, can cause serious gastrointestinal events including bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs.

NSAIDs exposures of both short and long duration have an increased risk of serious GI event. Evidence from observational studies suggests that Piroxicam may be associated with a high risk of serious gastrointestinal toxicity, relative to other NSAIDs.

3 and below). g. 5).

Serious GI complications Identification at risk subjects:

The risk for developing serious GI complications increases with age. Age over 70 years is associated with high risk of complications. The administration to patients older than 80 years should be avoided. 3), and in the elderly. These patients should commence treatment on the lowest dose available.

When GI bleeding or ulceration occurs in patients receiving piroxicam the treatment should be withdrawn. 8). 5). Patients and physicians should remain alerted for signs and symptoms of GI ulceration and/or bleeding during Piroxicam treatment.

Patients should be asked to report any new or unusual abdominal symptom during treatment. If a gastrointestinal complication is suspected during treatment, Piroxicam should be discontinued immediately and additional clinical evaluation and treatment should be considered.

3. Contra-indications History of gastro-intestinal ulceration, bleeding or perforation. Patient history of gastrointestinal disorders that predispose to bleeding d i s o r d e r s s u c h a s u l c e r a t i v e c o l i ti s , C r oh n 's d i s e a s e , ga s t r o i n t e s t i n al 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 acetyl-salicylic acid at analgesic doses. Concomitant use with anticoagulants.

History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as erythema multiform, Stevens-Johnson syndrome, toxic epidermal necrolysis. Hypersensitivity to the active substance and excipients, previous skin reaction (regardless of severity) to piroxicam, other NSAIDs and other medications.

Piroxicam should not be given to patients in whom aspirin and other non- steroidal anti-inflammatory drugs induce the symptoms of asthma, rhinitis, angioedema or urticaria. Piroxicam should be avoided in patients with porphyria. Severe heart failure.

Last trimester of pregnancy.