PIROXICAM

Posology Treatment with piroxicam should only 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 lowest 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.

Piroxicam has been shown to be associated with increased risk of gastrointestinal complications. g. misoprostol or proton pump inhibitors), particularly in the elderly. Use in the 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:

The capsules should be swallowed with a drink of water, preferably with or after food. 4).

4) Reproductive system and breast disorders Female fertility decreased General disorders and administration site conditions Oedema (mainly of the ankle) Malaise Investigations Increased serum transaminase Positive ANA (antinuclear System organ class Very common ≥ 1/10 Common ≥ 1/100 to < 1/10 Uncommon 1/1000 to < 1/100 Rare ≥1/10000 to <1000 Very rare <1/10000 Not known (cannot be estimated from available data) levels Weight increase Decreases in haemoglobin and haematocrit un-associated with obvious gastrointestinal bleeding antibody), Weight decrease Gastrointestinal: These are the most commonly encountered side-effects but, in most instances, do not interfere with the course of therapy.

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 gastrointestinal tract than aspirin.

Some epidemiological studies have suggested that piroxicam is associated with higher risk of gastrointestinal adverse reactions compared with some NSAIDs, but this has not been confirmed in all studies. 2). Oedema, hypertension and cardiac failure, have been reported in association with NSAID treatment.

The possibility of precipitating congestive heart failure in elderly patients or those with compromised cardiac function should therefore be borne in mind. 4).

Liver function:

Changes in various liver function parameters have been observed. g. ), Piroxicam should be discontinued.

Other:

Routine ophthalmoscopy and slit-lamp examination have revealed no evidence of ocular changes. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

2, and GI and cardiovascular (CV) 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 adverse events including bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, which can be fatal. 2). Administration of doses of greater than 20 mg per day carries an increased risk of GI side effects.

Evidence from observational studies suggests that piroxicam may be associated with a high risk of serious gastrointestinal toxicity, relative to other NSAIDs. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs.

3 and below). g. 2).

Serious GI Complications Identification of 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 over 80 years should be avoided. 5). g. misoprostol or proton pump inhibitors) must be considered for these at-risk patients.

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.

Cardiovascular and cerebrovascular effects Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

1. 1. History of gastro-intestinal ulceration, bleeding or perforation. 2. Patient history of gastrointestinal disorders that predispose to bleeding disorders such as ulcerative colitis, Crohn’s disease, gastrointestinal cancers or diverticulitis.

3. Patients with active peptic ulceration, inflammatory gastrointestinal disorder or gastrointestinal bleeding. 4. Concomitant use with other NSAIDs, including COX-2 selective NSAIDs and acetylsalicylic acid at analgesic doses. 5. Concomitant use with anticoagulants.

6. History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. 7. Previous skin reaction (regardless of severity) to piroxicam other NSAIDs and other medications.

8. Piroxicam should not be given to patients in whom aspirin and other non-steroidal anti-inflammatory drugs induce the symptoms of asthma, nasal polyps, angioedema or urticaria. 9. Severe heart failure. 10. During the last trimester of pregnancy.