S3 - As per indications listed below.
S2 - Emergency treatment of acute gout attacks; treatment of post-operative traumatic conditions such as pain, swelling and inflammation; for a maximum period of 5 days.
(and dosage form):
Piroxicam beta-cyclodextrin 191,2 mg equivalent to piroxicam 20 mg
A 3.1 Anti-rheumatics (anti-inflammatory agents).
Piroxicam is a non-steroidal anti- inflammatory agent, which also possesses analgesic and antipyretic properties. Brexecam is piroxicam formulated as a complex with beta-cyclodextrin in a molar ratio 1:2,5 beta-cyclodextrin is a carriermolecule for piroxicam making it very soluble in water and allowing for the rapid and complete absorption of piroxicam. The improved bioavailability leads to a rapid increase in plasma levels and peak value is reached at an early stage. The elimination half-life of Brexecam is the same as that of piroxicam (i.e. 35-45 hours).
Brexecam is indicated for avariety of conditions requiring anti-inflammatory and/or analgesic activity, including rheumatoid arthritis, osteo-arthritis (arthrosis, degenerative joint disease), ankylosing spondylitis, acute musculoskeletal disorders and acute gout.
Brexecam must not be used in subjects known to be hypersensitive to piroxicam, nor in subjects with gastroduodenal ulcer, gastritis, dyspepsia, impaired hepatic or renal disorders, uncontrolled heart failure, uncontrolled hypertension, blood dyscrasia or haemorrhagic diathesis. It is possible that cross sensitivity with acetylsalicylic acid or other NSAIDs may exist. Therefore piroxicam must not be administered to patients in whom acetylsalicylic acid or other NSAIDs induce symptoms of asthma, rhinitis or urticaria. The product should not be used by pregnant or lactating women and by children. Brexecam should not be used in patients on coumarin-type anticoagulants.
The product must be used under strict medical control in patients with a medical history of disorders of the upper gastro-intestinal tract. Particular caution must be taken in subjects with cardiocirculatory failure, arterial hypertension, reduced hepatic or renal function, alterations in blood parameters. Bronchial asthma and elderly patients. Piroxicam like other NSAIDs, decreases platelet aggregation and prolongs bleeding - see Drug interactions. Piroxicam can alter the state of alertness to such an extent as to affect driving a vehicle or carrying out an activity that requires quick reflexes.
DOSAGE AND DIRECTIONS FOR USE:
Take one tablet per day. In elderly patients it may be necessary to reduce the dosage (half a tablet) and limit the duration of treatment.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most commonly found side-effects are nausea epigastric distress, constipation and diarrhoea. Other possible reactions are hypersensitivity signs, such as skin rash, headache, vertigo, asthenia, blood chemistry modifications, and increase in blood urea. The increase in blood urea is not associated with an increase of serum creatinine.
Less common adverse reactions are: gastric ulcers with or without haemorrhages, vomiting, allergic oedema of the face and hands, blurred vision, tinnitus, aplastic anemia, leucopenia, eosinophilia, pancytopenia, thrombocytopenia, increase in parameters of liver functions, jaundice, acute renal insufficiency, water retention that may occur in the form of oedema (mainly ankle oedema), or cardiocirculatory disorders (hypertension, congestive heart failure). Sporadic cases of gastric ulcer with perforation, Stevens-Johnson's syndrome, Lyell's syndrome-, agranulocytosis, bladder disorders, shock and warning symptoms, acute heart failure. Stomatitis, alopecia and nail growth disorders have been reported. Brexecam increases plasma lithium levels.
Drug and Laboratory Interactions: Piroxicam decreases platelet aggregation and prolongs bleeding; this should be remembered when blood tests are carried out and when patients undergo contemporary treatment with medicines that inhibit platelet aggregation.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
For symptoms of overdosage see 'Side-Effects and Special Precautions'. Treatment is supportive and symptomatic.
Yellow, hexagonal tablets with a median bisection line.
Blister packs containing 30 tablets.
Store below 30°C. Keep out of reach of children.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
The Premier Pharmaceutical Co. Ltd.
Adcock Ingram Park
17 Harrison Avenue, Bryanston Ext. 77
Private Bag X69, Bryanston, 2021
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
New addition to this site: April 2004
Source: Pharmaceutical Industry
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