(and dosage form):
Each suppository contains 20 mg piroxicam.
A 3.1 Antirheumatics (Anti-inflammatory agents).
Xycam is a non-steroidal anti-inflammatory agent, an inhibitor of prostaglandin biosynthesis, in vitro. Xycam also exerts antipyretic and analgesic effects.
The mean plasma half-life is about 50 hours. After absorption, Xycam is extensively (99%) bound to plasma proteins. At steady state (e.g. after 7 to 12 days), concentrations of Xycam in plasma and synovial fluid are approximately equal. Less than 5% of the medicine is excreted unchanged in the urine. The major metabolic transformation in man is hydroxylation in the liver of the pyridyl ring, and this inactive metabolite and its glucuronide conjugate account for about 60% of the medicine excreted in the urine and faeces.
Xycam suppositories are indicated for a variety of conditions requiring anti-inflammatory and/or analgesic activity such as rheumatoid arthritis, osteo-arthritis and ankylosing spondylitis.
Sensitivity to piroxicam or similar compounds.
Safety of use during pregnancy or lactation has not been established.
Not recommended for children under the age of 12 years.
The potential exists for cross sensitivity to aspirin and other non-steroidal anti-inflammatory medicines. Xycam should not be given to patients in whom aspirin and other non-steroidal anti-inflammatory medicines induce the symptoms of asthma, rhinitis or urticaria.
Peptic ulceration or a history of gastro-intestinal haemorrhage.
Unsafe in patients with acute porphyria.
Care should be exercised when administering Xycam to patients with significant impairment of renal function.
Xycam should not be used in patients on coumarin type anticoagulants.
Xycam decreases platelet aggregation and prolongs bleeding time.
Xycam should be used with caution in patients with cardiovascular disorders where oedema may worsen the condition.
DOSAGE AND DIRECTIONS FOR USE:
Rheumatoid Arthritis, Osteo-Arthritis, Ankylosing Spondylitis.
The usual dose is one suppository daily, given as a single dose. The majority of patients will be maintained on a dose of one suppository (20 mg) daily.
Directions For Use:
Gently insert the suppository into the rectum, pointed end first, pushing it in with the finger as far as it will comfortably go. Wash hands thoroughly before and after insertion.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disturbances are the most common side-effects occurring with Xycam. Diarrhoea may occur.
Peptic ulceration and gastro-intestinal bleeding have been reported as have decreased platelet aggregation and prolonged bleeding times. Oedema and changes in liver function tests have also occurred.
Some patients may develop increased serum transaminase levels and alkaline phosphatase levels during treatment with cam. Where the abnormality continues or worsens, Xycam must be discontinued.
Blood urea elevation has been observed. These elevations are not progressive over the course of treatment with Xycam; a plateau being reached which returns to or towards baseline levels if treatment is stopped. The rise in blood urea is not associated with elevations in serum creatinine.
Dermal sensitivity reactions, usually in the form of skin rash, have been reported. Stevens-Johnson syndrome may develop.
Decreases in haemoglobin and haematocrit, independent of gastro-intestinal bleeding, have occurred. Thrombocytopenia and non-thrombocytopenic purpura (Henoch-Schönlein), aplastic anaemia, leucopenia and eosinophilia have been reported, and constitute indications for immediate withdrawal of Xycam therapy.
Central nervous system effects such as dizziness, headache, somnolence, and vertigo have been reported with the use of Xycam.
Other side-effects which have been reported include blurred vision, tinnitus and pruritis.
Xycam should be used with caution in patients with a history of gastro- intestinal haemorrhage or ulcers or aspirin sensitivity.
Xycam is highly protein bound and therefore, might be expected to displace other protein bound medicines.
Xycam increases plasma lithium levels.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-Effects and Special Precautions".
In the event of overdosage, supportive and symptomatic therapy is indicated.
A white, torpedo-shaped suppository.
Packs of 10 suppositories.
Store below 25°C. Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.
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