INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo XYCAM-20 CAPSULES
XYCAM DISPERSIBLE TABLETS

SCHEDULING STATUS:
S3
S2

PROPRIETARY NAME
(and dosage form):

XYCAM-20 CAPSULES
XYCAM DISPERSIBLE TABLETS

COMPOSITION:
XYCAM-20 contains 20 mg
piroxicam.
XYCAM DISPERSIBLE TABLETS contain 20 mg piroxicam.

PHARMACOLOGICAL CLASSIFICATION:
A 3.1 Antirheumatics (Anti-inflammatory agents).

PHARMACOLOGICAL ACTION:
Piroxicam is a non-steroidal anti-inflammatory agent, an inhibitor of prostaglandin biosynthesis, in vitro. It also exerts antipyretic and analgesic effects. Piroxicam is completely absorbed after oral administration; peak concentration in the plasma occurs after 2 to 4 hours. Neither food nor antacids alter the rate or extent of absorption. Mean plasma half-life is about 50 hours. After absorption, Piroxicam is extensively (99 % ) bound to plasma proteins. At steady state (e.g. after 7 to 12 days), concentrations of Piroxicam 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.

INDICATIONS:
S2 For the emergency treatment of acute gout attacks.
  For the treatment of post-traumatic conditions such as pain swelling and inflammation for a maximum period of 5 days.
S3 Xycam is indicated for a variety of conditions requiring anti-inflammatory and/or analgesic activity such as rheumatoid arthritis, osteo-arthritis, ankylosing spondylitis, acute musculo-skeletal disorders and acute gout.

CONTRA-INDICATIONS:
Hepatic dysfunction.
Sensitivity to piroxicam or similar compounds.
Safety of use during pregnancy or lactation has not been established.
Not recommended for use in children.
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 bleeding.
Unsafe in patients with acute porphyria.

WARNINGS:
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:
Xycam should preferably be taken after meals or with food to reduce gastro-intestinal irritation. Xycam should be taken with a full glass (240 mL) of water and the patient should remain in an upright position for 15 to 30 minutes after administration.
Xycam dispersible tablets may be taken whole with fluid or dispersed in a minimum of 50 mL water and then swallowed.
Rheumatoid Arthritis, Osteo-Arthritis, Ankylosing Spondylitis
The usual dose is 20 mg daily in single or divided doses with a range of 10 - 30 mg daily.
Long term administration of doses higher than 30 mg carries an increased risk of gastro-intestinal side-effects.
Acute Musculoskeletal Disorders
An initial dose of 40 mg daily may be given for the first two days in single or divided doses. For the remainder of the 7 to 14 day treatment period, the dose should be reduced to 20 mg daily.
Acute Gout
The usual dose is 40 mg daily for 5 - 7 days.
Xycam is not indicated for the long term management of gout.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disturbances are the most common side-effects occurring with Xycam. Administration of doses higher than 30 mg carries an increased risk of gastro-intestinal side-effects. 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 and alkaline phosphatase levels during treatment with Xycam. 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, 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.

IDENTIFICATION:
Xycam-20 capsule: An opaque brown capsule, printed in white ink with "XYCAM 20" on the one part and a mortar and pestle on the other.
Xycam dispersible tablet: A white, oblong, biconvex tablet, engraved with "XYCAM" on the one side and a mortar and pestle on the other.
PRESENTATION:
Xycam-20 capsules: Securitainers of 30 and 500 capsules.
Xycam dispersible tablets: Securitainers of 30 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C
Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
Xycam-20 capsules:         V/3.1/250
Xycam dispersible tablets:         Y/3.1/227

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
3/7/91
        G935
                A&S PRINTERS

Updated on this site: February 2004
Source: Community Pharmacy

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