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

Logo PIXICAM 20 (tablets)

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

PIXICAM 20 (tablets)

COMPOSITION
Each tablet contains
Piroxicam 20 mg

PHARMACOLOGICAL CLASSIFICATION
A.3.1 Antirheumatics (anti-inflammatory agents)

PHARMACOLOGICAL ACTION:
Piroxicam has analgesic, anti-inflammatory and anti-pyretic properties.
Piroxicam is well absorbed from the gastro-intestinal tract: peak plasma concentrations are reached 3 to 5 hours after an oral dose. It is metabolized in the liver by hydroxylation and conjugation with glucuronic acid and is excreted predominantly in the urine with smaller amounts in the faeces. Enterohepatic recycling occurs. Less than 5% of the dose is excreted unchanged. Piroxicam is extensively bound to plasma proteins (about 99%) and has a long plasma half life of approximately 50 hours.

INDICATIONS
It is used in musculoskeletal and joint disorders such as ankylosing spondylitis, osteoarthritis and rheumatoid arthritis. In addition, Piroxicam may be used in acute musculoskeletal conditions and acute gout.

CONTRA-INDICATIONS
Piroxicam should not be given to patients with active peptic ulceration, patients with a hyper-sensitivity to piroxicam, aspirin or other NSAID's.
Safety during pregnancy and lactation has not yet been established.
Asthmatic patients in whom attacks of asthma urticaria or acute rhinitis are precipitated by aspirin or other medicines with prostaglandin synthetase inhibiting activity.

DOSAGE AND DIRECTIONS FOR USE
Ankylosing spondylitis, osteoarthritis and rheumatoid arthritis:
The usual dose is 20 mg daily, although doses of 10-30 mg daily have been used.
Long term administration of 30 mg or more daily, has been associated with an increase in gastro-intestinal side effects. Because of the long half-life, steady-state concentrations are not reached for 7-12 days, but will occur sooner if a loading dose is given.
Acute musculo-skeletal conditions:
40 mg daily for 2 days, followed by 20 mg daily for 1-2 weeks.
Acute gout:
40 mg daily for 5-7 days.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
The most frequent adverse effects are gastro-intestinal disturbances; reactions range from abdominal discomfort, nausea and vomiting, and abdominal pain to serious gastro-intestinal bleeding or activation of peptic ulcer.
Central nervous system -related side-effects include headache, dizziness, nervousness, tinnitus, depression, drowsiness and insomnia.
Hypersensitivity reactions may occur and include fever and rashes.
Hepatotoxicity and aseptic meningitis which occur less frequently may also be hypersensitivity reactions. (Patients with collagen disease may be at increased risk of developing aseptic meningitis)
Piroxicam can provoke bronchospasm in patients with asthma and may cause cystitis, haematuria, acute renal failure, interstitial nephritis and nephrotic syndrome.
Other adverse effects include anaemias, thrombocytopenia, neutropenia, eosinophilia, agranulocytosis, abnormalities in liver function tests, blurred vision, changes in visual colour perception, and toxic amblyopia. Piroxicam should be discontinued in patients who experience blurred or diminished vision, or changes in colour vision.
Piroxicam should be given with care to the elderly, to patients with asthma or bronchospasm, bleeding disorders, cardiovascular disease, a history of peptic ulceration and in liver or renal failure. Patients with Chronic hepatic failure, cirrhosis, diuretic-induced volume depletion or renal insufficiency require local synthesis of vasodilating prostaglandins to maintain renal perfusion and therefore these patients are at greater risk of developing renal dysfunction due to NSAID-induced inhibition of renal prostaglandin synthesis.
In view of the product's inherent potential to cause oedema, heart failure may be precipitated in some compromised patients

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See side effects and special precautions.
Treatment of overdosage should be symptomatic and supportive.

IDENTIFICATION
Round, biconvex with a score notch, uniform white to light yellow tablet 9 mm x 4 mm.

PRESENTATION
PIXICAM 20 is available in packs of 30 and 100 tablets.

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

REGISTRATION NUMBER
29/3.1/0752

NAME AND BUSINESS ADDRESS OF APPLICANT
Hexal Pharma (SA) (PTY) Ltd
101 Wang House
10 De Mazenod Road
Durban
4001

DATE OF PUBLICATION OF THIS PACKAGE INSERT
February 1997

Updated on this site: February 2000

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