Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: Kiara Health (Pty) Ltd, 72 Steel Road, Spartan, Kempton Park, 1619, South Africa
PIXICAM 20 is used in musculoskeletal and joint disorders such as ankylosing spondylitis, osteoarthritis and rheumatoid arthritis. In addition, PIXICAM 20 may be used in acute musculoskeletal conditions and acute gout.
Due to its safety profile (see 4.2 Posology and method of administration, 4.3 Contraindications and 4.4 Special warnings and precautions for use), PIXICAM 20 is not a first line option should an NSAID be indicated. The decision to prescribe PIXICAM 20 should be based on an assessment of the individual patient’s overall risks (see 4.3 Contraindications and 4.4 Special warnings and precautions for use).
The prescription of PIXICAM 20 should be initiated by physicians with experience in the diagnostic evaluation and treatment of patients with inflammatory or degenerative rheumatic diseases.
The recommended starting daily dose is 20 mg.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see 4.4 Special warnings and precautions for use). 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.
Given that PIXICAM 20 has been shown to be associated with an increased risk of gastrointestinal complications, the possible need for combination therapy with gastroprotective agents (e.g. misoprostol or proton pump inhibitors) should be carefully considered, in particular for elderly patients.
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.
40 mg daily for 2 days (in single or divided doses), followed by 20 mg daily for 1-2 weeks.
40 mg daily (in single or divided doses), for 4-6 days. PIXICAM 20 (piroxicam) is not indicated for long-term management of gout.
For oral administration.
The tablets may be swallowed whole with adequate water or may be dispersed in a small quantity of water, in a glass and the solution then swallowed.
The main symptoms are gastrointestinal disturbances, such as nausea, vomiting, abdominal pain, dizziness, headache, confusion, tinnitus, hyperventilation including respiratory alkalosis.
Furthermore, sedation, hyperpyrexia, respiratory and metabolic acidosis, toxic circulatory failure, renal impairment (haematuria, proteinuria, acute renal failure) as well as hepatic impairment (hypoprothrombinaemia); cerebral and pulmonary oedema, enhanced convulsibility and coma. In children, hypoglycaemia is possible.
No specific antidote exists. Intensive medical supervision may be necessary. The long half-life of PIXICAM 20 is to be considered.
Based on animal tests, administration of antacids and activated charcoal is assumed to possibly accelerate the excretion of PIXICAM 20.
Studies indicate that administration of activated charcoal may result in reduced absorption and reabsorption of PIXICAM 20, thus reducing the total amount of active drug available.
According to current data, haemodialysis is not suited – on account of the high protein binding of PIXICAM 20 – to eliminate PIXICAM 20 from the blood.
36 months when stored at or below 25°C. Protect from light.
This medicine does not require any special storage conditions.
PIXICAM 20 is available in packs of 30 and 100 dispersible tablets.
Supplied in white HDPE securitainers or polypropylene foil blisters.
No special requirements.
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