PYROCAPS Capsule Ref.[51188] Active ingredients: Piroxicam

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2023  Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill, Ext. 1, Roodepoort, 1724, South Africa

4.1. Therapeutic indications

Pyrocaps is indicated for a variety of conditions requiring anti-inflammatory and/or analgesic activity, such as rheumatoid arthritis: osteo-arthritis (arthrosis, degenerative joint disease); ankylosing spondylitis: acute musculoskeletal disorders and acute gout.

4.2. Posology and method of administration

Rheumatoid arthritis, osteo-arthritis (arthrosis, degenerative joint disease); ankylosing spondylitis

The usual daily dose for the relief of signs and symptoms of rheumatoid arthritis or osteoarthritis is 20mg given in single or divided doses. Since steady state concentrations in plasma are not reached for seven to ten days, maximal therapeutic responses should not be expected for two weeks. Long-term administration of doses higher than 30 mg carries an increased risk of gastrointestinal side-effects.

Acute musculoskeletal disorders

Therapy should be initiated with 40mg daily for the first two days given in single or divided doses. For the remainder of the seven to fourteen days treatment period, the dose should be reduced to 20mg daily.

Acute gout

Therapy should be initiated by a single oral dose of 40mg followed on the next four to six days by 40 mg given in a single or divided dosage. PYROCAPS is not indicated for the long-term management of gout.

Method of administration

PYROCAPS is for oral administration.

4.9. Overdose

In the event of overdosage with Piroxicam, supportive and symptomatic therapy is indicated. Studies reported indicate that administration of activated charcoal may result in reduced reabsorption of piroxicam, thus reducing the total amount of active medicine available. Although there are no studies reported to date, haemodialysis is probably not useful in enhancing elimination of piroxicam since the medicine is highly protein-bound

6.3. Shelf life

24 months.

6.4. Special precautions for storage

Store at or below 25°C in the original pack.

Do not remove the blisters from the carton until required for use.

KEEP OUT OF REACH OF CHILDREN.

6.5. Nature and contents of container

Bottles of 30 capsules.

Patient ready packs of different pack sizes.

6.6. Special precautions for disposal and other handling

Return all unused or expired medicines to your pharmacist for safe disposal. Do not dispose of unused medicines in drains or sewerage systems (e.g. toilets).

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