Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Sandoz SA (Pty) Ltd<sup>1</sup>, Waterfall 5-lr, Magwa Crescent West, Waterfall City, Jukskei View, 2090 1 Company Reg. No.: 1990/001979/07
Symptomatic treatment of inflammation and pain in osteoarthritis and rheumatoid arthritis.
Treatment of pain post dental surgery.
Treatment of mild to moderate post-operative pain.
Treatment of mild to moderate musculoskeletal pain.
Treatment of mild to moderate primary dysmenorrhoea.
Relief of signs and symptoms of ankylosing spondylitis.
As the cardiovascular risks of COXLEON may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
Osteoarthritis: The recommended daily dose is 200 mg taken as a single or as two divided doses.
Doses up to 400 mg per day have been studied.
Rheumatoid arthritis: The recommended daily dose is 100 mg or 200 mg twice per day.
Post dental surgery pain: The recommended dose is 100 mg to 200 mg up to a maximum daily dose of 400 mg. Dosing intervals should not be less than 4 hours.
Mild to moderate post-operative pain: The recommended dose is 200 mg once daily. Some patients may benefit from an additional 200 mg dose.
Mild to moderate musculoskeletal pain: The recommended dose is 200 mg twice daily.
Mild to moderate primary dysmenorrhoea: The recommended dose is 400 mg initially, followed by an additional 200 mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily.
Ankylosing spondylitis: The recommended daily dose is 200 mg, administered as a single dose or as 100 mg twice per day. Some patients may benefit from a total daily dose of 400 mg.
No dosage adjustment is necessary. However, for elderly patients with a lower than average body weight (50 kg), it is advisable to initiate therapy at the lowest recommended dose.
No dosage adjustment is necessary in patients with mild hepatic impairment. Introduce COXLEON at the lowest recommended dose in patients with moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment (see section 4.3).
No dosage adjustment is necessary in patients with mild or moderate renal impairment. There is no clinical experience in patients with severe renal impairment (see section 4.3).
Children: COXLEON has not been studied in patients under 18 years old.
Oral use.
In the event of suspected overdose, appropriate supportive medical care should be provided. Dialysis is unlikely to be an efficient method of removal.
24 months.
Store at or below 25°C.
An outer carton containing transparent PVC/TE/PVDC/silver aluminium blisters.
Pack sizes: COXLEON 100 and COXLEON 200 are packed in 10’s, 30’s and 60’s.
Not all pack sizes may be marketed.
No special requirements.
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