Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill, Ext.1, Roodepoort, 1724, South Africa
CORICIB is indicated for:
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient’s overall risks (see section 4.4).
CORICIB is administered orally. CORICIB may be taken with or without food. CORICIB should be administered for the shortest duration possible and the lowest effective daily dose should be used.
Osteo-arthritis (OA): The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, the dose may be increased to 60 mg once daily.
Rheumatoid Arthritis (RA): The recommended dose is 90 mg once daily. In some patients, 60 mg once daily may provide adequate therapeutic benefit.
Ankylosing Spondylitis: The recommended dose is 90 mg once daily. In some patients, 60 mg once daily may provide adequate therapeutic benefit.
Short term relief of Acute Pain: The recommended dose is 90 mg or 120 mg once daily, limited to a maximum of 8 days treatment.
Acute Gouty Arthritis: The recommended dose is 120 mg once daily, limited to a maximum of 8 days treatment.
Primary Dysmenorrhoea: The recommended dose is 120 mg once daily.
Post-operative Dental Pain: The recommended dose is 90 mg once daily.
Doses greater than those recommended for each indication have either not demonstrated additional efficacy or have not been studied.
Therefore:
The dose for OA should not exceed 60 mg daily.
The dose for RA should not exceed 90 mg daily.
The dose for ankylosing spondylitis should not exceed 90 mg daily.
The dose for acute gout should not exceed 120 mg daily.
The dose for acute pain and primary dysmenorrhoea should not exceed 120 mg daily. The dose for postoperative acute dental surgery pain should not exceed 90 mg daily.
As the cardiovascular risks of CORICIB may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient’s need for symptomatic relief and response to therapy should be re-evaluated periodically (see section 4.4).
No dosage adjustment in CORICIB is necessary for the elderly. Although the elderly may be more susceptible to renal, gastrointestinal and cardiovascular adverse effects (see section 4.4). When using CORICIB in the elderly and in patients with renal, hepatic or cardiac dysfunction, medically appropriate supervision should be intensified. If these patients show deterioration during treatment, appropriate measures should be taken, including discontinuation of CORICIB.
In patients with mild hepatic insufficiency (Child Pugh score 5 to 6), a dose of 60 mg once daily should not be exceeded.
In patients with moderate hepatic insufficiency (Child-Pugh score 7 to 9), the dose should be reduced; a dose of 60 mg every other day should not be exceeded, administration of CORICIB 30 mg* once daily can also be considered.
Clinical experience is limited particularly in patients with moderate hepatic dysfunction. There are no clinical or pharmacokinetic data in patients with severe hepatic insufficiency (Child-Pugh score >9), therefore the use of CORICIB is contraindicated in these patients (see section 4.3 and 5.2).
No dosage adjustment is necessary for patients with lesser degrees of renal insufficiency (creatinine clearance ≥30 mL/min). The use of CORICIB in patients with creatinine clearance <30 mL/min is contraindicated (see section 4.3).
When using CORICIB in the elderly and in patients with renal, hepatic or cardiac dysfunction, medically appropriate supervision should be intensified. If patients show deterioration during treatment, appropriate measures should be taken, including discontinuation of CORICIB.
The most frequently observed adverse experiences were gastrointestinal events, renovascular events.
In the event of overdose, it is reasonable to employ the usual supportive measures e.g. remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.
Etoricoxib is not dialysable by haemodialysis; it is not known whether etoricoxib is dialysable by peritoneal dialysis.
36 months.
Store at or below 25°C.
Protect from moisture. Keep blister in carton until required for use.
The tablets are packed in cold form blisters. Each blister strip contains 7 tablets. Carton contains 7 or 28 tablets.
Cold form blister pack: Cold form blister pack comprises of cold form blister laminate composed of oriented polyamide, aluminium foil and PVC film with backing of hard tempered aluminium foil coated with heat seal lacquer on the inner side.
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