Source: Health Sciences Authority (SG) Revision Year: 2025 Publisher: Organon Singapore Pte. Ltd., 16 Raffles Quay, #18-01 Hong Leong Building, Singapore 048581
EXINEF tablets are indicated for:
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks, taking into consideration other available therapeutic options (see 4.3 'Contra-indications' and 4.4 'Special warnings and precautions for use').
EXINEF is administered orally and may be taken with or without food. The onset of drug effect may be faster when EXINEF is administered without food. This should be considered when rapid symptomatic relief is needed. EXINEF should be administered for the shortest duration possible and the lowest effective daily dose should be used.
The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered.
The recommended dose is 60 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 90 mg once daily may increase efficacy. Once the patient is clinically stabilised, down-titration to a 60 mg once daily dose may be appropriate. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered.
The recommended dose is 60 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 90 mg once daily may increase efficacy. Once the patient is clinically stabilised, down-titration to a 60 mg once daily dose may be appropriate. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered.
The recommended dose is 120 mg once daily. Etoricoxib 120 mg should be used only for the acute symptomatic period, limited to a maximum of 8 days treatment. In clinical trials for acute gouty arthritis, etoricoxib was given for 8 days.
For acute pain conditions, the recommended dose is 90 mg or 120 mg once daily. EXINEF should be used only for the acute symptomatic period, limited to a maximum of 8 days treatment.
The recommended dose is 120 mg once daily.
The recommended dose is 90 mg once daily, limited to a maximum of 3 days. Some patients may require additional post-operative analgesia.
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 dysmenorrhea should not exceed 120 mg daily.
The dose for post-procedure dental surgery pain should not exceed 90 mg daily.
As the cardiovascular risks of selective COX-2 inhibitors 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 4.4 'Special warnings and precautions for use').
No dosage adjustment is necessary for patients with creatinine clearance ≥30 ml/min (see 5.2 'Pharmacokinetic properties'). The use of etoricoxib in patients with creatinine clearance <30 ml/min is contra-indicated (see 4.3 'Contra- indications' and 4.4 'Special warnings and precautions for use').
In patients with mild hepatic insufficiency (Child-Pugh score 5-6) a dose of 60 mg once daily should not be exceeded. In patients with moderate hepatic insufficiency (Child-Pugh score 7-9) the recommended dose of 60 mg every other day should not be exceeded; administration of 30 mg once daily can also be considered. Clinical experience is limited, particularly in patients with moderate hepatic insufficiency and caution is advised. There is no clinical experience in patients with severe hepatic insufficiency (Child-Pugh score >9); therefore, its use is contra-indicated in these patients (see 4.3 'Contra-indications', 4.4 'Special warnings and precautions for use' and 5.2 'Pharmacokinetic properties').
Etoricoxib is contra-indicated in children and adolescents under 16 years of age (see 4.3 'Contra-indications').
In clinical studies, administration of single doses of etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. There have been reports of acute overdosage with etoricoxib, although adverse experiences were not reported in the majority of cases. The most frequently observed adverse experiences were consistent with the safety profile for etoricoxib (e.g., 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 GI 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.
Refer to outer carton.
Refer to outer carton.
EXINEF Tablets 60 mg, 90 mg and 120 mg are available in cartons of 100's.
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