ETOXIB FILM-COATED TABLETS 120MG

SINGAPORE PHARMACEUTICAL PRIVATE LIMITED

SINGAPORE PHARMACEUTICAL PRIVATE LIMITED

Therapeutic

Prescription Only

TABLET, FILM COATED

**4.2 Posology and method of administration** Posology As the cardiovascular risks of etoricoxib 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, especially in patients with osteoarthritis (see sections 4.3, 4.4, 4.8 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Osteoarthritis_ 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. _Rheumatoid arthritis_ 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 has clinically stabilized, a dose reduction to 60 mg once daily may be appropriate. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered. _Ankylosing spondylitis_ 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 has clinically stabilized, a dose reduction to 60 mg once daily may be appropriate. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered. _Treatment of acute pain_ For acute pain conditions, the recommended dose is 90 mg or 120 mg once daily. Etoricoxib should be used only for the acute symptomatic period, limited to a maximum of 8 days treatment. _Acute gouty arthritis_ 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. _Primary Dysmenorrhea_ The recommended dose is 120 mg once daily. _Post-Procedure Dental Pain_ The recommended dose is 90 mg once daily, limited to a maximum of 3 days. Some patients may require other postoperative analgesia in addition to Etoxib during the three day treatment period. 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. Special populations _Elderly patients_ No dosage adjustment is necessary for elderly patients. As with other drugs, caution should be exercised in elderly patients (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Patients with hepatic impairment_ Regardless of indication, in patients with mild hepatic dysfunction (Child-Pugh score 5–6) a dose of 60 mg once daily should not be exceeded. In patients with moderate hepatic dysfunction (Child-Pugh score 7–9), regardless of indication, the 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 dysfunction and caution is advised. There is no clinical experience in patients with severe hepatic dysfunction (Child-Pugh score ≥10); therefore, its use is contra-indicated in these patients (see sections 4.3, 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Patients with renal impairment_ No dosage adjustment is necessary for patients with creatinine clearance ≥30 ml/min (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The use of etoricoxib in patients with creatinine clearance <30 ml/min is contra-indicated (see sections 4.3 and 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Paediatric population_ Etoricoxib is contra-indicated in children and adolescents under 16 years of age (see section 4.3). Method of administration Etoxib is administered orally and may be taken with or without food. The onset of the effect of the medicinal product may be faster when Etoxib is administered without food. This should be considered when rapid symptomatic relief is needed.