ETORI-120 FILM COATED TABLETS 120 MG

INDICATIONS:

Etoricoxib Tablets is indicated in adults and adolescents 16 years of age and older for the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of inflammation associated with acute gouty arthritis.

Etoricoxib Tablets is indicated in adults and adolescents 16 years of age and older for the treatment of acute pain, including that related to primary dysmenorrhea and minor dental procedures.

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 CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

CONTRAINDICATIONS:

Etoricoxib is contra-indicated in:

• patients with known hypersensitivity to etoricoxib or any of the excipients of this medicinal product
• patients with congestive hearth failure (NYHA II–IV)
• patients with established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease (including patients who have recently undergone coronary artery bypass graft surgery or angioplasty)
• patients with hypertension whose blood pressure has not been adequately controlled
• patients with active peptic ulceration or gastrointestinal (GI) bleeding
• patients with severe hepatic dysfunction (Child-Pugh score >9)
• patients with estimated creatinine clearance <30 ml/min
• patients who have developed signs of asthma, acute rhinitis, nasal polyps, angioneurotic oedema or urticaria following the administration of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)
• pregnancy and lactation (see ‘Pregnancy and lactation’ and 5.3 ‘Preclinical safety data’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
• children and adolescents under 16 years of age
• patients with inflammatory bowel disease

RECOMMENDED DOSAGE:

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.

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 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.

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 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.

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.

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.

Primary dysmenorrhea

The recommended dose is 120 mg once daily.

Postoperative dental surgery 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 Etoricoxib Tablets 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 and ankylosing spondylitis should not exceed 90 mg daily.

The dose for acute gout should not exceed 120 mg daily, limited to a maximum of 8 days treatment.

The dose for acute pain and primary dysmenorrhea should not exceed 120 mg daily.

The dose for postoperative acute dental surgery pain should not exceed 90 mg daily, limited to a maximum of 3 days.

Special populations

Elderly patients

No dosage adjustment is necessary for elderly patients. As with other drugs, caution should be exercised in elderly patients.

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 30 mg once daily should not be exceeded.

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.

Patients with renal impairment

No dosage adjustment is necessary for patients with creatinine clearance ≥30 ml/min (see ‘Pharmacokinetic properties’ – 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 ‘Contra-indications’ and ‘Special warnings and precautions for use’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic insufficiency

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, particulary 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 ‘Contra-indications’, ‘Special warnings and precautions for use’ and ‘Pharmacokinetic properties’ – 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 ‘Contra-indications’).