ETOXIB FILM-COATED TABLETS 30MG [SIN16126P]

Product Info

ETOXIB FILM-COATED TABLETS 30MG

[SIN16126P]

4.1 Therapeutic indications

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

Etoxib 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 sections 4.3, 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Active peptic ulceration or active gastro-intestinal (GI) bleeding.

• Patients who, after taking acetylsalicylic or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors, experience asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions.

• Pregnancy and lactation (see sections 4.6 and 5.3 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10).

• Estimated renal creatinine clearance <30 ml/min.

• Children and adolescents under 16 years of age.

• Inflammatory bowel disease.

• Congestive heart failure (NYHA II–IV).

• Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled.

• 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).