ETOVITAE FILM COATED TABLET 120MG [SIN16210P]

Product Info

ETOVITAE FILM COATED TABLET 120MG

[SIN16210P]

4.1 Therapeutic indications

ETOVITAE tablets are indicated for:

• Symptomatic relief of osteoarthritis (OA),

• Rheumatoid arthritis (RA),

• Symptomatic relief of ankylosing spondylitis (AS),

• Pain and signs of inflammation associated with acute gouty arthritis,

• 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

ETOVITAE is administered orally and may be taken with or without food. The onset of drug effect may be faster when ETOVITAE is administered without food. This should be considered when rapid symptomatic relief is needed. ETOVITAE should be administered for the shortest duration possible and the lowest effective daily dose should be used.

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. ETOVITAE 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.

Post-Procedure Dental Pain
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’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal insufficiency: No dosage adjustment is necessary for patients with creatinine clearance ≥ 30 ml/min (see 5.2 ‘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 4.3 ‘Contra- indications’ and 4.4 ‘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, 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’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric use: Etoricoxib is contra-indicated in children and adolescents under 16 years of age (see 4.3 ‘Contra-indications’).

4.3 Contra-indications

Etoricoxib is contra-indicated in:

• patients with known hypersensitivity to etoricoxib or to any of the excipients of this medicinal product

• patients with congestive heart 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 gastro-intestinal (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 4.6 ‘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