Etoricoxib Stada Dosage/Direction for Use

Posology: As the cardiovascular risks of etoricoxib may increase with dose and duration of exposure, Etoricoxib STADA should be used at the lowest effective dose for shortest possible time. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (see Contraindications, Precautions, Adverse Reactions, and Pharmacology: Pharmacodynamics under Actions).
Osteoarthritis: The recommended dose is 30 mg etoricoxib once daily. This dose (30mg) is provided by other preparation. In some patients with insufficient relief from symptoms, an increased dose of 60 mg etoricoxib 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 etoricoxib once daily. In some patients with insufficient relief from symptoms, an increased dose of 90 mg etoricoxib once daily may increase efficacy. Once the patient is clinically stabilised, down-titration to a 60 mg etoricoxib once daily dose may be appropriate. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered.
Ankylosing spondylitis (Bekhterev's disease): The recommended dose is 60 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 90 mg etoricoxib once daily may increase efficacy. Once the patient is clinically stabilised, down-titration to a 60 mg etoricoxib once daily dose may be appropriate. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered.
Acute pain conditions: For acute pain conditions, etoricoxib should be used only for the acute symptomatic period.
Acute gouty arthritis: The recommended dose is 120 mg etoricoxib once daily. In clinical trials for acute gouty arthritis, etoricoxib was given for 8 days.
Postoperative dental surgery pain: The recommended dose is 90 mg etoricoxib once daily, limited to a maximum of 3 days. Some patients may require other postoperative analgesia in addition to etoricoxib 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 osteoarthritis should not exceed 60 mg etoricoxib daily.
The dose for rheumatoid arthritis and ankylosing spondylitis should not exceed 90 mg etoricoxib daily.
The dose for acute gout should not exceed 120 mg etoricoxib daily, limited to a maximum of 8 days treatment.
The dose for postoperative acute dental surgery pain should not exceed 90 mg etoricoxib daily, limited to a maximum of 3 days.
Special populations: Elderly: No dosage adjustment is necessary for elderly patients. As with other drugs, caution should be exercised in elderly patients (see Precautions).
Patients with hepatic impairment: Regardless of indication, in patients with mild hepatic dysfunction (Child-Pugh score 5-6) a dose of 60 mg etoricoxib 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 etoricoxib once daily should not be exceeded. The dosage of 30mg can only be provided by other preparations.
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 Contraindications, Precautions, and Pharmacology: Pharmacokinetics under Actions).
Patients with renal impairment: No dosage adjustment is necessary for patients with creatinine clearance ≥ 30 ml/min (see Pharmacology: Pharmacokinetics under Actions). The use of etoricoxib in patients with creatinine clearance < 30 ml/min is contraindicated (see Contraindications and Precautions).
Paediatric population: Etoricoxib is contra-indicated in children and adolescents under 16 years of age (see Contraindications).
Method of administration: Etoricoxib STADA is for oral use and may be taken with or without food. The onset of the effect of the medicinal product may be faster when Etoricoxib STADA is administered without food. This should be considered when rapid symptomatic relief is needed.