|Dosage and administration||
Dosage: As the cardiovascular risks of etoricoxib may increase with dose and treatment duration, the lowest effective daily dose should be used and for the shortest possible duration. Efficacy of the treatment with etoricoxib should be assessed, especially in patients with osteoarthritis.
– Hypersensitivity to etoricoxib or any of the excipients of the product.
|Warnings and precautions for use||
– Gastrointestinal effects (stomach, esophagus):
|Recommendation for pregnancy and breastfeeding||
|Effects on ability to drive and use machines||
Etoricoxib may cause dizziness, headache or drowsiness, which can affect the ability to drive and operate machines.
|Interactions, incompatibilities of medicine||
– Anticoagulants: Etoricoxib was associated with an approximate 13% increase in prothrombin time. Therefore, patients receiving oral anticoagulants such as warfarin should be closely monitored for their prothrombin time, particularly in the first few days when therapy with etoricoxib is initiated or the dose is changed.
|Undesirable effects (ADRs)||
The following undesirable effects have been reported from clinical trials or post-marketing practices, and attention should be paid to the risk of thrombotic cardiovascular events (see Conditions where caution should be taken):
|Overdose and management||
– Agietoxib tablet, containing etoricoxib, is a potent, orally active, highly selective cyclooxygenase-2 (COX-2) inhibitor.
– Orally administered etoricoxib is well absorbed. The mean oral bioavailability is approximately 100% and peak plasma concentrations are reached at approximately 1 hour.
|Storage conditions, shelf-life, quality specification of the medicine||
Storage conditions: Protect from humidity and light, below 30 degrees C.
Each AGIETOXIB 90 tablet contains:
Etoricoxib . . . . . . . . . . .. . . . . . . . . . . . .90 mg
AGIETOXIB 90: Cardboard box containing 3 blisters of 10 film coated tablets.
– AGIETOXIB is indicated in adults and adolescents from 16 years old for: Symptomatic treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, relief of acute pain and treatment of acute gouty arthritis.
– Short-term treatment of moderate pain associated with dental surgery.