Composition
Aroxia 120 Tablet: Each tablet contains Etoricoxib INN 120 mg.
Pharmacology
Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.
Indications
Aroxia (Etoricoxib) is indicated for relief of pain and inflammation in:
Osteoarthritis, Rheumatoid arthritis, Other chronic musculoskeletal disorders, acute gout, Dysmenorrhea & dental surgery
Dosage and Administration
Adult and adolescent over 16 years:
Osteoarthritis, chronic musculoskeletal disorders & dysmenorrhoea: 60 mg once daily, Rheumatoid arthritis: 90 mg once daily, Pain following dental surgery & acute gout: 120 mg once daily
Contraindications
Aroxia (Etoricoxib) is contraindicated to patients with known hypersensitivity to Aroxia (Etoricoxib), patients with active peptic ulceration or gastro-intestinal (GI) bleeding, 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), patient having inflammatory bowel disease, severe congestive heart failure, to children and adolescents under 16 years of age.
Warning & Precautions
Caution should be taken when initiating treatment with Aroxia (Etoricoxib) in patients with considerable dehydration. It is advisable to rehydrate patients prior to starting therapy with Aroxia (Etoricoxib). The possibility of fluid retention, oedema of hypertension should be taken into consideration when Aroxia (Etoricoxib) is used in patients with pre-existing oedema, hypertension, or heart failure. Independent of treatment, patients with a prior history of GI perforation, ulcers and bleeding (PUB) and patients greater than 65 years of age are known to be at a higher risk for a PUB.
Side Effects
Dry mouth taste disturbance, mouth ulcers, flatulence, constipation, appetite and weight change, chest pain, fatigue, paraesthesia, influenza-like syndrome & myalgia.
Drug Interactions
Oral anticoagulants, diuretics and ACE inhibitors, Acetylsalicylic acid, Cyclosporin and Tacrolimus, Lithium, Methotrexate, oral contraceptives, Ketoconazole, Rifampicin and Antacids have interaction with Aroxia (Etoricoxib).
Use in Pregnancy and Lactation
As with other drugs known to inhibit prostaglandin synthesis, use of Aroxia (Etoricoxib) should be avoided in late pregnancy because it may cause premature closure of the ductus arteriosus. Aroxia (Etoricoxib) should be used during the first two trimesters of pregnancy only if the potential benefit justifies the potential risk to the foetus. Aroxia (Etoricoxib) is not known whether this drug is excreted in human milk.
Storage
Store at a cool & dry place, protect from light & moisture. Keep out of the reach of children.
Packing
Aroxia 120 Tablet: Box containing 2 x 10 tablets in blister pack.
