Generic
Etoricoxib
Indications
Etoricoxib is indicated for the symptomatic relief of- Osteoarthritis (OA) Rheumatoid arthritis (RA) Ankylosing spondylitis, and The pain and signs of inflammation associated with acute gouty arthritis. For the short-term treatment of moderate pain associated with dental surgery.
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.
Dosage Administration
Adult and adolescent over 16 years: 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. Rheumatoid arthritis: The recommended dose is 90 mg once daily. Ankylosing spondylitis: The recommended dose is 90 mg once daily. Acute gouty arthritis: The recommended dose is 120 mg 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 once daily, limited to a maximum of 3 days. Some patients may require additional postoperative analgesia. 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.
Contraindications
Hypersensitivity to the active substance or to any of the excipients. Active peptic ulceration or active gastro-intestinai (Gl) bleeding. Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors. Pregnancy and lactation. 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 ll-IV). Patients with hypertension whose blood pressure is persistently elevated above 140/90 mmHg and has not been adequately controlled. Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
Side Effects
Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.
Pregnancy And Lactation
The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.
Therapeutic
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
Storage Conditions
Store at a temperature of below 30�C, protect from light & moisture. Keep out of reach of children.
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