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Therapeutic Indications
Etoricoxib is indicated for the symptomatic relief of osteoarthritis, rheumatoid arthritis, acute gouty arthritis, acute pain associated with dental surgery, and primary dysmenorrhoea
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Abbreviated Prescribing Information
RETOZ India
Name of Medicinal Product: RETOZ (Etoricoxib) Dosage form and Strength: Each film-coated tablet contains: Etoricoxib 60 mg, 90 mg or 120 mg. Therapeutic Indication: Etoricoxib is indicated for the symptomatic relief of osteoarthritis & rheumatoid arthritis, acute gouty arthritis, acute pain associated with dental surgery, primary dysmenorrhoea. Dosage and Administration: Adult dose: The usual recommended dose for Etoricoxib is as follows: Osteoarthritis or chronic musculoskeletal pain: 60 mg/day, Rheumatoid arthritis: 90 mg/day, Primary dysmenorrhoea: 60-120 mg/day, Postoperative dental pain: 120 mg/day, Acute gouty arthritis: 120 mg/day. Use in Special Populations: Patients with renal impairment: No dose adjustment is necessary for patients with mild to moderate renal impairment. For patients with severe renal impairment (creatinine clearance <30 ml/min), the use of Etoricoxib is contraindicated. Patients with hepatic impairment: In patients with mild hepatic insufficiency (Child-Pugh score 56) a dose of 60 mg once daily should not be exceeded. In patients with moderate hepatic insufficiency (Child-Pugh score 79), the recommended dose of 60 mg every other day should not be exceeded. There is no clinical experience in patients with severe hepatic insufficiency (Child-Pugh score>9); therefore, its use is contra-indicated in these patients. Elderly Patients: No dose adjustment required. Children: Etoricoxib is contra-indicated in children and adolescents under 16 years of age. Pregnancy: Etoricoxib is contra-indicated in all trimesters of pregnancy. If a woman becomes pregnant during treatment, Etoricoxib should be discontinued. The use of Etoricoxib, as with any drug known to inhibit COX2, is not recommended in women attempting to conceive. Lactation: Etoricoxib should not be used during lactation as the safety of Etoricoxib during lactation has not been established. Contraindications: Previous hypersensitivity to Etoricoxib, Active peptic ulcer disease or GI bleeding, Patients with a history of bronchospasm with rhinoconjunctivitis or urticaria/ angioedema associated with aspirin or other nonsteroidal antiinflammatory agents (adult-onset asthma, chronic rhinitis, nasal polyps, and chronic urticaria/angioedema predispose to these reactions) (risk of anaphylactic-like reactions), Severe renal or hepatic disease, Patients with inflammatory bowel disease, Patients with severe congestive heart failure, Pregnancy and Lactation, Children and adolescents under 16 years of age. Precautions: History of mild allergic phenomena related to ingestion of other nonsteroidal antiinflammatory drugs (e.g., rash), Conditions predisposing to gastrointestinal events (e.g., history of peptic ulcer, upper gastrointestinal disease, ulcerative colitis; smoking; advancing age; concurrent aspirin or corticosteroids; alcohol abuse; stress), Patients with hypertension, recent MI, angina, or other cardiovascular disease (potential for fluid retention; etoricoxibmay possess prothrombotic activity), patients with bleeding disorders (potential exacerbation). Undesirable effects: Etoricoxib is generally well tolerated. The adverse events seen with Etoricoxib are generally mild and transient. Commonly occurring adverse events are headache, diarrhea, upper respiratory tract infection and nausea. Other adverse effects reported are dizziness, pharyngitis, epigastric discomfort, hypertension and lower extremity oedema. The incidence of investigator- reported upper GI perforations, ulcers and bleeds with Etoricoxib was less than half that associated with traditional non-COX-selective NSAIDs. Overdose: No overdoses of Etoricoxib were reported during clinical trials. In clinical studies, administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the GI tract, employ clinical monitoring, and institute supportive therapy, if required. Etoricoxib is not dialysable by haemodialysis; it is not known whether Etoricoxib is dialysable by peritoneal dialysis. Warning: This drug should be used with caution in patients suffering from Coronary Heart Disease (CHD)/Cardiovascular Disorder.
Further information is available on request.
Date of development-03-03.2022. Date of expiry-03.03.2023
GGI-CO-A1-AQS-300001386-BANNERS-E22-1121