Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ETORICOXIB
ORGANON PHARMA INDONESIA TBK - Indonesia
ETORICOXIB
120.0 MG
TABLET SALUT SELAPUT
DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT
ROVI PHARMA INDUSTRIAL SERVICES - Spain
2021-07-17
LOCAL PRODUCT CIRCULAR TABLETS ARCOXIA™ (ETORICOXIB, MSD) CARDIOVASCULAR RISK • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Elderly patients and patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. (See WARNINGS). • ARCOXIA is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS). GASTROINTESTINAL RISK • NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. (See WARNINGS). ASTHMA AND SKIN REACTION Arcoxia is contraindicated to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAID (SEE PRECAUTIONS). CONGESTIVE HEART FAILURE AND EDEMA ARCOXIA should be used with caution in patients with fluid retention or heart failure (see WARNINGS) HEPATIC EFFECTS A patients with symptoms and /or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with ARCOXIA (see PRECAUTIONS). RENAL EFFECTS Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion (see PRECAUTIONS) THERAPEUTIC CLASS ARCOXIA* (etoricoxib) is a member of a class of arthritis/analgesia medications called Coxibs. ARCOXIA is a highly selective inhibitor of cyclooxygenase-2 (COX-2). COMPOSITION Each film coated tablet contains etoricoxib 60 mg (ARCOXIA 60), 90 mg (ARCO Baca dokumen lengkapnya