《msds-diclofenac sodium extended-release》.pdf

® Voltaren -XR (diclofenac sodium extended-release) tablets, USP Tablets of 100 mg Rx only Prescribing Information 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. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. (See WARNINGS.) • Voltaren®-XR (diclofenac sodium extended-release) tablets, USP are contraindicated for the treatment of perioperative 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 inflammation, 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.) DESCRIPTION Voltaren®-XR (diclofenac sodium extended-release) tablets, USP is a benzeneacetic acid derivative. Voltaren-XR is available as extended-release tablets of 100 mg (light pink) for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C H Cl NNaO , and it has the following structural formula 14 10 2 2 The inactive ingredients in Voltaren-XR include: cetyl alcohol, hydroxypropyl methylcellulose, iron oxide, magnesium stearate, polyethylene glycol, polysorbate, povidone, silicon dioxide, sucrose, talc, titanium dioxide. CLINICAL PHARMACOLOGY Pharmacodynamics Voltaren®-XR (diclofenac sodium extended-release) tablets, USP is a non-steroidal