Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)
St Marys Medical Park Pharmacy
DICLOFENAC SODIUM
DICLOFENAC SODIUM 50 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
DICLOFENAC SODIUM - DICLOFENAC SODIUM TABLET, DELAYED RELEASE ST MARYS MEDICAL PARK PHARMACY ---------- DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP 40-9184 REVISED – JUNE 2012 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). Diclofenac sodium delayed-release tablets 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 Diclofenac sodium delayed-release tablets, USP are a benzeneacetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.13. Its molecular formula is C H C NNaO , and it has the following structural formula Each enteric-coated tablet for oral administration contains 50 mg or 75 mg of diclofenac sodium, USP. In addition, each tablet contains the following inactive ingredients: aluminum hydrate, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium starch glycolate (Type A), stearic acid, synthetic black iron oxide, talc, and titanium dioxide. 14 10 l2 2 CLINICAL PHARMACOLOGY PHARMACODYNAMICS Diclofenac sodium delayed-release tablets, USP are a non-steroidal anti-inflammatory drug (NSAID) tha Przeczytaj cały dokument