Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
OXAPROZIN (UNII: MHJ80W9LRB) (OXAPROZIN - UNII:MHJ80W9LRB)
Physicians Total Care, Inc.
OXAPROZIN
OXAPROZIN 600 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of oxaprozin tablet, USP and other treatment options before deciding to use oxaprozin tablet, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Oxaprozin Tablet, USP is indicated: - For relief of the signs and symptoms of osteoarthritis - For relief of the signs and symptoms of rheumatoid arthritis - For relief of the signs and symptoms of juvenile rheumatoid arthritis Oxaprozin tablet, USP is contraindicated in patients with known hyper-sensitivity to oxaprozin. Oxaprozin tablet, USP should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions and PRECAUTIONS, Preexisting asthma). Oxaprozin tablet, USP is contraindicated for the treatment of peri-operative pain in
Oxaprozin tablets, USP, 600 mg are available as: white to off-white, capsule shaped film coated tablets with “391” debossed on one side and scored on the other side in the bottles of 30 (NDC 54868-4548-1 ), 60 (NDC 54868-4548-0 ) and 100 (NDC 54868-4548-2 ). Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in tight, light-resistant container as defined in the USP, with child resistant closure. CARACO PHARMACEUTICAL LABORATORIES, LTD. DETROIT, MI 48202 C.S.No. 5220T06
Abbreviated New Drug Application
OXAPROZIN - OXAPROZIN TABLET PHYSICIANS TOTAL CARE, INC. ---------- BOXED WARNING 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). Oxaprozin Tablet, USP, 600 mg is contraindicated for 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). DESCRIPTION Oxaprozin, USP is a nonsteroidal anti-inflammatory drug (NSAID), chemically designated as 4,5- diphenyl-2-oxazole-propionic acid, and has the following chemical structure: The empirical formula for oxaprozin, USP is C H NO , and the molecular weight is 293. Oxaprozin, USP is a white to off-white powder with a slight odor and a melting point of 162°C to 163°C. It is slightly soluble in alcohol and insoluble in water, with an octanol/water partition coefficient of 4.8 at physiologic pH (7.4). The pK in water is 4.3. Oxaprozin oral tablets contain 600 mg of oxaprozin, USP. Inactive ingredients in oxaprozin tablets, USP are microcrystalline cellulose, methylcellulose, magnesium stearate, starch, sodium starch glycolate, polyethylene glycol, polysorbate 80 and titanium dioxide. CLINICAL PHARMACOLOGY Pharmacodynamics Oxaprozin is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic properties in animal models. The mechanism of action of oxaprozin like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase Lugege kogu dokumenti