国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
OXAPROZIN (UNII: MHJ80W9LRB) (OXAPROZIN - UNII:MHJ80W9LRB)
Rebel Distributors Corp
OXAPROZIN
OXAPROZIN 600 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of oxaprozin tablets and other treatment options before deciding to use oxaprozin tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Oxaprozin tablets are 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 tablets are contraindicated in patients with known hypersensitivity to oxaprozin. Oxaprozin tablets 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 tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary a
Abbreviated New Drug Application
Rebel Distributors Corp ---------- Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Rx only (See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important information I should know about medicines called Non-Steroidal Anti- Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: • with longer use of NSAID medicines • in people who have heart disease NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).” NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: • can happen without warning symptoms • may cause death The chance of a person getting an ulcer or bleeding increases with: • taking medicines called “corticosteroids” and “anticoagulants” • longer use • smoking • drinking alcohol • older age • having poor health NSAID medicines should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: • different types of arthritis • menstrual cramps and other types of short-term pain Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine • for pain right before or after heart bypass surgery Tell your healthcare provider: • about all of your medical conditions. • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist. • if you are pregnant. NSAID m 阅读完整的文件
OXAPROZIN- OXAPROZIN TABLET, FILM COATED REBEL DISTRIBUTORS CORP ---------- OXAPROZIN DESCRIPTION Oxaprozin is a non-steroidal anti-inflammatory drug (NSAID), chemically designated as 4,5-diphenyl-2- oxazole-propionic acid, and has the following chemical structure: C H NO M.W. 293 Oxaprozin 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. Inactive ingredients in oxaprozin oral tablets are carnauba wax, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80, pregelatinized starch, and titanium dioxide. CLINICAL PHARMACOLOGY PHARMACODYNAMICS Oxaprozin is a non-steroidal 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 inhibition. PHARMACOKINETICS (SEE TABLE 1) Absorption Oxaprozin is 95% absorbed after oral administration. Food may reduce the rate of absorption of oxaprozin, but the extent of absorption is unchanged. Antacids do not significantly affect the extent and rate of oxaprozin absorption. TABLE 1: OXAPROZIN PHARMACOKINETIC PARAMETERS [MEAN (% CV)] (1200 MG) Healthy Adults (19 to 78 years) 18 15 3 a Total Drug Unbound Drug Single N = 35 Multiple N = 12 Single N = 35 Multiple N = 12 T (hr) 3.09 (39) 2.44 (40) 3.03 (48) 2.33 (35) Oral Clearance (L/hr/70 kg) 0.150 (24) 0.301 (29) 136 (24) 102 (45) Apparent Volume of Distribution at Steady State (V /F; L/70 kg) 11.7 (13) 16.7 (14) 6230 (28) 2420 (38) Elimination Half-life (hr) 54.9 (49) 41.4 (27) 27.8 (34) 19.5 (15) Distribution In dose proportionality studies utilizing 600, 1200, and 1800 mg doses, the pharmacokinetics of ox 阅读完整的文件