Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
NABUMETONE (UNII: LW0TIW155Z) (NABUMETONE - UNII:LW0TIW155Z)
H.J. Harkins Company, Inc.
NABUMETONE
NABUMETONE 500 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. Nabumetone tablets are contraindicated in patients with known hypersensitivity to nabumetone or its excipients. Nabumetone 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: General: Pre-existing Asthma:) Nabumetone tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).
500 mg-White film-coated, oval-shaped biconvex tablets debossed with IG on one side and 257 on the other are supplied in bottles of 100 (NDC 68462-358-01) and 500 (NDC 68462-358-05). 750 mg-Beige colored, film-coated, oval-shaped biconvex tablets debossed with IG on one side and 258 on the other are supplied in bottles of 100 (NDC 68462-359-01), and 500 (NDC 68462-359-05).
Abbreviated New Drug Application
NABUMETONE - NABUMETONE TABLET, FILM COATED H.J. Harkins Company, Inc. ---------- MEDICATION GUIDE FOR NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSALDS) (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 (NSALDS)? 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 (NSALDS)? 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 Læs hele dokumentet
NABUMETONE - NABUMETONE TABLET, FILM COATED H.J. HARKINS COMPANY, INC. ---------- NABUMETONE TABLETS USP RX ONLY 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 a greater risk (See WARNINGS). Nabumetone tablets are 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). DESCRIPTION Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure: Nabumetone is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2400 at pH 7.4. Each tablet, for oral administration contains either 500 mg or 750 mg of nabumetone. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxyl propyl methyl cellulose, sodium lauryl sulphate, colloidal silicon dioxide and magnesium stearate. The 500 mg tablets also contain opadry white (Titanium dioxide, Hypromellose 3cP, Hypromellose 6cP, Macrogol and Polysorbate 80) and the 750 mg tablets contain opadry beige (Hypromellose 6cP, titanium dioxide, iron oxide yellow, iron oxide red and Macrogol). CLINICAL PHARMACOLOGY Nabumetone is a non-steroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyreti Læs hele dokumentet