Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
NABUMETONE (UNII: LW0TIW155Z) (NABUMETONE - UNII:LW0TIW155Z)
Amneal Pharmaceuticals of New York LLC
NABUMETONE
NABUMETONE 500 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of Nabumetone Tablets USP and other treatment options before deciding to use Nabumetone Tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Nabumetone Tablets USP 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 product 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 , Preexisting Asthma ). Nabumetone tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).
Nabumetone Tablets USP are available as follows: 500 mg: White, oval-shaped, unscored, film-coated tablet debossed with the numbers “93” on one face of the tablet and “15” on the other. They are available in bottles of 100 tablets (NDC 0115-1657-01) and 1000 tablets (NDC 0115-1657-03). 750 mg: Beige, oval-shaped, unscored, film-coated tablet debossed with the numbers “93” on one face of the tablet and “16” on the other. They are available in bottles of 100 tablets (NDC 0115-1658-01) and 1000 tablets (NDC 0115-1658-03). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel Distributed by: Impax Generics Hayward, CA 94544 Rev. V 6/2016
Abbreviated New Drug Application
Amneal Pharmaceuticals of New York LLC ---------- Medication Guide for Nonsteroidal Anti- inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effect, including: • Increased risk of a heart attack or stroke that can lead to death. The risk may happen early in treatment and may increase: • with increasing doses of NSAIDs • with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: • anytime during use • without warning symptoms • that may cause death The risk of getting an ulcer or bleeding increases with: • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs • taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” • increasing doses of NSAIDs • older age • longer use of NSAIDs • poor health • smoking • advanced liver disease • drinking alcohol • bleeding problems NSAIDs should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are NSAIDs? NSAIDs 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 NSAIDs? Do not take NSAIDs: • if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. • right before or after heart bypass surgery. Before taking NSAIDs, tell your healthcare provider about all of Прочитайте повний документ
NABUMETONE- NABUMETONE TABLET, FILM COATED AMNEAL PHARMACEUTICALS OF NEW YORK LLC ---------- NABUMETONE TABLETS USP RX ONLY CARDIOVASCULAR THROMBOTIC EVENTS •Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see WARNINGS and PRECAUTIONS]. •Nabumetone tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see CONTRAINDICATIONS and 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). Throughout this package insert, the term NSAID refers to a non-aspirin non-steroidal anti- inflammatory drug. DESCRIPTION Nabumetone, USP is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2- butanone. It has the following structure: C H O M.W. 228.3 Nabumetone, USP 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 2,400 at pH 7.4. Each tablet, for oral administration, contains either 500 mg or 750 mg of nabumetone, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulphate, sodium starch glycolate, talc, and titanium dioxide. The 750 mg tablets also contain black iron oxide, red iron oxide, and yellow iron oxide. CLINICAL PHARMACOLOGY Nabumetone is a non-steroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic properties in ph Прочитайте повний документ