Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
STAT RX USA LLC
IBUPROFEN
IBUPROFEN 400 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of Ibuprofen tablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted. IBU tablets are contraindicated in patients with known hypersensitivity to ibuprofen. IBU 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
IBU tablets are available in the following strengths, colors and sizes: 400 mg (white, oval, debossed 4I) Bottles of 30 NDC 16590-124-30 Bottles of 40 NDC 16590-124-40 Bottles of 60 NDC 16590-124-60 Bottles of 90 NDC 16590-124-90 600 mg (white, caplet, debossed 6I) Bottles of 30 NDC 16590-126-30 Bottles of 56 NDC 16590-126-56 Bottles of 60 NDC 16590-126-60 Bottles of 84 NDC 16590-126-62 Bottles of 90 NDC 16590-126-90 Bottles of 100 NDC 16590-126-71 Bottles of 120 NDC 16590-126-72 Bptt;es pf 270 NDC 16590-126-86 800 mg (white, caplet, debossed 8I) Bottles of 30 NDC 16590-125-30 Bottles of 40 NDC 16590-125-40 Bottles of 50 NDC 16590-125-50 Bottles of 60 NDC 16590-125-60 Bottles of 90 NDC 16590-125-90 Bottles of 100 NDC 16590-125-71 Bottles of 120 NDC 16590-125-72 Store at room temperature. Avoid excessive heat 40°C (104°F). Distributed by: Dr. Reddy’s Laboratories, Inc. Bridgewater, NJ 08807 USA Issued February, 2010 Relabeling and Repackaging by : STAT Rx USA LLC Gainesville, GA 30501
Abbreviated New Drug Application
IBUPROFEN - IBUPROFEN TABLET STAT RX USA LLC ---------- 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). IBU tablets are 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. (SeeWARNINGS). DESCRIPTION IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - (_p_ - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water(less than 1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below: IBU, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide. CLINICAL PHARMACOLOGY IBU tablets contain ibuprofen which possesses analgesic and antipyretic activities. Its mode of action, like that of other NSAIDs, is not completely understood, but may be related to prosta gland in synthetase inhibition. In clinical studies in patients with rheumatoid arthritis and osteoarthritis, Ibuprofen tablets have been shown to be comparable to aspirin in controlling pain and inflammation and to be associated with a statisticall Прочитайте повний документ