Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
Bryant Ranch Prepack
IBUPROFEN
IBUPROFEN 400 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual 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 hypersensitivityto ibuprofen. IBU tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin orother NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions, and PRECAUTIONS, Preexisting Ast
Product: 63629-1468 NDC: 63629-1468-1 20 TABLET in a BOTTLE NDC: 63629-1468-2 30 TABLET in a BOTTLE NDC: 63629-1468-3 40 TABLET in a BOTTLE NDC: 63629-1468-4 60 TABLET in a BOTTLE NDC: 63629-1468-5 90 TABLET in a BOTTLE NDC: 63629-1468-7 100 TABLET in a BOTTLE NDC: 63629-1468-6 120 TABLET in a BOTTLE NDC: 63629-1468-8 21 TABLET in a BOTTLE NDC: 63629-1468-9 15 TABLET in a BOTTLE
Abbreviated New Drug Application
IBUPROFEN- IBUPROFEN TABLET Bryant Ranch Prepack ---------- MEDICATION GUIDE Medication Guide forNon-Steroidal Anti-Inflammatory Drugs (NSAIDs) What it the most important information I should know about medicines called Non-Steroidal Anti- Inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: • Increased risk of a heart attack or stroke that can lead to death. This 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 use of NSAIDs ° longer use of NSAIDs ° smoking ° drinking alcohol ° older age ° poor health ° advanced liver disease ° 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 NSAIDs? Do not take NSAIDs: • if you 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 your medical conditions, Прочетете целия документ
IBUPROFEN- IBUPROFEN TABLET BRYANT RANCH PREPACK ---------- IBUPROFEN BOXED WARNING 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). IBU 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 gastrointestinaladverse events including bleeding, ulceration, and perforationof the stomach or intestines, which can be fatal. These eventscan occur at any time during use and without warning symptoms.Elderly patients are at greater risk for serious gastrointestinalevents. (See WARNINGS). DESCRIPTION IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - (_p_ - isobutylphenyl) propionic acid. Ibuprofen is a white powde rwith a melting point of 74-77° C and is very slightly soluble in water(<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 availablein 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystallinecellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide. CLINICAL PHARMACOLOGY IBU tablets contain ibuprofen which possesses analgesic andantipyretic activities. Its mode of action, like that of other NSAIDs, isnot completely understood, but may be related to prostaglandin synthetaseinhibition. In clinical studies in patients with rheumatoid arthritis andosteoarthritis, Ibuprofen tablets have been shown to be comparableto aspirin in controlling pain and inflammation and to be associatedwith a statistically significant redu Прочетете целия документ