Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
Major Pharmaceuticals
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 ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen tablets in children have not been conducted. Ibuprofen tablets are contraindicated in patients with known hypersensitivityto ibuprofen. Ibuprofen 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 Asthma). Ibuprofen tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery(see WARNINGS ).
Ibuprofen tablets are available in the following strengths, colors and sizes: 400 mg : Oval shaped, white, film-coated tablet debossed "4I" on one side. Cartons of 100 Tablets (10 tablets each blister pack x 10) NDC 0904-5853-61 Bottle of 100 Tablets NDC 0904-5853-60 Bottle of 500 Tablets NDC 0904-5853-40 600 mg : Caplet shaped, white, film-coated tablet Debossed "6I" on one side. Cartons of 100 Tablets (10 tablets each blister pack x 10) NDC 0904-5854-61 Bottle of 100 Tablets NDC 0904-5854-60 Bottle of 500 Tablets NDC 0904-5854-40 800 mg : Caplet shaped, white, film-coated tablet debossed "8I" on one side. Cartons of 100 Tablets (10 tablets each blister pack x 10) NDC 0904-5855-61 Bottle of 100 Tablets NDC 0904-5855-60 Bottle of 500 Tablets NDC 0904-5855-40 Store at room temperature. Avoid excessive heat 40°C (104°F). Distributor: Dr. Reddy’s Laboratories Inc., Princeton, NJ 08540 Made in India Packaged and Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 USA Refer to package label for Distributor's NDC Number Revised: April 2022
Abbreviated New Drug Application
IBUPROFEN- IBUPROFEN TABLET Major Pharmaceuticals ---------- MEDICATION GUIDE Medication Guide forNon-Steroidal Anti-Inflammatory Drugs (NSAIDs) What is 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, Прочитать полный документ
IBUPROFEN- IBUPROFEN TABLET MAJOR PHARMACEUTICALS ---------- IBU TABLETS BOXED WARNING CARDIOVASCULAR THROMBOTIC EVENTS • • GASTROINTESTINAL RISK • DESCRIPTION Ibuprofen 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: Ibuprofen, 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 Ibuprofen tablets contain ibuprofen which possesses analgesic andantipyretic activities. Its mode of action, like that of other NSAIDs, isnot completely understood, but may be ™ 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 ERROR! HYPERLINK REFERENCE NOT VALID.). Ibuprofen tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (See CONTRAINDICATIONS and WARNINGS). 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). 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 Прочитать полный документ