Country: United States
Language: English
Source: NLM (National Library of Medicine)
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
Cardinal Health 107, LLC
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 Asthm
IBU tablets are available in the following strengths, colors and sizes: 400 mg (white, oval, debossed 4I) Overbagged with 10 tablets per bag, NDC 55154-1380-0 600 mg (white, caplet, debossed 6I) Overbagged with 10 tablets per bag, NDC 55154-0741-0 800 mg (white, caplet, debossed 8I) Overbagged with 10 tablets per bag, NDC 55154-1342-0 Store at room temperature. Avoid excessive heat 40°C (104°F). Manufactured by: Dr. Reddy’s Laboratories Louisiana, LLC Shreveport, LA 71106 USA Distributed By: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 Distributed by: Cardinal Health Dublin, OH 43017 L43008771118 L40890251118 L42451221118 Revised: April 2019
Abbreviated New Drug Application
Cardinal Health 107, LLC ---------- 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, including if you: • ha Read the complete document
IBUPROFEN- IBUPROFEN TABLET, FILM COATED CARDINAL HEALTH 107, LLC ---------- IBU TABLETS BOXED WARNING CARDIOVASCULAR THROMBOTIC EVENTS 1. 1. GASTROINTESTINAL RISK 1. 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. ™ 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). 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). 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 Read the complete document