Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
Denton Pharma, Inc. dba Northwind Pharmaceuticals
IBUPROFEN
IBUPROFEN 800 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 ). 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 hypersensitivity to ibuprofen. Ibuprofen tablets should not be given to patients who have experienced asthma, urticarial, 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 W
Ibuprofen tablets are available in the following strengths, colors and sizes: 800 mg (white to off-white, caplet, 'I 10' debossing on one side and plain on the other side) Bottles of 21; NDC 70934-032-21 Bottles of 15; NDC 70934-032-15 Bottles of 30; NDC 70934-032-30 Bottles of 40; NDC 70934-032-40 Bottles of 60; NDC 70934-032-60 Bottles of 90; NDC 70934-032-90 Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature]. Avoid excessive heat above 40ºC (104ºF). Manufactured by: Granules India Limited Hyderabad-500 081, India MADE IN INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Toll-free: 1-877-272-7901 Issued: October 2016 For more information, please call to 1-877-770-3183. Rev: May/2019
Abbreviated New Drug Application
IBUPROFEN- IBUPROFEN TABLET, FILM COATED Denton Pharma, Inc. dba Northwind Pharmaceuticals ---------- SPL MEDGUIDE Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important information I should know about medicines called Nonsteroidal 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 doses 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 take NSAIDs? Do not take NSAIDs: · if you have had an asthma attack, hives, or other allergic reaction with aspirin or an Baca dokumen lengkap
IBUPROFEN- IBUPROFEN TABLET, FILM COATED DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS ---------- IBUPROFEN TABLETS, USP 400MG, 600MG AND 800MG BOXED WARNING CARDIOVASCULAR THROMBOTIC EVENTS · Non-steroidal 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). · Ibuprofen Tablets is 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). DESCRIPTION Ibuprofen 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 (<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 available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide. CLINICAL PHARMACOLOGY Ibuprofen 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 prostaglandin synthetase inhibition. In clinical studies in patients with rheumatoid arthritis and Baca dokumen lengkap