Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
FLURBIPROFEN (UNII: 5GRO578KLP) (FLURBIPROFEN - UNII:5GRO578KLP)
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
FLURBIPROFEN
FLURBIPROFEN 100 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of flurbiprofen tablets and other treatment options before deciding to use flurbiprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Flurbiprofen tablets are indicated: - For relief of the signs and symptoms of rheumatoid arthritis. - For relief of the signs and symptoms of osteoarthritis. Flurbiprofen tablets are contraindicated in patients with known hypersensitivity to flurbiprofen. Flurbiprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs. Severe, rarely fatal, anaphylactic-like reactions to non-steroidal anti-inflammatory drugs have been reported in such patients (see WARNINGS , Anaphylactoid Reactions and PRECAUTIONS , Preexisting Asthma ). Flurbiprofen tablets are contraindicated for the treatment of peri-operative pain in the setting o
Flurbiprofen tablets USP, 100 mg are round, blue, film-coated tablets debossed “93”-“711” available in bottles of 100 and 500. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. I 9/2010
Abbreviated New Drug Application
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ---------- Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Rx only (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 Non-Steroidal Anti- Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: • with longer use of NSAID medicines • in people who have heart disease NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).” NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: • can happen without warning symptoms • may cause death The chance of a person getting an ulcer or bleeding increases with: • taking medicines called “corticosteroids” and “anticoagulants” • longer use • smoking • drinking alcohol • older age • having poor health NSAID medicines should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine • for pain right before or after heart bypass surgery Tell your healthcare provider: • about all of your medical conditions. • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and ph Citiți documentul complet
FLURBIPROFEN- FLURBIPROFEN TABLET, FILM COATED LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC ---------- FLURBIPROFEN TABLETS USP, 100 MG 0711 RX ONLY 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). Flurbiprofen 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 (see WARNINGS). DESCRIPTION Flurbiprofen is a member of the phenylalkanoic acid derivative group of non-steroidal anti-inflammatory drugs. Flurbiprofen tablets USP are round, blue, film-coated tablets for oral administration. Flurbiprofen is a racemic mixture of (+)S- and (-)R- enantiomers. Flurbiprofen is a white or slightly yellow crystalline powder. It is slightly soluble in water at pH 7.0 and readily soluble in most polar solvents. The chemical name is [1,1’-biphenyl]-4-acetic acid,2-fluoro-α-methyl-, (±)-. It has the following structural formula: C H FO M.W. 244.26 Each tablet, for oral administration, contains 100 mg flurbiprofen. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide, and FD&C Blue #1 aluminum lake. CLINICAL PHARMACOLOGY PHARMACODYNAMICS Flurbiprofen tablets contain flurbiprofen, a non-steroidal anti-inflammatory drug Citiți documentul complet