Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
Flurbiprofen (UNII: 5GRO578KLP) (flurbiprofen - UNII:5GRO578KLP)
CARACO PHARMACEUTICAL LABORATORIES, LTD.
Flurbiprofen
TABLET
50 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of Flurbiprofen tablet, USP and other treatment options before deciding to use Flurbiprofen tablet, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Flurbiprofen tablet, USP is indicated: - For relief of the signs and symptoms of rheumatoid arthritis. - For relief of the signs and symptoms of osteoarthritis. Flurbiprofen tablets, USP are contraindicated in patients with known hypersensitivity to flurbiprofen. Flurbiprofen tablet, USP should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs. Severe, rarely fatal, anaphylactic-like reactions to nonsteroidal anti-inflammatory drugs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions, and PRECAUTIONS, Preexisting Asthma). Flurbiprofen tablet, USP is contraindicated for the treatment of peri-operative pain
Flurbiprofen Tablets 50 mg Rounded convex, beige, debossed “164” on one side. Bottles of 100 NDC 57664-164-08 Bottles of 2000 NDC 57664-164-20 Flurbiprofen Tablets 100 mg Rounded convex, beige, debossed “165” on one side. Bottles of 100 NDC 57664-165-08 Bottles of 500 NDC 57664-165-13 Store at controlled room temperature 15° - 30°C (59° - 86°F) [see USP]. Dispense in tight, light-resistant container. CARACO PHARMACEUTICAL LABORATORIES, LTD. DETROIT, MI 48202 Stock No. 5104T03
CARACO PHARMACEUTICAL LABORATORIES, LTD. ---------- 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 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 pharmacist. • if you are pregnan Przeczytaj cały dokument
FLURBIPROFEN- FLURBIPROFEN TABLET CARACO PHARMACEUTICAL LABORATORIES, LTD. ---------- BOXED WARNING 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 tablet, USP is 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 tablet, USP contain flurbiprofen, which is a member of the phenylalkanoic acid derivative group of nonsteroidal anti-inflammatory drugs. Flurbiprofen tablet, USP are white, oval, 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-alphamethyl-, (±)-. The molecular weight is 244.26. Its molecular formula is C H FO and it has the following structural formula: Each tablet, for oral administration contains 50 mg or 100 mg of Flurbiprofen. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, titanium dioxide, polydextrose, hydroxypropyl methylcellulose, polyethylene glycol, yellow iron oxide, black iron oxide, glyceryl triacetate. CLINICAL PHARMACOLOGY PHARMACODYNAMI Przeczytaj cały dokument