Flurbiprofen (Tablet)

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Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): (See the end of this Medication Guide for a list of prescription NSAID medicines.)<br/>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: 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: NSAID medicines should only be used:<br/>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:<br/>Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?: Do not take an NSAID medicine: Tell your healthcare provider:<br/>What are the possible side effects of Non-Steroidal Anti-inflammatory Drugs (NSAIDs)?: Serious side effects include: Other side effects include: Get emergency help right away if you have any of the following symptoms: Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.<br/>Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): NSAID medicines that need a prescription *Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC label warns that long term continuous use may increase the risk of heart attack or stroke. All registered trademarks in this document are the property of their respective owners. This Medication Guide has been approved by the U.S. Food and Drug Administration.

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 CHFOand 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.

dailymed-ingredient:Flurbiprofen

Flurbiprofen Tablets 50 mg Rounded convex, beige, debossed���164���on one side. Bottles of 100 NDC 57664-164-08Bottles of 2000 NDC 57664-164-20 Flurbiprofen Tablets 100 mg Rounded convex, beige, debossed���165���on one side. Bottles of 100 NDC 57664-165-08Bottles 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

BOXED WARNING: Cardiovascular Risk Gastrointestinal Risk

dailymed-ingredient:black_iron_oxide, dailymed-ingredient:colloidal_silicon_dioxide, dailymed-ingredient:croscarmellose_sodium, dailymed-ingredient:glyceryl_triacetate, dailymed-ingredient:hydroxypropyl_methylcellulose, dailymed-ingredient:lactose_monohydrate, dailymed-ingredient:magnesium_stearate, dailymed-ingredient:microcrystalline_cellulose, dailymed-ingredient:polydextrose, dailymed-ingredient:polyethylene_glycol, dailymed-ingredient:povidone, dailymed-ingredient:titanium_dioxide, dailymed-ingredient:yellow_iron_oxide

General: Flurbiprofen tablet, USP cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. The pharmacological activity of Flurbiprofen tablet, USP in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed non-infectious, painful conditions.<br/>Hepatic effects: Borderline elevations of one or more liver tests may occur in up to 15% of patients taking nonsteroidal anti-inflammatory drugs, including Flurbiprofen tablet, USP. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with nonsteroidal anti-inflammatory drugs. In addition, rare cases of severe hepatic reactions, including jaundice, fulminant hepatitis, liver necrosis, and hepatic failure, some of them with fatal outcomes have been reported. A patient with symptoms and/or signs suggesting liver dysfunction, or with abnormal liver test values, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with Flurbiprofen tablet, USP. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (eg, eosinophilia, rash, etc.), Flurbiprofen tablet, USP should be discontinued.<br/>Hematological effects: Anemia is sometimes seen in patients receiving nonsteroidal anti-inflammatory drugs, including Flurbiprofen tablet, USP. This may be due to fluid retention, GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with nonsteroidal anti-inflammatory drugs, including Flurbiprofen tablet, USP, should have their hemoglobin or hematocrit checked periodically even if they do not exhibit any signs or symptoms of anemia. Nonsteroidal anti-inflammatory drugs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Flurbiprofen tablet, USP does not generally affect platelet counts, prothrombin time (PT), or partial thromboplastin time (PTT). Patients receiving Flurbiprofen tablet, USP who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.<br/>Preexisting asthma: Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs has been reported in such aspirin-sensitive patients, Flurbiprofen tablet, USP should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.<br/>Vision changes: Blurred and/or diminished vision has been reported with the use of Flurbiprofen tablet, USP and other nonsteroidal anti-inflammatory drugs. Patients experiencing eye complaints should have ophthalmologic examinations.<br/>Information For Patients: Information For Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed. In late pregnancy, as with other NSAIDs, Flurbiprofen tablet, USP should be avoided because it may cause premature closure of the ductus arteriosus.<br/>Laboratory Tests: Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs of symptoms of GI bleeding. Patients on long-term treatment with nonsteroidal anti-inflammatory drugs should have their CBC and chemistry profile checked periodically. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (eg, eosinophilia, rash etc.), or abnormal liver tests persist or worsen, Flurbiprofen tablet, USP should be discontinued.<br/>Drug Interactions: ACE-inhibitors: Reports suggest that nonsteroidal anti-inflammatory drugs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking nonsteroidal anti-inflammatory drugs concomitantly with ACE-inhibitors. Anticoagulants: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. The physician should be cautious when administering Flurbiprofen tablet, USP to patients taking warfarin or other anticoagulants. Aspirin: Concurrent administration of aspirin lowers serum flurbiprofen concentrations . The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of flurbiprofen and aspirin is not generally recommended because of the potential for increased adverse effects. Beta-adrenergic blocking agents: Flurbiprofen attenuated the hypotensive effect of propranolol but not atenolol . The mechanism underlying this interference is unknown. Patients taking both flurbiprofen and a beta-blocker should be monitored to ensure that a satisfactory hypotensive effect is achieved. Diuretics: Clinical studies, as well as post marketing observations, have shown that Flurbiprofen tablet, USP can reduce the natriuretic effect-of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure , as well as diuretic efficacy. Lithium: NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the nonsteroidal anti-inflammatory drug. Thus, when nonsteroidal anti-inflammatory drugs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. Methotrexate: Nonsteroidal anti-inflammatory drugs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when nonsteroidal anti-inflammatory drugs are administered concomitantly with methotrexate.<br/>Pregnancy:<br/>Teratogenic effects : Pregnancy Category C: Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women. Flurbiprofen tablet, USP should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.<br/>Nonteratogenic effects: Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during late pregnancy should be avoided.<br/>Labor and Delivery: In rat studies with nonsteroidal anti-inflammatory drugs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of Flurbiprofen tablet, USP on labor and delivery in pregnant women are unknown.<br/>Nursing Mothers: Concentrations of flurbiprofen in breast milk and plasma of nursing mothers suggest that a nursing infant could receive approximately 0.10 mg flurbiprofen per day in the established milk of a woman taking Flurbiprofen tablet, USP 200 mg/day. Because of possible adverse effects of prostaglandin-inhibiting drugs on neonates, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.<br/>Pediatric Use: Safety and effectiveness in pediatric patients have not been established.<br/>Geriatric Use: As with any NSAID, caution should be exercised in treating the elderly (65 years and older). Clinical experience with Flurbiprofen tablet, USP suggests that elderly patients may have a higher incidence of gastrointestinal complaints than younger patients, including ulceration, bleeding, flatulence, bloating, and abdominal pain. To minimize the potential risk for gastrointestinal events, the lowest effective dose should be used for the shortest possible duration . Likewise, elderly patients are at greater risk of developing renal decompensation . The pharmacokinetics of flurbiprofen do not seem to differ in elderly patients from those in younger individuals . The rate of absorption of Flurbiprofen tablet, USP was reduced in elderly patients who also received antacids, although the extent of absorption was not affected .

Flurbiprofen

CARDIOVASCULAR EFFECTS: Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events . Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke . Hypertension NSAIDs including Flurbiprofen tablet, USP, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including Flurbiprofen tablet, USP, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy. Congestive Heart Failure and Edema Fluid retention and edema have been observed in some patients taking NSAIDs. Flurbiprofen tablet, USP should be used with caution in patients with fluid retention or heart failure.<br/>Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation: NSAIDs, including Flurbiprofen tablet, USP, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk. NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients treated with neither of these riskfactors. Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population. To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulcerations and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.<br/>Renal Effects: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state. Advanced Renal Disease In clinical studies, the elimination half-life of flurbiprofen was unchanged in patients with renal impairment. Flurbiprofen metabolites are eliminated primarily by the kidneys. Elimination of 4'- hydroxy-flurbiprofen was reduced in patients with moderate to severe renal impairment. Therefore, treatment with Flurbiprofen tablet, USP is not recommended in these patients with advanced renal disease. If Flurbiprofen tablet, USP therapy must be initiated, close monitoring of the patients renal function is advisable . Anaphylactoid Reactions As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to Flurbiprofen tablet, USP. Flurbiprofen tablet, USP should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs . Emergency help should be sought in cases where an anaphylactoid reaction occurs.<br/>Pregnancy: In late pregnancy, as with other NSAIDs, Flurbiprofen tablet, USP should be avoided because it may cause premature closure of the ductus arteriosus.

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Flurbiprofen