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Indications/Uses
Piroxicam (Feldene Flash) is a non-steroidal anti-inflammatory drug (NSAID) indicated for a variety of conditions requiring anti-inflammatory and/or analgesic activity, such as rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis (arthrosis, degenerative joint disease), ankylosing spondylitis, acute musculo-skeletal disorders, acute gout, pain after operative intervention and following acute trauma, for the treatment of primary dysmenorrhea in patients 12 years of age or older, and for the relief of fever and pain associated with acute upper respiratory tract inflammation.
Dosage/Direction for Use
Undesirable effects may be minimized by using the minimum effective dose for the shortest duration necessary to control symptoms.
Dosage: Rheumatoid Arthritis, Osteoarthritis (Arthrosis, Degenerative Joint Disease), Ankylosing Spondylitis: The recommended starting dose is 20 mg given as a single daily dose. The majority of patients will be maintained on 20 mg daily. A relatively small group of patients may be maintained on 10 mg daily (see Gastrointestinal (GI) Effects under Precautions).
Acute Gout: Because of its GI safety profile (see Contraindications and Precautions), piroxicam (Feldene Flash) should not be used in first-line treatment for acute gout when an NSAID is indicated. For the same reason, it should not be used to treat acute gout in patients most at risk of developing serious GI adverse events (see Precautions). Therapy should be initiated by a single dose of 40 mg, followed on the next 4 to 6 days with 40 mg daily, given in single or divided doses. Piroxicam (Feldene Flash) is not indicated for the long term management of gout.
Acute Musculoskeletal Disorders: Because of its GI safety profile (see Contraindications and Precautions), piroxicam (Feldene Flash) should not be used in first-line treatment for acute musculoskeletal disorders when an NSAID is indicated. For the same reason, it should not be used to treat acute musculoskeletal disorders in patients most at risk of developing serious GI adverse events (see Precautions). Therapy should be initiated with 40 mg daily for the first two days given in single or divided doses. For the remainder of the 7 to 14 day treatment period, the dose should be reduced to 20 mg daily.
Post-operative and Post-traumatic Pain: The recommended dose is 20 mg, given as a single daily dose.
Dysmenorrhea: Because of its GI safety profile (see Contraindications and Precautions), piroxicam (Feldene Flash) should not be used in first-line treatment for dysmenorrhea when an NSAID is indicated. For the same reason, it should not be used to treat dysmenorrhea in patients most at risk of developing serious GI adverse events (see Precautions). The treatment of primary dysmenorrhea is initiated at the earliest onset of symptoms with a recommended starting dose of 40 mg given as a single daily dose for the first two days. Treatment may be continued thereafter with a single daily dose of 20 mg for the next one to three days as necessary.
Upper Respiratory Tract Inflammation: The adult dosage is 10 mg or 20 mg orally once daily for five to seven days.
Use in Children: Juvenile Rheumatoid Arthritis (JRA): The recommended dosages for children with JRA are based on body weight as follows: See Table 1.
Administration: Oral: Piroxicam (Feldene Flash) tablets may be swallowed with water, or placed on the tongue to disperse and then swallowed with saliva or water as a suspension. Piroxicam (Feldene Flash) tablet dissolves almost instantly in the mouth in the presence of water or saliva.
Combined Administration: The total daily dosage of Piroxicam (Feldene Flash) administered as fast dissolving tablet should not exceed the maximum recommended daily dosage as indicated previously.
Dosage: Rheumatoid Arthritis, Osteoarthritis (Arthrosis, Degenerative Joint Disease), Ankylosing Spondylitis: The recommended starting dose is 20 mg given as a single daily dose. The majority of patients will be maintained on 20 mg daily. A relatively small group of patients may be maintained on 10 mg daily (see Gastrointestinal (GI) Effects under Precautions).
Acute Gout: Because of its GI safety profile (see Contraindications and Precautions), piroxicam (Feldene Flash) should not be used in first-line treatment for acute gout when an NSAID is indicated. For the same reason, it should not be used to treat acute gout in patients most at risk of developing serious GI adverse events (see Precautions). Therapy should be initiated by a single dose of 40 mg, followed on the next 4 to 6 days with 40 mg daily, given in single or divided doses. Piroxicam (Feldene Flash) is not indicated for the long term management of gout.
Acute Musculoskeletal Disorders: Because of its GI safety profile (see Contraindications and Precautions), piroxicam (Feldene Flash) should not be used in first-line treatment for acute musculoskeletal disorders when an NSAID is indicated. For the same reason, it should not be used to treat acute musculoskeletal disorders in patients most at risk of developing serious GI adverse events (see Precautions). Therapy should be initiated with 40 mg daily for the first two days given in single or divided doses. For the remainder of the 7 to 14 day treatment period, the dose should be reduced to 20 mg daily.
Post-operative and Post-traumatic Pain: The recommended dose is 20 mg, given as a single daily dose.
Dysmenorrhea: Because of its GI safety profile (see Contraindications and Precautions), piroxicam (Feldene Flash) should not be used in first-line treatment for dysmenorrhea when an NSAID is indicated. For the same reason, it should not be used to treat dysmenorrhea in patients most at risk of developing serious GI adverse events (see Precautions). The treatment of primary dysmenorrhea is initiated at the earliest onset of symptoms with a recommended starting dose of 40 mg given as a single daily dose for the first two days. Treatment may be continued thereafter with a single daily dose of 20 mg for the next one to three days as necessary.
Upper Respiratory Tract Inflammation: The adult dosage is 10 mg or 20 mg orally once daily for five to seven days.
Use in Children: Juvenile Rheumatoid Arthritis (JRA): The recommended dosages for children with JRA are based on body weight as follows: See Table 1.
Administration: Oral: Piroxicam (Feldene Flash) tablets may be swallowed with water, or placed on the tongue to disperse and then swallowed with saliva or water as a suspension. Piroxicam (Feldene Flash) tablet dissolves almost instantly in the mouth in the presence of water or saliva.
Combined Administration: The total daily dosage of Piroxicam (Feldene Flash) administered as fast dissolving tablet should not exceed the maximum recommended daily dosage as indicated previously.
Overdosage
In the event of overdosage with piroxicam (Feldene Flash), supportive and symptomatic therapy is indicated. Studies indicate that administration of activated charcoal may result in reduced absorption and re-absorption of piroxicam (Feldene Flash) thus reducing the total amount of active drug available.
Although there are no studies to date, hemodialysis is probably not useful in enhancing elimination of piroxicam (Feldene Flash) since the drug is highly protein-bound.
Although there are no studies to date, hemodialysis is probably not useful in enhancing elimination of piroxicam (Feldene Flash) since the drug is highly protein-bound.
Administration
Should be taken with food: Allow to melt in the mouth.
Contraindications
Absolute contraindications: Not to be given to those patients who have history of: Stroke: Cerebrovascular accident, CVA.
Heart attack: Myocardial infarction, MI.
Coronary artery bypass graft: CABG.
Uncontrolled hypertension.
Congestive heart failure (CHF), NYHA II-IV.
Contraindications: Piroxicam (Feldene Flash) is contraindicated in: Patients with a history of gastro-intestinal ulceration, bleeding or perforation.
Patients with active peptic ulcerations.
Patients with known hypersensitivity to piroxicam (Feldene Flash) or to any of the excipients, namely, gelatin, mannitol, aspartame, citric acid anhydrous, lactose, corn starch, magnesium stearate, and sodium lauryl sulphate. The potential exists for cross sensitivity to aspirin and other NSAIDs. Piroxicam (Feldene Flash) should not be given to patients in whom aspirin and other NSAIDs induce the symptoms of asthma, nasal polyps, angioedema or urticaria.
Treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Patients with severe renal and hepatic failure.
Patients with severe heart failure.
Heart attack: Myocardial infarction, MI.
Coronary artery bypass graft: CABG.
Uncontrolled hypertension.
Congestive heart failure (CHF), NYHA II-IV.
Contraindications: Piroxicam (Feldene Flash) is contraindicated in: Patients with a history of gastro-intestinal ulceration, bleeding or perforation.
Patients with active peptic ulcerations.
Patients with known hypersensitivity to piroxicam (Feldene Flash) or to any of the excipients, namely, gelatin, mannitol, aspartame, citric acid anhydrous, lactose, corn starch, magnesium stearate, and sodium lauryl sulphate. The potential exists for cross sensitivity to aspirin and other NSAIDs. Piroxicam (Feldene Flash) should not be given to patients in whom aspirin and other NSAIDs induce the symptoms of asthma, nasal polyps, angioedema or urticaria.
Treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Patients with severe renal and hepatic failure.
Patients with severe heart failure.
Special Precautions
The use of piroxicam (Feldene Flash) with concomitant systemic non-aspirin NSAIDs including cyclooxygenase 2 (COX-2) inhibitors should be avoided. Concomitant use of a systemic NSAID and another systemic NSAID may increase frequency of gastrointestinal ulcers and bleeding.
Cardiovascular Effects: NSAIDs may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. The relative increase of this risk appears to be similar in those with or without known CV disease or CV risk factors. However, patients with known CV disease or CV risk factors may be at greater risk in terms of absolute incidence, due to their increased rate at baseline. To minimize the potential risk for an adverse CV event in patients treated with piroxicam (Feldene Flash), 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 toxicity and the steps to take if they occur (see Contraindications).
Hypertension: As with all NSAIDs, piroxicam (Feldene Flash) can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. NSAIDs, including piroxicam (Feldene Flash), should be used with caution in patients with hypertension. Blood pressure should be monitored closely during the initiation of therapy with piroxicam (Feldene Flash) and throughout the course of therapy.
Fluid Retention and Edema: As with other drugs known to inhibit prostaglandin synthesis, fluid retention and edema have been observed in some patients taking NSAIDs, including piroxicam (Feldene Flash). Therefore, piroxicam (Feldene Flash) should be used with caution in patients with compromised cardiac function and other conditions predisposing to, or worsened by, fluid retention. Patients with pre-existing congestive heart failure or hypertension should be closely monitored.
Gastrointestinal (GI) Effects: NSAIDs, including piroxicam (Feldene Flash), 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. Administration of doses of greater than 20 mg/day carries an increased risk of gastrointestinal side effects. Evidence from observational studies suggests that piroxicam (Feldene Flash) may be associated with a high risk of serious gastrointestinal toxicity, relative to other NSAIDs. When GI bleeding or ulceration occurs in patients receiving piroxicam (Feldene Flash), the treatment should be withdrawn. Patients most at risk of developing these types of GI complications with NSAIDs are the elderly, patients with CV disease, patients using concomitant corticosteroids, antiplatelet drugs (such as aspirin), selective serotonin reuptake inhibitors, patients ingesting alcohol or patients with a prior history of, or active, gastrointestinal disease, such as ulceration, GI bleeding or inflammatory conditions. Therefore, piroxicam (Feldene Flash) should be used with caution in these patients (see Dosage & Administration and Contraindications).
Renal Effects: In rare cases, NSAIDs may cause interstitial nephritis, glomerulitis, papillary necrosis and the nephrotic syndrome. NSAIDs inhibit the synthesis of renal prostaglandin which plays a supportive role in the maintenance of renal perfusion in patients whose renal blood flow and blood volume are decreased. In these patients, administration of an NSAID may precipitate overt renal decompensation, which is typically followed by recovery to pretreatment state upon discontinuation of NSAID therapy. Patients at greatest risk of such a reaction are those with congestive heart failure, liver cirrhosis, nephrotic syndrome and overt renal disease. Such patients should be carefully monitored while receiving NSAID therapy.
Caution should be used when initiating treatment with piroxicam (Feldene Flash) in patients with severe dehydration. Caution is also recommended in patients with kidney disease (see Contraindications).
Because of extensive renal excretion of piroxicam (Feldene Flash) and its biotransformation products lower doses of piroxicam (Feldene Flash) should be considered in patients with impaired renal function, and they should be carefully monitored (see Contraindications and Pharmacology: Pharmacokinetics under Actions).
Hepatic Effects: Piroxicam (Feldene Flash) can cause fatal hepatitis and jaundice. Although such reactions are rare, if abnormal liver function tests persist or worsen, if clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), piroxicam (Feldene Flash) should be discontinued.
Skin Reactions: Serious skin reactions, some of them fatal, including drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including piroxicam (Feldene Flash). Patients appear to be at highest risk for these events early in the course of therapy, the onset of the event occurring in the majority of cases within the first month of treatment. Piroxicam (Feldene Flash) should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Cases of fixed drug eruption (FDE) have been reported with piroxicam. Piroxicam should not be reintroduced in patients with history of piroxicam-related FDE. Potential cross reactivity might occur with other oxicams (see Adverse Reactions).
Ophthalmologic Effects: Because of reports of adverse eye findings with NSAIDs, it is recommended that patients who develop visual complaints during treatment with piroxicam (Feldene Flash) have an ophthalmic evaluation.
Poor Metabolizers of CYP2C9 Substrates: Patients who are known or suspected to be poor CYP2C9 metabolizers based on previous history/experience with other CYP2C9 substrates should be administered piroxicam (Feldene Flash) with caution as they may have abnormally high plasma levels due to reduced metabolic clearance (see Pharmacology: Pharmacokinetics: Metabolism and Elimination: Pharmacogenetics under Actions).
Use with Oral Anti-coagulants: The concomitant use of NSAIDs, including piroxicam (Feldene Flash), with oral anticoagulants increases the risk of GI and non-GI bleeding and should be given with caution. Oral anticoagulants include warfarin/coumarin-type and novel oral anticoagulants (e.g., apixaban, dabigatran, rivaroxaban). Anticoagulation/INR should be monitored in patients taking a warfarin/coumarin-type anticoagulant (see Interactions).
General: For patients with phenylketonuria: because of its aspartame content, Piroxicam (Feldene Flash) tablets contain phenylalanine 0.140 mg per 20 mg dose.
When used for the relief of pain and inflammation in upper respiratory tract inflammation, it should be remembered that NSAIDs are only a symptomatic therapy. When given to patients with such conditions, appropriate concomitant antibacterial therapy should be considered.
Effects on Ability to Drive and Use Machines: The effect of piroxicam (Feldene Flash) on the ability to drive or operate machinery has not been studied.
Cardiovascular Effects: NSAIDs may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. The relative increase of this risk appears to be similar in those with or without known CV disease or CV risk factors. However, patients with known CV disease or CV risk factors may be at greater risk in terms of absolute incidence, due to their increased rate at baseline. To minimize the potential risk for an adverse CV event in patients treated with piroxicam (Feldene Flash), 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 toxicity and the steps to take if they occur (see Contraindications).
Hypertension: As with all NSAIDs, piroxicam (Feldene Flash) can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. NSAIDs, including piroxicam (Feldene Flash), should be used with caution in patients with hypertension. Blood pressure should be monitored closely during the initiation of therapy with piroxicam (Feldene Flash) and throughout the course of therapy.
Fluid Retention and Edema: As with other drugs known to inhibit prostaglandin synthesis, fluid retention and edema have been observed in some patients taking NSAIDs, including piroxicam (Feldene Flash). Therefore, piroxicam (Feldene Flash) should be used with caution in patients with compromised cardiac function and other conditions predisposing to, or worsened by, fluid retention. Patients with pre-existing congestive heart failure or hypertension should be closely monitored.
Gastrointestinal (GI) Effects: NSAIDs, including piroxicam (Feldene Flash), 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. Administration of doses of greater than 20 mg/day carries an increased risk of gastrointestinal side effects. Evidence from observational studies suggests that piroxicam (Feldene Flash) may be associated with a high risk of serious gastrointestinal toxicity, relative to other NSAIDs. When GI bleeding or ulceration occurs in patients receiving piroxicam (Feldene Flash), the treatment should be withdrawn. Patients most at risk of developing these types of GI complications with NSAIDs are the elderly, patients with CV disease, patients using concomitant corticosteroids, antiplatelet drugs (such as aspirin), selective serotonin reuptake inhibitors, patients ingesting alcohol or patients with a prior history of, or active, gastrointestinal disease, such as ulceration, GI bleeding or inflammatory conditions. Therefore, piroxicam (Feldene Flash) should be used with caution in these patients (see Dosage & Administration and Contraindications).
Renal Effects: In rare cases, NSAIDs may cause interstitial nephritis, glomerulitis, papillary necrosis and the nephrotic syndrome. NSAIDs inhibit the synthesis of renal prostaglandin which plays a supportive role in the maintenance of renal perfusion in patients whose renal blood flow and blood volume are decreased. In these patients, administration of an NSAID may precipitate overt renal decompensation, which is typically followed by recovery to pretreatment state upon discontinuation of NSAID therapy. Patients at greatest risk of such a reaction are those with congestive heart failure, liver cirrhosis, nephrotic syndrome and overt renal disease. Such patients should be carefully monitored while receiving NSAID therapy.
Caution should be used when initiating treatment with piroxicam (Feldene Flash) in patients with severe dehydration. Caution is also recommended in patients with kidney disease (see Contraindications).
Because of extensive renal excretion of piroxicam (Feldene Flash) and its biotransformation products lower doses of piroxicam (Feldene Flash) should be considered in patients with impaired renal function, and they should be carefully monitored (see Contraindications and Pharmacology: Pharmacokinetics under Actions).
Hepatic Effects: Piroxicam (Feldene Flash) can cause fatal hepatitis and jaundice. Although such reactions are rare, if abnormal liver function tests persist or worsen, if clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), piroxicam (Feldene Flash) should be discontinued.
Skin Reactions: Serious skin reactions, some of them fatal, including drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including piroxicam (Feldene Flash). Patients appear to be at highest risk for these events early in the course of therapy, the onset of the event occurring in the majority of cases within the first month of treatment. Piroxicam (Feldene Flash) should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Cases of fixed drug eruption (FDE) have been reported with piroxicam. Piroxicam should not be reintroduced in patients with history of piroxicam-related FDE. Potential cross reactivity might occur with other oxicams (see Adverse Reactions).
Ophthalmologic Effects: Because of reports of adverse eye findings with NSAIDs, it is recommended that patients who develop visual complaints during treatment with piroxicam (Feldene Flash) have an ophthalmic evaluation.
Poor Metabolizers of CYP2C9 Substrates: Patients who are known or suspected to be poor CYP2C9 metabolizers based on previous history/experience with other CYP2C9 substrates should be administered piroxicam (Feldene Flash) with caution as they may have abnormally high plasma levels due to reduced metabolic clearance (see Pharmacology: Pharmacokinetics: Metabolism and Elimination: Pharmacogenetics under Actions).
Use with Oral Anti-coagulants: The concomitant use of NSAIDs, including piroxicam (Feldene Flash), with oral anticoagulants increases the risk of GI and non-GI bleeding and should be given with caution. Oral anticoagulants include warfarin/coumarin-type and novel oral anticoagulants (e.g., apixaban, dabigatran, rivaroxaban). Anticoagulation/INR should be monitored in patients taking a warfarin/coumarin-type anticoagulant (see Interactions).
General: For patients with phenylketonuria: because of its aspartame content, Piroxicam (Feldene Flash) tablets contain phenylalanine 0.140 mg per 20 mg dose.
When used for the relief of pain and inflammation in upper respiratory tract inflammation, it should be remembered that NSAIDs are only a symptomatic therapy. When given to patients with such conditions, appropriate concomitant antibacterial therapy should be considered.
Effects on Ability to Drive and Use Machines: The effect of piroxicam (Feldene Flash) on the ability to drive or operate machinery has not been studied.
Use In Pregnancy & Lactation
Fertility: Based on the mechanism of action, the use of NSAIDs, including piroxicam (Feldene Flash), may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of NSAIDs, including piroxicam (Feldene Flash), should be considered.
Pregnancy: Although no teratogenic effects were seen in animal testing, the use of piroxicam (Feldene Flash) during pregnancy is not recommended. Piroxicam (Feldene Flash) inhibits prostaglandin synthesis and release through a reversible inhibition of the cyclo-oxygenase enzyme. This effect, as with other NSAIDs has been associated with an increased incidence of dystocia and delayed parturition in pregnant animals when drug administration was continued into late pregnancy. NSAIDs are also known to induce premature closure of the ductus arteriosus in infants. Therefore, piroxicam (Feldene Flash) should be avoided during the third trimester of pregnancy.
Inhibition of prostaglandin synthesis might adversely affect pregnancy. Data from epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss.
If used during second or third trimester of pregnancy, NSAIDs may cause fetal renal dysfunction which may result in reduction of amniotic fluid volume or oligohydramnios in severe cases. Such effects may occur shortly after treatment initiation and are usually reversible upon discontinuation. Pregnant women on piroxicam (Feldene Flash) should be closely monitored for amniotic fluid volume.
Lactation: The presence of piroxicam (Feldene Flash) in breast milk has been determined during initial and long term dosing conditions (52 days). Piroxicam (Feldene Flash) appeared in breast milk at about 1% to 3% of the maternal plasma concentration. No accumulation of piroxicam (Feldene Flash) occurred in milk relative to that in plasma during treatment. Piroxicam (Feldene Flash) is not recommended for use in nursing mothers as the clinical safety has not been established.
Pregnancy: Although no teratogenic effects were seen in animal testing, the use of piroxicam (Feldene Flash) during pregnancy is not recommended. Piroxicam (Feldene Flash) inhibits prostaglandin synthesis and release through a reversible inhibition of the cyclo-oxygenase enzyme. This effect, as with other NSAIDs has been associated with an increased incidence of dystocia and delayed parturition in pregnant animals when drug administration was continued into late pregnancy. NSAIDs are also known to induce premature closure of the ductus arteriosus in infants. Therefore, piroxicam (Feldene Flash) should be avoided during the third trimester of pregnancy.
Inhibition of prostaglandin synthesis might adversely affect pregnancy. Data from epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss.
If used during second or third trimester of pregnancy, NSAIDs may cause fetal renal dysfunction which may result in reduction of amniotic fluid volume or oligohydramnios in severe cases. Such effects may occur shortly after treatment initiation and are usually reversible upon discontinuation. Pregnant women on piroxicam (Feldene Flash) should be closely monitored for amniotic fluid volume.
Lactation: The presence of piroxicam (Feldene Flash) in breast milk has been determined during initial and long term dosing conditions (52 days). Piroxicam (Feldene Flash) appeared in breast milk at about 1% to 3% of the maternal plasma concentration. No accumulation of piroxicam (Feldene Flash) occurred in milk relative to that in plasma during treatment. Piroxicam (Feldene Flash) is not recommended for use in nursing mothers as the clinical safety has not been established.
Adverse Reactions
Piroxicam (Feldene Flash) is generally well tolerated. Gastrointestinal symptoms are the most commonly encountered side effects but in most instances do not interfere with the course of therapy.
Objective evaluations of gastric mucosal appearances and intestinal blood loss show that 20 mg/day of piroxicam (Feldene Flash) administered either in single or divided daily doses is significantly less irritating to the gastrointestinal tract than acetylsalicylic acid.
The following table lists adverse drug reactions (ADRs) within each standard System Organ Class (SOC) by decreasing order of medical seriousness or clinical importance. (See Table 2.)
Objective evaluations of gastric mucosal appearances and intestinal blood loss show that 20 mg/day of piroxicam (Feldene Flash) administered either in single or divided daily doses is significantly less irritating to the gastrointestinal tract than acetylsalicylic acid.
The following table lists adverse drug reactions (ADRs) within each standard System Organ Class (SOC) by decreasing order of medical seriousness or clinical importance. (See Table 2.)
Drug Interactions
Acetylsalicylic acid: As with other NSAIDs, the use of piroxicam (Feldene Flash) in conjunction with acetylsalicylic acid or the concomitant use of two NSAIDs is not recommended because data are inadequate to demonstrate that the combination produces greater improvement than that achieved with the drug alone and the potential for adverse reactions is increased.
Studies in man have shown that the concomitant administration of piroxicam (Feldene Flash) and acetylsalicylic acid resulted in a reduction of plasma levels of piroxicam (Feldene Flash) to about 80% of the normal values.
Piroxicam interferes with the antiplatelet effect of low-dose aspirin, and thus may interfere with aspirin's prophylactic treatment of CV disease.
Anti-coagulants: Bleeding has been reported rarely when piroxicam (Feldene Flash) has been administered to patients on coumarin type anti-coagulants. Patients should be monitored closely if piroxicam (Feldene Flash) and oral anticoagulants are administered together.
Piroxicam (Feldene Flash), like other NSAIDs, decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined.
Antacids: Concomitant administration of antacids had no effect on piroxicam (Feldene Flash) plasma levels.
Anti-hypertensives including diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II antagonists (AIIA) and beta-blockers: NSAIDs can reduce the efficacy of diuretics and other anti-hypertensive drugs including ACE inhibitors, AIIA and beta blockers.
In patients with impaired renal function (e.g., dehydrated patients or elderly patients with the renal function compromised), the co-administration of an ACE inhibitor or an AIIA and/or diuretics with a cyclo-oxygenase inhibitor can increase the deterioration of the renal function, including the possibility of acute renal failure, which is usually reversible.
The occurrence of these interactions should be considered in patients taking piroxicam (Feldene Flash) with an ACE inhibitor or an AIIA and/or diuretics. Therefore, the concomitant administration of these drugs should be done with caution, especially in elderly patients. Patients should be adequately hydrated and the need to monitor the renal function should be assessed in the beginning of the concomitant treatment and periodically thereafter.
Cardiac glycosides (digoxin and digitoxin): NSAIDs may exacerbate cardiac failure, reduce glomerular filtration rate (GFR) and increase plasma glycoside levels. Concomitant administration of digoxin or digitoxin had no effect on the plasma levels of piroxicam (Feldene Flash) or either drug.
Cimetidine: Results of two separate studies indicate a slight increase in absorption of piroxicam (Feldene Flash) following cimetidine administration but no significant changes in elimination parameters. Cimetidine increases the area under the curve (AUC0-120 hours) and Cmax of piroxicam (Feldene Flash) by approximately 13% to 15%. Elimination rate constants and half-life show no significant differences. The small but significant increase in absorption is unlikely to be clinically significant.
Cholestyramine: Cholestyramine has been shown to enhance the oral clearance and decrease the half-life of piroxicam (Feldene). To minimize this interaction, it is prudent to administer piroxicam (Feldene Flash) at least 2 hours before or 6 hours after cholestyramine.
Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding.
Cyclosporine: Increased risk of nephrotoxicity.
Lithium and other protein-bound agents: Piroxicam (Feldene Flash) is highly protein-bound, and therefore might be expected to displace other protein-bound drugs. The physician should closely monitor patients for change in dosage requirements when administering piroxicam (Feldene Flash) to patients on highly protein-bound drugs. NSAIDs, including piroxicam (Feldene Flash), have been reported to increase steady state plasma lithium levels. It is recommended that these levels be monitored when initiating, adjusting and discontinuing piroxicam (Feldene Flash).
Methotrexate: When methotrexate is administered concurrently with NSAIDs, including piroxicam, NSAIDs may decrease elimination of methotrexate resulting in increased plasma levels of methotrexate. Caution is advised, especially in patients receiving high doses of methotrexate.
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
Studies in man have shown that the concomitant administration of piroxicam (Feldene Flash) and acetylsalicylic acid resulted in a reduction of plasma levels of piroxicam (Feldene Flash) to about 80% of the normal values.
Piroxicam interferes with the antiplatelet effect of low-dose aspirin, and thus may interfere with aspirin's prophylactic treatment of CV disease.
Anti-coagulants: Bleeding has been reported rarely when piroxicam (Feldene Flash) has been administered to patients on coumarin type anti-coagulants. Patients should be monitored closely if piroxicam (Feldene Flash) and oral anticoagulants are administered together.
Piroxicam (Feldene Flash), like other NSAIDs, decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined.
Antacids: Concomitant administration of antacids had no effect on piroxicam (Feldene Flash) plasma levels.
Anti-hypertensives including diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II antagonists (AIIA) and beta-blockers: NSAIDs can reduce the efficacy of diuretics and other anti-hypertensive drugs including ACE inhibitors, AIIA and beta blockers.
In patients with impaired renal function (e.g., dehydrated patients or elderly patients with the renal function compromised), the co-administration of an ACE inhibitor or an AIIA and/or diuretics with a cyclo-oxygenase inhibitor can increase the deterioration of the renal function, including the possibility of acute renal failure, which is usually reversible.
The occurrence of these interactions should be considered in patients taking piroxicam (Feldene Flash) with an ACE inhibitor or an AIIA and/or diuretics. Therefore, the concomitant administration of these drugs should be done with caution, especially in elderly patients. Patients should be adequately hydrated and the need to monitor the renal function should be assessed in the beginning of the concomitant treatment and periodically thereafter.
Cardiac glycosides (digoxin and digitoxin): NSAIDs may exacerbate cardiac failure, reduce glomerular filtration rate (GFR) and increase plasma glycoside levels. Concomitant administration of digoxin or digitoxin had no effect on the plasma levels of piroxicam (Feldene Flash) or either drug.
Cimetidine: Results of two separate studies indicate a slight increase in absorption of piroxicam (Feldene Flash) following cimetidine administration but no significant changes in elimination parameters. Cimetidine increases the area under the curve (AUC0-120 hours) and Cmax of piroxicam (Feldene Flash) by approximately 13% to 15%. Elimination rate constants and half-life show no significant differences. The small but significant increase in absorption is unlikely to be clinically significant.
Cholestyramine: Cholestyramine has been shown to enhance the oral clearance and decrease the half-life of piroxicam (Feldene). To minimize this interaction, it is prudent to administer piroxicam (Feldene Flash) at least 2 hours before or 6 hours after cholestyramine.
Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding.
Cyclosporine: Increased risk of nephrotoxicity.
Lithium and other protein-bound agents: Piroxicam (Feldene Flash) is highly protein-bound, and therefore might be expected to displace other protein-bound drugs. The physician should closely monitor patients for change in dosage requirements when administering piroxicam (Feldene Flash) to patients on highly protein-bound drugs. NSAIDs, including piroxicam (Feldene Flash), have been reported to increase steady state plasma lithium levels. It is recommended that these levels be monitored when initiating, adjusting and discontinuing piroxicam (Feldene Flash).
Methotrexate: When methotrexate is administered concurrently with NSAIDs, including piroxicam, NSAIDs may decrease elimination of methotrexate resulting in increased plasma levels of methotrexate. Caution is advised, especially in patients receiving high doses of methotrexate.
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
Caution For Usage
Instructions for Use/Handling: Due to the physical nature of the freeze dried tablet, the blister pack is not a traditional push through type. The heat seal lacquer has been specially developed to allow the lidding material to be peeled to expose the tablet. Individual tablets are exposed in this manner.
The tablet may be swallowed with water, or placed on the tongue to disperse and then swallowed with the saliva. The fast dissolving tablet dissolves almost instantly in the mouth in the presence of water or saliva.
The tablet may be swallowed with water, or placed on the tongue to disperse and then swallowed with the saliva. The fast dissolving tablet dissolves almost instantly in the mouth in the presence of water or saliva.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacologic Category: Non-steroidal Anti-inflammatory Drug (NSAID).
Pharmacology: Pharmacodynamics: Piroxicam (Feldene Flash) is a non-steroidal anti-inflammatory agent, which also possesses analgesic and antipyretic properties. Edema, erythema, tissue proliferation, fever, and pain can all be inhibited in laboratory animals by the administration of piroxicam (Feldene Flash).
It is effective regardless of the etiology of the inflammation. While its mode of action is not fully understood, independent studies in vitro as well as in vivo have shown that piroxicam (Feldene Flash) interacts at several steps in the immune and inflammation responses through: Inhibition of prostanoid synthesis, including prostaglandins, through a reversible inhibition of the cyclooxygenase enzyme.
Inhibition of neutrophil aggregation.
Inhibition of polymorphonuclear cell and monocyte migration to the area of inflammation.
Inhibition of lysosomal enzyme release from stimulated leucocytes.
Inhibition of superoxide anion generation by the neutrophil.
Reduction of both systemic and synovial fluid rheumatoid factor production in patients with seropositive rheumatoid arthritis.
It is established that piroxicam (Feldene Flash) does not act by pituitary-adrenal axis stimulation. In vitro studies have not revealed any negative effects on cartilage metabolism.
In clinical studies piroxicam (Feldene Flash) has been found effective as an analgesic in pain of various etiologies (post-traumatic pain, post-episiotomy pain and post-operative pain). The onset of analgesia is prompt.
In primary dysmenorrhea the increased levels of endometrial prostaglandins cause uterine hypercontractility resulting in uterine ischemia and pain. Piroxicam (Feldene Flash), as a potent inhibitor of prostaglandin synthesis, has been shown to reduce uterine hypercontractility and to be effective in the treatment of primary dysmenorrhea.
Pharmacokinetics: Absorption and Distribution: Piroxicam (Feldene Flash) is well absorbed following oral administration. With food there is a slight delay in the rate but not the extent of absorption following oral administration. Stable plasma concentrations are maintained throughout the day on once-daily dosage. Continuous treatment with 20 mg/day for periods of 1 year produces similar blood levels to those seen once steady state is first achieved.
Drug plasma concentrations are proportional for 10 and 20 mg doses and generally peak within three to five hours after administration. A single 20 mg dose generally produces peak piroxicam (Feldene Flash) plasma levels of 1.5 to 2 mcg/ml while maximum drug plasma concentrations, after repeated daily ingestion of 20 mg piroxicam (Feldene Flash), usually stabilize at 3 to 8 mcg/ml. Most patients approximate steady state plasma levels within 7 to 12 days.
Treatment with a loading dose regimen of 40 mg daily for the first two days followed by 20 mg daily thereafter allows a high percentage (approximately 76%) of steady state levels to be achieved immediately following the second dose. Steady state levels, area under the curves and elimination half-life are similar to that following a 20 mg daily dose regimen.
A multiple dose comparative study of the bioavailability of the injectable form with the oral capsule has shown that after intramuscular administration of piroxicam, plasma levels are significantly higher than those obtained after ingestion of capsules during the 45 minutes following administration the first day, during 30 minutes the second day and 15 minutes the seventh day. Bioequivalence exists between the two dosage forms.
A multiple dose comparative study of the pharmacokinetics and the bioavailability of Piroxicam (Feldene Flash) tablets with the oral capsule has shown that after once daily administration for 14 days, the mean plasma piroxicam concentration time profiles for capsules and piroxicam (Feldene Flash) tablets were nearly superimposable. There were no significant differences between the mean steady state Cmax values, Cmin values, T½, or Tmax values. This study concluded that piroxicam (Feldene Flash) tablet is bioequivalent to the capsule after once daily dosing. Single dose studies have demonstrated bioequivalence as well, when the tablet is taken with or without water.
Metabolism and Elimination: Piroxicam (Feldene Flash) is extensively metabolized and less than 5% of the daily dose is excreted unchanged in urine and feces. Piroxicam (Feldene Flash) metabolism is predominantly mediated via cytochrome P450 CYP 2C9 in the liver. One important metabolic pathway is hydroxylation of the pyridyl ring of the piroxicam (Feldene Flash) side chain, followed by conjugation with glucuronic acid and urinary elimination. The plasma half-life is approximately 50 hours in man.
Patients who are known or suspected to be poor CYP2C9 metabolizers based on previous history/experience with other CYP2C9 substrates should be administered piroxicam (Feldene Flash) with caution as they may have abnormally high plasma levels due to reduced metabolic clearance (see Poor Metabolizers of CYP2C9 Substrates under Precautions).
Pharmacogenetics: CYP2C9 activity is reduced in individuals with genetic polymorphisms, such as the CYP2C9*2 and CYP2C9*3 polymorphisms. Limited data from two published reports showed that subjects with heterozygous CYP2C9*1/*2 (n=9), heterozygous CYP2C9*1/*3 (n=9), and homozygous CYP2C9*3/*3 (n=1) genotypes showed 1.7-, 1.7-, and 5.3-fold higher piroxicam (Feldene Flash) systemic levels, respectively, than the subjects with CYP2C9*1/*1 (n=17, normal metabolizer genotype) following administration of an oral single dose. The mean elimination half life values of piroxicam (Feldene Flash) for subjects with CYP2C9*1/*3 (n=9) and CYP2C9*3/*3 (n=1) genotypes were 1.7- and 8.8-fold higher than subjects with CYP2C9*1/*1 (n=17). It is estimated that the frequency of the homozygous*3/*3 genotype is 0% to 5.7% in various ethnic groups.
Toxicology: Preclinical Safety Data: Subacute and chronic toxicity studies have been carried out in rats, mice, dogs, and monkeys, using doses which ranged from 0.3 mg/kg/day to 25 mg/kg/day. The latter dose is approximately 90 times the recommended human dose level. The only pathology seen was that characteristically associated with the animal toxicology of non-steroidal anti-inflammatory agents; namely, renal papillary necrosis and gastrointestinal lesions. With regard to the latter, the monkey proved to be quite resistant to this effect and the dog unusually sensitive.
Pharmacology: Pharmacodynamics: Piroxicam (Feldene Flash) is a non-steroidal anti-inflammatory agent, which also possesses analgesic and antipyretic properties. Edema, erythema, tissue proliferation, fever, and pain can all be inhibited in laboratory animals by the administration of piroxicam (Feldene Flash).
It is effective regardless of the etiology of the inflammation. While its mode of action is not fully understood, independent studies in vitro as well as in vivo have shown that piroxicam (Feldene Flash) interacts at several steps in the immune and inflammation responses through: Inhibition of prostanoid synthesis, including prostaglandins, through a reversible inhibition of the cyclooxygenase enzyme.
Inhibition of neutrophil aggregation.
Inhibition of polymorphonuclear cell and monocyte migration to the area of inflammation.
Inhibition of lysosomal enzyme release from stimulated leucocytes.
Inhibition of superoxide anion generation by the neutrophil.
Reduction of both systemic and synovial fluid rheumatoid factor production in patients with seropositive rheumatoid arthritis.
It is established that piroxicam (Feldene Flash) does not act by pituitary-adrenal axis stimulation. In vitro studies have not revealed any negative effects on cartilage metabolism.
In clinical studies piroxicam (Feldene Flash) has been found effective as an analgesic in pain of various etiologies (post-traumatic pain, post-episiotomy pain and post-operative pain). The onset of analgesia is prompt.
In primary dysmenorrhea the increased levels of endometrial prostaglandins cause uterine hypercontractility resulting in uterine ischemia and pain. Piroxicam (Feldene Flash), as a potent inhibitor of prostaglandin synthesis, has been shown to reduce uterine hypercontractility and to be effective in the treatment of primary dysmenorrhea.
Pharmacokinetics: Absorption and Distribution: Piroxicam (Feldene Flash) is well absorbed following oral administration. With food there is a slight delay in the rate but not the extent of absorption following oral administration. Stable plasma concentrations are maintained throughout the day on once-daily dosage. Continuous treatment with 20 mg/day for periods of 1 year produces similar blood levels to those seen once steady state is first achieved.
Drug plasma concentrations are proportional for 10 and 20 mg doses and generally peak within three to five hours after administration. A single 20 mg dose generally produces peak piroxicam (Feldene Flash) plasma levels of 1.5 to 2 mcg/ml while maximum drug plasma concentrations, after repeated daily ingestion of 20 mg piroxicam (Feldene Flash), usually stabilize at 3 to 8 mcg/ml. Most patients approximate steady state plasma levels within 7 to 12 days.
Treatment with a loading dose regimen of 40 mg daily for the first two days followed by 20 mg daily thereafter allows a high percentage (approximately 76%) of steady state levels to be achieved immediately following the second dose. Steady state levels, area under the curves and elimination half-life are similar to that following a 20 mg daily dose regimen.
A multiple dose comparative study of the bioavailability of the injectable form with the oral capsule has shown that after intramuscular administration of piroxicam, plasma levels are significantly higher than those obtained after ingestion of capsules during the 45 minutes following administration the first day, during 30 minutes the second day and 15 minutes the seventh day. Bioequivalence exists between the two dosage forms.
A multiple dose comparative study of the pharmacokinetics and the bioavailability of Piroxicam (Feldene Flash) tablets with the oral capsule has shown that after once daily administration for 14 days, the mean plasma piroxicam concentration time profiles for capsules and piroxicam (Feldene Flash) tablets were nearly superimposable. There were no significant differences between the mean steady state Cmax values, Cmin values, T½, or Tmax values. This study concluded that piroxicam (Feldene Flash) tablet is bioequivalent to the capsule after once daily dosing. Single dose studies have demonstrated bioequivalence as well, when the tablet is taken with or without water.
Metabolism and Elimination: Piroxicam (Feldene Flash) is extensively metabolized and less than 5% of the daily dose is excreted unchanged in urine and feces. Piroxicam (Feldene Flash) metabolism is predominantly mediated via cytochrome P450 CYP 2C9 in the liver. One important metabolic pathway is hydroxylation of the pyridyl ring of the piroxicam (Feldene Flash) side chain, followed by conjugation with glucuronic acid and urinary elimination. The plasma half-life is approximately 50 hours in man.
Patients who are known or suspected to be poor CYP2C9 metabolizers based on previous history/experience with other CYP2C9 substrates should be administered piroxicam (Feldene Flash) with caution as they may have abnormally high plasma levels due to reduced metabolic clearance (see Poor Metabolizers of CYP2C9 Substrates under Precautions).
Pharmacogenetics: CYP2C9 activity is reduced in individuals with genetic polymorphisms, such as the CYP2C9*2 and CYP2C9*3 polymorphisms. Limited data from two published reports showed that subjects with heterozygous CYP2C9*1/*2 (n=9), heterozygous CYP2C9*1/*3 (n=9), and homozygous CYP2C9*3/*3 (n=1) genotypes showed 1.7-, 1.7-, and 5.3-fold higher piroxicam (Feldene Flash) systemic levels, respectively, than the subjects with CYP2C9*1/*1 (n=17, normal metabolizer genotype) following administration of an oral single dose. The mean elimination half life values of piroxicam (Feldene Flash) for subjects with CYP2C9*1/*3 (n=9) and CYP2C9*3/*3 (n=1) genotypes were 1.7- and 8.8-fold higher than subjects with CYP2C9*1/*1 (n=17). It is estimated that the frequency of the homozygous*3/*3 genotype is 0% to 5.7% in various ethnic groups.
Toxicology: Preclinical Safety Data: Subacute and chronic toxicity studies have been carried out in rats, mice, dogs, and monkeys, using doses which ranged from 0.3 mg/kg/day to 25 mg/kg/day. The latter dose is approximately 90 times the recommended human dose level. The only pathology seen was that characteristically associated with the animal toxicology of non-steroidal anti-inflammatory agents; namely, renal papillary necrosis and gastrointestinal lesions. With regard to the latter, the monkey proved to be quite resistant to this effect and the dog unusually sensitive.
MedsGo Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
Features
Brand
Feldene Flash
Full Details
Dosage Strength
20 mg
Drug Ingredients
- Piroxicam
Drug Packaging
Tablet 100's
Generic Name
Piroxicam
Dosage Form
Tablet
Registration Number
DRP-1990
Drug Classification
Prescription Drug (RX)