Etodolac tab 500 mg

NSAIDs 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.

Patients receiving Etodolac tablets, who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored. Pre-existing Asthma Patients with asthma may have aspirin-sensitive asthma.

The use of aspirin in patients with aspirin-sensitive asthmas 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, Etodolac should not be administered to patients with this form of aspirin sensitivity and should be used with caution in all patients with pre-existing asthma.

Information for Patients Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of on-going therapy. Cardiovascular Thrombotic Events Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately see WARNINGS.

Etodolac, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis.

Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms. Patients should be advised to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible.

Heart Failure And Edema Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur see WARNINGS. Patients should be informed of the warning signs and symptoms of hepatotoxicity e. If these occur, patients should be instructed to stop therapy and seek immediate medical therapy. Patients should be informed of the signs of an anaphylactoid reaction e.

In late pregnancy, the third trimester, as with other NSAIDs, Etodolac should be avoided because they may cause premature closure of the ductus arteriosus. Laboratory Tests Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding. Appropriate measures should be taken in case such signs of anemia occur. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur e.

Antacids The concomitant administration of antacids has no apparent effect on the extent of absorption of Etodolac. Aspirin When Etodolac is administered with aspirin, its protein binding is reduced, although the clearance of free Etodolac is not altered.

The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of Etodolac and aspirin is not generally recommended because of the potential of increased adverse effects. Cyclosporine, Digoxin, Methotrexate Etodolac, like other NSAIDs, through effects on renal prostaglandins, may cause changes in the elimination of these drugs leading to elevated serum levels of cyclosporine, digoxin, methotrexate, and increased toxicity.

Nephrotoxicity associated with cyclosporine may also be enhanced. Patients receiving these drugs who are given Etodolac, or any other NSAID, and particularly those patients with altered renal function, should be observed for the development of the specific toxicities of these drugs.

NSAIDs, such as Etodolac, should not be administered prior to or concomitantly with high doses of methotrexate. NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices.

This may indicate that they could enhance the toxicity of methotrexate. Diuretics Etodolac has no apparent pharmacokinetic interaction when administered with furosemide or hydrochlorothiazide.

Nevertheless, clinical studies, as well as postmarketing observations have shown that Etodolac can reduce the natriuretic effect of furosemide and thiazides in some patients with possible loss of blood pressure control. This response has been attributed to inhibition of renal prostaglandin synthesis. Glyburide Etodolac has no apparent pharmacokinetic interaction when administered with glyburide. Lithium NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance.

Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. Although in vivo studies have not been done to see if Etodolac clearance is changed by co-administration of phenylbutazone, it is not recommended that they be co-administered.

Phenytoin Etodolac has no apparent pharmacokinetic interaction when administered with phenytoin. Warfarin 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 that of users of either drug alone. Short-term pharmacokinetic studies have demonstrated that concomitant administration of warfarin and Etodolac results in reduced protein binding of warfarin, but there was no change in the clearance of free warfarin.

There was no significant difference in the pharmacodynamic effect of warfarin administered alone and warfarin administered with Etodolac as measured by prothrombin time. Thus, concomitant therapy with warfarin and Etodolac should not require dosage adjustment of either drug. However, caution should be exercised because there have been a few spontaneous reports of prolonged prothrombin times, with or without bleeding, in Etodolac-treated patients receiving concomitant warfarin therapy.

Close monitoring of such patients is therefore recommended. Diagnostic dip-stick methodology, used to detect ketone bodies in urine, has resulted in false-positive findings in some patients treated with Etodolac. Generally, this phenomenon has not been associated with other clinically significant events.

No dose relationship has been observed. Etodolac treatment is associated with a small decrease in serum uric acid levels. These levels then remained stable for up to 1 year of therapy. Etodolac was not mutagenic in in vitro tests performed with S. However, data from the in vitro human peripheral lymphocyte test showed an increase in the number of gaps 3 to 5.

Pregnancy Teratogenic Effects Pregnancy Category C In teratology studies, isolated occurrences of alterations in limb development were found and included polydactyly, oligodactyly, syndactyly, and unossified phalanges in rats and oligodactyly and synostosis of metatarsals in rabbits. However, the frequency and the dosage group distribution of these findings in initial or repeated studies did not establish a clear drug or dose-response relationship.

Animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women. Nonteratogenic Effects Etodolac should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.

Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system closure of ductus arteriosus , use during pregnancy particularly during the third trimester should be avoided. Labor and Delivery In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred.

The effects of Etodolac on labor and delivery in pregnant women are unknown. It is not known whether Etodolac is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Etodolac, 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.

Pediatric Use Safety and effectiveness in pediatric patients below the age of 18 have not been established. In Etodolac clinical studies, no overall differences in safety or effectiveness were observed between these patients and younger patients. In particular, elderly or debilitated patients who receive NSAID therapy seem to tolerate gastrointestinal ulceration or bleeding less well than other individuals, and most spontaneous reports of fatal GI events are in this population.

In clinical trials, most adverse reactions were mild and transient. Read the label of any other medicine you are using to see if it contains aspirin Bayer, Bufferin , ibuprofen, ketoprofen, or naproxen. Avoid exposure to sunlight or artificial UV rays sunlamps or tanning beds. Etodolac can make your skin more sensitive to sunlight and sunburn may result. Before taking etodolac, tell your doctor if you are allergic to any drugs, are a smoker, or if you have any of the following conditions: A history of heart attack, stroke, or blood clot A history of stomach ulcers or bleeding Liver or kidney disease Polyps in your nose A bleeding or blood clotting disorder If you have any of these conditions, you may need a dose adjustment or special tests to safely take etodolac.

Pregnancy and Etodolac This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking etodolac during the last three months of pregnancy may harm the unborn baby. 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.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. Hypertension NSAIDs, including etodolac capsules, can lead to onset of new hypertension or worsening of preexisting 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 etodolac capsules, should be used with caution in patients with hypertension. Etodolac capsules should be used with caution in patients with fluid retention or heart failure.

Gastrointestinal Effects — Risk of Ulceration , Bleeding, and Perforation NSAIDs, including etodolac capsules, 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.

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.

Other factors that increase the risk for 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 ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. 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 non-steroidal 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 ACEinhibitors, and the elderly.

Renal pelvic transitional epithelial hyperplasia , a spontaneous change occurring with variable frequency, was observed with increased frequency in treated male rats in a 2 year chronic study. Advanced Renal Disease No information is available from controlled clinical studies regarding the use of etodolac capsules in patients with advanced renal disease. Therefore, treatment with etodolac capsules is not recommended in these patients with advanced renal disease.

If etodolac capsule therapy must be initiated, close monitoring of the patient's renal function is advisable. Anaphylactoid Reactions As with other NSAIDs, anaphylactoid reactions may occur in patients without prior exposure to etodolac capsules. Etodolac capsules 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. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. 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 etodolac capsules in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis , liver necrosis, and hepatic failure, some of them with fatal outcomes, have been reported.

If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur e. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis.

Patients on long-term treatment with NSAIDs, including etodolac capsules, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia. NSAIDs 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.

Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Preexisting Asthma Patients with asthma may have aspirin-sensitive asthma. Etodolac is not significantly removed from the blood in patients undergoing hemodialysis. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required. Anaphylactoid Reactions As with other NSAIDs, anaphylactoid reactions may occur in patients without prior exposure to etodolac capsules. Nervous system - Insomnia, somnolence. Nevertheless, clinical studies, as well as post marketing observations have shown that etodolac can reduce the natriuretic effect of furosemide and thiazides in some patients. If etodolac capsule therapy must be initiated, close monitoring of the patient's renal function is advisable. Duration of relief averaged 4 to 5 hours for mg of Etodolac and 5 to 6 hours for mg of Etodolac as measured by when approximately half of the patients required remedication. NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Etodolac is eliminated primarily by the kidney. Pregnancy and Etodolac This medication may be harmful to an unborn baby. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDsand may occur following overdose. However, caution should be exercised because there have been a few spontaneous reports of prolonged prothrombin times, with or without bleeding, in etodolac-treated patients receiving etodolac warfarin therapy, etodolac tab 500 mg. Advanced Renal Disease No information is available from controlled clinical studies regarding the use of etodolac capsules in patients tab advanced renal disease. 500 Effects - Risk of Ulceration, Bleeding, and Perforation NSAIDs, including Etodolac, can cause serious gastrointestinal GI adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, etodolac tab 500 mg, small intestine or large intestine, which can be fatal.

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