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- Patient Information:
Details with Side Effects
In patients taking Lodine (etodolac) or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1-10% of patients are:
Adverse-reaction information for Lodine (etodolac) was derived from 2,629 arthritic patients treated with Lodine (etodolac capsules and tablets) in double-blind and open-label clinical trials of 4 to 320 weeks in duration and worldwide postmarketing surveillance studies. In clinical trials, most adverse reactions were mild and transient. The discontinuation rate in controlled clinical trials, because of adverse events, was up to 10% for patients treated with Lodine (etodolac) .
New patient complaints (with an incidence greater than or equal to 1%) are listed below by body system. The incidences were determined from clinical trials involving 465 patients with osteoarthritis treated with 300 to 500 mg of Lodine (etodolac) b.i.d. (i.e., 600 to 1000 mg/day).
Incidence Greater Than Or Equal To 1%—Probably Causally Related
Body as a whole—Chills and fever.
Nervous system—Asthenia/malaise*, dizziness*, depression, nervousness.
Special senses—Blurred vision, tinnitus.
*Drug-related patient complaints occurring in 3 to 9% of patients treated with Lodine (etodolac) . Drug-related patient-complaints occurring in fewer than 3%, but more than 1%, are unmarked.
Incidence Less Than 1%—Probably Causally Related
(Adverse reactions reported only in worldwide postmarketing experience, not seen in clinical trials, are considered rarer and are italicized.)
Digestive system—Thirst, dry mouth, ulcerative stomatitis, anorexia, eructation, elevated liver enzymes, cholestatic hepatitis, hepatitis, cholestatic jaundice, duodenitis, jaundice, hepatic failure, liver necrosis, peptic ulcer with or without bleeding and/or perforation, intestinal ulceration, pancreatitis.
Metabolic and nutritional—Edema, serum creatinine increase, hyperglycemia in previously controlled diabetic patients.
Skin and appendages—Angioedema, sweating, urticaria, vesiculobullous rash, cutaneous vasculitis with purpura, Stevens-Johnson Syndrome, toxic epidermal necrolysis, hyperpigmentation, erythema multiforme.
Special senses—Photophobia, transient visual disturbances.
Urogenital system—Elevated BUN, renal failure, renal insufficiency, renal papillary necrosis.
Incidence Less Than 1%—Causal Relationship Unknown
(Medical events occurring under circumstances where causal relationship to Lodine (etodolac) is uncertain. These reactions are listed as alerting information for physicians.)
Body as a whole—Infection, headache.
Metabolic and nutritional—Change in weight.
Nervous system—Paresthesia, confusion.
Additional Adverse Reactions Reported with NSAIDS
Body as a whole—Sepsis, death
Hemic and lymphatic system—Lymphadenopathy
Respiratory system—Respiratory depression, pneumonia
Urogenital system—Oliguria/polyuria, proteinuria
Read the Lodine (etodolac) Side Effects Center for a complete guide to possible side effects
Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors (see WARNINGS).
The concomitant administration of antacids has no apparent effect on the extent of absorption of Lodine (etodolac) . However, antacids can decrease the peak concentration reached by 15% to 20% but have no detectable effect on the time-to-peak.
When Lodine (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
Lodine (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 Lodine (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 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 NSAIDs are administered concomitantly with methotrexate.
Etodolac has no apparent pharmacokinetic interaction when administered with furosemide or hydrochlorothiazide. Nevertheless, clinical studies, as well as postmarketing observations have shown that Lodine (etodolac) 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 (see WARNINGS, Renal Effects), as well as to assure diuretic efficacy.
Etodolac has no apparent pharmacokinetic interaction when administered with glyburide.
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 NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.
Phenylbutazone causes increase (by about 80%) in the free fraction of etodolac. Although in vivo studies have not been done to see if etodolac clearance is changed by coadministration of phenylbutazone, it is not recommended that they be coadministered.
Etodolac has no apparent pharmacokinetic interaction when administered with phenytoin.
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 Lodine® (etodolac capsules and tablets) 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 Lodine (etodolac) as measured by prothrombin time. Thus, concomitant therapy with warfarin and Lodine (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.
Drug/Laboratory Test Interactions
The urine of patients who take Lodine (etodolac) can give a false-positive reaction for urinary bilirubin (urobilin) due to the presence of phenolic metabolites of etodolac. Diagnostic dip-stick methodology, used to detect ketone bodies in urine, has resulted in false-positive findings in some patients treated with Lodine (etodolac) . Generally, this phenomenon has not been associated with other clinically significant events. No dose relationship has been observed.
Lodine (etodolac) treatment is associated with a small decrease in serum uric acid levels. In clinical trials, mean decreases of 1 to 2 mg/dL were observed in arthritic patients receiving etodolac (600 mg to 1000 mg/day) after 4 weeks of therapy. These levels then remained stable for up to 1 year of therapy.
Last reviewed on RxList: 9/10/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Lodine Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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