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In patients taking DAYPRO ALTA (oxaprozin potassium tablets), oxaprozin, or other NSAIDs , the following are the most frequently reported adverse experiences occurring in approximately 1-10% of patients (see CLINICAL STUDIES, Osteoarthritis):
Gastrointestinal experiences including
Non-gastrointestinal experiences including
abnormal renal function, anemia, confusion, depression, disturbance of sleep, dizziness, dysuria or frequency, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes, sedation, somnolence, tinnitus.
Additional adverse experiences reported in less than 1% of patients
Digestive system-- alteration in taste, dry mouth, eructation, esophagitis, gastritis, glossitis, hematemesis, hemorrhoidal or rectal bleeding, hepatitis, jaundice, liver failure, pancreatitis, stomatitis.
Metabolic and nutritional-- hyperglycemia, weight changes.
Skin and appendages-- alopecia. angioedema, increased sweating, photosensitivity, pseudoporphyria, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell'ssyndrome), urticaria.
Urogenital system--acute interstitial nephritis, acute renal failure, cystitis, decreased menstrual flow, hematuria, increase in menstrual flow, nephrotic syndrome, oliguria/polyuria, proteinuria, renal insufficiency.
Read the Daypro Alta (oxaprozin) Side Effects Center for a complete guide to possible side effects
When DAYPRO ALTA (oxaprozin) is administered with aspirin, its protein binding is reduced, although the clearance of free DAYPRO ALTA (oxaprozin) is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of oxaprozin potassium and aspirin is not generally recommended because of the potential of increased adverse effects.
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.
Coadministration of oxaprozin with methotrexate results in approximately a 36% decrease in oral plasma clearance of methotrexate. A reduction in methotrexate dosage may be considered due to the potential for increased methotrexate toxicity associated with the increased exposure.
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. Oxaprozin has been shown to alter the pharmacokinetics of enalapril (significant decrease in dose-adjusted AUC0-24hr and Cmax) and its active metabolite enalaprilat (significant increase in dose-adjusted AUC0-24).
Clinical studies, as well as post-marketing observations, have shown that DAYPRO ALTA 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 patients should be observed closely for signs of renal failure (see WARNINGS, Renal Effects), as well as to assure diuretic efficacy.
DAYPRO ALTA (oxaprozin) , like other NSAIDs, has produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration was increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by NSAIDs. Thus, when NSAIDs and lithium are administered concurrently, lithium level should be monitored and subjects should be observed carefully for signs of lithium toxicity.
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 the users of either drug alone.
While oxaprozin does alter the pharmacokinetics of glyburide, coadministration of oxaprozin to type II non-insulin dependent diabetic patients did not affect the area under the glucose concentration curve or the magnitude or duration of control. However, it is advisable to monitor patients' blood glucose in the beginning phase of glyburide and oxaprozin co-therapy.
H2— receptor antagonists
The total body clearance of oxaprozin was reduced by 20% in subjects who concurrently received therapeutic doses of cimetidine or ranitidine; no other pharmacokinetic parameter was affected. A change of clearance of this magnitude lies within the range of normal variation and is unlikely to produce a clinically detectable difference in the outcome of therapy.
Subjects receiving 1200 mg oxaprozin once daily with 100 mg metoprolol twice daily exhibited statistically significant but transient increases in sitting and standing blood pressures after 14 days. Therefore, routine blood pressure monitoring should be considered in these patients when starting oxaprozin therapy.
Laboratory Test Interactions:
False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking oxaprozin. This is due to lack of specificity of the screening tests. False-positive test results maybe expected for several days following discontinuation of oxaprozin therapy. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish oxaprozin from benzodiazepines.
Last reviewed on RxList: 4/17/2008
This monograph has been modified to include the generic and brand name in many instances.
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