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Monitor patients with concomitant use of naproxen with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding |
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Naproxen is not a substitute for low dose aspirin for cardiovascular protection. |
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Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. |
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During concomitant use of naproxen with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects |
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The concomitant use of naproxen with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. |
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During concomitant use of naproxen and digoxin, monitor serum digoxin levels. |
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NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis. |
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During concomitant use of naproxen and lithium, monitor patients for signs of lithium toxicity. |
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Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). |
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During concomitant use of naproxen and methotrexate, monitor patients for methotrexate toxicity. |
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Concomitant use of naproxen and cyclosporine may increase cyclosporine’s nephrotoxicity. |
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During concomitant use of naproxen and cyclosporine, monitor patients for signs of worsening renal function. |
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Concomitant use of naproxen with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy |
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The concomitant use of naproxen with other NSAIDs or salicylates is not recommended. |
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Concomitant use of naproxen and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information). |
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During concomitant use of naproxen and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration. |
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Concomitant administration of some antacids (magnesium oxide or aluminum hydroxide) and sucralfate can delay the absorption of naproxen. |
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Concomitant administration of antacids such as magnesium oxide or aluminum hydroxide, and sucralfate with naproxen is not recommended. |
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Concomitant administration of cholestyramine can delay the absorption of naproxen. |
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Concomitant administration of cholestyramine with naproxen is not recommended. |
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Probenecid given concurrently increases naproxen anion plasma levels and extends its plasma half-life significantly. |
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Patients simultaneously receiving naproxen and probenecid should be observed for adjustment of dose if required. |
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Naproxen is highly bound to plasma albumin; it thus has a theoretical potential for interaction with other albumin-bound drugs such as coumarin-type anticoagulants, sulphonylureas, hydantoins, other NSAIDs, and aspirin. |
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Patients simultaneously receiving naproxen and a hydantoin, sulphonamide or sulphonylurea should be observed for adjustment of dose if required. |
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Naproxen may decrease platelet aggregation and prolong bleeding time. |
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This effect should be kept in mind when bleeding times are determined. |
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The administration of naproxen may result in increased urinary values for 17-ketogenic steroids because of an interaction between the drug and/or its metabolites with m-di-nitrobenzene used in this assay. |
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Although 17-hydroxy-corticosteroid measurements (Porter-Silber test) do not appear to be artifactually altered, it is suggested that therapy with naproxen be temporarily discontinued 72 hours before adrenal function tests are performed if the Porter-Silber test is to be used. |
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Naproxen may interfere with some urinary assays of 5-hydroxy indoleacetic acid (5HIAA). |
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This effect should be kept in mind when urinary 5-hydroxy indoleacetic acid are determined. |
Parameter (units) |
Naproxen 500 mg Q12h/5 days (1000 mg) |
Naproxen Sodium Extended-Release 2 x 500 mg Tablets (1000 mg) Q24h/5 days |
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Mean | SD | Range | Mean | SD | Range | |
AUC 0-24 (mcg x h/mL) | 1446 | 168 | 1167 to 1858 | 1448 | 145 | 1173 to 1774 |
Cmax (mcg/mL) | 95 | 13 | 71 to 117 | 94 | 13 | 74 to 127 |
Cavg (mcg/mL) | 60 | 7 | 49 to 77 | 60 | 6 | 49 to 74 |
Cmin (mcg/mL) | 36 | 9 | 13 to 51 | 33 | 7 | 23 to 48 |
Tmax (hrs) | 3 | 1 | 1 to 4 | 5 | 2 | 2 to 10 |
Dispense with Medication Guide available at: www.tevausa.com/medguides | |
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Anti-inflammatory Drugs (NSAIDs)?”
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Manufactured For: |