Indicated for:

• Relief of the signs and symptoms of osteoarthritis

• Relief of the signs and symptoms of rheumatoid arthritis

• Relief of the signs and symptoms of juvenile rheumatoid arthritis in pediatric patients 6-16 years of age

Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use

DAYPRO is contraindicated in patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients and In the setting of CABG surgery.

NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Patients with a prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs had a greater than 10-times increased risk for developing a GI bleed compared to patients without these risk factors. Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include longer duration of NSAID therapy; concomitant use of oral corticosteroids, aspirin, anticoagulants, or selective serotonin reuptake inhibitors (SSRIs); smoking; use of alcohol; older age; and poor general health status. Most postmarketing reports of fatal GI events occurred in elderly or debilitated patients. Additionally, patients with advanced liver disease and/or coagulopathy are at increased risk for GI bleeding.

The maximum recommended total daily dose of DAYPRO in adults is 1800 mg (26 mg/kg, whichever is lower) in divided doses. In children, doses greater than 1200 mg have not been studied.

Patients with low body weight should initiate therapy with 600 mg once daily. Patients with severe renal impairment or on dialysis should also initiate therapy with 600 mg once daily. If there is insufficient relief of symptoms in such patients, the dose may be cautiously increased to 1200 mg, but only with close monitoring

Avoid the use of DAYPRO in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events.

DAYPRO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Avoid the use of DAYPRO in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If DAYPRO is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as oxaprozin, increases the risk of serious gastrointestinal (GI) events.

Strategies to Minimize the GI Risks in NSAID-treated patients:

• Use the lowest effective dosage for the shortest possible duration
• Avoid administration of more than one NSAID at a time
• Avoid use in patients at higher risk unless benefits are expected to outweigh the increased risk of bleeding. For such patients, as well as those with active GI bleeding, consider alternate therapies other than NSAIDs
• Remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy
• If a serious GI adverse event is suspected, promptly initiate evaluation and treatment, and discontinue DAYPRO until a serious GI adverse event is ruled out
• In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding

NSAIDs, including DAYPRO, can lead to new onset of hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events.

Oxaprozin has been associated with anaphylactic reactions in patients with and without known hypersensitivity to oxaprozin and in patients with aspirin-sensitive asthma.

NSAIDs, including oxaprozin, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as DAYPRO. Some of these events have been fatal or life-threatening.

Oxaprozin has been associated with rash and/or mild photosensitivity in dermatologic testing.

Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs even in some patients without renal impairment. In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state.

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury.

Elevations of ALT or AST (three or more times the upper limit of normal [ULN]) have been reported in approximately 1% of NSAID-treated patients in clinical trials. In addition, rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure have been reported.

Anemia has occurred in NSAID-treated patients. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis.

NSAIDs, including DAYPRO, may increase the risk of bleeding events. Co-morbid conditions such as coagulation disorders or concomitant use of warfarin, other anticoagulants, antiplatelet agents (e.g., aspirin), serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk.

Monitor patients with concomitant use of DAYPRO 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.

NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).

In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure.

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.

The concomitant use of oxaprozin with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.

NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. During concomitant use of DAYPRO and lithium, monitor patients for signs of lithium toxicity.

Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction) because NSAID administration may result in increased plasma levels of methotrexate, especially in patients receiving high doses of methotrexate.

Concomitant use of DAYPRO and cyclosporine may increase cyclosporine nephrotoxicity.

Concomitant use of oxaprozin with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy. The concomitant use of oxaprozin with other NSAIDs or salicylates is not recommended.

Concomitant use of DAYPRO and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity.

Concomitant use of corticosteroids with DAYPRO may increase the risk of GI ulceration or bleeding.

During concomitant use of DAYPRO and glyburide, monitor patient’s blood glucose in the beginning phase of cotherapy.

NSAIDs are associated with reversible infertility. Consider withdrawal of DAYPRO in women who have difficulties conceiving.

Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation.

Lactation studies have not been conducted with DAYPRO. It is not known whether DAYPRO is excreted in human milk. 

GoToSource

• Use in pediatric patients under 6 years of age. GoToSource

• Use in patients under 18 years of age for osteoarthritis and rheumatoid arthritis. GoToSource

• Relief of postoperative oral surgery pain. GoToSource

• Gout. GoToSource

• Fibromyalgia. GoToSource

• Systemic lupus erythematosus. GoToSource

Stevens-johnson syndrome and toxic epidermal necrolysis (severe skin disorder). GoToSource

Liver injury. GoToSource

Allergic reactions, analgesic nephropathy (kidney injury) and increased bleeding times. GoToSource

Hypertension (high blood pressure). GoToSource

Pseudoporphyria (blistering skin condition). GoToSource

Submucosal hemorrhages or mucosal bleeding (bleeding from the mucosal lining of areas such as the mouth and nose). GoToSource

Myocardial infarction, stroke and tinnitus (ringing in the ears). GoToSource

Prolonged gestation and premature closure of the ductus arteriosus. GoToSource

Lawsuits filed for stevens-johnson syndrome and toxic epidermal necrolysis.