Drug: Daypro Alta

DAYPRO ALTA (oxaprozin potassium tablets) is a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each blue, capsule-shaped tablet contains oxaprozin potassium (678mg equivalent to 600mg of oxaprozin) for oral administration. The chemical name for oxaprozin potassium is 4,5-diphenyl-2-oxazolepropionic acid, potassium salt. Its empirical formula is C18H14NO3K and molecular weight is 331. Oxaprozin potassium is a white to off white powder with a melting point of 215°C. It is slightly soluble in alcohol and very soluble in water. The PK in water is 9.7. It has the following structural formula: Inactive ingredients in DAYPRO ALTA (oxaprozin) tablets include microcrystalline cellulose, hydroxypropyl methylcellulose, pregelatinized corn starch, stearic acid, colloidal silicon dioxide, polyethylene glycol, titanium dioxide, FD&C Blue #1 Aluminum Lake, and pharmaceutical glaze.

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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 Abdominal pain, anorexia, constipation, diarrhea, dyspepsia, flatulence, gross gastrointestinal bleeding/perforation, GI ulcers (gastric/duodenal), heartburn, nausea, vomiting. 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 Body as a whole-- anaphylactic reactions, appetite changes, death, fever, infection, sepsis, serum sickness. Cardiovascular system-- arrhythmia, blood pressure changes, congestive heart failure, hypertension, hypotension, myocardial infarction, palpitations, syncope, tachycardia, vasculitis. Digestive system-- alteration in taste, dry mouth, eructation, esophagitis, gastritis, glossitis, hematemesis, hemorrhoidal or rectal bleeding, hepatitis, jaundice, liver failure, pancreatitis, stomatitis. Hemic and lymphatic system-- agranulocytosis, aplastic anemia, ecchymosis, eosinophilia, hemolytic anemia, leukopenia, lymphadenopathy, melena, pancytopenia, purpura, thrombocytopenia. Metabolic and nutritional-- hyperglycemia, weight changes. Nervous system-- anxiety, asthenia, coma, convulsions, dream abnormalities, drowsiness, hallucinations, insomnia, malaise, meningitis, nervousness, paresthesia, tremors, vertigo, weakness. Respiratory system-- asthma, dyspnea, pneumonia, pulmonary infections, respiratory depression, sinusitis, symptoms of upper respiratory tract infection. Skin and appendages-- alopecia. angioedema, increased sweating, photosensitivity, pseudoporphyria, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell'ssyndrome), urticaria. Special senses-- blurred vision, conjunctivitis, hearing impairment. 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 effectsLearn More »

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Carefully consider the potential benefits and risks of DAYPRO ALTA (oxaprozin) and other treatment options before deciding to use DAYPRO ALTA (oxaprozin) . Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). After observing the response to initial therapy with DAYPRO ALTA (oxaprozin) , the dose and frequency should be adjusted to suit an individual patient's needs. Osteoarthritis and Rheumatoid Arthritis: The recommended dose of DAYPRO ALTA for the relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis is 1200 mg (two 600 mg tablets) once a day. Divided doses may be tried in patients unable to tolerate single doses. For osteoarthritis patients of low body weight of with milder disease, an initial dose of one 600 mg tablet once a day may be appropriate. The maximum total daily dose is 1200 mg.

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Aspirin 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. 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. 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. ACE-Inhibitors 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). Diuretics 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. Lithium 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. 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 the users of either drug alone. Glyburide 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. Beta-blockers 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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DAYPRO ALTA (oxaprozin) is contraindicated in patients with known hypersensitivity to oxaprozin potassium. DAYPRO ALTA (oxaprozin) should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS - Anaphylactoid Reactions, and PRECAUTIONS - Pre-existing Asthma). DAYPRO ALTA (oxaprozin) is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).Last reviewed on RxList: 4/17/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

DAYPRO ALTA (oxaprozin) is contraindicated in patients with known hypersensitivity to oxaprozin potassium. DAYPRO ALTA (oxaprozin) should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS - Anaphylactoid Reactions, and PRECAUTIONS - Pre-existing Asthma). DAYPRO ALTA (oxaprozin) is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).Last reviewed on RxList: 4/17/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDS, and may occur following an overdose. Patients should be managed by symptomatic and supportive care following NSAID overdose, There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic maybe indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

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DAYPRO ALTA (oxaprozin) 600 mg tablets are blue, capsule-shaped, film-coated, with Searle 1391 printed on one side. NDC Number Size 0025-5500-01 bottle of 100 0025-5500-03 bottle of 500 0025-5500-02 carton of 100 unit dose Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) (see USP Controlled Room Temperature) in tightly-closed container. Protect from moisture. G.D. Searle LLC., Division of Pfizer Inc, NY, NY 10017. Revised January 2007. FDA Rev date: 7/5/2007 Last reviewed on RxList: 4/17/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General DAYPRO ALTA should not be used concomitantly with other oxaprozin-containing products, since all such products circulate in the plasma as the oxaprozin anion. DAYPRO ALTA (oxaprozin) cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. 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 DAYPRO ALTA (oxaprozin) in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions. Hepatic Effects Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs including DAYPRO ALTA (oxaprozin) . These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs. 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. A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with DAYPRO ALTA (oxaprozin) . If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.). DAYPRO ALTA (oxaprozin) should be discontinued. Photosensitivity Oxaprozin has been associated with rash and/or mild photosensitivity in dermatologic testing. An increased incidence of rash on sun-exposed skin was seen in some patients in clinical trials. Hematological Effects Anemia is sometimes seen in patients receiving NSAIDs, including DAYPRO ALTA (oxaprozin) . 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 DAYPRO ALTA (oxaprozin) , 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. Patients receiving DAYPRO ALTA (oxaprozin) who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored. Preexisting Asthma Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma 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, DAYPRO ALTA (oxaprozin) should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma. Information for Patients: Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed.
  • DAYPRO ALTA (oxaprozin) , like other NSAIDs, may cause CV side effects, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up (see WARNINGS, Cardiovascular Effects).
  • DAYPRO ALTA (oxaprozin) , 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. Patients should be apprised of the importance of this follow-up (see WARNINGS: Gastrointestinal Effects: Risk of Ulceration, Bleeding and Perforation).
  • DAYPRO ALTA (oxaprozin) , like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS and TEN, which may result in hospitalization and even death. 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 hypersensitivity such as itching, and should ask for medical advice when observing any indicative sign 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.
  • Patients should promptly report, signs or symptoms of unexplained weight gain, or edema to their physicians.
  • Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness and “flu-like” symptoms). 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.g. difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help (see WARNINGS, Anaphylactoid reactions).
  • In late pregnancy, as with other NSAIDs, DAYPRO ALTA (oxaprozin) should be avoided because it 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 Patients on long-term treatment with NSAIDs should have their CBC and a chemistry profile checked periodically. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (e.g., eosinophilia, rash, etc.) or if abnormal liver tests persist or worsen, DAYPRO ALTA (oxaprozin) should be discontinued. Carcinogenesis, mutagenesis, impairment of fertility In oncogenicity studies, oxaprozin administration for 2 years was associated with the exacerbation of liver neoplasms (hepatic adenomas and carcinomas) in male CD mice, but not in female CD mice or rats. The significance of this species-specific finding to man is unknown. Oxaprozin did not display mutagenic potential. No evidence of genetic toxicity or cell-transforming ability was found in test results from the Ames test, forward mutation in yeast and Chinese hamster ovary (CHO) cells, DNA repair testing in CHO cells, micronucleus testing in mouse bone marrow, chromosomal aberration testing in human lymphocytes, or cell transformation testing in mouse fibroblast. Oxaprozin administration was not associated with impairment of fertility in male and female rats at oral doses up to 200mg/kg/day (1180 mg/m2/day); the usual human dose is 17 mg/kg/day, or (629 mg/m2/day). However, testicular degeneration was observed in beagle dogs treated with 37.5 to 150 mg/kg/day (750 to 3000 mg/m2/day) of oxaprozin for 6 months, or 37.5 mg/kg/day for 42 days, a finding not confirmed in other species. The clinical relevance of this finding is not known. Pregnancy Teratogenic Effects: Pregnancy Category C. There are no adequate or well-controlled studies in pregnant women. Teratology studies with oxaprozin were performed in mice, rats, and rabbits. In mice and rats, no drug-related developmental abnormalities were observed at 50 to 200mg/kg/day of oxaprozin (225 to 900 mg/m2/day). However, in rabbits, infrequent malformed fetuses were observed in dams treated with 7.5 to 30mg/kg/day of oxaprozin (the usual human dosage range). Animal reproduction studies are not always predictive of human response. Oxaprozin should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. Nonteratogenic Effects Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly late pregnancy) 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 DAYPRO ALTA (oxaprozin) on labor and delivery in pregnant women are unknown. Nursing Mothers It is not known whether this drug is excreted in human milk; however, oxaprozin was found in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from DAYPRO ALTA (oxaprozin) , 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 of DAYPRO ALTA (oxaprozin) in pediatric patients have not been established. Geriatric Use Age was not shown to have an effect on the pharmacokinetics of DAYPRO ALTA (oxaprozin) following 600, 1200 and 1800 rug doses or on the incidence of adverse reactions reported (see CLINICAL PHARMACOLOGY, Special Populations). In a controlled 6-month clinical trial of 803 patients (322 of whom received DAYPRO ALTA (oxaprozin) ), about 40% of whom were elderly, there was basically no difference detected in terms of the total number of subjects reporting adverse events with respect to age. As with any NSAID, the elderly are likely to tolerate adverse reactions less well than younger patients. Caution should be exercised in treating the elderly (65 years and older), and extra care should be taken when choosing a dose. Oxaprozin is substantially excreted by the kidney, and the risk of toxic reactions to DAYPRO ALTA (oxaprozin) may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see WARNINGS, Renal Effects).Last reviewed on RxList: 4/17/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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