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Daypro Alta (Tablet, Film Coated)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3164

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Daypro Alta (Tablet, Film Coated)
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Carefully consider the potential benefits and risks of DAYPRO ALTA and other treatment options before deciding to use DAYPRO ALTA. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals . After observing the response to initial therapy with DAYPRO ALTA, the dose and frequency should be adjusted to suit an individual patient's needs.<br/>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.
dailymed-instance:descripti...
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 CHNOKand 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 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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Pharmacodynamics: DAYPRO ALTA, the potassium salt of oxaprozin, is a nonsteroidal anti-inflammatory drug (NSAID), which dissociates into the active moiety oxaprozin in vivo. Oxaprozin has been shown to have anti-inflammatory, analgesic, and antipyretic properties in animal models. The mechanism of action of DAYPRO ALTA, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition.<br/>Pharmacokinetics: (see Table 1)<br/>Absorption: After oral administration, DAYPRO ALTA dissociates into free oxaprozin which is 95% absorbed. Peak plasma concentration occurs at about 1 hour and 45 minutes after single dose administration (see Table 1). When DAYPRO ALTA is administered with food, the peak concentration of oxaprozin is delayed by about 45 minutes, but theextent of absorption is unchanged. Antacids do not significantly affect the extent and rate of oxaprozin absorption.<br/>Distribution: In dose proportionality studies utilizing 600, 1200 and 1800 mg doses, the pharmacokinetics of oxaprozin in healthy subjects has demonstrated nonlinear kinetics of both the total and unbound drug in opposite directions, i.e., dose exposure related increase in the clearance of total drug and decrease in the clearance of the unbound drug. Concentration dependent changes in the protein binding also resulted in changes inthe oxaprozin volume of distribution, which increased for the total drug but decreased for the unbound drug. The apparent volume of distribution (Vd/F) of total oxaprozin is approximately 10���16 L/70 kg. Oxaprozin potassium is 99% bound to plasma proteins, primarily to albumin. At therapeutic drug concentrations, the plasma protein binding of oxaprozin is saturable, resulting in a higher proportion of the free drug as the total drug concentration is increased. With increases in single doses or following repetitive once-daily dosing, the apparent volume of distribution and clearance of total drug increased, while that of unbound drug decreased due to the effects of nonlinear protein binding. Oxaprozin is expected to be excreted in human milk based on its physical���chemical properties, however, the amount of oxaprozin excreted in breast milk has not been evaluated.<br/>Metabolism: Several oxaprozin metabolites excreted in human urine or feces are considered not to have significant pharmacologic activity. Oxaprozin is primarily metabolized by the liver, by both microsomal oxidation (65%) and glucuronic acid conjugation (35%). Ester and ether glucuronides are the major conjugatedmetabolites of oxaprozin. A small amount (<5%) of active phenolic metabolites is produced, but the contribution to overall activity is limited.<br/>Excretion: Sixty-five percent (65%) of the dose is excreted into the urine and 35% in the feces as metabolites. Renal elimination of oxaprozin metabolites is a major pathway of elimination. Biliary excretion of unchanged oxaprozin is a minor pathway. After multiple doses of DAYPRO ALTA (1200mg QD), post-steady state mean elimination half-lives of total oxaprozin and protein unbound oxaprozin were 38.0 and 16.4 hrs, respectively (see Table 1).<br/>Special Populations:<br/>Drug Interactions:
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DAYPRO ALTA is contraindicated in patients with known hypersensitivity to oxaprozin potassium. DAYPRO ALTA 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 . DAYPRO ALTA is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery .
dailymed-instance:supply
DAYPRO ALTA 600 mg tablets are blue, capsule-shaped, film-coated, with Searle 1391 printed on one side. NDC Number Size0025-5500-01 bottle of 1000025-5500-03 bottle of 5000025-5500-02 carton of 100 unit dose Store at 25��C (77��F); excursions permitted to 15���30��C (59���86��F) (see USP Controlled Room Temperature) in tightly-closed container. Protect from moisture.
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Cardiovascular Risk:<br/>Gastrointestinal Risk:
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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 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 in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.<br/>Hepatic Effects: Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs including DAYPRO ALTA. 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. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.). DAYPRO ALTA should be discontinued.<br/>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.<br/>Hematological Effects: Anemia is sometimes seen in patients receiving NSAIDs, including DAYPRO ALTA. 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, 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 who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.<br/>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 should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.<br/>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.<br/>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 should be discontinued.<br/>Drug Interactions:<br/>Aspirin: When DAYPRO ALTA is administered with aspirin, its protein binding is reduced, although the clearance of free DAYPRO ALTA 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.<br/>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.<br/>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 AUCand C) and its active metabolite enalaprilat (significant increase in dose-adjusted AUC).<br/>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 , as well as to assure diuretic efficacy.<br/>Lithium: DAYPRO ALTA, 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 bemonitored and subjects should be observed carefully for signs of lithium toxicity.<br/>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.<br/>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.<br/>H���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 inthe outcome of therapy.<br/>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.<br/>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.<br/>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/m/day); the usual human dose is 17 mg/kg/day, or (629 mg/m/day). However, testicular degeneration was observed in beagle dogs treated with 37.5 to 150 mg/kg/day (750 to 3000 mg/m/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.<br/>Pregnancy:<br/>Teratogenic Effects:<br/>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.<br/>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 on labor and delivery in pregnant women are unknown.<br/>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, a decision should be made whether to discontinue nursing orto discontinue the drug, taking into account the importance of the drug to the mother.<br/>Pediatric Use: Safety and effectiveness of DAYPRO ALTA in pediatric patients have not been established.<br/>Geriatric Use: Age was not shown to have an effect on the pharmacokinetics of DAYPRO ALTA following 600, 1200 and 1800 rug doses or on the incidence of adverse reactions reported . In a controlled 6-month clinical trial of 803 patients (322 of whom received DAYPRO ALTA), 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 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 .
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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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oxaprozin potassium
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Daypro Alta (Tablet, Film Coated)
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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 : 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.
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Carefully consider the potential benefits and risks of DAYPRO ALTA and other treatment options before deciding to use DAYPRO ALTA. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals . DAYPRO ALTA is indicated:
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Daypro Alta