PHARMACIA

Daypro ALTA(tm) (oxaprozin potassium tablets)

DESCRIPTION

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 215degC. It is slightly soluble in alcohol and very soluble in water. The PK in water is 9.7. It has the following structural formula:

OK O

O

N

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.

CLINICAL PHARMACOLOGY

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.

Pharmacokinetics: (see Table 1)

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 the extent of absorption is unchanged. Antacids do not significantly affect the extent and rate of oxaprozin absorption.

Table 1

Oxaprozin Pharmacokinetic Parameters with Daypro ALTA Dosing (1200 mg); Mean (%CV)

Healthy Adults (18-42 years; N= 12-24)

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 in the 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.

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 conjugated metabolites of oxaprozin. A small amount (<5%) of active phenolic metabolites is produced, but the contribution to overall activity is limited.

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).

Special Populations

Pediatric:

Daypro ALTA has not been investigated in patients <16 years of age.

Geriatric:

As with any NSAID, caution should be exercised in treating the elderly (65 years and older). No dosage adjustment is necessary in the elderly for pharmacokinetic reasons, although many elderly may need a reduced dose due to low body weight or disorders associated with aging.

Gender:

No differences in pharmacokinetic parameters have been observed between male and female subjects in studies of Daypro ALTA.

Race:

Pharmacokinetic differences due to race have not been identified in studies of Daypro ALTA.

Hepatic Insufficiency:

Approximately 95% of oxaprozin is metabolized by the liver. However, patients with well-compensated cirrhosis do not require reduced doses of oxaprozin as compared to patients with normal hepatic function. Nevertheless, caution should be observed in patients with severe hepatic dysfunction.

Cardiac Failure:

Well-compensated cardiac failure does not affect the plasma protein binding or the pharmacokinetics of oxaprozin.

Renal Insufficiency:

The pharmacokinetics of oxaprozin has been investigated in patients with renal insufficiency. Oxaprozin's renal clearance decreased proportionally with creatinine clearance (CrCl). Since only about 5% of oxaprozin dose is excreted unchanged in the urine, the decrease in total body clearance becomes clinically important only in those subjects with highly decreased CrCl. Oxaprozin is not significantly removed from the blood in patients undergoing hemodialysis or CAPD due to its high protein binding. Oxaprozin plasma protein binding may decrease in patients with severe renal deficiency. Dosage adjustment may be necessary in patients with renal insufficiency (see PRECAUTIONS - Renal Effects).

Drug Interactions

(Also see PRECAUTIONS, Drug Interactions)

General:

The coadministration of oxaprozin and antacids, acetaminophen, or conjugated estrogens resulted in no statistically significant changes in pharmacokinetic parameters in single- and/or multiple-dose studies.

CLINICAL STUDIES

Osteoarthritis:

Daypro ALTA 1200 mg once daily was evaluated for the relief of the signs and symptoms of osteoarthritis in a 6-month placebo-controlled study versus oxaprozin acid in over 300 patients. In this trial, treatment with Daypro ALTA resulted in improvement in WOMAC (Western Ontario and McMaster Universities) osteoarthritis index, a composite of pain, stiffness, and functional measures in OA. Daypro ALTA demonstrated significant reduction in joint pain compared to placebo and was found to be comparable to 1200 mg once daily of oxaprozin acid.

With respect to GI events, Daypro ALTA appeared to be less well tolerated than oxaprozin acid in this study. The rates for symptomatic ulcers (2.2%) and nausea (13%) for Daypro ALTA treated patients were higher than the rates observed with oxaprozin acid (0% and 6%, respectively) (see ADVERSE REACTIONS).

Rheumatoid arthritis:

Oxaprozin, the active component of Daypro ALTA (oxaprozin potassium tablets), was evaluated for the relief of the signs and symptoms of rheumatoid arthritis in placebo and active controlled clinical trials in a total of 646 patients. Oxaprozin was given in single or divided daily doses of 600 to 1800 mg/day and was found to be comparable to 2600 to 3900 mg/day of aspirin.

CONTRAINDICATIONS

Daypro ALTA is contraindicated in patients with known hypersensitivity to oxaprozin. 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 (see WARNINGS - Anaphylactoid Reactions, and PRECAUTIONS - Pre-existing Asthma).

WARNINGS

Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding, and Perforation:

Serious gastrointestinal toxicity, such as inflammation, bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, can occur at any time, with or without warning symptoms, in patients treated with nonsteroidal anti- inflammatory drugs (NSAIDs). Minor upper gastrointestinal problems, such as dyspepsia, are common and may also occur at any time during NSAID therapy. Therefore, physicians and patients should remain alert for ulceration and bleeding, even in the absence of previous GI tract symptoms. Patients should be informed about the signs and/or symptoms of serious GI toxicity and the steps to take if they occur. The utility of periodic laboratory monitoring has not been demonstrated, nor has it been adequately assessed. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. It has been demonstrated that

upper GI ulcers, gross bleeding or perforation, caused by NSAIDs, appear to occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. These trends continue thus, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk. NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore special care should be taken in treating this population. To minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration. For high risk patients, alternate therapies that do not involve NSAIDs should be considered. Studies have shown that patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding and who use NSAIDs have a greater than 10-fold risk for developing a GI bleed than patients with neither of these risk factors. In addition to a past history of ulcer disease, pharmacoepidemiological studies have identified several other co-therapies or co-morbid conditions that may increase the risk for GI bleeding such as: treatment with oral corticosteroids, treatment with anticoagulants, longer duration of NSAID therapy, older age, smoking, alcoholism, and poor general health status.

Anaphylactoid Reactions:

As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to Daypro ALTA. Daypro ALTA should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs (see CONTRAINDICATIONS and PRECAUTIONS - Pre-existing Asthma). Emergency help should be sought in cases where an anaphylactoid reaction occurs.

Advanced Renal Disease:

In cases with advanced kidney disease, treatment with Daypro ALTA is not recommended. If NSAID therapy, however, must be initiated, close monitoring of the patient's kidney function is advisable (see PRECAUTIONS - Renal Effects).

Pregnancy:

In late pregnancy, as with other NSAIDs, Daypro ALTA should be avoided because it may cause premature closure of the ductus arteriosus.

PRECAUTIONS

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 used to substitute for corticosteroids or to treat for 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 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. 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.

Renal Effects:

Caution should be used when initiating treatment with Daypro ALTA in patients with considerable dehydration. It is advisable to rehydrate patients first and then start therapy with Daypro ALTA. Caution is also recommended in patients with pre-existing kidney disease (see WARNINGS - Advanced Renal Disease).

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal medullary changes. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of nonsteroidal anti-inflammatory drug therapy is usually followed by recovery to the pretreatment state. Metabolites of Daypro ALTA are eliminated primarily by the kidneys. The extent to which these metabolites may accumulate in patients with renal failure has not been studied. As with other NSAIDs whose metabolites are excreted by the kidneys, patients with significantly impaired renal function should be more closely monitored.

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. This may be due to fluid retention, GI 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.

All drugs which inhibit the biosynthesis of prostaglandins may interfere to some extent with platelet function and vascular responses to bleeding. 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. Daypro ALTA does not generally affect platelet counts, prothrombin time (PT), or partial thromboplastin time (PTT). 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.

Fluid Retention and Edema:

Fluid retention and edema have been observed in some patients taking NSAIDs. Therefore, as with other NSAIDs, Daypro ALTA should be used with caution in patients with fluid retention, hypertension, or heart failure.

Pre-existing 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.

Information for Patients:

Daypro ALTA, like other drugs of its class, can cause discomfort and, rarely, more serious side effects, such as gastrointestinal bleeding, which may result in hospitalization and even fatal outcomes. 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 signs or symptoms. Patients should be apprised of the importance of this follow-up (see WARNINGS - Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding and Perforation).

Patients should report to their physicians signs or symptoms of gastrointestinal ulceration or bleeding, skin rash, weight gain, or edema. 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 also be instructed to seek immediate emergency help in the case of an anaphylactoid reaction (see WARNINGS). In late pregnancy, as with other NSAIDs, Daypro ALTA should be avoided because it will cause premature closure of the ductus arteriosus.

Laboratory Tests:

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.

Drug Interactions

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 Daypro ALTA and aspirin is not generally recommended because of the potential of increased adverse effects.

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: 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 AUC0-24hr). 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.

Furosemide:

Clinical studies, as well as post-marketing observations, have shown that NSAIDs 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 PRECAUTIONS - Renal Effects), as well as to assure diuretic efficacy.

Lithium:

NSAIDs have 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 cotherapy.

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 may be expected for several days following discontinuation of oxaprozin therapy. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish oxaprozin from benzodiazepines.

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 on labor and delivery in pregnant women are unknown.

Nursing Mothers:

Studies of oxaprozin excretion in human milk have not been conducted; however, oxaprozin was found in the milk of lactating rats. Since the effects of oxaprozin on infants are not known and since there is a potential for serious adverse reactions in nursing infants, caution should be exercised if oxaprozin is administered to nursing women.

Pediatric Use:

Safety and effectiveness of Daypro ALTA in pediatric patients have not been established.

Geriatric Use:

Age was not shown to have an effect on the pharmacokinetics of Daypro ALTA following 600, 1200 and 1800 mg 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), 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 (see PRECAUTIONS Renal Effects).

OVERDOSAGE

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 may be 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.

DOSAGE AND ADMINISTRATION

As with other NSAIDs, the lowest dose should be sought for each patient, especially patients at increased risk due to renal or hepatic disease, low body weight, advanced age, a known ulcer diathesis, or known sensitivity to NSAID effects. Therefore, after observing the response to initial therapy with Daypro ALTA, 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.

HOW SUPPLIED

Daypro ALTA 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 25deg C (77degF); excursions permitted to 15-30degC (59-86degF) {see USP Controlled Room Temperature} in tightly-closed container. Protect from moisture.

Rx only

October 2002

G. D. Searle LLC A subsidiary of Pharmacia Corp. Chicago IL 60680 USA

PHARMACIA

Daypro ALTA(tm)

(oxaprozin potassium tablets)

part number