DAYPRO® Contraindications (oxaprozin) | Pfizer Medical Information - US

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4 CONTRAINDICATIONS

DAYPRO is contraindicated in the following patients:

Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to oxaprozin or any components of the drug product [see Warnings and Precautions (5.7, 5.9)]
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 [see Warnings and Precautions (5.7, 5.8)]
In the setting of CABG surgery [see Warnings and Precautions (5.1)]

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Resources

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...

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WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

...

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1 INDICATIONS AND USAGE

DAYPRO is indicated:

For relief of the signs and symptoms of osteoarthritis
For relief of the signs and symptoms of rheumatoid arthritis
For relief of the signs...

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2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Instructions

Carefully consider the potential benefits and risks of DAYPRO and other treatment options before deciding...

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3 DOSAGE FORMS AND STRENGTHS

DAYPRO (oxaprozin) caplets: 600 mg caplets, white, capsule-shaped, scored, film-coated, with DAYPRO debossed on one side and 1381 on the other side.

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4 CONTRAINDICATIONS

DAYPRO is contraindicated in the following patients:

Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to oxaprozin or any components of the drug...

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5 WARNINGS AND PRECAUTIONS

5.1 Cardiovascular Thrombotic Events

Clinical trials of several cyclooxygenase-2 (COX-2) selective and nonselective NSAIDs of up to three...

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6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Cardiovascular Thrombotic Events [see ...

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7 DRUG INTERACTIONS

See Table 2 for clinically significant drug interactions with oxaprozin [see Clinical Pharmacology (12.3)].

...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Use of NSAIDs,...

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10 OVERDOSAGE

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal...

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11 DESCRIPTION

DAYPRO (oxaprozin) caplet is a nonsteroidal anti-inflammatory drug, available as caplets of 600 mg for oral administration. The chemical name is 4,5-diphenyl-2-oxazole-propionic acid. The molecular weight is...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Oxaprozin has analgesic, anti-inflammatory, and antipyretic properties.

The mechanism of action of DAYPRO,...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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14 CLINICAL STUDIES

14.1 Osteoarthritis

DAYPRO was evaluated for the management of the signs and symptoms of osteoarthritis in a total of 616 patients in active...

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16 HOW SUPPLIED/STORAGE AND HANDLING

DAYPRO (oxaprozin) 600 mg caplets are white, capsule-shaped, scored, film-coated, with DAYPRO debossed on one side and 1381 on the other side, supplied as:

...

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Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
This Medication Guide has been approved by the U.S. Food and Drug Administration.			Revised: November 2022...

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

For medical information about DAYPRO, please visit...

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Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.