HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
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DAYPRO® (oxaprozin)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
DAYPRO® Quick Finder
Highlights
Boxed Warning
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
- ...
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Indications and Usage
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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Dosage and Administration
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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Dosage Forms and Strengths
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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Contraindications
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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Warnings and Precautions
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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Drug Interactions
...
7 DRUG INTERACTIONS
See Table 2 for clinically significant drug interactions with oxaprozin [see Clinical Pharmacology (12.3)].
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Use of NSAIDs,...
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Overdosage
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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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
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Clinical Studies
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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How Supplied/Storage and Handling
...
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
| 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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Report Adverse Event
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.
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.
(800)-332-1088.