Oxaprozin

Oxaprozin
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

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Black Box Warning

Boxed Warning See full prescribing information for complete Boxed Warning. Cardiovascular Risk: (Content) NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Oxaprozin Tablet, USP, 600 mg is contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

Overview

Oxaprozin is an analgesic and NSAID that is FDA approved for the treatment of osteoarthritis, rheumathoid arthritis and juvenile rheumatoid arthritis. There is a Black Box Warning for this drug as shown here. Common adverse reactions include abdominal pain, constipation, diarrhea, flatulence, indigestion, loss of appetite and nausea.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Oxaprozin FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Oxaprozin in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Oxaprozin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Oxaprozin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Oxaprozin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Oxaprozin in pediatric patients.

Contraindications

There is limited information regarding Oxaprozin Contraindications in the drug label.

Warnings

Boxed Warning See full prescribing information for complete Boxed Warning. Cardiovascular Risk: (Content) NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Oxaprozin Tablet, USP, 600 mg is contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

There is limited information regarding Oxaprozin Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Oxaprozin Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Oxaprozin Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Oxaprozin Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Oxaprozin in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Oxaprozin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Oxaprozin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Oxaprozin in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Oxaprozin in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Oxaprozin in geriatric settings.

Gender

There is no FDA guidance on the use of Oxaprozin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Oxaprozin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Oxaprozin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Oxaprozin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Oxaprozin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Oxaprozin in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Oxaprozin Administration in the drug label.

Monitoring

There is limited information regarding Oxaprozin Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Oxaprozin and IV administrations.

Overdosage

There is limited information regarding Oxaprozin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Oxaprozin Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Oxaprozin Mechanism of Action in the drug label.

Structure

There is limited information regarding Oxaprozin Structure in the drug label.

Pharmacodynamics

There is limited information regarding Oxaprozin Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Oxaprozin Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Oxaprozin Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Oxaprozin Clinical Studies in the drug label.

How Supplied

There is limited information regarding Oxaprozin How Supplied in the drug label.

Storage

There is limited information regarding Oxaprozin Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Oxaprozin Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Oxaprozin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Oxaprozin Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Oxaprozin Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Oxaprozin

File:Oxaprozin.svg
Clinical data
Pregnancy category	C
Routes of administration	Oral
ATC code	M01AE12 (WHO)
Pharmacokinetic data
Bioavailability	95%
Protein binding	99%
Metabolism	Liver—65% oxidation and 35% glucuronic acid conjugation. 5% are active phenolic metabolites.
Elimination half-life	54.9 hours
Identifiers
IUPAC name 3-(4,5-diphenyl-1,3-oxazol-2-yl)propanoic acid
CAS Number	21256-18-8
PubChem CID	4614
DrugBank	APRD00030
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C18H15NO3
Molar mass	293.317 g/mol

Oxaprozin (brand name: Daypro) is a non-narcotic, non-steroidal anti-inflammatory drug (NSAID), used to relieve the inflammation, swelling, stiffness, and joint pain associated with osteoarthritis and rheumatoid arthritis. Chemically, it is a propionic acid derivative. It is available in 600 mg tablets. Normal adult dosage is 1200 mg daily, not to exceed 1800 mg per day. Safety and efficacy has been established in children over 6 years with juvenile rheumatoid arthritis only, and there is an increased risk of adverse reactions in the elderly population.