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: 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

Oxaprozin tablet, USP is contraindicated in:

• Patients with known hyper-sensitivity to oxaprozin.
• 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.
• Peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
• Patients with active gastrointestinal bleeding.

Warnings

Boxed Warning See full prescribing information for complete Boxed Warning. Cardiovascular Risk: 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.

Cardiovascular Effects

Cardiovascular Thrombotic Events

• Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.
• There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events.
• Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.

Hypertension

• NSAIDs including oxaprozin, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including oxaprozin, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.

Congestive Heart Failure and Edema

• Fluid retention and edema have been observed in some patients taking NSAIDs. oxaprozin should be used with caution in patients with fluid retention or heart failure.

Gastrointestinal Effects- Risk of Ulceration, Bleeding, and Perforation

• NSAIDs, including oxaprozin, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs 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 with longer duration of use, 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. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients treated with neither of these risk factors. Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. 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 in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulcerations and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.
• Oxaprozin tablet, USP is contraindicated in patients with active GI bleeding.

Renal Effects

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. 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 NSAID therapy is usually followed by recovery to the pretreatment state.

Advanced renal disease

No information is available from controlled clinical studies regarding the use of oxaprozin in patients with advanced renal disease. Therefore, treatment with oxaprozin is not recommended in these patients with advanced renal disease. If oxaprozin therapy must be initiated, close monitoring of the patient's renal function is advisable.

Anaphylactoid reactions As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to oxaprozin. Oxaprozin 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, PREEXISTING ASTHMA). Emergency help should be sought in cases where an anaphylactoid reaction occurs.

Skin Reactions NSAIDs, including oxaprozin, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

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

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.