DAYPRO® Highlights

(oxaprozin)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use DAYPRO safely and effectively. See full prescribing information for DAYPRO.

DAYPRO (oxaprozin) caplets, for oral use
Initial U.S. Approval: 1992

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

See full prescribing information for complete boxed warning.

•
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (5.1)
•
DAYPRO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (4, 5.1)
•
NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events (5.2)

INDICATIONS AND USAGE

DAYPRO is a non-steroidal anti-inflammatory drug indicated for:

•
Relief of signs and symptoms of Osteoarthritis (OA) (1)
•
Relief of signs and symptoms of Rheumatoid Arthritis (RA) (1)
•
Relief of signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) (1)

DOSAGE AND ADMINISTRATION

•
Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals (2.1)
•
OA: 1200 mg (two 600 mg caplets) given orally once a day (2.2, 2.5, 14.1)
•
RA: 1200 mg (two 600 mg caplets) given orally once a day (2.3, 2.5, 14.2)
•
JRA: 600 mg once daily in patients 22–31 kg. 900 mg once daily in patients 32–54 kg. 1200 mg once daily in patients ≥55 kg (2.4, 2.5)

DOSAGE FORMS AND STRENGTHS

DAYPRO (oxaprozin) caplets: 600 mg (3)

CONTRAINDICATIONS

•
Known hypersensitivity to oxaprozin or any components of the drug product (4)
•
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4)
•
In the setting of CABG surgery (4)

WARNINGS AND PRECAUTIONS

•
Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop (5.3)
•
Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure (5.4, 7)
•
Heart Failure and Edema: Avoid use of DAYPRO in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure (5.5)
•
Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of DAYPRO in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function (5.6)
•
Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs (5.7)
•
Exacerbation of Asthma Related to Aspirin Sensitivity: DAYPRO is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity) (5.8)
•
Serious Skin Reactions: Discontinue DAYPRO at first appearance of skin rash or other signs of hypersensitivity (5.9)
•
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically (5.10)
•
Fetal Toxicity: Limit use of NSAIDs, including DAYPRO, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus (5.11, 8.1)
•
Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia (5.12, 7)

ADVERSE REACTIONS

Most common adverse reactions (>3%) are: constipation, diarrhea, dyspepsia, nausea, rash (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Drugs that Interfere with Hemostasis (e.g., warfarin, aspirin, selective serotonin reuptake inhibitors [SSRIs]/serotonin norepinephrine reuptake inhibitors [SNRIs]): Monitor patients for bleeding who are concomitantly taking DAYPRO with drugs that interfere with hemostasis. Concomitant use of DAYPRO and analgesic doses of aspirin is not generally recommended (7)
•
Angiotensin Converting Enzyme (ACE) Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with DAYPRO may diminish the antihypertensive effect of these drugs. Monitor blood pressure (7)
•
ACE Inhibitors and ARBs: Concomitant use with DAYPRO in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function (7)
•
Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects (7)
•
Digoxin: Concomitant use with DAYPRO can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels (7)

USE IN SPECIFIC POPULATIONS

Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of DAYPRO in women who have difficulties conceiving (8.3)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 11/2022

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use DAYPRO safely and effectively. See full prescribing information for DAYPRO.

DAYPRO (oxaprozin) caplets, for oral use
Initial U.S. Approval: 1992

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

See full prescribing information for complete boxed warning.

•
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (5.1)
•
DAYPRO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (4, 5.1)
•
NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events (5.2)

INDICATIONS AND USAGE

DAYPRO is a non-steroidal anti-inflammatory drug indicated for:

•
Relief of signs and symptoms of Osteoarthritis (OA) (1)
•
Relief of signs and symptoms of Rheumatoid Arthritis (RA) (1)
•
Relief of signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) (1)

DOSAGE AND ADMINISTRATION

•
Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals (2.1)
•
OA: 1200 mg (two 600 mg caplets) given orally once a day (2.2, 2.5, 14.1)
•
RA: 1200 mg (two 600 mg caplets) given orally once a day (2.3, 2.5, 14.2)
•
JRA: 600 mg once daily in patients 22–31 kg. 900 mg once daily in patients 32–54 kg. 1200 mg once daily in patients ≥55 kg (2.4, 2.5)

DOSAGE FORMS AND STRENGTHS

DAYPRO (oxaprozin) caplets: 600 mg (3)

CONTRAINDICATIONS

•
Known hypersensitivity to oxaprozin or any components of the drug product (4)
•
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4)
•
In the setting of CABG surgery (4)

WARNINGS AND PRECAUTIONS

•
Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop (5.3)
•
Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure (5.4, 7)
•
Heart Failure and Edema: Avoid use of DAYPRO in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure (5.5)
•
Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of DAYPRO in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function (5.6)
•
Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs (5.7)
•
Exacerbation of Asthma Related to Aspirin Sensitivity: DAYPRO is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity) (5.8)
•
Serious Skin Reactions: Discontinue DAYPRO at first appearance of skin rash or other signs of hypersensitivity (5.9)
•
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically (5.10)
•
Fetal Toxicity: Limit use of NSAIDs, including DAYPRO, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus (5.11, 8.1)
•
Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia (5.12, 7)

ADVERSE REACTIONS

Most common adverse reactions (>3%) are: constipation, diarrhea, dyspepsia, nausea, rash (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Drugs that Interfere with Hemostasis (e.g., warfarin, aspirin, selective serotonin reuptake inhibitors [SSRIs]/serotonin norepinephrine reuptake inhibitors [SNRIs]): Monitor patients for bleeding who are concomitantly taking DAYPRO with drugs that interfere with hemostasis. Concomitant use of DAYPRO and analgesic doses of aspirin is not generally recommended (7)
•
Angiotensin Converting Enzyme (ACE) Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with DAYPRO may diminish the antihypertensive effect of these drugs. Monitor blood pressure (7)
•
ACE Inhibitors and ARBs: Concomitant use with DAYPRO in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function (7)
•
Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects (7)
•
Digoxin: Concomitant use with DAYPRO can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels (7)

USE IN SPECIFIC POPULATIONS

Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of DAYPRO in women who have difficulties conceiving (8.3)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 11/2022
Medication Guide

Health Professional Information

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