DAYPRO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DAYPRO (DAYPRO).
Nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), reducing prostaglandin synthesis and thereby alleviating pain and inflammation.
| Metabolism | Primarily hepatic via CYP2C9; undergoes glucuronidation. |
| Excretion | Renal (approx. 70-80% as unchanged drug and glucuronide conjugate; biliary/fecal excretion accounts for the remainder). |
| Half-life | Approximately 40-70 hours (mean ~50 h), allowing once-daily dosing; steady-state reached in 4-6 days. |
| Protein binding | >99% bound primarily to albumin. |
| Volume of Distribution | 0.15-0.2 L/kg; indicates limited extravascular distribution mainly in plasma and extracellular fluid. |
| Bioavailability | Oral: approximately 80-90%. |
| Onset of Action | Oral: 1-2 hours for analgesic effect; anti-inflammatory effect may require several days to weeks. |
| Duration of Action | Analgesic: 12-24 hours; anti-inflammatory: sustained over 24 hours with once-daily dosing. |
600 mg orally once daily; max 1200 mg/day
| Dosage form | TABLET |
| Renal impairment | CrCl 30-59 mL/min: 600 mg once daily; CrCl <30 mL/min: 400 mg once daily; hemodialysis: 400 mg once daily after dialysis |
| Liver impairment | Child-Pugh Class A: no adjustment; Class B: 400 mg once daily; Class C: avoid use |
| Pediatric use | Not approved for pediatric use |
| Geriatric use | Initiate at 400 mg once daily; max 600 mg once daily; monitor renal function |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DAYPRO (DAYPRO).
| Breastfeeding | Oxaprozin is excreted into breast milk in low concentrations (M/P ratio approximately 0.1-0.3). Due to potential adverse effects on infant renal function and platelet function, caution is advised. Avoid long-term use; short-term use with infant monitoring recommended. |
| Teratogenic Risk | Daypro (oxaprozin) is a nonsteroidal anti-inflammatory drug (NSAID) with teratogenic potential. First trimester: Avoid; associated with increased risk of miscarriage and cardiac defects. Second trimester: Use only if clearly needed; possible oligohydramnios and fetal renal impairment. Third trimester: Contraindicated due to risk of premature closure of ductus arteriosus, oligohydramnios, and neonatal pulmonary hypertension. |
■ FDA Black Box 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. DAYPRO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
| Serious Effects |
Aspirin allergy, history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs, perioperative pain in the setting of CABG surgery, advanced renal disease, and pregnancy (third trimester).
| Precautions | Cardiovascular risk, gastrointestinal bleeding and ulceration, renal toxicity, hypertension, anaphylactoid reactions, serious skin reactions, hematologic toxicity (anemia), hepatic effects, asthma exacerbation, fluid retention, and use in pregnancy (avoid in late pregnancy). |
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| Fetal Monitoring | Monitor maternal renal function, blood pressure, and signs of gastrointestinal bleeding. Fetal monitoring includes ultrasound for amniotic fluid volume and ductus arteriosus patency if used in third trimester. Neonatal monitoring for thrombocytopenia and renal impairment if exposure occurs near delivery. |
| Fertility Effects | NSAIDs including oxaprozin may impair female fertility by inhibiting prostaglandin synthesis, affecting ovulation and implantation. Reversible upon discontinuation. No data on male fertility effects. |