ORUVAIL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ORUVAIL (ORUVAIL).
Nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2), thereby reducing prostaglandin synthesis, leading to decreased inflammation, pain, and fever.
| Metabolism | Primarily hepatic via CYP2C9; undergoes extensive first-pass metabolism. Major metabolites include hydroxylated and carboxylated derivatives. |
| Excretion | Primarily renal excretion of metabolites (60-80%) with less than 1% unchanged drug; biliary/fecal excretion accounts for 20-40%. |
| Half-life | 5-9 hours (terminal elimination half-life); in elderly or renal impairment, may extend up to 20 hours; clinical context: dosing adjustments recommended in renal impairment. |
| Protein binding | 99% bound primarily to albumin. |
| Volume of Distribution | 0.1-0.2 L/kg; indicates low tissue distribution consistent with extensive protein binding. |
| Bioavailability | Oral: 80-100% (immediate-release); topical: approximately 5% systemic absorption. |
| Onset of Action | Oral: 1-2 hours (analgesic effect); topical: 2-4 hours. |
| Duration of Action | Oral: 6-8 hours; topical: 8-12 hours; clinical notes: duration may be prolonged with extended-release formulations. |
| Molecular Weight | 254.28 |
100 to 200 mg orally twice daily
| Dosage form | CAPSULE, EXTENDED RELEASE |
| Renal impairment | GFR 30-89 mL/min: no adjustment; GFR <30 mL/min: contraindicated |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B or C: contraindicated |
| Pediatric use | Not recommended for use in pediatric patients |
| Geriatric use | Initiate at lowest effective dose (100 mg/day); monitor renal function and gastrointestinal bleeding risk |
| 1st trimester | Avoid; associated with risk of oligohydramnios and cardiovascular malformations. |
| 2nd trimester | Avoid; may cause premature closure of ductus arteriosus and oligohydramnios. |
| 3rd trimester | Avoid; risks include premature closure of ductus arteriosus, oligohydramnios, and neonatal renal impairment. |
Clinical note
Comprehensive clinical and safety monograph for ORUVAIL (ORUVAIL).
| Placental transfer | Crosses placenta; detectable in fetal tissues. |
| Breastfeeding | Ketoprofen is excreted into breast milk in low amounts; use with caution due to potential adverse effects in neonates, particularly gastrointestinal and renal effects. |
| Lactation Rating |
■ 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 increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Oruvail is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
| Serious Effects |
Active peptic ulcer diseaseHistory of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDsSevere renal impairment (eGFR <30 mL/min)Significant hepatic impairmentHistory of gastrointestinal bleeding or perforationThird trimester of pregnancy (avoid, may cause premature closure of ductus arteriosus)Hypersensitivity to ketoprofen or any component of the formulation
| Precautions | Cardiovascular thrombotic events; gastrointestinal bleeding, ulceration, and perforation; hypertension; congestive heart failure; renal toxicity; anaphylactoid reactions; serious skin reactions; hematologic toxicity; use with caution in patients with asthma, pre-existing renal impairment, or hepatic impairment. |
| Food/Dietary |
Loading safety data…
| L3 (Moderately Safe) |
| Teratogenic Risk | First trimester: Avoid; associated with increased risk of cardiac defects and gastroschisis (OR 1.21-3.08). Second trimester: Caution; NSAIDs may cause oligohydramnios. Third trimester: Contraindicated; risk of premature ductus arteriosus closure and persistent pulmonary hypertension. |
| Fetal Monitoring | Monitor fetal echocardiography if used in 1st trimester. Ultrasound for amniotic fluid volume if used >48 hours after 20 weeks. Monitor ductus arteriosus with Doppler in 3rd trimester. |
| Fertility Effects | Reversible inhibition of ovulation due to prostaglandin synthesis inhibition. May delay follicular rupture. Impact on male fertility not established. |
| Take with food or milk to minimize gastrointestinal irritation. Avoid alcohol as it increases risk of GI bleeding. No significant food-drug interactions; however, high-fat meals may delay absorption but does not affect overall bioavailability. |
| Clinical Pearls | Oruvail (ketoprofen extended-release) is an NSAID with analgesic, anti-inflammatory, and antipyretic effects. Due to its extended-release formulation, it should not be crushed or chewed. Use with caution in patients with renal impairment, history of GI bleeding, or cardiovascular disease. Monitor renal function and blood pressure periodically. It inhibits platelet aggregation similarly to aspirin but is reversible. May mask signs of infection. |
| Patient Advice | Take exactly as prescribed; do not crush or chew the capsules. · Take with food or milk to reduce stomach upset. · Avoid alcohol and other NSAIDs (including over-the-counter ibuprofen or naproxen). · Report any signs of GI bleeding (black/tarry stools, vomiting blood), unexplained weight gain, edema, or worsening kidney function (decreased urination). · May cause dizziness or drowsiness; avoid driving until you know how it affects you. · Do not use if you have a history of asthma, hives, or allergic reaction to aspirin or NSAIDs. · Inform all healthcare providers that you are taking this medication, especially before surgery. |