FENOPROFEN CALCIUM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FENOPROFEN CALCIUM (FENOPROFEN CALCIUM).
Nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2) enzymes, reducing prostaglandin synthesis, thereby exerting analgesic, anti-inflammatory, and antipyretic effects.
| Metabolism | Primarily hepatic via glucuronidation; minor metabolism via CYP450. Fenoprofen calcium is extensively metabolized to fenoprofen glucuronide and other metabolites. |
| Excretion | Primarily renal; approximately 90% of a dose is excreted in urine as glucuronide conjugates and unchanged drug; <2% excreted in feces. |
| Half-life | Terminal elimination half-life is 2–3 hours; may be prolonged in elderly and patients with hepatic impairment. |
| Protein binding | 99% bound to albumin. |
| Volume of Distribution | Approximately 0.08–0.1 L/kg; low Vd indicates limited extravascular distribution. |
| Bioavailability | Oral bioavailability is essentially complete (≈100%) due to rapid and complete absorption. |
| Onset of Action | Oral: analgesic effect begins within 30–60 minutes; peak effect at 1–2 hours. |
| Duration of Action | Duration of analgesia is 4–6 hours; anti-inflammatory effects may persist longer with regular dosing. |
Oral: 300-600 mg every 6-8 hours as needed; maximum 3200 mg/day.
| Dosage form | TABLET |
| Renal impairment | CrCl 30-59 mL/min: reduce dose by 50% or extend interval to 8-12 hours. CrCl <30 mL/min: contraindicated. |
| Liver impairment | Child-Pugh Class A: no adjustment. Child-Pugh Class B or C: avoid use due to increased risk of GI bleeding and fluid retention. |
| Pediatric use | Children ≥6 months: 25-50 mg/kg/day in divided doses every 6-8 hours; maximum 3 g/day. |
| Geriatric use | Initiate at lowest effective dose (300 mg every 8 hours); monitor renal function and for GI bleeding; avoid in severe renal impairment. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FENOPROFEN CALCIUM (FENOPROFEN CALCIUM).
| Breastfeeding | Limited data; M/P ratio not established. Low levels likely excreted in breast milk. Use with caution, especially in preterm infants due to potential prostaglandin inhibition effects; consider alternative agents. |
| Teratogenic Risk | First trimester: Limited data; NSAIDs are not strongly associated with major malformations but risk of spontaneous abortion may be increased. Second trimester: Fetal renal impairment and oligohydramnios with prolonged use; avoid unless necessary. Third trimester: Contraindicated due to risk of premature ductus arteriosus closure, pulmonary hypertension, oligohydramnios, and fetal/neonatal renal dysfunction. |
■ FDA Black Box Warning
NSAIDs increase the risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Elderly patients and those with prior history of peptic ulcer disease or GI bleeding are at greater risk.
| Serious Effects |
["Known hypersensitivity to fenoprofen or any NSAID","History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs","Coronary artery bypass graft (CABG) surgery perioperative pain","Active peptic ulcer disease or GI bleeding","Advanced renal disease","Third trimester of pregnancy (risk of premature closure of ductus arteriosus)"]
| Precautions | ["Cardiovascular thrombotic events (MI, stroke)","Hypertension","Congestive heart failure","Gastrointestinal effects (ulceration, bleeding)","Renal toxicity (impaired renal function, papillary necrosis)","Anaphylactoid reactions","Serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)","Hematologic effects (prolonged bleeding time)","Hepatic effects (elevated liver enzymes)","Fluid retention and edema"] |
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| Fetal Monitoring | Monitor maternal blood pressure, renal function, and signs of fluid retention. Fetal: Ultrasound for oligohydramnios and ductus arteriosus patency if used chronically after 20 weeks. |
| Fertility Effects | Reversible inhibition of ovulation and luteal phase defects due to prostaglandin synthesis inhibition; effect resolves after discontinuation. May impair implantation. |