TRICOR
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRICOR (TRICOR).
Tricor (fenofibrate) activates peroxisome proliferator-activated receptor alpha (PPARα), leading to increased lipolysis and clearance of triglyceride-rich lipoproteins, and reduced hepatic VLDL secretion. It also increases HDL cholesterol synthesis.
| Metabolism | Primarily hepatic metabolism via glucuronidation (UGT1A1, UGT1A3, UGT2B7); also via CYP3A4 and CYP2C8 to a lesser extent. |
| Excretion | Renal: approximately 60% as fenofibric acid and its glucuronide conjugate; fecal: approximately 25% |
| Half-life | Terminal elimination half-life of fenofibric acid is approximately 20 hours (range 10-27 hours). Clinical context: supports once-daily dosing; steady state achieved within 5-7 days. |
| Protein binding | Approximately 99% bound to albumin. |
| Volume of Distribution | 0.9 L/kg, indicating extensive tissue distribution. |
| Bioavailability | Oral: approximately 81% (Tricor tablets) under fed conditions; food significantly increases absorption. |
| Onset of Action | Oral: significant reduction in triglycerides and LDL-cholesterol observed within 2 weeks. |
| Duration of Action | Duration of lipid-lowering effect persists throughout the 24-hour dosing interval. Maximal effect achieved by 4-8 weeks. |
Oral: 48 mg to 145 mg once daily, taken with meals. For hypertriglyceridemia: 48 to 145 mg/day; for severe hypertriglyceridemia: start 48 mg/day and titrate to 145 mg/day. For mixed dyslipidemia: 145 mg once daily.
| Dosage form | TABLET |
| Renal impairment | GFR 30-59 mL/min: dose reduction required, maximum 48 mg/day. GFR <30 mL/min or dialysis: contraindicated. Not recommended for use in severe renal impairment. |
| Liver impairment | Child-Pugh Class A: caution, no specific dose adjustment defined. Child-Pugh Class B or C: contraindicated due to risk of accumulation. |
| Pediatric use | Not approved for pediatric use in the US. In adolescents (10-16 years) with severe hypertriglyceridemia, limited data: start 48 mg/day; may increase to 145 mg/day after 8 weeks if triglycerides remain elevated. Use only if potential benefit outweighs risk. |
| Geriatric use | Start at low end of dosing range (48 mg/day) due to age-related renal function decline. Monitor renal function regularly. Maximum dose 145 mg/day if GFR ≥60 mL/min. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRICOR (TRICOR).
| Breastfeeding | Unknown if excreted in human milk. M/P ratio not available. Due to potential for tumorigenicity in animal studies, manufacturer advises discontinue nursing or drug. Alternative agents preferred. |
| Teratogenic Risk | FDA Pregnancy Category C. First trimester: No adequate studies; animal studies show fetal toxicity (skeletal malformations, growth retardation) at doses 1-2 times human exposure. Second and third trimesters: Potential risk of fetal harm; use only if maternal benefit outweighs risk. Avoid in severe maternal cholestasis due to drug accumulation. |
■ FDA Black Box Warning
None
| Serious Effects |
["Severe renal impairment (CrCl <30 mL/min)","Gallbladder disease","Active liver disease or unexplained persistent liver function abnormalities","Known hypersensitivity to fenofibrate or any ingredient","Nursing mothers"]
| Precautions | ["Hepatotoxicity: Monitor liver enzymes; discontinue if enzyme levels persist >3 times ULN","Cholelithiasis: Increased cholesterol saturation of bile; contraindicated in gallbladder disease","Pancreatitis: Risk with severe hypertriglyceridemia or during therapy","Myopathy/Rhabdomyolysis: Increased risk when combined with statins, especially in renal impairment or elderly","Renal impairment: Dose adjustment required (contraindicated if CrCl <30 mL/min)","Venous thromboembolism: Potential increased risk"] |
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| Fetal Monitoring |
| Monitor maternal liver function, creatinine, glucose, and lipid profile regularly. Fetal ultrasound for growth restriction and skeletal development if used in pregnancy. Assess for maternal hepatotoxicity and rhabdomyolysis. |
| Fertility Effects | No human data. In animal studies, fenofibrate reduced fertility indices and increased estrous cycle length at high doses. Theoretical risk of hormonal disruption due to PPARα activation. |