Medication Safety Issues
Sound-alike/look-alike issues:
Fibricor may be confused with Tricor
TriCor may be confused with Fibricor, Tracleer
TriLipix may be confused with Trileptal, TriLyte
Storage/Stability
Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Protect Fibricor, Lipofen, Lofibra, TriCor, Triglide, and Trilipix from moisture. Protect Fibricor, Lofibra tablets, Lipofen, and Triglide from light.
Lipidil EZ, Lipidil Supra [Canadian products]: Store at 15°C to 30°C (59°F to 86°F). Protect from light and moisture.
Adverse Reactions
>10%: Hepatic: Increased serum transaminases (≥3 x ULN: 5% to 13%)
1% to 10%:
Cardiovascular: Pulmonary embolism (≤5%), thrombophlebitis (≤5%)
Central nervous system: Dizziness (≥3%), pain (≥3%)
Dermatologic: Skin rash (1%), urticaria (1%)
Gastrointestinal: Abdominal pain (5%), diarrhea (≥3%), dyspepsia (≥3%), constipation (2%)
Hepatic: Abnormal hepatic function tests (8%), increased serum alanine aminotransferase (3%), increased serum aspartate aminotransferase (3%)
Neuromuscular & skeletal: Arthralgia (≥3%), limb pain (≥3%), myalgia (≥3%), increased creatine phosphokinase in blood specimen (3%)
Respiratory: Nasopharyngitis (≥3%), sinusitis (≥3%), upper respiratory tract infection (≥3%), rhinitis (2%)
<1%, postmarketing, and/or case reports: Acute renal failure, agranulocytosis, anaphylaxis, anemia, angioedema, asthenia, cholestatic hepatitis, chronic active hepatitis, decreased HDL cholesterol (severe), decreased hematocrit, decreased hemoglobin, decreased white blood cell count, drug reaction with eosinophilia and systemic symptoms, headache, hepatic cirrhosis, hepatitis, hepatocellular hepatitis, hypersensitivity reaction, increased serum creatinine, interstitial pulmonary disease, muscle spasm, myopathy, pancreatitis, renal failure syndrome, rhabdomyolysis, severe dermatological reaction (severe cutaneous adverse reactions [SCAR]), skin photosensitivity, Stevens-Johnson syndrome, thrombocytopenia, toxic epidermal necrolysis
–
