Fibrovas Tablets (Micronized Fenofibrate + Atorvastatin)

• Composition :
  Each tablet contains micronized Fenofibrate 160mg + Atorvastatin 10mg.
• Indications :
  It is indicated for the treatment of combined hyperlipidemia in patients with normal hepatic and renal function.
• Pharmacodynamics :
  Fenofibrate The active moiety of Fenofibrate is fenofibric acid. The lipid-modifying effects of fenofibric acid in human hepatocyte cultures by the activation of peroxisome proliferators activated receptor α (PPARα). Through this mechanism, fenofibrate increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apoprotein C-III. Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol.
• Dosage and administration :
  One tablet, once daily at night.
• Contraindications :
  Fenofibrate- Severe renal dysfunction, Active liver disease, Gallbladder disease and Hypersensitivity to active ingredient, Atorvastatin- Active liver disease, Hypersensitivity.
• Precautions and warnings :
  Fenofibrate-Periodic monitoring is required for myopathy, Liver Function and HDL cholesterol levels, fenofibrate should be discontinued if gallstones are found and in mild to moderate hematologic Changes. Caution should be exercised with Anticoagulants co-administration. Atorvastatin - Myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis. Liver dysfunction, Patients with Recent Stroke or TIA, Endocrine function, Hepatic Impairment
• Use in pregnancy, lactation & pediatrics :
  Contra-indicated in pregnancy and lactating woman. Safety and efficacy in pediatric patients has not been established.
• Drug interactions :
  Fenofibrate- Prolongation of the PT/INR with Anticoagulants, immunosuppressants can produce nephrotoxicity, Patients should take fenofibrate at least 1 hour before or 4 to 6 hours after a bile acid binding resin to avoid impeding its absorption, Myopathy, including rhabdomyolysis with Colchicine is noted. Atorvastatin- caution should be exercised with Strong Inhibitors of CYP 3A4, Clarithromycin, Combination of Protease inhibitors, itraconazole, cyclosporine, digoxin, oral contraceptives and rifampin.
• Adverse reactions :
  The most common adverse reactions, Fenofibrate are - abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis. Atorvastatin- nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection.
• Therapy Area :
  Lipid Lowering agents