Turbovas F Tablets (Rosuvastatin + Micronized Fenofibrate )

• Composition :
  Each tablet contains Rosuvastatin 10 mg with micronized Fenofibrate 160 mg.
• Indications :
  For the treatment of combined hyperlipidaemia in patients with normal hepatic and renal function.
• Pharmacodynamics :
  Rosuvastatin is an inhibitor of HMG-CoA reductase, an enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Fenofibrate is a lipid modifying effects reported in humans are mediated via activation of Peroxisome Proliferator Activated Receptor type alpha (PPARα).
• Dosage and administration :
  Once daily, orally after food any time of the day.
• Contraindications :
  Hypersensitivity to the active substance(s) or to any of the excipients. Active liver and gall bladder diseasewhich may include unexplained persistent elevations in hepatic transaminase levels, pregnant and nursing women. Severe renal dysfunction, including patients receiving dialysis
• Precautions and warnings :
  Skeletal muscle effects (e.g., myopathy and rhabdomyolysis). Monitor liver enzymes before and during treatment. Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including Rosuvastatin.Fenofibrate can reversibly increase serum creatinine levels. Monitor renal function periodically in patients with renal impairment. Fenofibrate increases cholesterol excretion into the bile, leading to risk of cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated. Exercise caution in concomitant treatment with coumarin anticoagulants. Adjust the dosage of coumarin to maintain the prothrombin time/INR at the desired level to prevent bleeding complications
• Use in pregnancy, lactation & pediatrics :
  Contraindicated in women who are or may become pregnant. Not indicated for nursing women. Safety and effectiveness have not been established in paediatric population.
• Drug interactions :
  Following drug interact with Rosuvastatin, caution to be taken with Cyclosporine, Gemfibrozil, Lopinavir/Ritonavir or atazanavir/ritonavir, Coumarin anticoagulants.
• Adverse reactions :
  The most commonly reported adverse events are headache, myalgia, abdominal pain, asthenia, nausea, abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis
• Therapy Area :
  Lipid Lowering agents