諾脂替 膜衣錠5，10，20毫克 R F.C. Tablets 5，10，20 mg 與 …

1 057843 057802 057803 R 5 10 20 Roty R Tablets 5 10 20 mg E231, E173, E232 ]]]] [[[[ ]]]]) lopinavir ritonavir atazzanavir ritonavir rosuvastatin 10mg ( [[[[ ]]]] [[[[ ]]]]) rosuvastatin gemfibrozil rosuvastatin 10 mg ( [[[[ ]]]] / ;[[[[ ]]]] ) (CLcr 30 mL/ ) rosuvastatin 5 mg 10 mg ( [[[[ ]]]] ;[[[[ ]]]] ) (((( )))) rosuvastatin ** rosuvastatin ( [ ]) ** (hepatic transaminase) ( [ ]) ** HMG-CoA ( [[[[ ]]]] [[[[ ]]]]) ** HMG-CoA rosuvastatin ( [[[[ ]]]]) (((( )))) 1.

2 2. (HbA1c) HMG-CoA (statin ) / 3. statin ( 1 3 ) HMG-CoA ( rosuvastatin ) (myoglobinuria) (rhabdomyolysis) (myopathy) (40 mg) rosuvastatin ( 65 ) rosuvastatin (fibrates niacin), gemfibrozil, cyclosporine, lopinavir/ritonavir ( [ ] [ ] (creatinine kinase) rosuvastatin ( ) rosuvastatin 12 ( ))

3 HMG-CoA rosuvastatin [AST(SGOT) or ALT(SGPT)] rosuvastatin rosuvastatin (ULN) 3 ALT AST UTN 3 rosuvastatin rosuvastatin / ( [[[[ ]]]]) rosuvastatin ( [ ]) CoumarinCoumarinCoumarinCoumarin rosuvastatin coumarin (the prothrombin time/INR) coumarin rosuvastatin rosuvastatin INR INR INR ( [[[[ ]]]]) rosuvastatin rosuvastatin (dipstick-positive proteinuria) (microscopic hematuria) rosuvastatin HMG-CoA rosuvastatin 40mg / rosuvastatin HMG-CoA ( rosuvastatin ) HbA1c ( [[[[ ]]]] rosuvastatin (cortisol) (adrenal reserve).)

4 rosuvastatin ( ketoconazole spironolactone cimetidine) (((( )))) * ( )( [[[[ ]]]]) * ( [[[[ ]]]]) 5,394 15 rosuvastatin ( ) * * * rosuvastatin 5,394 ( 2%) * * * * * Each tablet contains rosuvastatin calcium mg mg eq to rosuvastatin 5 mg 10 mg 20mg rosuvastatin 1. Fredrickson IIa IIb LDL-C B Apo B HDL-C 2. (Fredrickson IV ); 3. ( ) rosuvastatin (III ) 4.

5 ( [LDL apheresis]) B(Apo B); (NCEP-ATP III) (TCL) 5 5. 5. 5. 5. (NCEP)(NCEP)(NCEP)(NCEP) CHDa CHD (10 20%) 100 mg/dL 100 mg/dL 130 mg/ dL (100-129 mg/dL )b 2 (10 20%) 130 mg/dL 130 mg/dL 10 10%~20% : 130 mg/dL 10 <10% : 160 mg/dL 0-1 c 160 mg/dL 160 mg/dL 190 mg/dL (160-189 mg/dL.)

6 ACHD b 100 mg/dL nicotinic acid fibrate c 0-1 10 10% 0-1 10 200 mg/dL ( ) 30 mg/dL 130 mg/dL ( NCEP ) 20 5 rosuvastatin ( ) 400 mg/dL( mmol/L) = ( + ) 400 mg/dL( mmol/L) rosuvastatin Fredrickson I III V ( ) rosuvastatin rosuvastatin (((( )))) (Fredrickson (Fredrickson (Fredrickson (Fredrickson IIIIIIII aaaa IIIIIIII bbbb )))) rosuvastatin 5- 20 mg rosuvastatin 10mg 5 mg cyclosporine ( [ ] ) ( 190 mg/dL)

7 20 mg rosuvastatin / 2-4 statinstatinstatinstatin statinstatinstatinstatin ROSUVASTATINROSUVASTATINROSUVASTATINROSU VASTATIN ROSUVASTATINROSUVASTATINROSUVASTATINROSU VASTATIN ROSUVASTATINROSUVASTATINROSUVASTATINROSU VASTATIN 2222----4444 rosuvastatin 20 mg rosuvastatin ( LDL apheresis ) 5 mg rosuvastatin 5 10 mg rosuvastatin ( [[[[ ]]]] / ;[[[[ ]]]].)

8 [[[[ ]]]] ) CyclosporineCyclosporineCyclosporineCycl osporine Lopinavir/RitonavirLopinavir/RitonavirLo pinavir/RitonavirLopinavir/Ritonavir Atazanavir/RitonavirAtazanavir/Ritonavir Atazanavir/RitonavirAtazanavir/Ritonavir cyclosporine rosuvastatin 5 mg ( [[[[ 1 2% 1 12 1 1 1 1 2%2%2%2% ROSUVASTATINROSUVASTATINROSUVASTATINROSU VASTATIN ** (%(%(%(% )))) rosuvastatin 5 mg N=291 rosuvastatin 10 mg N=283 rosuvastatin 20 mg N=64 rosuvastatin 40 mg N=106 Total rosuvastatin 5 mg 40mg N=744 N=382 0 * COSTART ( ) ( [[[[ ]]]]) (glutamyl transpeptidase) (alkaline phosphatase) (bilirubin) METEOR 981 rosuvastatin 40 mg(n=700) (n=281) rosuvastatin ( [[[[ ]]]])]]]]

9 2% 2 2 2 2 2 METEORMETEORMETEORMETEOR 2%2%2%2% ROSUVASTATINROSUVASTATINROSUVASTATINROSU VASTATIN ** (%(%(%(% )))) rosuvastatin 40 mg N=700 N=281 Blood CPK ALT 3 ULM * MedDRA CPK creatine phosphokinase ULN upper limit of normal JUPITER 17,802 rosuvastatin 20mg (n=8901) (n=8901) 2 rosuvastatin JUPITER rosuvastatin ( ) ( ) rosuvastatin HbA1c rosuvastatin HbA1c ( [[[[ ]]]] [[[[ ]]]]) 2% 3 3 3 3 3 JUPITERJUPITERJUPITERJUPITER ROSUVASTATINROSUVASTATINROSUVASTATINROSU VASTATIN ** 2%2%2%2% (%(%(%(% )))) rosuvastatin 20 mg N=8901 N=8901 * MedDRA 10101010----17171717 rosuvastatin (CK) 10 ULN rosuvastatin 130 4 (3% 2 10mg 2 20mg )CK 10 ULN 46 ( [[[[ ]]]])

10 [[[[ ]]]] rosuvastatin statin ( ) (((( )))) HIV boceprevir telaprevir nefazodone CCCC yclosporineyclosporineyclosporineyclospo rine Cyclosporine rosuvastatin AUC 7 cyclosporine rosuvastatin 5 mg ( [[[[ ]]]] [[[[ ] [[[[ ]]]]) GemfibrozilGemfibrozilGemfibrozilGemfibr ozil Gemfibrozil rosuvastatin rosuvastatin gemfibrozil rosuvastatin 10 mg ( [[[[ ]]]] [[[[ ]]]]) rosuvastatin ritonavir rosuvastatin Lopinavir/ritonavir atazanavir/ritonavir rosuvastatin (AUC) 3 ( 3-[ ])]]]