mg (1) (2) QT (3) 1 400mg 1 1 2
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- あきひさ かりこめ
- 5 years ago
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1 mg mg 1 C21H24FN3O4 HCl [(4aS, 7aS) [3,4 b] 6 ] 4 1,4 3 1-Cyclopropyl-6-fluoro-8-methoxy-7-[(4aS,7aS)-octahydropyrrolo[3,4-b]pyridine -6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid monohydrochloride
2 mg (1) (2) QT (3) 1 400mg 1 1 2
3 mg mg 400mg
4 1 400mg UV/VIS IR 1H-NMR 13 C-NMR X ph % 0.1% IR HPLC HPLC IR 1 H-NMR 400mg 4
5 2 50mg 200mg AUC Cmax Cmax BA % 6 % % IR IR IR % 0.1mol/L 900mL BA CE HPLC CE HPLC 2 CE HPLC % 5
6 in vitro HPLC 50mg 400mg Cmax Cmax AUC 50mg 400mg 25 /60%RH/ 2 /36 40 /75%RH/ 2 /12 60 / /6 40 /75%RH/ /6 15 lx / 2mm / lx hr /60%RH/ PTP /24 40 /75%RH/ PTP /9 60 /6 50 /3 / 40 /75%RH 6
7 30 /60%RH/ 3 lx / / lx hr % LD mg/kg 758mg/kg 500mg/kg 1320mg/kg mg/kg 105mg/kg mg/kg 130mg/kg mg/kg 112mg/kg 100mg/kg 146mg/kg mg/kg 1335mg/kg mg/kg/ 100mg/kg/ mg/kg/ 100mg/kg/ /150mg/kg/ 250mg/kg/ mg/kg/ 250/150mg/kg/ GOT GPT GLDH 50mg/kg/ mg/kg/ 100mg/kg/ 150mg/kg/ 150mg/kg/ 7
8 mg/kg/ 10mg/kg/ 30mg/kg/ 90mg/kg/ GPT GLDH QT 10mg/kg/ mg/kg/ 500mg/kg/ GPT,GOT LDH 750mg/kg/ 100mg/kg/ 750mg/kg/ 4 GPT GOT LDH mg/kg/ mg/kg/ 135mg/kg/ GLDH 45mg/kg/ 13 60mg/kg/ 60mg/kg/ mg/kg/ 100mg/kg/ GPT GOT ALP 500mg/kg/ LDH 20mg/kg/ 100mg/kg/ mg/kg/ 45mg/kg/ GPT GLDH 135mg/kg/ GOT 15mg/kg/ mg/kg/ 100mg/kg/ 500mg/kg/ 500mg/kg/ 20mg/kg/ 100mg/kg/ 500mg/kg/ mg/kg/ 100mg/kg/ 500mg/kg/ 8
9 20mg/kg/ 500mg/kg/ 100mg/kg/ mg/kg/ 30mg/kg/ 30mg/kg/ 100mg/kg/ 10mg/kg/ mg/kg/ 100mg/kg/ 500mg/kg/ F1 500mg/kg/ 4 F2 20mg/kg/ 100mg/kg/ F1 100mg/kg/ F1 500mg/kg/ V79 V79 CHO in vitro DNA TA102 V79 TA102 DNA 400mg/ 7 in vitro 25 in vivo 6.5 ASA PCA PHA PCA 150mg/kg/ 4 1 9
10 in vitro 100µg/mL 436mg/kg 7 261mg/kg/ 436mg/kg/ 300mg/kg 100mg/kg/ 7 UV-LNA DNA DNA V mg/kg/ 30mg/kg/ 90mg/kg/ 10mg/kg/ mg/kg/ 2 60mg/kg/ ERG a b 30mg/kg/ 12 in vitro 100µg/mL 10
11 AUC Cmax AUC 53 11
12 in vitro MIC MIC90 S.aureus MSSA µg/ml S.aureus MRSA µg/ml S.epidermidis µg/ml S.pyogenes µg/ml S. pneumoniae PSSP µg/ml S. pneumoniae PRSP µg/ml E.coli µg/ml K. pneumoniae µg/ml E.cloacae µg/ml E.aerogenes µg/ml P.mirabilis µg/ml P.vulgaris µg/ml H.influenzae µg/ml P.anaerobicus µg/ml P.asaccharolyticus µg/ml P.magnus µg/ml P.micros µg/ml P.acnes µg/ml M.pneumoniae µg/ml C.pneumoniae µg/ml L.pneumophila µg/ml SPFX TFLX LVFX CPFX S. pneumoniae M. catarrhalis H. influenzae CAM MBC MIC 2 MIC Postantibiotic effect PAE MIC 4MIC 10MIC 3 3 S.aureus PAE 1MIC hr 4MIC hr 10MIC hr S.pneumoniae 1MIC hr 4MIC hr 10MIC hr E.coli PAE 1MIC hr 4MIC hr 10MIC hr H.influenzae 1MIC hr 4MIC hr 10MIC hr E.coli PAE CPFX SPFX S.aureus S.pyogenes CPFX SPFX S.aureus 20mg/kg S.pyogenes 80mg/kg 100% E.coli K.pneumoniae CPFX SPFX 1mg/kg 2.5mg/kg 12
13 100% 2 ED50 ED mg/ mg/kg ED50 SPFX CPFX LVFX 2 12 S.pneumoniae H.influenzae mg/kg S.pneumoniae 1/100 SPFX 1/10,000 CPFX H.influenzae 10mg/kg S.aureus mg/kg 1/1000 SPFX 80mg/kg 80mg/kg 1/1000 SPFX CPFX DNA DNA DNA 4MIC < CPFX S.aureus E.coli S.pneumoniae 170 1/2 1/20 7 S.aureus MIC 8 S.pneumoniae 100 CPFX S.aureus MIC ,000 S.pneumoniae 1000 PMN McCoy PMN McCoy n=5 M-1 MIC 1 >128µg/mL 16 13
14 100mg/kg 100mg/kg 10mg/kg 100mg/kg 31.5mg/kg 100mg/kg 100mg/kg 10µg/mL 100mg/kg in vivo in vitro 120mg/kg 120mg/kg 1 300mg/kg 75mg/kg µg 5nM GABA GABA IC M CPFX ENX in vivo QT 100mg/kg QT QTc 100mg/kg 30mg/kg QT 30mg/kg QT QTc 2mg/kg/min QTc QT QTc QTc 30mg/kg 0.5mg/kg/min Cmax 24.3µg/mL 400mg Cmax 4.13µg/mL 5.9 QT QT 14
15 QTc QTc 200µg/mL Torsades de pointes 120mg/kg 2mg/kg/min QTc 6 1 SPFX QTc Torsades de pointes 2 QT HERG Ikr 7 7 CPFX CPFX 1.0µg/mL MIC 400mg Cmax 1.78µg/mL 0.68µg/mL MIC90 100mg/kg QT 400mg Cmax
16 Cmax mg 14C- Tmax 0.5h 3.63h T1/2 2.1h 0.5 8h 17.0h 10 48h T1/2 10.3h 10-31h 194h h T1/2 1.56h 0.5 8h 10.2h h 160h h 9.18 mg/kg T1/2 1.21h 4 8 h CL 2.55L/h/kg Vss 3.63 L/kg Tmax 0.083h 5 T1/2 1.25h 3 8 h AUC 77.8% 53.4% 9.18 mg/kg T1/ h h CL 4.21L/h/kg Vss 3.70 L/kg Tmax 0.25h T1/2 1.28h 4 8 h AUC 77.5% 2.75 mg/kg 15 T1/ h 8.64h h CL L/h/kg Vss L/kg 9.18 mg/kg Tmax h T1/ h h AUC µg h/ml % 14C mg/kg T1/ h 1.5 8h 1 8 AUC µg eq. h/ml AUC µg h/ml CL L/h/kg AUC
17 0.472µg h/ml % 9.18 mg/kg Tmax 1.00h 0.083h 12 Cmax 0.787µg/mL 2.86µg/mL 1/4 AUC 2.81µg h/ml 2.80µg h/ml mg/kg mg/kg 1 Wistar 14C mg/kg 0.5 T/P % FB Wistar 14C - 5 mg/kg 24 7 FB30 14C - 5 mg/kg
18 18 14C - 5 mg/kg % 17 14C - 5 mg/kg mg/kg Cmax 2.32µg/g 0.773µg/mL AUC 4.97µg/g 1.49µg/mL 50 mg/kg Cmax 18.8µg/g 4.42µg/mL AUC µg h/g 7.65µg h/ml AUC0-6 T/P AUC AUC 35.3µg h/g µg h/g µg h/g 3.98 in vivo 4.6 mg/kg % 9.18 mg/kg % % µg/ml 14 C - in vitro % % 14C PE/P
19 M-1 M-2 M-3 M-4 M-5 M-6 M-7 M-8 M-9 M-1 M-2 M-1 M % 71 79% M-2 15% 22% M-2 1/3 1/4 M-1 M-1 MIC 1 >128µg/mL M-2 M-2 2% 3% M-1 75% M-2 M-3 2 3% M-1 36% M-1 32% M-5 18% M-2 14% M % M % M-2 M-1 M-2 CYP CYP M-1 14C mg/kg % 86.8% 5.14% 92.6% A ur 3 19
20 % 62.0% 14C mg/kg/ C mg/kg % 29.0% 60.9% 4.90% 20.6% 80.5% % 18.1% 67.6% 18% 85% 3.3% 14C mg/kg 8 1/3 3/4 AUC 46% % 1 100mg 200mg 400 mg 600 mg mg AUC Cmax 400mg Cmax =4.13µg/mL Tmax =1.75h AUC=51.51µg h/ml T1/2=13.9h A ur =21.5% 400mg Cmax =4.06µg/mL AUC =32.35µg h/ml 7 Cmax =4.08µg/mL AUC =46.67µg h/ml 1 24 A ur 23.6% % % 200 mg 1 Cmax AUC 2.37µg/mL 22.33µg h/ml 2.07µg/mL 21.90µg h/ml A ur 17.5% 18.6% mg % 20
21 86.2% 3 50 mg 100 mg 200 mg 400 mg 600 mg 800 mg mg AUC Cmax 400mg Cmax =2.50µg/mL Tmax =1.50h AUC=26.9µg h/ml T1/2=13.1h A ur=20.1% mg 200 mg mg mg mg mg Tmax h Cmax AUC Cmax 45.5µg h/ml 4.32µg/mL 32.2µg h/ml 2.78µg/mL AUCnorm Cmax norm 6.92kg h/l 0.66kg/L 6.54kg h/l 0.56kg/L Tmax T1/2 1.03h 11.9h 1.29h 13.3h % % 400mg No No No No AUC Cmax No µg h/ml 4.08µg/mL No µg h/ml 3.24µg/mL No
22 47.97µg h/ml 4.52µg/mL No µg h/ml 3.33µg/mL Tmax h T1/ h AUC norm Cmax norm No kg h/l 0.64kg/L No kg h/l 0.57kg/L No kg h/l 0.85kg/L No kg h/l 0.67kg/L No kg No kg No kg No kg AUC Cmax mg mg 8 Cmax AUC 1.55µg/mL 19.27µg h/ml 1.31µg/mL 18.85µg h/ml 1.92µg/mL 24.85µg h/ml Cmax norm AUCnorm 0.60kg/L 7.81kg h/l 0.64kg/L 8.01kg h/l 7 Child-Pugh ClassA B Cmax µg/mL AUC µg h/ml Cmax AUC Class B 22
23 M-1 Cmax AUC Child-Pugh ClassA B Cmax µg/mL AUC µg h/ml M-2 AUC µg h/ml 8 CLcr ml/min/1.73m 2 >90 group group group3 30 group 4 4 Cmax AUC CLR A ur group1 4.38µg/mL 43.4µg h/ml 2.3L/h 24.2% group2 4.92µg/mL 40.1µg h/ml 2.0L/h 19.5% group3 3.45µg/mL 35.8µg h/ml 1.9L/h 16.4% group4 3.16µg/mL 43.9µg h/ml 0.9L/h 9.5% group 4 group 1 AUC Cmax 72.1% A ur CLR M-1 AUC group4/group % 9 Cmax 39% AUC 41% Cmax 28.9% AUC 40.0% Tmax A ur Cmax 41% AUC 61% Tmax A ur 15% Cmax 84.5% AUC 97.4% Cmax 85% AUC 94% Cmax / 149.6% 133.5% AUC0-24 / 107.5% / 103.7% Cmax 79.2% AUC 87.9% Cmax AUC 23
24 Cmax AUC Cmax 83.2% AUC 95.5% 10 50mg mg mg mg 231/232A 400mg 232B 50mg mg mg mg mg 232A 400mg 232B Cmax AUC 50mg 400mg AUIC AUC/MIC 125 HPLC-FL 1.78µg/mL 0.68µg/mL biopsy / MIC90 24
25 AUIC125 AUIC AUC/MIC 125 AUIC in vitro 1993 Forrest A PK/PD AUIC 125 AUIC AUIC AUIC / M-1 M-2 Cmax AUC Cmax AUC 2 / Cmax AUC / transepithelial elimination CYP450 2 CYP450 25
26 50% M-1 M-2 Cmax AUC QT 400mg Group 4 AUC AUC AUC M-1 M-2 20% 3% 14% 337mL/min 144mL/min 177mL/min 229mL/min 43mL/min 20% / AUC M-2 14% M-1 AUC M-2 M-1 No.0148 / 26
27 AUC M-2 transepithelial elimination Rohwedder 24 60% 20% AUC / / 14C- 5 mg/kg in vitro % 51.6% 66.9% 70.3% 78.1% 87.8% 88.4% g eq./g g eq./g C- 164 ADME 27
28 No mg 600mg 1 100mg 200mg mg mg 6 200mg % 600mg % QTc 600mg sec sec sec. QT p=0.001 p=0.044 t 0.47sec. 2 No mg 6 6 GOT GPT 7 GLDH % % 5 GOT GPT GLDH 1 No.2 6 GOT 184IU/L GPT 435IU/L 28 IgM IgG EBV-VCA IgG IgM 28
29 EBV-EBNA HBs HBe HBc IgM HA IgM IgG HCV 1 3 No mg % % QTc sec. Bifidobacterium Eubacterium Peptostreptococcus 2 C.difficile C.difficile D No mg 100 mg 200mg mg 600mg % 9 50mg % mg % mg % mg 1 Al-P 29
30 2 5 No mg % % No n= mg 5 2 n= mg % mg % mg % % mg mg mg 500mg 200mg 1/004 2/004 1/ / mg U/L No
31 mg % % mg % % No mg GOT GPT
32 37 No / / / / / / mg No Child-Pugh class A 6 class B 2 400mg Child-Pugh class B mg % % CLCR>90mL/min/1.73m
33 3 CLCR 60 90mL/min/1.73m CLCR 30mL/min/1.73m mg QTc 10 No.0163 QT mg 800mg 400mg 2 QT QTc QT ETT 400mg 800mg 400mg 18 QT SD msec Bazett QTc msec Fridericia QTc msec ETT QT mg QT RR=1000msec % RR=400msec % 800mg QT RR1000msec % % 11 No mg 7 400mg 8 LFLX 400mg UVB nm UVA nm 400nm MED 33
34 Minimal Erythema Dose 24 MED LFLX nm nm MED 70% 0 20% MED LFLX 200mg 400mg LFLX vs. 200mg 400mg p 0.05 Wilcoxon test UVA UVB MED 12 No mg TSH T3 T4 TSH T3 T4 3/8 2/8 1 2/4 4 CK QTc 1 QTc 62msec QTc 30msec 1 13 No mg mg 40 AMPC 500mg / mg mg 35 AMPC mg 87.9% 29/33 400mg 77.1% 27/35 AMPC 77.8% 28/36 200mg 23.7% 9/38 400mg 27.5% 11/40 AMPC 23.1% 9/39 200mg 1 AMPC
35 200mg 400mg 1 AMPC No D D mg mg 11 CFIX 400mg % 200mg 60.0% 6/10 400mg 45.4% 5/11 CFIX 85.7% 6/7 200mg 4 CFIX mg 400mg CEX 500mg mg mg 28 CEX 28 / mg mg 22 CEX mg mg 15 CEX mg 95.2% 20/21 400mg 100.0% 22/22 CEX 100.0% 26/26 200mg 72.2% 13/18 400mg 80.0% 12/15 CEX 80.0% 12/15 200mg 60.0% 18/30 400mg 67.9% 19/28 CEX 57.1% 16/28 200mg 5 400mg
36 200mg 400mg CAM 500mg mg mg 27 CAM 27 CAM mg mg 27 CAM mg mg 27 CAM mg mg 10 CAM mg 88.5% 23/26 400mg 92.6% 25/27 CAM 87.5% 21/24 200mg 60.0% 6/10 400mg 90.0% 9/10 CAM 76.9% 10/13 200mg 15.4% 4/26 400mg 18.5% 5/27 CAM 16.0% 4/25 CAM D mg ST 160/800mg ST ST % 36/36 ST 70.6% 12/ % 30/36 ST 70.6% 12/ % 45/57 ST 56.0% 14/ % 28/57 ST 32.0% 8/25 5 ST 2 1) CAM 200mg 400mg 1 1 CAM 500mg 36
37 mg mg 224 CAM mg mg 224 CAM mg mg 177 CAM mg mg 47 CAM mg 93.9% 169/ mg 94.4% 167/177 CAM 94.3% 164/ mg 49.3% 113/ mg 50.9% 114/224 CAM 50.0% 111/222 5% 200mg 3.9% 400mg 4.5% CAM 5.9% 200mg 3.5% 400mg 8.0% CAM 5.9% 200mg 6.1% 400mg 8.0% CAM 5.4% 200mg 7 400mg11 CAM 11 CAM 19 D mg CAM 500mg CAM CAM CAM CAM 49 / 17 7 CAM CAM CAM CAM CAM % 184/194 CAM 94.7% 178/188 37
38 CAM 95% [-3.7%, 5.3%] -10% CAM 96.4% 106/110 CAM 96.2% 100/104 95% [-5.8%, 6.2%] -10% CAM 49.3% 117/237 CAM 50.0% 118/236 5% 25% 60 CAM 24% 57 9% 22 CAM 9% 21 8% 20 CAM 12% 29 5% 13 CAM 5% 11 7% 16 CAM 6% 15 5% 11 CAM 3% 8 4% 10 CAM 7% CAM CAM CAM 18 6 CAM CAM AMPC 400mg 10 AMPC 1000mg AMPC AMPC AMPC % 162/177 AMPC 89.7% 166/ % 61/68 AMPC 82.4% 56/ % 118/200 AMPC 49.0% 102/208 5% 5.0% AMPC 2.9% 6.0% AMPC 11.1% 7.0% AMPC 1.0% 8.5% AMPC 5.8% 5.5% AMPC 1.0% 21 D
39 400mg % % 184/ % 106/ % 106/ % 122/254 5% 4.7% 9.8% 7.9% 5.9% 22 D CXM-AX mg mg1 1 CXM-AX mg mg 225 CXM-AX mg mg 55 CXM-AX mg mg 170 CXM-AX mg mg 73 CXM-AX mg 91.0% 161/ mg 92.4% 157/170 CXM-AX 87.0% 161/ mg 93.5% 72/77 400mg 91.8% 67/73 CXM-AX 84.7% 72/85 200mg 44.8% 100/ mg 45.3% 102/225 CXM-AX 47.4% 111/234 5% 200mg 5.4% 400mg 5.8% CXM-AX 6.8% 200mg 9.9% 400mg 8.0% CXM-AX 6.4% 200mg 3.1% 400mg 9.8% CXM-AX 5.6% 200mg 3.1% 400mg 5.3% CXM-AX 3.0% 1 23 D CAM 400mg mg CAM500mg1 2 39
40 CAM CAM CAM CAM 251 / CAM % 228/ % 234/256 CAM 92.0% 231/ % 127/ % 135/148 CAM 85.3% 110/ % 131/ % 138/302 CAM 47.8% 149/312 5% 5 5.8% % CAM 2.6% 5 5.4% % CAM 6.1% 5 4.2% % CAM 7.7% 5 3.8% % CAM 2.9% 5 2.2% % CAM 9.0% CAM 400mg1 1 CAM500mg CAM CAM CAM CAM CAM % 287/322 CAM 88.4% 289/ % 89/115 CAM 62.3% 71/ % 165/374 CAM 46.4% 172/371 5% 4.0% CAM 3.8% 4.0% CAM 4.6% 6.1% CAM 4.9% 4.3% CAM 4.6% 1 25 D CEX 40
41 400mg1 1 CEX500mg CEX CEX CEX CEX CEX % 162/180 CEX 91.2% 156/ % 62/68 CEX 91.2% 52/ % 67/201 CEX 33.8% 67/198 5% 3.5% CEX 6.6% 7.5% CEX 4.0% CEX mg1 1 CEX500mg CEX CEX CEX CEX CEX % 177/191 CEX 92.8% 180/ % 89/100 CEX 93.8% 105/ % 112/227 CEX 45.5% 102/224 5% 12.8% 29/227 CEX 4.5% 10/ % 15/227 CEX 3.6% 8/ % 12/227 CEX 4.0% 9/ D CXM-AX mg1 1 7 CXM-AX250mg CXM-AX
42 CXM-AX CXM-AX CXM-AX % 154/191 CXM-AX 91.2% 176/ % 119/232 CXM-AX 44.1% 101/229 5% 4.7% CXM-AX 5.7% 15.1% 35/232 CXM-AX 6.1% 14/ % 26/232 CXM-AX 6.6% 15/ % 12/232 CXM-AX 3.1% 7/ CXM-AX mg1 1 7 CXM-AX 250mg CXM-AX CXM-AX CXM-AX CXM-AX 225 / CXM-AX % 204/211 CXM-AX 90.7% 204/ % 103/109 CXM-AX 83.5% 96/ % 105/242 CXM-AX 35.1% 88/251 5% 4.5% 10/242 CXM-AX 4.0% 7/ % 23/242 CXM-AX 6.0% 15/ CXM-AX mg1 1 CXM-AX250mg CXM-AX CXM-AX CXM-AX
43 223 CXM-AX % 200/223 CXM 89.3% 209/ % 126/263 CXM-AX 40.9% 112/274 5% 8.4% 22/263 CXM-AX 5.8% 16/ % 29/263 CXM-AX 4.0% 11/ % 20/263 CXM-AX 6.2% 17/ % 16/263 CXM-AX 3.3% 9/ CXM-AX mg1 1 CXM-AX250mg CXM-AX CXM-AX CXM-AX CXM-AX CXM-AX % 203/217 CXM-AX 94.6% 210/ % 84/86 CXM 94.4% 68/ % 81/245 CXM 29.1% 73/251 5% 9.8% 24/245 CXM-AX 6.4% 16/ D mg % 270/ % 64/ % 188/371 5% 10.0% 37/ % 33/ % 42/ % 21/371 43
44 mg % 299/ % 221/434 5% 5.8% 25/ % 57/ % 28/ % 20/ mg1 1 OFLX 200mg OFLX OFLX OFLX % 80/138 OFLX 67.6% 92/ % 109/218 OFLX 45.9% 105/229 5% 6.0% 13/218 OFLX 2.6% 6/ % 11/218 OFLX 3.5% 8/ % 17/218 OFLX 3.5% 8/ % 13/218 OFLX 3.9% 9/ % 36/218 OFLX 6.1% 42/ / / mg mg1 2 44
45 400mg mg % 224/ % 198/ % 173/ % 196/326 5% 4.7% 16/ % 30/ % 17/ % 15/ % 21/ % 25/ % 60/ % 84/ % 13/ % 38/ % 29/ % 25/ % 19/ % 12/ D mg 1 1 LVFX 1 100mg [] [18 ] 1 100mg1 3 [ 1 500mg1 2 ] 10mg/ [ ] / [ ] PCR [ ] 7 [ ] 3 [ ] LVFX ITT 45
46 / LVFX LVFX LVFX % 32 LVF LVFX LVF % 58/117 LVFX 65.1% 84/129 p=0.029 Cochran-Mantel-Haenszel test 94.0% 110/117 LVFX 94.6% 122/129 LVFX -0.80% 95% [-6.28%, 4.68%] -10% LVFX 92.3% 36/39 LVFX 82.6% 38/ % 19/19 LVFX 82.8% 24/ % 19/22 LVFX 86.4% 19/ % 38/41 LVFX 92.7% 43/51 S.pneumoniae 100.0% 14/14 LVFX 85.7% 18/21 H.influenzae 100.0% 14/14 LVFX 85.7% 12/14 M.catarrhalis 80.0% 4/5 LVFX 100.0% 5/5 S.aureus 100.0% 2/2 LVFX 85.7% 6/7 36.2% 54/149 LVFX 33.3% 51/ % 23/149 LVFX 14.4% 22/153 5% 3.4% 5/149 LVFX 5.2% 8/ % 8/149 LVFX 5.2% 8/ LVFX LVFX 2 BOOP 1 LVFX mg
47 7 205 / % % 140/ % 57/58 100% 26/ % 57/ % 87/200 5% 8.5% % % % mg % % 107/ % 37/ % 54/ % 16/ % 93/ % 30/ % 42/ % 21/ % 53/159 5% 5.7% 9 47
48 PRSP mg 1 1 AUIC AUC/MIC mg mg mg mg 34 AUIC MIC mg 100% 12/12 400mg 100% 34/34 MIC mg 50% 6/12 400mg 100% 34/34 MIC mg 0% 0/12 400mg 56% 19/ MIC 400mg 48
49 400mg 1 1 AUIC / / / / / % 21/ mg % 142/ % 33/ % 17/ % 2/
50 % 92.9% 92.9% 89.4% 90% 85.3% 85% 60 26% 43% MIC 94.6% 92.7% 38/ % 38/ % 110/ % 122/ % 38/ % 36/ % 42/ % 37/ CRP 6 K. pneumoniae H. parainfluenzae 5 4 S. pneumoniae 2 S. aureus H. influenzae 1 50
51 MSSA MIC µg/mL µg/mL µg/mL 96.0% 24/ % 33/41 100% 10/10 MIC µg/mL 0.5µg/mL 0.1 2µg/mL PISP 12 2µg/mL PRSP 1 13 PISP PRSP 84.6% 22/ % 21/23 1µg/mL 96.0% 24/ % 54/149 LVFX 33.3% 51/ % 1 0.7% mg 1.2% 47/4, % 42/3,689 51
52 10/ % LVFX 4/ % GOT GPT 2 BOOP 1 QT Torsades de pointes 11 5, % QT Torsades de pointes Torsades de pointes Torsades de pointes Torsades de pointes mg QTc 500mg mg 18,409 Torsades de pointes QTc Torsades de pointes 52
53 400mg 1/ 500mg 1/ 24.3% 24.8% 7.4% 1.7% 5.0% 0.3% 1.7% 3.7% 2.0% 0.3% 1.3% 400mg 1/ 400mg 1/ 8.2% 8% 5.7% 4% 5.7% 4% 2.9% 3% QT Torsades de pointes 400mg 1/ 200mg 2/ QT c 200mg 400mg 200mg/ 21.2% 118/ mg/ 27.1% 1373/ mg/ 200mg/ 20.1% 112/ mg/ 26.5% 1342/ mg/ 1.1% 6/ mg/ 0.6% 31/
54 200mg/ 1 400mg/ 0.2% 9/ mg/ 5.4% 30/ mg/ 4.5% 227/ mg/ 6 1.1% mg/ % mg/ 22.6% 52/ mg/ 22.7% 51/ % 42/ mg/ 4.7% 11/ mg/ 3.1% 7/ % 4/ mg/ 400mg/ 400mg/ 200mg/ 400mg/ 400mg/ 200mg/ 400mg/ 200mg/ 400mg/ 1 200mg/ 12.2% 68/ mg/ 18.1% 918/ mg/ 2.9% 16/ mg/ 5.5% 279/ mg / 60kg 5 10% 54
55 22.0% 63/ % 68/222 % kg 30-<40 40-<50 50-<60 60-<70 70-< /7 77/ / / / / /10 53/127 72/ / / /28 % kg 30-<40 40-<50 50-<60 60-<70 70-< / / /37 15/87 20/89 10/46 5/ /90 32/90 5/ / /5 Torsades de pointes Torsades de pointes 12 5 QT 2 NEC146 QT 60msec Cmax CPMP QTc 400mg 2.7% 21/ % 5/ % 17/759 55
56 60,000 Torsades de pointes Torsades de pointes Torsades de pointes QT 1800 No.0163 QT c 400mg 478.4msec 800mg 457.5msec 460msec QT QT Torsades de pointes CCDS Company Core Data Sheet / / /10 56
57 12 / / / /10 400mg/ 25.3% 2,013/7, % 2.5% 0.6% 0.5% % 400mg/ 500mg/ 4.5% 26/ % 23/ % 1.4% 0.3% 1.4% CCDS 0.1% CCDS 0.01%~0.1% CCDS 57
58 mg 6 400mg H.influenzae 22% 16% C.pneumoniae 2% 34% M.pneumoniae 34% 16% 95.8% 95.5% 93.5% 94.5% S.pneumoniae 14/14 100% 17/17 100% H.influenzae 14/14 100% 22/ % M.pneumoniae 21/ % 23/ % C.pneumoniae 1/1 47/ % 58
59 GCP 59
60 GCP GCP QT 60
61 mg QT QT 61 QT QT QT QT 61
62 mg 1 PK/PD 1 400mg 400mg mg 2 200mg Cmax AUCtau age Young Middle-aged Elderly gender male female male female male female n AUCtau mg*h/l 58.2 / / / / / / 1.11 AUCtau,norm kg*h/l 8.84 / / / / / / 1.14 Cmax mg/l 4.85 / / / / / / 1.09 Cmax,norm kg/l 0.74 / / / / / / 1.14 tmax h 1.5 (1-3) 2 (1-4) 1 (1-4) 2 (1-4) 1 (1-2) 2 (1-3) t1/2 h 12.6 / / / / / / 1.10 AUCtau,norm = AUCtau / (dose body weight), Cmax,norm = Cmax / (dose body weight) geometric mean / geometric sd, median (range) for tmax
63 % 99/ % 19/ % 12/ % 0/10 Cmax AUCtau kg mg AUCtau (kg) Cmax kg kg kg kg n Cmax (mg/l) 5.74/ / / /1.21 AUCtau (mg * h/l) 66.8/ / / /1.18 Geometric mean/geometric sd kg % % 26.7% % % % (1) 40kg kg 1 200mg kg 200mg 1 200mg kg
64 40kg 200mg 200mg 200mg Cmax AUC 400mg MIC 200mg PK/PD 200mg MIC class respiratory quinolone respiratory quinolone
65 200mg 200mg QT 23 QT QT QT 65
66 50kg QT QT QT QT QT kg 40 QT 1 400mg msec 452msec 30 msec QTc 1997 EMEA The assessment of the potential for QT interval prolongation by non-cardiovascular medicinal products. Ref.3901, CPMP/986/96, London 1997 QTc QTc 30msec QTc 450msec 470msec QTc 6 1 QTc 1.48 / / 10 Davis et.al. Annals of Internal Medicine 111(12):1041-3,
67 QT QT QT QT/QTc QT/QTc mg 1 1 SPFX 1 300mg QT/QTc Cmax QTcF SD 1 7 QTcF SPFX SPFX % [ ] msec % [ ] msec Cmax QTcF msec n 1 QTcF n 7 QTcF 400 mg ±6.4 (-4.2, 24.3) ± 9.7 (-0.9, 46.7) SPFX 300 mg ±13.3 (-33.2, 39.8) ±16.1 (10.6, 72.4) Arithmetic mean±sd(range) 1 7 QTc % SPFX % 67
68 SPFX QT/QTc Cmax QTcF SPFX QTcF 1 QTcF 7 1 QTcF 46.7msec SPFX 7 QTcF 72.4msec Cmax QTcF msec 400 mg 1 7 n QTcF n QTcF ±8.2 (-4.2, 24.3) ±10.1 (-0.9, 29.7) ±7.2 ( 3.2, 23.7) ± 8.0 ( 3.6, 26.8) ±4.1 ( 7.8, 19.1) ±10.0 ( 5.0, 33.4) ±4.4 ( 9.9, 22.4) ±11.3 ( 8.9, 46.7) ±6.4 (-4.2, 24.3) ± 9.7 (-0.9, 46.7) SPFX 300 mg ±12.1 (-11.2, 34.0) ±10.7 (10.6, 45.0) ±10.3 ( 6.4, 39.8) ±11.2 (11.2, 47.1) ± 9.8 ( 8.7, 38.6) ±16.2 (15.9, 66.7) ±18.8 (-33.2, 31.8) ±17.1 (17.8, 72.4) SPFX ±13.3 (-33.2, 39.8) ±16.1 (10.6, 72.4) Arithmetic mean±sd (range) 1 SPFX Cmax AUCtau Cmax,norm AUCtau,norm Day 1 (n=20) Day 7 (n=20) Day 1 (n=20) Day 7 (n=19) AUC mg*h/l 48.5 / / AUCtau mg*h/l 37.5 / / / / 1.18 AUCtau,norm kg*h/l 5.99 / / / /
69 Cmax Cmax,norm tmax t1/2 mg/l kg/l h h 3.59 / / (1-6) 10.8 / / / (1-4) 12.3 / / / (1-4) 9.0 / / / (1-4) 10.4 / 1.14 geometric mean/geometric s.d, median (range) for tmax SPFX n=20 n=19 n=19 n=19 AUC AUCtau AUCtau,norm Cmax Cmax,norm tmax t1/2 mg*h/l mg*h/l kg*h/l mg/l kg/l h h 28.3 / / / / / (1-6) 17.7 / / / / / (1-4) 20.8 / / / / / / (1-6) 18.4 / / / / / (1-6) 18.8 / 1.16 geometric mean/geometric s.d, median (range) for tmax 27.5% 11/40 SPFX 30.8% 12/ % 11/40 SPFX 15.4% 6/ % 7/20 SPFX 10.5% 2/19 SPFX QT QT/QTc QT/QTc mg 400mg mg
70 1 2 A 200 mg SPFX 200 mg B SPFX 200 mg 200 mg C 400 mg SPFX 200 mg D SPFX 200 mg 400 mg C 1 QT/QTc Cmax QTcF 1 200mg SPFX QTcF 7 200mg 400mg SPFX QTcF 200mg 400mg QTcF 400mg 200mg 90% , 9.5 msec , 17.5 msec 7 400mg QTcF Treatment Group 200 mg 400 mg n QTcF Day 1 6.2±5.4 (-2.9, 14.4) 6.9±5.5 (-1.1, 16.3) 6.5±5.3 (-2.9, 16.3) n Day 7 6.0± 9.6 (-8.2, 18.3) 17.2±12.8 (-0.4, 39.6) 11.6±12.4 (-8.2, 39.6) ±6.9 ( 4.6, 26.9) ± 7.6 ( 6.2, 28.8) ±3.9 ( 7.4, 21.6) ± 8.9 ( 9.8, 41.2) ±5.5 ( 4.6, 26.9) ±10.1 ( 6.2, 41.2) SPFX 200 mg ±7.7 ( 2.1, 24.9) ±10.8 ( 2.4, 47.8) ±8.2 (-5.2, 25.3) ±14.5 ( 0.4, 74.1) ±8.2 (-5.2, 25.3) ±13.7 ( 0.4, 74.1) Arithmetic mean±sd (range) 200mg 400mg 1 7 QTc SPFX 200mg msec QTcF Cmax AUCtau Cmax,norm AUCtau,norm 70
71 200 mg 400 mg SPFX 200 mg n=20 n=20 n=20 n=20 n=40 n=40 AUC mg*h/l 28.5 / / / AUCtau mg*h/l 22.5 / / / / / / 1.20 AUCtau,norm kg*h/l 6.42 / / / / / / 1.16 Cmax mg/l 2.21 / / / / / / 1.30 Cmax,norm kg/l 0.63 / / / / / / 1.21 tmax h 1 (1-3) 1 (1-3) 1 (1-3) 1 (1-3) 2 (1-6) 2.6 (1-6) t1/2 h 10.4 / / / / / / 1.22 geometric mean/geometric s.d, median (range) for tmax 200mg 10.0% 2/20 400mg 19.0% 4/21 SPFX 12.5% 5/40 400mg 1 QT QT ICH E14 QT SPFX QT QT QT 7 QTcF 200mg 400mg SPFX SPFX QT 1 71
72 400mg SPFX200mg SPFX 200mg QT mg 7 QTcF 30msec Torsades de Pointes Thorough QT/QTc Study E14 step 4 Shah RR. Br J Clin Pharmacol 2002;54: IMS IMS CPFX DDD 2,985,766 29,616,149 39,135,895 62,296,215 71,408,784 76,087,137 45,345, , , , , , DDD CPFX DDD 273,598, ,038, ,473, ,626, ,642, ,233,000 40,188,710 1, , , ,
73 DDD CPFX CPFX DDD Defined Daily Dose CPFX CPFX 10 / CPFX CPFX CPFX gemifloxacin respiratory quinolone Donowitz et.al., Acute pneumonia 73
74 pp.819, Principles and Practice of Infectious Disease. 6 th ed., mgQD 100mgTID AUC/MIC AUC/MIC Peak/MIC Craig et.al., Pharmacodynamics of Quinolone Antimicrobial Agents, Quinolone Antimicrobial Agetns, 3 rd Ed., 2003 respiratory quinolone in vitro MIC mgQD 100mgTID 82.6% 38/ % 36/39 35 QT respiratory quinolone QT respiratory quinolone 74
75 H.influenzae 45.5% 15/ % 30/ % 37/ % 41/ % 53/ % 62/ % 162/ % 52/ % 156/171 2 β- β- QT 3 (1)
76 25 60%RH 30 % 25 60%RH 30 4 (1) mg 1 1 (1) (1) 76
77 .,, ) ) M-1 AUC M-2 8 AUC 9. 10) Cmax mg mg 215 Cmax % 3% 14% Group 4 30 ml/min/1.73 m 2 AUC M-1 ) M AUC M M AUC M-2 M-1 AUC M-2 77
78 . 1) ) 37 No.0162 No ) ) 2 CLCR>90mL/min/ 2 CLCR> m mL/min/ 1.73m CLCR CLCR 90mL/min/1.73m mL/min/1.73m 2. 3) ) QT QT Dispersion 27.1 QTc SD SD msec Bazett 17.8msec Bazett QTc 27.9 QTc Dispersion msec Fridericia msec Fridericia QTc QTc Dispersion. 4) ETT QT 17 ETT QT 17 QTc 400mg QT QT RR=1000msec mg QT 5.1% RR=400msec RR= % msec % RR=400msec 800mg % QT 800mg RR1000msec 800mg QT RR=1000msec. 4) 10. 2) D D ) ) 400mg 8.0% 400mg 8.5% 15. 1)
79 96.8% 92.9% 182/ /190. 2) CXM-AX1 2 CXM-AX500mg /. 2) % 228/ % 234/ % 222/ % 234/256 CAM 92.0% 231/251 CAM 89.2% 224/251. 3) ) ) 4.5% 10/ % 11/ CXM-AX 4.0% 7/251 CXM-AX 4.0% 10/ % 23/ % 27/242. 4) ) 85.4% 299/ % 299/327. 5) 2.8% 36/218 OFLX 2.8% 6/218 OFLX % 42/ % 14/229. 5) % 5.0% ) LVFX 92.7% 43/51 LVFX 84.3% 43/ ) 76.9% 30/ % 30/ % 77.8%. 92.9% 92.9% 89.4% 92.9% 92.8% 89.4% 3) % 84.3% 3) 38/46 43/ ) % 1.8% 4) 17 79
80 (1). 4 QTc QT msec QT n=17 400mg 800mg QT /23.7 (348.3, 418.6) 393.8/33.4 (338.8, 478.4) 395.6/28.0 (355.7, 457.5) QT /20.7 (325.5, 397.3) 370.5/24.2 (325.9, 424.8) 373.3/23.7 (334.9, 417.9) QT /19.2 (312.6, 380.3) 354.2/20.2 (316.5, 395.0) 357.1/21.6 (316.1, 396.8) QT /17.2 (297.0, 356.7) 333.4/16.6 (304.3, 363.0) 335.9/19.1 (296.2, 370.4) QT /13.9 (273.3, 324.2) 306.3/12.4 (288.7, 328.5) 307.8/16.0 (275.2, 336.4) QT /9.2 (245.7, 279.2) 270.0/10.1 (249.5, 291.5) 270.1/13.3 (241.3, 292.8) QT=A-B*exp (-C*RR) A B C / 80
50mg 75mg (1) H 3 C O OH HO H O O H OH SO H 3 Na H H N H 2 N NH OH H N O O H H O OH H 3 C H O O N H H H HO H NH CH 3 HN HO H OH O H OH H NH
3240 14 8 8 50mg 75mg 13 6 25 1-(1) H 3 C O OH HO H O O H OH SO H 3 Na H H N H 2 N NH OH H N O O H H O OH H 3 C H O O N H H H HO H NH CH 3 HN HO H OH O H OH H NH O N O C 56 H 70 N 9 NaO 23 S 1292.26 5-[(1S,2S)-2-
エディロールカプセルインタビューフォーム
2012 4 5 873112 2008 () 1 0.5g 0.5g 0.75g 0.75g JAN EldecalcitolJAN 2011 1 21 2011 3 11 2011 4 11 TEL0120-591-818 03-3985-5599 8:3017:00 http://www.taishotoyama.co.jp/ 20124 http://www.info.pmda.go.jp/
200mg 2005 3 876179 2002 3 3 200mg VFEND for Intravenous Use (1) (2) [4.1 ] (3) [4.2 ] (1) [1] (2) (3) [1] 3
1.8.2 Page MIC () MIC 50 / MIC 90 µg/ml Candida albicans (54) / Candida glabrata (25) 0.25 / 0.5 Candida guilliermondii a) (2)
1.8.2 Page1 1.8.2 96% 2002 40 B 1 123 (1) in vitro 1) in vitro C. glabrata C. krusei 1 2 19951997 3 1999 2002 MIC MIC 2 1.8.2 Page2 1 19951997 MIC () MIC 50 / MIC 90 µg/ml Candida albicans (54) 0.016 /
日本化学療法学会雑誌第59巻第5号
Streptococcus pneumoniae Haemophilus influenzae Moraxella catarrhalis S. pneumoniae H. influenzae M. catarrhalis S. pneumoniae H. influenzae M. catarrhalis S. pneumoniae H. influenzae M. catarrhalis S.
日本化学療法学会雑誌第57巻第5号
in vitro Key words Streptococcus pneumoniae β Haemophilus influenzae Escherichia coli I Table. Antibacteriallevofloxacinactivityagainstclinicalisolates Organism Year Susceptibility(%)(Numberofstrains)
(1) ) ) (2) (3) (4) (5) (1) (2) b (3)..
... -1... -1... -2... -6.... -1 (1)... -1 1)... -1 2)... -14 (2)... -19 (3)... -52 (4)... -18 (5)... -136.... -196 (1)... -196 (2) b... -224 (3)... -233.... -251.... -286.... -289 (1)... -289 (2)... -32
日本化学療法学会雑誌第55巻第S-1号
µ µ Key words Streptococcus pneu- moniae S. pneumoniae µ µ I γ H H C HN F F O N O CO H H C SO H H O Fig.. ChemicalstructureofGRNX. γ γ II Haemophilus influenzae Pseudomonas aeruginosa Streptococcus intermedius
) Meropenem Chemotherapy (Tokyo) ) panipenem/betamipron Chemotherapy (Tokyo) ) Meropenem Chemotherapy (Toky
2.7 2.7.5 1) 199846410-437 2) UTI ( )UTI ( 3 )Chemotherapy (Tokyo) 1986 34408-441 3) () 199745762-778 4) 1992 5) 199543 6) Chemotherapy (Tokyo) 199139687-689 7) Imipenem/Cilastatin sodium (MK-0787/MK-0791)
600mg 600mg CTD 2 2.5 2.5 Page 3 2.5...7 2.5.1...7 2.5.2...27 2.5.3...28 2.5.4...42 2.5.5...55 2.5.6...79 2.5.7...97 2.5 Page 5 73 67 31 48 48A 102 104 105 106 ALP ALT(GPT) AST(GOT) AUC AUEC BID BUN
日本化学療法学会雑誌第57巻第4号
Streptococcus pneumoniae Haemophilus influenzae β β Key words I β Enterococcus faecium Pseudomonas aeruginosa Streptococcus pneumoniae S. pneumoniae Haemophilus influenzae S. pneumoniae H. influenzae Table.
THE JAPANESE JOURNAL OF ANTIBIOTICS 67 3 June 2014 STFX mg mg mg mg mg 1
June 2014 THE JAPANESE JOURNAL OF ANTIBIOTICS 67 3 175 29 1 2 2 2 2 2 3 4 4 5 5 2 2 1 2 3 4 5 2014 4 15 STFX 50 mg 10% 2011 8 1 100 mg 1 1 2011 12 2013 5 226 1,186 1,089 1,069 2.11% 23/1,089 1.10% 12/1,089
THE JAPANESE JOURNAL OF ANTIBIOTICS 68 3 June 2015 Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis % 2 S. pneumon
June 2015 THE JAPANESE JOURNAL OF ANTIBIOTICS 68 3 189 49 1 : 14 1 2 2 3 1 2 3 2015 4 3 1 : 14 CVA/AMPC 1 : 14 27 CVA/AMPC 1 : 14 88.5% Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis
日本化学療法学会雑誌第57巻第S-2号
µ µ Key words µ µ µ I Table1. Subjectprofilesin(A)singleand(B)multiple-dosestudies (A)Single-dosestudy Age (yr) Height (cm) Bodyweight (kg) BMI (kg/m ) Ccr(Cockcroft) (ml/min) Ethnicity dose(mg) n 5 5.1±.,3
日本医師会雑誌第131巻第10号
B C 100 12 11 13 3 C 4 C Q&A B C 54 B B B B Q&A B B HBV 20 HBV B B B B HBV HBV HBV HBV 2 HBV HBV HBV A HBV HBV HBV HBV HBV Q37 HBV HBV HBV 1015 B B B Q51 B HBV B B HBV B HBV HBV HBV B B B HBV B HBV HBV
日本化学療法学会雑誌第56巻第S-1号
Key words Streptococcus pneumoniae µ µ H F Cl H H N N H N F COOH O Fig.1. Sitafloxacinstructure. I γ S. pneumoniae Haemophilus influenzae Table1. Observationandtestschedule Observation/Tests Informedconsent
CTD 2 2.6 5.3mg 0.4mg 0.6mg 0.8mg 1.0mg 1.2mg 1.4mg 1.6mg 1.8mg 2.0mg 12mg 2.6 Page 3 2.6.6...5 2.6.6.1...6 2.6.6.2...9 2.6.6.3...9 2.6.6.4... 11 2.6.6.5... 11 2.6.6.6... 11 2.6.6.7... 11 2.6.6.8... 11
2.7.6 MJR a MRI CT b 2 Beecham r-afs mg/ mg/ Gn-RH 742
MJR-35 34 1 1 a MRICT b 2Beecham r-afs 3 4 20 4 mg/ 20 40 5 6 2 1 2 3 44 mg/ 5 6 7 8 4 Gn-RH 742 9 10 11 12 1 20 60 1 1MJR-351 mg/ 0.25 2 Lot. No. 2MJR-352 mg/ 1 1 Lot. No. 3MJR-354 mg/ 1 2 Lot. No. 2
125 2 P 1st washout 2 PB P mg/dL nd washout 2 P 5.5mg/dL< mg/dL <2.5mg/dL P P 2 D D 3 Ca 10
. (1) 125 1 125 Renagel PB-94 P intact-pth P 1 b c a b 1 18 2 3 3 3 1 P 4 D 1 5 6 7 2 1HIV 2 3 4 5Hb 8.0g/dL ALT 48IU/L 6 7 PB-94 440mg 403mg 1-196 125 2 P 1st washout 2 PB-94 1 2 4 4 P 2.5 5.5mg/dL 1
日本化学療法学会雑誌第61巻第6号
β Moraxella catarrhalis Escherichia coli Citrobacter Klebsiella pneumoniae Enterobacter cloacae Serratia marcescens Proteus Pseudomonas aeruginosa Acinetobacter Bacteroides fragilis β Haemophilus influenzae
Tanigawara Y, Nomura H, Kagimoto N, Okumura K, Hori R. Premarketing population pharmacokinetic study of levofloxacin in normal sub
250 mg500 mg 2.7.5 2.7.5 2.7.5 2.7.2 1 Tanigawara Y, Nomura H, Kagimoto N, Okumura K, Hori R. Premarketing population pharmacokinetic study of levofloxacin in normal subjects and patients with infectious
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19 11 13 300 18 3 31 1300mg 4 6 C 15 H 22 FN 3 O 6 359.35 + -1-5--β-D--5--1,2--2- -4- 19 11 13 300 18 3 31 A B B A 30 1 2 21 7 1 1 1.31m 2 900mg 1.31m 2 1.64m 2 1,200mg 1.64m 2 1,500mg B 30 1 2 14 7 1
まえがき
JAAS0012006 1 -------------------------------------------------------------------------------------------------------- 1 2 --------------------------------------------------------------------------------------------------------
日本化学療法学会雑誌第64巻第4号
β β Moraxella catarrhalisescherichia colicitrobacter Klebsiella pneumoniaeenterobacter cloacaeserratia marcescens Proteus Providencia Pseudomonas aeruginosaacinetobacter Bacteroides fragilis β β E. colik.
高脂血症の検査
35 30 Buffy coatbuffy coat EDTA Na Na Ca RBC Hb Ht WBC Plt ESR TP Alb CRP GOTGPTLDH BUN Cre UA HbA1C TC TG NaKClCaPFe B12 36 RBC 410530 /μl 380480 /μl Hb 13.517.6g/dL 11.315.2g/dL Ht 3648% 3443% MCV MCH
日本化学療法学会雑誌第57巻第1号
In vitro Streptococcus pneumoniae Escherichia coli in vitro Streptococcus pneumoniae Escherichia coli µs. pneumoniae E. coli µ Key words in vitrostreptococcus pneumoniae Escherichia coli Escherichia coli
日本化学療法学会雑誌第56巻第1号
β β β β β Streptococcus pneumoniaehaemophilus influenzaemoraxella catarrhalismycoplasma pneumoniaechlamydia pneumoniae β Key wordsβ mys nilc laci ngis Table. Assessmentschedule Parameters Patientcharacteristics
小児感染免疫第25巻第2号
Vol. 25No. 2145 1,2 1 1 1 1 2 2 2 TFLX 9 TFLX 450 mg16.6 mgkg TFLX 30 kg TFLX 2009 10 TFLX 1 1 2 3,4 TFLX 9 22 6 18 19 TFLX 450 mg150 mg 1 1 1 3 16.6 mgkg 20 20 0 21 3 135.0 cm0.1 S.D. 27.0 kg0.8 S.D.
ケイセントラ_製品情報概要_H1-4_収載_新発売
DIC 135-627 12 CONTENTS 34 32 33 1 2 K 34 3 4 5 12 12 18 24 3 31 31 31 33 KVKA K K VKA VKA K - PT-INR KC S 1996VKA VKA 3 KK CS 33 34 35 35 35 36 36 K 32 33 213 4VKA 12VKAFDA Kcentra 42 217 1 in vitro 1
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2001 4 26 2003 5 22 2004 7 12 2004 7 15 54 2004 7 21 14 2004 9 16 62 IUPAC4--2--N,N --5-p --1-2 17.07 mg/kg / 100 0.17 mg/kg /ADI cyazofamidiso IUPAC 4--2--N,N- -5-p --1-4-chloro-2-cyano-N,N -dimethyl-5-p
HOE901 A S S Gly Ile Val Glu Gln Cys Cys Thr Ser Ile Cys Ser Leu Tyr Gln Leu Glu Asn Tyr Cys Gly
HOE901 A S S Gly Ile Val Glu Gln Cys Cys Thr Ser Ile Cys Ser Leu Tyr Gln Leu Glu Asn Tyr Cys Gly 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 S S S Phe Val Asn Gln His Leu Cys Gly Ser His Leu
ESL ()-methyl 3-{4-[2-hydroxy-3-(isopropylamino)pro poxy]phenyl} propanoate monohydrochloride H 3 C O O JAN( ) JAN( )esmolol hydrochloride r-inn( )esm
![ESL ()-methyl 3-{4-[2-hydroxy-3-(isopropylamino)pro poxy]phenyl} propanoate monohydrochloride H 3 C O O JAN( ) JAN( )esmolol hydrochloride r-inn( )esm](/thumbs/85/92935308.jpg "ESL ()-methyl 3-{4-[2-hydroxy-3-(isopropylamino)pro poxy]phenyl} propanoate monohydrochloride H 3 C O O JAN( ) JAN( )esmolol hydrochloride r-inn( )esm")
1 186 186 (1) - 192 (2) (ISAintrinsic sympathomimetic activity) 199 (3) ( MSAmembrane stabilizing activity) 2 (4) 21 (5) 212 (6) 216 (7) 219 (8) 224 (9) (ASL-8123) - 229 (1) d-esl l-esl - 231 2 235 235
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20 2 14 18 10 16 1 1.0mg 0.035mg 2 1 20 2 14 18 10 16 1 1 1 52 1 1 21 7 28 1 29 2 1 20 1 24 18 10 16 1 1 21 7 28 1 29 1 NET 1.0mg EE 0.035mg *NET *NET 1999 2007 *NET *NET 88 NSAIDs GnRH GnRH NSAIDs 20
日本化学療法学会雑誌第57巻第6号
Streptococcus pneumoniae Haemophilus influenzae Moraxella catarrhalis S. pneumoniae S. pneumoniae β β H. influenzae S. pneumoniae H. influenzae M. catarrhalis Key words Otalgia Fever Item Crying,Iritation,
2.7 臨床概要
2.7 臨床概要 A/G Al-P ALT AST AT- AUC AZM BIPM BP BUN CEZ CFPN-PI CFU CLcr Cmax CNS COPD CPFX CRP CS CYP CVA DBT DHP-I DIC DRPM DRPM-DC FAS γ-gtp GCP GNB GNF-GNR GPB HAM - Staphylococcus C P450 -I Full Analysis
日本化学療法学会雑誌第51巻第2号
piperacillin piperacillin PIPC. g Cmax CL PIPC CL CLR CLNR CL PIPC g g Cmax PIPC Key words: piperacillin Piperacillin PIPC PIPC g g PIPC Cmax g g ml g g ml g g ml T T T PIPC g g T Ccr ml min AUCCmax PIPC
参考資料５ 農薬評価書 メタアルデヒド（食品安全委員会資料）
1 3 3 4 5. 6 1. 6 2. 6 3. 6 4. 6 5. 6 6. 6 7. 6. 7 1. 7 2. 8 (1) 8 (2) 9 (3) 9 (4) 10 (5) 10 3. 11 (1) 11 (2) 11 (3) 11 (4) 12 4. 12 (1) 12 (2) 12 (3) 13 5. 13 6. 13 7. 14 8. 15 9. 16 10. 16 (1) 90 16-1
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1% 1 mg 1 mg 2 CTD 6 Section 2.6.1 Introduction 2.6.1 H 1 descarboethoxyloratadinesch 34117 7.9 SCH 34117 2.6.1-1 O OC 2 H 5 Cl N N JAN Loratadine (JANINN) ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]
IMUSERA 3 3 4 4 5 5 5 5 6 1 1 12 18 25 25 31 31 31 31 32 32 37 43 43 45 48 48 48 48 49 5 1 2 3 4 3 4 1.56mg.5mg D- 3 15.9mm 5.8mm.96g FTY.5mg FTY.5mg OH NH2 OH H3C HCI 5 6 7 BCG Torsades de pointes a 2
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1.4 特 許 状 況 - 1 - - 2 - 1.5 起 原 又 は 発 見 の 経 緯 及 び 開 発 の 経 緯 FCT CT RH ... 1.5-1... 1.5-1... 1.5-1... 1.5-1... 1.5-2... 1.5-2... 1.5-2... 1.5-3...1.5-4... 1.5-5 i 10mg FCT 1 1 6 15 5mg CT 1 1 2 6 4mg CT
CHEMOTHERAPY Methicillin-resistant S.aureus(MRSA) coccus epidermidis 105 Streptococcus pyogenes E.faecali senterococcus avium Enterococcus faecium Str
cefaclor(ccl),cefuroxime(cxm),cefixime (CFIX),cefteram(CFTM),cefdinir(CFDN) pneumoniae,streptococcus pyogenes Moraxella catarrhalis,haemophilus influenzae,escherichia coli, Klebsiella pneumoniae,proteus
日本化学療法学会雑誌第54巻第S-1号
β β β Key words β β I HP- -CD CHR RHC R R R R CHR R R R R RHC R R R CHR R R R RHC CHR R H CH CH Fig.. Structuralformulaofhydroxypropyl-β -cyclodextrin(hp-β -CD). CH n H β β β β Table-. Dosageandadministration(Singleadministrationstudy)
(1) (2) (1) (2) (1) Seg (2) Seg (3) Seg (4) Seg (1) (2) (3) ( ) (1) (PCA)...12
(1)...109 (2)...110 (1) 28...111 (2) 28...113 (1) Seg...115 (2) Seg...117 (3) Seg...119 (4) Seg...120 (1)...122 (2)...122 (3) ( )...126 (1) (PCA)...127 (2) Draize...128 (1) Ames...129 2 in vitro...132
Table 1. Antibacterial activitiy of grepafloxacin and other antibiotics against clinical isolates
Table 1. Antibacterial activitiy of grepafloxacin and other antibiotics against clinical isolates Table 2-1. Summary of patients treated with grepafloxacin for respiratory infection 1) Out: outpatient,
400 46 THE JAPANESE JOURNAL OF ANTIBIOTICS 65 6 Dec. 2012 LVFX 100 mg 3 / 7 150 mg 2 / 7 2 2006 2008 9 LVFX PK PD 2009 7 100 mg 1 3 500 mg 1 1 AUC/MIC
Dec. 2012 THE JAPANESE JOURNAL OF ANTIBIOTICS 65 6 399 45 2012 11 5 LVFX 500 mg 1 1 20 Chlamydia trachomatis C. trachomatismycoplasma genitalium M. genitalium LVFX 1 500 mg 1 1 7 22 22 C. trachomatis 17
1 MR 63 2 IF 10 3 IF 2 IF IF IF 3 IF A4 9 IF IF IF 11 1 IF IF 4 IF IF MR IF IF MR Drug Safety Update IF
2003 7 3 872189 873919 IF 1998 9 PROBEAN CAP. 1 250mg Polyenephosphatidylcholine 1998 9 16 1999 7 9 1999 7 FAX IF 2003 7 1 MR 63 2 IF 10 3 IF 2 IF IF IF 3 IF A4 9 IF IF IF 11 1 IF IF 4 IF IF MR IF IF MR
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19 10 16 0.5g 1g 1g 18 8 2 1 0.5g 1 1g 1 1g 1-6 C 18 H 16 N 8 N a2 O 7 S 3 3½H 2 O 661.60 (6R,7R)-7-[(Z)-2-( -4-)-2- ]-3-(6- -2- -5- -2,5--1,2,4- -3- )-8- -5--1- [4.2.0] -2--2-3½ Disodium(6R,7R)-7-[(Z)-2-(aminothiazol-4-yl)-2-methoxyiminoacetylamino]-3-(6-hyd
C033** of 7 C034** PEG-IFN-2b + IFN -2b + 78 HCV-RNA PEG-IFN-2b IFN-2b n=250 n=200 n= =10 % % 85 % 74 % %
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Fig.1 Chemical structure of BAY o 9867 CHEMOTHERAPY 43 Table 3 Antibacterial spectrum of gram negative bacteria Medium:Heart infusion agar (Nissui) Method:Agar dilution (Streak) CHEMOTHERAPY DEC 1985
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