盐酸二甲双胍片说明书 - sihuanpharm.com

1 2007 03 07 2010 10 01 2013 06 25 2015 12 01 2016 03 21 2018 09 26 2018 10 11 2018 11 30 2019 04 23 MetforminHydrochlorideTablets YansuanErjiashuangguaPian 1,1- C4H11N5 HCl 2 10 ( ) eGFR 90mL/ 2 3 10-15 2g ( )

2 1 3 1 / 1 2g 120mg/dL 10 25% eGFR 60mL/ eGFR45 59mL/ eGFR<45mL/ 10% 1%~10% 1% , ~1% ~ < B12 10-16 eGFR<45mL/ B12

3 NSAIDs / pH < 5mmol/L / : eGFR<45mL/ : : 48 : 48 : B12 ( B12 ) B12 2 3 B12 ( )

4 2 1 10-12 15 10-12 10-12 10 10 1. 2. ( ) AUC Cmax AUC 3. ( ) / 4.

5 AUC 5. 6. 7. 2 8. 20% 9% Tmax 9. 10. 85g 170mL/min Ames 600mg/kg/ 3 600mg/kg/ 2 6 900mg/kg/ 104 1500mg/kg/ 91 2000mg 4 900mg/kg/ Tmax Cmax 50-60% 40% AUC 25%

6 Vd 400mL/min / 2 7 AUC0-t 14 33% 40% 12 / 2 12 / 4 12 / 5 24 YBH06162018 H11020127 13 101113 010 61563510 010 61563510