盐酸二甲双胍片说明书.doc

. . . .g.b. x. . . . b. . . -. . . . . . . . . . b- mg. . aucauccmax. /. auc. . . . . metformin:11-20.25g231g1.5g2g1. 2 3 4 b121;21. 5mg/dl2;3;4;5;61. 2. 3. 4. 35. 10-162200010 65801. 2. 3. 4. 5. hbalc1%2%1. ,2. 3 4 5 24h5002032220101001()2prandimetprandimetprandimet () tablets initial u.s. approval: 2008: : ? . (4, 5.2)? . (4, 5.1) ? . (4, 5.7, 7.2, 12.3)? ph (5.1):? 1 (1) ? prandimet (2)?1mg/500mg(2)? 10mg/2500mg4mg/1000mg(2) ? 15(2)? prandmet(2) :? 1 mg repaglinide/500 mg metformin hcl (3) ? 2 mg repaglinide/500 mg metformin hcl (3)? prandimet(4, 5.2)? prandimet (5.3) ? (5.4)? (5.5 ) ? prandimet nph. (5.6)? prandimet(4, 5.7, 7.2, 12.3)? (5.8)? b12. (5.9)? prandimet (5.10)? prandimet(5.15).? 10% (6.2)? (6.1, 6.2), 1-888-novo-444 or fda at 1-800-fda-1088 or .? (7.1) ? cyp2c8cyp3a4.cyp2c8cyp3a4(7.2) 17: 6/20081* - 1 2 3 4 5 5.1 5.2 5.3 5.4 5.5 5.6 nph- 5.7 5.8 5.9 b12 5.10 5.11 5.12 5.13 6.1 6.2 6.3 7 7.17.2cyp2c8cyp3a4/ 8 8.1 8.3 8.4 8.5 10 11 12 12.1 12.3 13 13.1 14 14.1 16 17 17.1 17.2 * ph (5.1)? prandimet1prandimet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a meglitinide and metformin hcl or who have inadequate glycemic control on a meglitinide alone or metformin hcl alone.:prandimet 1.2prandimetprandimet 10mg/2500mg. 4mg/1000m