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krish ☆ India, 2013-12-18 12:47 (4572 d 10:54 ago) Posting: # 12072 Views: 3,375 |
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Dear All, The guidance in FDA for metformin and some other anti diabetic drugs gives us the below information. The drug products should be administered with 240 mL of a 20% glucose solution in water, followed by 60 mL of the glucose solution administered every 15 minutes for up to 4 hours after dosing. Glucose administration is to avoid hypo glycemia related adverse events in healthy subjects But Can any one please let me know why only 20% glucose? why only 60ml ? and why upto 4 hours? thanks and regards, KRISH  Edit: Category changed. [Helmut] |
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Dr_Dan ★★ Germany, 2013-12-19 12:42 (4571 d 10:59 ago) @ krish Posting: # 12078 Views: 2,786 |
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Dear KRISH Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore according to the SmPC does not produce hypoglycaemia. So maybe the recommandation is a general recommendation applying also for other anti diabetic drugs. Also the 4 hours do not make much sense since after oral administration maximum plasma concentration (Cmax) is reached in approximately 2.5 hours (tmax). I could imagine that the recommendation refers to the fact that metformin absorption is saturable and incomplete after oral administration, but I do not know.  Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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mittyri ★★ Russia, 2013-12-19 20:06 (4571 d 03:35 ago) @ krish Posting: # 12082 Views: 2,750 |
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Dear Krish, ❝ But Can any one please let me know why only 20% glucose? why only 60ml ? and why upto 4 hours? Only assumptions: The dose of glucose was calculated on the basis of PD effect and FDA likes 20% glucose solution  Also see a nice answer from Helmut here. — Kind regards, Mittyri |
Ing. Helmut Schütz