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Special Populations Patients With Type 2 Diabetes
Multiple-dose studies with glyburide in patients with type 2 diabetes demonstrate drug level con-centration-time curves similar to single-dose studies, indicating no buildup of drug in tissue depots. In the presence of normal renal function, there are no differences between single-or multiple-dose pharmacokinetics of metformin between patients with type 2 diabetes and normal subjects (see Table 1), nor is there any accumulation of metformin in either group at usual clinical doses. Text Continues Below
Hepatic Insufficiency
No pharmacokinetic studies have been conducted in patients with hepatic insufficiency for either glyburide or metformin. Renal Insufficiency No information is available on the pharmacokinetics of glyburide in patients with renal insufficiency. In patients with decreased renal function (based on creatinine clearance), the plasma and blood half-life of metformin is prolonged and the renal clearance is decreased in proportion to the decrease in creatinine clearance (see Table 1; also, see WARNINGS). Geriatrics There is no information on the pharmacokinetics of glyburide in elderly patients. Limited data from controlled pharmacokinetic studies of metformin in healthy elderly subjects sug-gest that total plasma clearance is decreased, the half-life is prolonged, and C max is increased, compared to healthy young subjects. From these data, it appears that the change in metformin pharmacokinetics with aging is primarily accounted for by a change in renal function (see Table 1). Metformin treatment should not be initiated in patients 80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced. CH 3
H 3 C
NH 2 H N N NH NH
° HCl Metformin Hydrochloride OCH 3
S O
O
O
O
Cl
NH
Glyburide
H N H N Table 1. Select Mean (± S. D.) Metformin Pharmacokinetic Parameters Following Single or Multiple Oral Doses of Metformin
Renal Subject Groups: Metformin C
max b T max c Clearance
Dose a (number of subjects) (g/ mL) (hrs) (mL/ min) Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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