Glucophage XR

[Metformin]

Special Populations Patients with Type 2 Diabetes

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.

The pharmacokinetics of GLUCOPHAGE XR in patients with type 2 diabetes are comparable to those in healthy normal adults.

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Renal Insufficiency

In patients with decreased renal function (based on measured 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).

Hepatic Insufficiency

No pharmacokinetic studies of metformin have been conducted in patients with hepatic insufficiency.

Geriatrics

Limited data from controlled pharmacokinetic studies of GLUCOPHAGE in healthy elderly subjects suggest that total plasma clearance of metformin 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). GLUCOPHAGE and GLUCOPHAGE XR (metformin hydrochloride extended-release tablets) treatment should not be initiated in patients 80 years of age unless measurement of cre-atinine clearance demonstrates that renal function is not reduced. (See WARNINGS and DOSAGE AND ADMINISTRATION.)

a All doses given fasting except the first 18 doses of the multiple dose studies
b Peak plasma concentration c Time to peak plasma concentration
d Combined results (average means) of five studies: mean age 32 years (range 23-59 years)
e Kinetic study done following dose 19, given fasting
f Elderly subjects, mean age 71 years (range 65-81 years)
g CL cr = creatinine clearance normalized to body surface area of 1.73 m 2

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