Glipizide and Metformin Hydrochloride (Page 2 of 10)

Specific 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.

Renal Impairment

The metabolism and excretion of glipizide may be slowed in patients with impaired renal

function (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION).

In patients with decreased renal function, the plasma and blood half-life of metformin is prolonged and the renal clearance is decreased (see Table 1; also, see WARNINGS).

Hepatic Impairment

The metabolism and excretion of glipizide may be slowed in patients with impaired hepatic function (see PRECAUTIONS).

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

Geriatrics:

There is no information on the pharmacokinetics of glipizide in elderly patients.

Limited data from controlled pharmacokinetic studies of metformin in healthy elderly subjects suggest that total plasma clearance is decreased, the half-life is prolonged, and Cmax 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).

Table 1 Select Mean (±S.D.) Metformin Pharmacokinetic Parameters Following Single or Multiple Oral Doses of Metformin
Subject Groups : Metformin Dose *( Number of Subjects ) Cmax ( µg / mL ) Tmax ( hrs ) Renal Clearnance ( mL / min )
*
All doses given fasting except the first 18 doses of the multiple-dose studies
Peak plasma concentration
Time to peak plasma concentration
§
SD = single dose
Combined results (average means) of five studies: mean age 32 years (range 23 to 59 years)
#
Kinetic study done following dose 19, given fasting
Þ
Elderly subjects, mean age 71 years (range 65 to 81 years)
ß
CLcr= creatinine clearance normalized to body surface area of 1.73 m2
Healthy , Nondiabetic Adults :
500 mg SD §(24) 1.03 (±0.33) 2.75 (±0.81) 600 (±132)
850 mg SD (74) 1.60 (±0.38) 2.64 (±0.42) 552 (±139)
850 mg t.i.d. for 19 doses #(9) 2.01(±0.42) 1.79 (±0.94) 642 (±173)
Adults with Type 2 Diabetes :
850 mg SD (23) 1.48 (±0.5) 3.32 (±1.08) 491 (±138)
850 mg t.i.d. for 19 doses # (9) 1.90 (±0.62) 2.01 (±1.22) 550 (±160)
Elderly Þ , Healthy Nondiabetic Adults :
850 mg SD (12) 2.45 (±0.70) 2.71 (±1.05) 412 (±98)
Renal impaired Adults : 850 mg SD
Mild (CLcr ß61 to 90 mL/min) (5) 1.86 (±0.52) 3.20 (±0.45) 384 (±122)
Moderate (CLcr 31 to 60 mL/min) (4) 4.12 (±1.83) 3.75 (±0.50) 108 (±57)
Severe (CLcr 10 to 30 mL/min) (6) 3.93 (±0.92) 4.01 (±1.10) 130 (±90)

Pediatrics:

No data from pharmacokinetic studies in pediatric subjects are available for glipizide. After administration of a single oral metformin hydrochloride 500 mg tablet with food, geometric mean metformin Cmax and AUC differed less than 5% between pediatric type 2 diabetic patients (12 to 16 years of age) and gender- and weight-matched healthy adults (20 to 45 years of age), all with normal renal function.

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