METFORMIN HYDROCHLORIDE (Page 5 of 8)

Drug Interactions

In Vivo Assessment of Drug Interactions

Table 5: Effect of Coadministered Drug on Plasma Metformin Systemic Exposure

*
All metformin and coadministered drugs were given as single doses
AUC = AUC(INF)
Ratio of arithmetic means
§
At steady state with topiramate 100 mg every 12 hours and metformin 500 mg every 12 hours; AUC = AUC0-12h

Coadministered Drug

Dose of Coadministered Drug *

Dose of Metformin *

Geometric Mean Ratio (ratio with/without coadministered drug)

No Effect = 1.00

AUC

C max

No dosing adjustments required for the following:

Glyburide

5 mg

850 mg

metformin

0.91

0.93

Furosemide

40 mg

850 mg

metformin

1.09

1.22

Nifedipine

10 mg

850 mg

metformin

1.16

1.21

Propranolol

40 mg

850 mg

metformin

0.90

0.94

Ibuprofen

400 mg

850 mg

metformin

1.05

1.07

Cationic drugs eliminated by renal tubular secretion may reduce metformin elimination.

Cimetidine

400 mg

850 mg

metformin

1.40

1.61

Carbonic anhydrase inhibitors may cause metabolic acidosis [See Warnings and Precautions (5.1)]

Topiramate

100 mg §

500 mg §

metformin

1.25§

1.17

Table 6: Effect of Metformin on Coadministered Drug Systemic Exposure

*
All metformin and coadministered drugs were given as single doses
AUC = AUC(INF) unless otherwise noted
Ratio of arithmetic means, p-value of difference <0.05
§
AUC(0-24 hr) reported
Ratio of arithmetic means

Coadministered Drug

Dose of Coadministered Drug *

Dose of Metformin *

Geometric Mean Ratio (ratio with/without metformin) No Effect = 1.00

AUC

C max

No dosing adjustments required for the following:

Glyburide

5 mg

850 mg

glyburide

0.78

0.63

Furosemide

40 mg

850 mg

furosemide

0.87

0.69

Nifedipine

10 mg

850 mg

nifedipine

1.10§

1.08

Propranolol

40 mg

850 mg

propranolol

1.01§

1.02

Ibuprofen

400 mg

850 mg

ibuprofen

0.97

1.01

Cimetidine

400 mg

850 mg

cimetidine

0.95§

1.01

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