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Drug DescriptionSide Effects & Drug InteractionsWarnings & Precautions
Clinical PharmacologyOverdosage & ContraindicationsIndications & DosagePatient Info

Glucophage XR

[Metformin]


Indications & Dosage
INDICATIONS AND USE

GLUCOPHAGE (metformin hydrochloride tablets) and GLUCOPHAGE XR (metformin hydrochloride extended-release tablets), as monotherapy, are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. GLUCOPHAGE is indicated in patients 10 years of age and older, and GLUCOPHAGE XR is indicated in patients 17 years of age and older.

GLUCOPHAGE or GLUCOPHAGE XR may be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults (17 years of age and older).

Text Continues Below



DOSAGE AND ADMINISTRATION

Concomitant GLUCOPHAGE or GLUCOPHAGE XR and Oral Sulfonylurea Therapy).

Furosemide

A single-dose, metformin-furosemide drug interaction study in healthy subjects demonstrated that pharmacokinetic parameters of both compounds were affected by co-adminis-tration. Furosemide increased the metformin plasma and blood C max by 22% and blood AUC by 15%, without any significant change in metformin renal clearance. When administered with met-formin, the C max and AUC of furosemide were 31% and 12% smaller, respectively, than when administered alone, and the terminal half-life was decreased by 32%, without any significant change in furosemide renal clearance. No information is available about the interaction of met-formin and furosemide when co-administered chronically.

Nifedipine

A single-dose, metformin-nifedipine drug interaction study in normal healthy volun-teers demonstrated that co-administration of nifedipine increased plasma metformin C max and AUC by 20% and 9%, respectively, and increased the amount excreted in the urine. T max and half-life were unaffected. Nifedipine appears to enhance the absorption of metformin. Metformin had minimal effects on nifedipine.

Cationic drugs

Cationic drugs (e. g., amiloride, digoxin, morphine, procainamide, quinidine, qui-nine, ranitidine, triamterene, trimethoprim, or vancomycin) that are eliminated by renal tubular secretion theoretically have the potential for interaction with metformin by competing for common renal tubular transport systems. Such interaction between metformin and oral cimetidine has been observed in normal healthy volunteers in both single-and multiple-dose, metformin-cimetidine drug interaction studies, with a 60% increase in peak metformin plasma and whole blood concentrations and a 40% increase in plasma and whole blood metformin AUC. There was no change in elimination half-life in the single-dose study. Metformin had no effect on cimetidine pharmacokinetics. Although such interactions remain theoretical (except for cimetidine), careful patient moni-toring and dose adjustment of GLUCOPHAGE or GLUCOPHAGE XR and/ or the interfering drug is recommended in patients who are taking cationic medications that are excreted via the proximal renal tubular secretory system.

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