Alcohol intake

Alcohol is known to potentiate the effect of metformin on lactate metabolism. Patients, therefore, should be warned against excessive alcohol intake, acute or chronic, while receiving Glipizide and Metformin HCl Tablets. Due to its effect on the gluconeogenic capacity of the liver, alcohol may also increase the risk of hypoglycemia.

Impaired hepatic function

Since impaired hepatic function has been associated with some cases of lactic acidosis, Glipizide and Metformin HCl Tablets should generally be avoided in patients with clinical or laboratory evidence of hepatic disease.

Vitamin B levels

In controlled clinical trials with metformin of 29 weeks duration, a decrease to subnormal levels of previously normal serum vitamin B, without clinical manifestations, was observed in approximately 7% of patients. Such decrease, possibly due to interference with B absorption from the B-intrinsic factor complex, is, however, very rarely associated with anemia and appears to be rapidly reversible with discontinuation of metformin or vitamin B supplementation.

Measurement of hematologic parameters on an annual basis is advised in patients on metformin and any apparent abnormalities should be appropriately investigated and managed (see PRECAUTIONS: Laboratory Tests).

Certain individuals (those with inadequate vitamin B or calcium intake or absorption) appear to be predisposed to developing subnormal vitamin B levels. In these patients, routine serum vitamin B measurements at two- to three-year intervals may be useful.

Change in clinical status of patients with previously controlled type 2 diabetes

A patient with type 2 diabetes previously well-controlled on metformin who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be eva luated promptly for evidence of ketoacidosis or lactic acidosis. eva luation should include serum electrolytes and ketones, blood glucose and, if indicated, blood pH, lactate, pyruvate, and metformin levels. If acidosis of either form occurs, Glipizide and Metformin HCl Tablets must be stopped immediately and other appropriate corrective measures initiated (see also WARNINGS).

Glipizide and Metformin HCl Tablets

Patients should be informed of the potential risks and benefits of Glipizide and Metformin HCl Tablets and of alternative modes of therapy.

They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of blood glucose, glycosylated hemoglobin, renal function, and hematologic parameters.

The risks of lactic acidosis associated with metformin therapy, its symptoms, and conditions that predispose to its development, as noted in the WARNINGS and PRECAUTIONS sections, should be explained to patients. Patients should be advised to discontinue Glipizide and Metformin HCl Tablets immediately and to p

Manufacturer
Heritage Pharmaceuticals Inc.

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Source
U.S. National Library of Medicine
DailyMed
Last Updated: 2nd of March 2011