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____ Vitamin B 12 levels In controlled clinical trials with metformin of 29 weeks duration, a decrease to subnormal levels of previously normal serum Vitamin B 12 , without clinical manifesta-tions, was observed in approximately 7% of patients. Such decrease, possibly due to interference with B 12 absorption from the B 12 -intrinsic factor complex, is, however, very rarely associated with anemia and appears to be rapidly reversible with discontinuation of metformin or Vitamin B 12 sup-plementation. 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 12 or calcium intake or absorption) appear to be predisposed to developing subnormal Vitamin B 12 levels. In these patients, routine serum Vitamin B 12 measurements at two-to three-year intervals may be useful. Text Continues Below
____ 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 evaluated promptly for evi-dence of ketoacidosis or lactic acidosis. Evaluation should include serum electrolytes and ketones, blood glucose and, if indicated, blood pH, lactate, pyruvate, and metformin levels. If acidosis of either form occurs, GLUCOVANCE must be stopped immediately and other appropriate corrective measures initiated (see also WARNINGS). Addition of Thiazolidinediones to GLUCOVANCE Therapy Hypoglycemia Patients receiving GLUCOVANCE in combination with a thiazolidinedione may be at risk for hypoglycemia. Weight gain Weight gain was seen with the addition of rosiglitazone to GLUCOVANCE, similar to that reported for thiazolidinedione therapy alone. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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