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Amaryl - Warnings & Precautions

[Glimepiride]



PRECAUTIONS

General

Hypoglycemia:

All sulfonylurea drugs are capable of producing severe hypoglycemia. Proper patient selection, dosage, and instructions are important to avoid hypoglycemic episodes. Patients with impaired renal function may be more sensitive to the glucose-lowering effect of AMARYL. A starting dose of 1 mg once daily followed by appropriate dose titration is recommended in those patients.

Debilitated or malnourished patients, and those with adrenal, pituitary, or hepatic insufficiency are particularly susceptible to the hypoglycemic action of glucose-lowering drugs.

Hypoglycemia may be difficult to recognize in the elderly and in people who are taking beta-adrenergic blocking drugs or other sympatholytic agents. Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when alcohol is ingested, or when more than one glucose-lowering drug is used. Combined use of glimepiride with insulin or metformin may increase the potential for hypoglycemia.

Loss of control of blood glucose:

When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a loss of control may occur. At such times, it may be necessary to add insulin in combination with AMARYL or even use insulin monotherapy.

The effectiveness of any oral hypoglycemic drug, including AMARYL, in lowering blood glucose to a desired level decreases in many patients over a period of time, which may be due to progression of the severity of the diabetes or to diminished responsiveness to the drug. This phenomenon is known as secondary failure, to distinguish it from primary failure in which the drug is ineffective in an individual patient when first given. Should secondary failure occur with AMARYL or metformin monotherapy, combined therapy with AMARYL and metformin or AMARYL and insulin may result in a response. Should secondary failure occur with combined AMARYL/metformin therapy, it may be necessary to initiate insulin therapy.
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