Pediatrics - GLUMETZA has been studied in adult patients only.

Transfer From Other Antidiabetic Therapy
When transferring patients from standard oral hypoglycemic agents other than chlorpropamide to GLUMETZA, no transition period is generally necessary.

When transferring patients from chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.

Concomitant GLUMETZA and Oral Sulfonylurea Therapy in Adult Patients
If patients have not responded to four weeks of the maximum dose of GLUMETZA monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing GLUMETZA at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred. Clinical and pharmacokinetic drug-drug interaction data are currently available only for metformin plus glyburide (glibenclamide). With concomitant GLUMETZA and sulfonylurea therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug.

However, attempts should be made to identify the minimum effective dose. With concomitant GLUMETZA and sulfonylurea therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken. (SeePackage Insert of the respective sulfonylurea.) If patients have not satisfactorily responded to one to three months of concomitant therapy with the maximum dose of GLUMETZA and the maximum dose of an oral sulfonylurea, consider therapeutic alternatives including switching to insulin with or without GLUMETZA.

Concomitant GLUMETZA and Insulin Therapy in Adult Patients
The current insulin dose should be continued upon initiation of GLUMETZA. GLUMETZA therapy should be initiated at 500mg once daily in patients on insulin therapy. For patients not responding adequately, the dose of GLUMETZA should be increased by 500mg after approximately 1week and by 500mg every week thereafter until adequate glycemic control is achieved. The maximum recommended daily dose of GLUMETZA is 2000mg.

It is recommended that the insulin dose be decreased by 10% to 25% when fasting plasma glucose concentrations decrease to less than 120mg/dL in patients receiving concomitant insulin and GLUMETZA. Further adjustment should be individualized based on glucose-lowering response.

Specific Patient Populations
GLUMETZA is not recommended for use in pregnancy. GLUMETZA is not recommended in pediatric patients (below the age of 18years). The initial and maintenance dosing of GLUMETZA should be conservative in patients with advanced age, due to the potential for decreased renal function in this population.

Any dosage adjustment should be based on a careful assessment of renal function.

Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of GLUMETZA. Monitoring of renal function is necessary to aid in prevention of lactic acidosis, particularly in the elderly. (SeeWARNINGS)

HOW SUPPLIED
GLUMETZA tablets 500mg are available as blue, filmcoated, oval-shaped tablets debossed with "GMZ" on one side and "