GLUMETZA: Extended Release Metformin

YEAH ! I have been on Glumetza for two months now .I take it once a day instead of with every meal .It is a slow release form of metformin .



Single oral doses of GLUMETZA from 500 mg to 2500 mg resulted in less than proportional increase in both AUC and Cmax. The mean Cmax values were 473 ± 145, 868 ± 223, 1171 ± 297, and 1630 ± 399 ng/mL for single doses of 500, 1000, 1500, and 2500 mg, respectively. For AUC, the mean values were 3501 ± 796, 6705 ± 1918, 9299 ± 2833, and 14161 ± 4432 ng·hr/mL for single doses of 500, 1000, 1500, and 2500 mg, respectively.
Low-fat and high-fat meals increased the systemic exposure (as measured by AUC) from GLUMETZA tablets by about 38% and 73%, respectively, relative to fasting. Both meals prolonged metformin Tmax by approximately 3 hours but Cmax was not affected.
In a two-way, single-dose crossover study in healthy volunteers, the 1000 mg tablet was found to be bioequivalent to two 500 mg tablets .

Nursing Mothers(NOT RECOMMENDED)
Studies in lactating rats show that metformin is excreted into milk and reaches levels comparable to those in plasma. Similar studies have not been conducted in nursing mothers. Thus, the potential for hypoglycemia in nursing infants after Metformin HCL Oral Solution may exist.
Depomed, Inc. and Santarus, Inc. announced new data suggesting that patients previously intolerant of metformin may be able to tolerate higher doses of metformin when treated with GLUMETZA® (metformin HCl extended release tablets).
About GLUMETZA®

GLUMETZA (metformin hydrochloride extended release tablets) is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes. GLUMETZA may be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults. GLUMETZA is available in 500 mg and 1000 mg tablets.

As with all metformin products, lactic acidosis due to metformin accumulation during treatment with GLUMETZA is a rare but potentially fatal occurrence.

May also occur in association with a number of pathophysiologic conditions.

The risk of lactic acidosis increases with the degree of renal dysfunction and the patient's age, especially patients greater than or equal to 80 years of age, and in those patients with congestive heart failure requiring pharmacologic management.

The risk of lactic acidosis while on GLUMETZA therapy may be significantly decreased by initial and regular monitoring of renal and liver function; using the minimum effective dose; withholding in the presence of any condition associated with hypoxemia, dehydration, or sepsis; avoidance in patients with hepatic disease; cautioning patients against excessive alcohol intake; temporarily discontinuing prior to any intravascular radiocontrast study or surgical procedure.

Lactic acidosis is a medical emergency requiring immediate discontinuation of GLUMETZA.

General supportive measures and prompt hemodialysis are recommended to correct the acidosis and remove the accumulated metformin.

GLUMETZA is contraindicated in patients with renal dysfunction, known hypersensitivity to metformin HCl or metabolic acidosis, including diabetic ketoacidosis. Use of concomitant medications that affect renal function or hemodynamic change may interfere with the disposition of metformin and should be used with caution.

Hypoglycemia does not occur in patients receiving GLUMETZA alone but could occur with deficient caloric intake or during concomitant use with other glucose-lowering agents or ethanol. Loss of glycemic control may occur when a stabilized patient is exposed to stress.

In clinical trials, the most common side effects with GLUMETZA monotherapy were diarrhea, nausea, dyspepsia, and upper abdominal pain. In a clinical trial of GLUMETZA combined with a sulfonylurea, the most common side effects included hypoglycemia, diarrhea, and nausea.

For additional information on the product, please access the prescribing information at http://www.glumetzaxr.com/.

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