Glumet/Glumet-XR

Glumet/Glumet-XR Dosage/Direction for Use

metformin

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Full Prescribing Info
Dosage/Direction for Use
General Dosing Recommendations: There is usually no fixed dosage regimen with any antidiabetic agent for the management of hyperglycemia in patients with diabetes mellitus. Dosage of metformin HCl tablets must be individualized based on both effectiveness and tolerance while not exceeding the maximum recommended daily doses.
During treatment initiation and dose titration, fasting plasma glucose should be used to determine the therapeutic response to metformin HCl tablet and identify the minimum effective dose. Thereafter, glycosylated hemoglobin (HbA1c) should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of metformin when used as monotherapy or in combination with other oral antidiabetic agents or insulin.
Monitoring of glycemic control through frequent measurements of fasting blood glucose and periodic testing of HbA1c will detect primary failure (i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication), and secondary failure (i.e., loss of adequate blood glucose lowering response after an initial period of effectiveness).
It is recommended that metformin HCl be administered with meals to ensure optimum delivery of metformin to the systemic circulation and minimize gastric intolerance. Administration of metformin in the fed state has been shown to significantly increase the systemic delivery of metformin compared to the fasted state.
Transfer from Metformin HCl Immediate-Release Tablet to Metformin HCl Extended-Release or Sustained-Release Tablet: In patients already treated with metformin HCl immediate-release tablet, the starting dose of metformin HCl extended-release or sustained-release tablet should be equivalent to the daily dose of metformin HCl immediate-release tablet. Switching to metformin HCl extended-release or sustained-release is not recommended in patients treated with metformin HCl immediate-release at doses above 2,000 mg per day. If glycemic control is still not achieved with metformin HCl extended-release or sustained-release tablets 2,000 mg per day, patients may be switched to metformin HCl immediate-release up to a maximum dose of 3,000 mg (Glumet 500 mg & 1 g/Glumet-XR) or 2,550 mg (Glumet 850 mg) per day.
Transfer from Other Antidiabetic Therapy: No transition period is generally necessary when transferring patients from standard oral hypoglycemic agents other than chlorpropamide. When transferring patients from chlorpropamide, exercise caution during the first two weeks because overlapping drug effects and hypoglycemia may occur due to prolonged retention of chlorpropamide in the body.
Concomitant Metformin and Oral Sulfonylurea Therapy: Gradual addition of an oral sulfonylurea while continuing maximum dose metformin therapy may be considered in patients who have not responded to four weeks of maximum dose metformin therapy.
Consider alternative therapies such as insulin (with or without metformin) if response to 1 to 3 months maximum dose of sulfonylurea and metformin combination therapy remains unsatisfactory.
Glumet 500 mg & 1 g/Glumet-XR: See Table 3.

Click on icon to see table/diagram/image

Recommended Oral Dose of Immediate-Release Metformin Tablet in Children 10 to 16 years Old with Type 2 Diabetes Mellitus: Usual starting dose: 500 mg twice a day, given with meals.
Dosage may be increased by 500 mg weekly up to a maximum of 2,000 mg daily given in divided doses.
The efficacy and safety of extended-release metformin in pediatric patients have not been established.
Concomitant Metformin and Insulin Therapy: The current insulin dose should be continued upon initiation of metformin therapy.
Initial Oral Dose of Metformin HCl Tablet: 500 mg once a day.
Metformin dose may be increased by 500 mg after approximately one week and by 500 mg every week thereafter until adequate glycemic control is achieved.
Maximum Recommended Daily Dose with Insulin: 2,500 mg.
It is recommended that the insulin dose be reduced by 10 to 25% when fasting plasma glucose concentrations decrease to less than 120 mg/dL. Individualize further dose adjustments based on patient response in patients receiving metformin with insulin.
Or, as prescribed by a physician.
Glumet 850 mg: See Table 4.

Click on icon to see table/diagram/image

Recommended Oral Dose in Children 10 to 16 Years Old: Usual starting dose: 500 mg two times a day or 850 mg once a day with meals.
Dosage may be increased by 500 mg weekly up to a maximum of 2,000 mg per day given in divided doses.
The efficacy and safety of extended-release or sustained-release metformin in pediatric patients have not been established.
Concomitant Metformin and Insulin Therapy: The current insulin dose should be continued upon initiation of metformin therapy.
Initial Oral Dose of Metformin HCl Tablet: 500 mg or 850 mg once a day.
Metformin dose may be increased by 500 mg after approximately one week and by 500 mg every week thereafter until adequate glycemic control is achieved.
Maximum Recommended Daily Dose with Insulin: 2,550 mg.
It is recommended that the insulin dose be reduced by 10 to 25% when fasting plasma glucose concentrations decrease to less than 120 mg/dL. Individualize further dose adjustments based on patient response in patients receiving metformin with insulin.
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