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Glipizide and metformin hcl

GLIPIZIDE AND METFORMIN HCL

Standard Dose
DOSAGE AND ADMINISTRATION General Considerations Dosage of Glipizide and Metformin HCl Tablets must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended daily dose of 20 mg glipizide/2000 mg metformin . Glipizide and Metformin HCl Tablets should be given with meals and should be initiated at a low dose, with gradual dose escalation as described below, in order to avoid hypoglycemia (largely due to glipizide), reduce GI side effects (largely due to metformin), and permit determination of the minimum effective dose for adequate control of blood glucose for the individual patient. With initial treatment and during dose titration, appropriate blood glucose monitoring should be used to determine the therapeutic response to Glipizide and Metformin HCl Tablets and to identify the minimum effective dose for the patient. Thereafter, HbA 1c should be measured at intervals of approximately 3 months to assess the effectiveness of therapy. The therapeutic goal in all patients with type 2 diabetes is to decrease FPG, PPG, and HbA 1c to normal or as near normal as possible. Ideally, the response to therapy should be evaluated using HbA 1c , which is a better indicator of long-term glycemic control than FPG alone. No studies have been performed specifically examining the safety and efficacy of switching to Glipizide and Metformin HCl Tablets therapy in patients taking concomitant glipizide (or other sulfonylurea) plus metformin. Changes in glycemic control may occur in such patients, with either hyperglycemia or hypoglycemia possible. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring. When colesevelam is coadministered with glipizide ER, maximum plasma concentration and total exposure to glipizide is reduced. Therefore, Glipizide and Metformin HCl Tablets should be administered at least 4 hours prior to colesevelam. Glipizide and Metformin HCl Tablets in Patients with Inadequate Glycemic Control on Diet and Exercise Alone For patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone, the recommended starting dose of Glipizide and Metformin HCl Tablets are 2.5 mg/250 mg once a day with a meal. For patients whose FPG is 280 mg/dL to 320 mg/dL a starting dose of Glipizide and Metformin HCl Tablets 2.5 mg/500 mg twice daily should be considered. The efficacy of Glipizide and Metformin HCl Tablets in patients whose FPG exceeds 320 mg/dL has not been established. Dosage increases to achieve adequate glycemic control should be made in increments of 1 tablet per day every 2 weeks up to maximum of 10 mg/1000 mg or 10 mg/2000 mg Glipizide and Metformin HCl Tablets per day given in divided doses. In clinical trials of Glipizide and Metformin HCl Tablets as initial therapy, there was no experience with total daily doses >10 mg/2000 mg per day. Glipizide and Metformin HCl Tablets in Patients with Inadequate Glycemic Control on a Sulfonylurea and/or Metformin For patients not adequately controlled on either glipizide (or another sulfonylurea) or metformin alone, the recommended starting dose of Glipizide and Metformin HCl Tablets are 2.5 mg/500 mg or 5 mg/500 mg twice daily with the morning and evening meals. In order to avoid hypoglycemia, the starting dose of Glipizide and Metformin HCl Tablets should not exceed the daily doses of glipizide or metformin already being taken. The daily dose should be titrated in increments of no more than 5 mg/500 mg up to the minimum effective dose to achieve adequate control of blood glucose or to a maximum dose of 20 mg/2000 mg per day. Patients previously treated with combination therapy of glipizide (or another sulfonylurea) plus metformin may be switched to Glipizide and Metformin HCl Tablets 2.5 mg/500 mg or 5 mg/500 mg; the starting dose should not exceed the daily dose of glipizide (or equivalent dose of another sulfonylurea) and metformin already being taken. The decision to switch to the nearest equivalent dose or to titrate should be based on clinical judgment. Patients should be monitored closely for signs and symptoms of hypoglycemia following such a switch and the dose of Glipizide and Metformin HCl Tablets should be titrated as described above to achieve adequate control of blood glucose. Recommendations for Use in Renal Impairment Assess renal function prior to initiation of Glipizide and Metformin HCl Tablets and periodically thereafter. Glipizide and Metformin HCl Tablets are contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2 . Initiation of Glipizide and Metformin HCl Tablets in patients with an eGFR between 30 - 45 mL/minute/1.73 m 2 is not recommended. In patients taking Glipizide and Metformin HCl Tablets whose eGFR later falls below 45 mL/min/1.73 m 2 , assess the benefit risk of continuing therapy. Discontinue Glipizide and Metformin HCl Tablets if the patient's eGFR later falls below 30 mL/minute/1.73 m 2 . (See WARNINGS .) Discontinuation for Iodinated Contrast Imaging Procedures Discontinue Glipizide and Metformin HCl Tablets at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart Glipizide and Metformin HCl Tablets if renal function is stable. Specific Patient Populations Glipizide and Metformin HCl Tablets are not recommended for use during pregnancy or for use in pediatric patients. The initial and maintenance dosing of Glipizide and Metformin HCl Tablets should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment requires a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of Glipizide and Metformin HCl Tablets to avoid the risk of hypoglycemia. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly. (See WARNINGS and PRECAUTIONS .)
Max Dose
See official label
Primary Use
INDICATIONS AND USAGE Glipizide and Metformin HCl Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Summary

Indications and usage INDICATIONS AND USAGE Glipizide and Metformin HCl Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Dosage and administration DOSAGE AND ADMINISTRATION General Considerations Dosage of Glipizide and Metformin HCl Tablets must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended daily dose of 20 mg glipizide/2000 mg metformin .

Structured Monograph

Clinical summary

Indications and usage INDICATIONS AND USAGE Glipizide and Metformin HCl Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dosage and administration DOSAGE AND ADMINISTRATION General Considerations Dosage of Glipizide and Metformin HCl Tablets must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended daily dose of 20 mg glipizide/2000 mg metformin . Glipizide and Metformin HCl Tablets should be given with meals and should be initiated at a low dose, with gradual dose escalation as described below, in order to avoid hypoglycemia (largely due to glipizide), reduce GI side effects (largely due to metformin), and permit determination of the minimum effective dose for adequate control of blood glucose for the individual patient. With initial treatment and during dose titration, appropriate blood glucose monitoring should be used to determine the therapeutic response to Glipizide and Metformin HCl Tablets and to identify the minimum effective dose for the patient. Thereafter, HbA 1c should be measured at intervals of approximately 3 months to assess the effectiveness of therapy. The therapeutic goal in all patients with type 2 diabetes is to decrease FPG, PPG, and HbA 1c to normal or as near normal as possible. Ideally, the response to therapy should be evaluated using HbA 1c , which is a better indicator of long-term glycemic control than FPG alone. No studies have been performed specifically examining the safety and efficacy of switching to Glipizide and Metformin HCl Tablets therapy in patients taking concomitant glipizide (or other sulfonylurea) plus metformin. Changes in glycemic control may occur in such patients, with either hyperglycemia or hypoglycemia possible. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring. When colesevelam is coadministered with glipizide ER, maximum plasma concentration and total exposure to glipizide is reduced. Therefore, Glipizide and Metformin HCl Tablets should be administered at least 4 hours prior to colesevelam. Glipizide and Metformin HCl Tablets in Patients with Inadequate Glycemic Control on Diet and Exercise Alone For patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone, the recommended starting dose of Glipizide and Metformin HCl Tablets are 2.5 mg/250 mg once a day with a meal. For patients whose FPG is 280 mg/dL to 320 mg/dL a starting dose of Glipizide and Metformin HCl Tablets 2.5 mg/500 mg twice daily should be considered. The efficacy of Glipizide and Metformin HCl Tablets in patients whose FPG exceeds 320 mg/dL has not been established. Dosage increases to achieve adequate glycemic control should be made in increments of 1 tablet per day every 2 weeks up to maximum of 10 mg/1000 mg or 10 mg/2000 mg Glipizide and Metformin HCl Tablets per day given in divided doses. In clinical trials of Glipizide and Metformin HCl Tablets as initial therapy, there was no experience with total daily doses >10 mg/2000 mg per day. Glipizide and Metformin HCl Tablets in Patients with Inadequate Glycemic Control on a Sulfonylurea and/or Metformin For patients not adequately controlled on either glipizide (or another sulfonylurea) or metformin alone, the recommended starting dose of Glipizide and Metformin HCl Tablets are 2.5 mg/500 mg or 5 mg/500 mg twice daily with the morning and evening meals. In order to avoid hypoglycemia, the starting dose of Glipizide and Metformin HCl Tablets should not exceed the daily doses of glipizide or metformin already being taken. The daily dose should be titrated in increments of no more than 5 mg/500 mg up to the minimum effective dose to achieve adequate control of blood glucose or to a maximum dose of 20 mg/2000 mg per day. Patients previously treated with combination therapy of glipizide (or another sulfonylurea) plus metformin may be switched to Glipizide and Metformin HCl Tablets 2.5 mg/500 mg or 5 mg/500 mg; the starting dose should not exceed the daily dose of glipizide (or equivalent dose of another sulfonylurea) and metformin already being taken. The decision to switch to the nearest equivalent dose or to titrate should be based on clinical judgment. Patients should be monitored closely for signs and symptoms of hypoglycemia following such a switch and the dose of Glipizide and Metformin HCl Tablets should be titrated as described above to achieve adequate control of blood glucose. Recommendations for Use in Renal Impairment Assess renal function prior to initiation of Glipizide and Metformin HCl Tablets and periodically thereafter. Glipizide and Metformin HCl Tablets are contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2 . Initiation of Glipizide and Metformin HCl Tablets in patients with an eGFR between 30 - 45 mL/minute/1.73 m 2 is not recomme

Boxed Warning

WARNING: LACTIC ACIDOSIS Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [see PRECAUTIONS ] Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided [see PRECAUTIONS ]. If metformin-associated lactic acidosis is suspected, immediately discontinue Glipizide and Metformin HCl Tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [see PRECAUTIONS ]. SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned to 1 of 4 treatment groups (Diabetes 19 (Suppl. 2):747-830, 1970). UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2½ times that of patients treated with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning. The patient should be informed of the potential risks and benefits of glipizide and of alternative modes of therapy. Although only 1 drug in the sulfonylurea class (tolbutamide) was included in this study, it is prudent from a safety standpoint to consider that this warning may also apply to other hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.

Monitoring

  • • WARNING: LACTIC ACIDOSIS Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.
  • • The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain.
  • • Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [see PRECAUTIONS ] Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.
  • • Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided [see PRECAUTIONS ].

Interaction Notes

  • • Drug Interactions Glipizide and Metformin HCl Tablets Certain drugs tend to produce hyperglycemia and may lead to loss of blood glucose control.
  • • These drugs include thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid.
  • • When such drugs are administered to a patient receiving Glipizide and Metformin HCl Tablets, the patient should be closely observed for loss of blood glucose control.
  • • When such drugs are withdrawn from a patient receiving Glipizide and Metformin HCl Tablets, the patient should be observed closely for hypoglycemia.