Used alone or in fixed combination with metformin as an adjunct to diet for the management of type 2 diabetes mellitus (noninsulin-dependent) in patients whose hyperglycemia cannot be controlled by diet alone.
Used in combination with one or more other oral antidiabetic agents or insulin as an adjunct to diet and exercise in patients who do not achieve adequate glycemic control with diet, exercise, and oral antidiabetic agent monotherapy.
Alternative therapy in some type 2 diabetic patients being treated with insulin. Useful in combination with insulin therapy to improve glycemic control and/or decrease insulin dosage in some type 2 diabetic patients.
Not effective as sole therapy for patients with type 1 diabetes mellitus; insulin is necessary.
Adjust dosage according to tolerance and urine and/or fasting blood glucose determinations. Monitor glycosylated hemoglobin (hemoglobin A1c, HbA1c) to determine minimum effective dosage or detect primary or secondary failure.
Administration
Oral Administration
Administer extended-release or conventional tablets once daily, generally with breakfast. Administer conventional tablets approximately 30 minutes before a meal.
Administer glipizide in fixed combination with metformin once daily with a meal.
Some patients may have a more satisfactory response when conventional oral tablets are administered in 2 or 3 divided doses daily. When dosage exceeds 15 mg daily as conventional tablets, administer in divided doses before meals of sufficient caloric content.
Extended-release tablets should be swallowed whole and should not be divided, chewed, or crushed.
Dosage
Adults
Diabetes Mellitus
Initial Dosage in Previously Untreated Patients
Oral
Conventional or extended-release tablets: Initially, 5 mg daily. Titrate dosage of conventional tablets in increments of 2.5–5 mg daily at intervals of at least several days (usually 3–7 days). Maximum once daily dosage, 15 mg.
For extended-release tablets, dosage adjustment should be based on at least 2 similar consecutive fasting glucose concentrations obtained at least 7 days after the previous dose adjustment.
Initial Dosage in Patients Transferred from Conventional to Extended-release Tablets
Oral
When transferring, administer the nearest equivalent total daily dosage once daily. Alternatively, 5 mg once daily as extended-release tablets and titrate dosage.
Initial Dosage in Patients Transferred from Other Oral Antidiabetic Agents
Oral
Individualize initial dosage of glipizide; usually 5–10 mg daily. The other oral antidiabetic agent may be discontinued abruptly.
Patients being transferred from a sulfonylurea agent with a longer half life (e.g., chlorpropamide) should be closely monitored for the occurrence of hypoglycemia during the initial 1–2 weeks. A drug-free interval of 2–3 days may be advisable before glipizide therapy is initiated as conventional tablets in patients being transferred from chlorpropamide, particularly if blood glucose concentration was adequately controlled with chlorpropamide.
Initial Dosage in Patients Transferred from Insulin
Oral
Initially, 5 mg once daily, if insulin requirements were ≤20 units daily. Abruptly discontinue insulin.
5 mg once daily if insulin requirements were >20 units daily, and reduce insulin dosage by 50%. Withdraw insulin gradually and adjust glipizide dosage in increments of 2.5–5 mg daily at intervals of at least several days.
Maintenance Dosage
Oral
Maintenance dosage varies considerably, ranging from 2.5–40 mg daily. Most patients require 5–25 mg daily as conventional tablets or 5–10 mg daily as extended-release tablets, but higher dosages may be necessary.
Combination Therapy with Other Oral Antidiabetic Agents
Oral
When added to therapy with other antidiabetic agents, the glipizide extended-release tablets may be initiated at a dosage of 5 mg daily. Base titration on clinical judgment.
Fixed combination: 2.5 mg of glipizide and 250 mg of metformin hydrochloride once daily with a meal in treatment-naive patients.
For more severe hyperglycemia (i.e., fasting plasma glucose concentrations of 280–320 mg/dL), 2.5 mg of glipizide and 500 mg of metformin hydrochloride twice daily.
Dosage may be increased in increments of one tablet (using the tablet strength at which therapy was initiated, either 2.5 mg glipizide/250 mg metformin hydrochloride or 2.5 mg glipizide/500 mg metformin hydrochloride) daily every 2 weeks until the minimum effective dosage required to achieve adequate glycemic control is reached.
Maximum daily dosage, 10 mg of glipizide and 2 g of metformin hydrochloride.
In previously treated patients with inadequate glycemic control with monotherapy, 2.5 or 5 mg of glipizide and 500 mg of metformin hydrochloride twice daily with the morning and evening meals.
The initial dosage of the fixed combination should not exceed the daily dosage of glipizide or metformin hydrochloride previously received.
Titrate upward in increments not exceeding 5 mg of glipizide and 500 mg of metformin hydrochloride until adequate glycemic control is reached.
Maximum daily dosage, 20 mg of glipizide and 2 g of metformin hydrochloride in previously treated patients.
For patients previouly receiving both glipizide (or another sulfonylurea antidiabetic agent) and metformin, the initial dosage of the fixed-combination preparation should not exceed the daily dosages of glipizide (or equivalent dosage of another sulfonylurea) and metformin hydrochloride currently being taken. Such patients should be monitored for signs and symptoms of hypoglycemia following the switch. In the transfer, the decision to switch to the nearest equivalent dosage or to titrate dosage is based on clinical judgment.
Prescribing Limits
Adults
Diabetes Mellitus
Oral
Maximum once-daily dose as conventional tablets is 15 mg.
Maximum total daily dosage is 40 mg as divided doses of conventional tablets or 20 mg as extended-release tablets.
Maximum daily dosage of the fixed combination, 10 mg of glipizide and 2 g of metformin hydrochloride.
Extended-release tablets: Use conservative initial and maintenance dosage.
Adjust dosage carefully.
Generally, do not use in patients with severe hepatic impairment.
Renal Impairment
Use conservative initial and maintenance dosage.
Use generally not recommended in patients with severe renal impairment.
Cautious dosing recommended.
Geriatric Patients
Conventional tablets: Initially, 2.5 mg daily.
Initially, 5 mg (extended-release tablets) may be used.
Use conservative initial and maintenance dosage of glipizide-containing formulations.
Adjust dosage carefully. Any dosage adjustment of glipizide in fixed combination with metformin hydrochloride requires careful assessment of renal function.
Dosage of glipizide and metformin hydrochloride in fixed combination should not be titrated to the maximum dosage.
Debilitated or Malnourished Patients
Conservative initial and maintenance dosage of conventional and extended-release tablets.
Dosage of glipizide and metformin hydrochloride in fixed combination should not be titrated to the maximum dosage.
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