GLUCOTROL® XL Highlights

(glipizide extended release tablets)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use GLUCOTROL XL safely and effectively. See full prescribing information for GLUCOTROL XL.

GLUCOTROL XL (glipizide) extended release tablets, for oral use
Initial U.S. Approval: 1994

INDICATIONS AND USAGE

GLUCOTROL XL is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)

Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis (1)

DOSAGE AND ADMINISTRATION

▪
Recommended starting dose is 5 mg once daily. Dose adjustment can be made based on the patient's glycemic control. Maximum recommended dose is 20 mg once daily (2.1).
▪
Administer with breakfast or the first meal of the day (2.1).
▪
For combination therapy with other blood-glucose-lowering agents, initiate the agent at the lowest recommended dose, and observe patients for hypoglycemia (2.2).

DOSAGE FORMS AND STRENGTHS

Tablets: 2.5 mg, 5 mg, 10 mg (3).

CONTRAINDICATIONS

▪
Known hypersensitivity to glipizide or any of the product's ingredients (4).
▪
Hypersensitivity to sulfonamide derivatives (4).

WARNINGS AND PRECAUTIONS

▪
Hypoglycemia: May be severe. Ensure proper patient selection, dosing, and instructions, particularly in at-risk populations (e.g., elderly, renally impaired) and when used with other anti-diabetic medications (5.1).
▪
Hemolytic Anemia: Can occur if glucose 6-phosphate dehydrogenase (G6PD) deficient. Consider a non-sulfonylurea alternative (5.2).
▪
Potential Increased Risk of Cardiovascular Mortality with Sulfonylureas: Inform patient of risks, benefits and treatment alternatives (5.3).
▪
Macrovascular Outcomes: No clinical studies have established conclusive evidence of macrovascular risk reduction with GLUCOTROL XL or any other anti-diabetic drug (5.4).

ADVERSE REACTIONS

Most common adverse reactions (incidence > 3%) are dizziness, diarrhea, nervousness, tremor, hypoglycemia and flatulence (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

▪
Certain medications may affect glucose metabolism, requiring GLUCOTROL XL dose adjustment and close monitoring of blood glucose (7.1).
▪
Miconazole: Monitor patients closely. Severe hypoglycemia can occur when GLUCOTROL and oral miconazole are used concomitantly (7.2, 12.3).
▪
Fluconazole: Monitor patients closely. An increase in GLUCOTROL AUC was seen after fluconazole administration (7.3, 12.3).
▪
Colesevelam: GLUCOTROL XL should be administered at least 4 hours prior to colesevelam (7.4, 12.3).

USE IN SPECIFIC POPULATIONS

▪
Geriatric, Hepatically Impaired Patients: At risk for hypoglycemia with GLUCOTROL XL. Use caution in dose selection and titration, and monitor closely (8.5, 8.6).

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 8/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use GLUCOTROL XL safely and effectively. See full prescribing information for GLUCOTROL XL.

GLUCOTROL XL (glipizide) extended release tablets, for oral use
Initial U.S. Approval: 1994

INDICATIONS AND USAGE

GLUCOTROL XL is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)

Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis (1)

DOSAGE AND ADMINISTRATION

▪
Recommended starting dose is 5 mg once daily. Dose adjustment can be made based on the patient's glycemic control. Maximum recommended dose is 20 mg once daily (2.1).
▪
Administer with breakfast or the first meal of the day (2.1).
▪
For combination therapy with other blood-glucose-lowering agents, initiate the agent at the lowest recommended dose, and observe patients for hypoglycemia (2.2).

DOSAGE FORMS AND STRENGTHS

Tablets: 2.5 mg, 5 mg, 10 mg (3).

CONTRAINDICATIONS

▪
Known hypersensitivity to glipizide or any of the product's ingredients (4).
▪
Hypersensitivity to sulfonamide derivatives (4).

WARNINGS AND PRECAUTIONS

▪
Hypoglycemia: May be severe. Ensure proper patient selection, dosing, and instructions, particularly in at-risk populations (e.g., elderly, renally impaired) and when used with other anti-diabetic medications (5.1).
▪
Hemolytic Anemia: Can occur if glucose 6-phosphate dehydrogenase (G6PD) deficient. Consider a non-sulfonylurea alternative (5.2).
▪
Potential Increased Risk of Cardiovascular Mortality with Sulfonylureas: Inform patient of risks, benefits and treatment alternatives (5.3).
▪
Macrovascular Outcomes: No clinical studies have established conclusive evidence of macrovascular risk reduction with GLUCOTROL XL or any other anti-diabetic drug (5.4).

ADVERSE REACTIONS

Most common adverse reactions (incidence > 3%) are dizziness, diarrhea, nervousness, tremor, hypoglycemia and flatulence (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

▪
Certain medications may affect glucose metabolism, requiring GLUCOTROL XL dose adjustment and close monitoring of blood glucose (7.1).
▪
Miconazole: Monitor patients closely. Severe hypoglycemia can occur when GLUCOTROL and oral miconazole are used concomitantly (7.2, 12.3).
▪
Fluconazole: Monitor patients closely. An increase in GLUCOTROL AUC was seen after fluconazole administration (7.3, 12.3).
▪
Colesevelam: GLUCOTROL XL should be administered at least 4 hours prior to colesevelam (7.4, 12.3).

USE IN SPECIFIC POPULATIONS

▪
Geriatric, Hepatically Impaired Patients: At risk for hypoglycemia with GLUCOTROL XL. Use caution in dose selection and titration, and monitor closely (8.5, 8.6).

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 8/2023
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