GLUCOTROL® XL (glipizide extended release tablets) Highlights Patient information

(glipizide extended release tablets)

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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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