GLUCOTROL® XL Principal Display Panel (glipizide extended release tablets) | Pfizer Medical Information - US

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PRINCIPAL DISPLAY PANEL - 2.5 mg Tablet Bottle Label - NDC 0049-0170

Pfizer
NDC 0049-0170-01

Glucotrol XL ®
(glipizide) extended release
Tablets

2.5 mg

GITS

30 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 2.5 mg Tablet Bottle Label - NDC 0049-0170

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Bottle Label - NDC 0049-0174

Pfizer
NDC 0049-0174-02

Glucotrol XL ®
(glipizide) extended release
Tablets

5 mg

GITS

100 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Bottle Label - NDC 0049-0174

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label - NDC 0049-0178

Pfizer
NDC 0049-0178-07

Glucotrol XL ®
(glipizide) extended release
Tablets

10 mg

GITS

100 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label - NDC 0049-0178

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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1 INDICATIONS AND USAGE

GLUCOTROL XL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

1.1...

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2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing

GLUCOTROL XL should be administered orally with breakfast or the first main meal of the day.

The recommended...

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3 DOSAGE FORMS AND STRENGTHS

GLUCOTROL XL (glipizide) Extended Release tablets:

2.5 mg, blue and imprinted with "GLUCOTROL XL 2.5" or "GXL 2.5" on one side

5 mg, white and imprinted with "GLUCOTROL XL 5" or "GXL...

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4 CONTRAINDICATIONS

Glipizide is contraindicated in patients with:

•: Known hypersensitivity to glipizide or any of the product's ingredients.
•: Hypersensitivity to sulfonamide derivatives...

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5 WARNINGS AND PRECAUTIONS

5.1 Hypoglycemia

All sulfonylurea drugs, including GLUCOTROL XL, are capable of producing severe hypoglycemia [see...

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6 ADVERSE REACTIONS

The following serious adverse reactions are discussed in more detail below and elsewhere in the labeling:

•: Hypoglycemia [see Warnings and...

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7 DRUG INTERACTIONS

7.1 Drugs Affecting Glucose Metabolism

A number of medications affect glucose metabolism and may require GLUCOTROL XL dose adjustment and close...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Available data from a...

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10 OVERDOSAGE

Overdosage of sulfonylureas including GLUCOTROL XL can produce severe hypoglycemia. Mild hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated with oral glucose. Severe...

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11 DESCRIPTION

GLUCOTROL XL (glipizide) is an oral sulfonylurea.

The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl] phenyl]sulfonyl]urea. The molecular formula is C...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Glipizide primarily lowers blood glucose by stimulating the release of insulin from the pancreas, an effect...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

A twenty month study in rats and an eighteen month study in mice at doses up to 75...

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15 REFERENCES

1. Diabetes, 19, SUPP. 2: 747–830, 1970

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16 HOW SUPPLIED/STORAGE AND HANDLING

GLUCOTROL XL (glipizide) Extended Release Tablets are supplied to provide 2.5 mg, 5 mg, and 10 mg round, biconvex tablets and imprinted with black ink as follows:

...

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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Inform patients of the potential adverse reactions of GLUCOTROL XL including hypoglycemia. Explain...

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This product's label may have been updated. For full prescribing information, please visit www.pfizer.com.

...

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Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.