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GLUCOTROL® XL (glipizide extended release tablets)
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.
GLUCOTROL® XL Quick Finder
Highlights
Indications and Usage
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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Dosage and Administration
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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Dosage Forms and Strengths
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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Contraindications
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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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hypoglycemia
All sulfonylurea drugs, including GLUCOTROL XL, are capable of producing severe hypoglycemia [see...
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Adverse Reactions
6 ADVERSE REACTIONS
The following serious adverse reactions are discussed in more detail below and elsewhere in the labeling:
- Hypoglycemia [see Warnings and Precautions (5.1...
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Drug Interactions
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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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data from a...
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Overdosage
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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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
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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References
15 REFERENCES
1. Diabetes, 19, SUPP. 2: 747–830, 1970
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How Supplied/Storage and Handling
...
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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Medication Guide
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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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*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 or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
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.
(800)-332-1088.