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GLUCOTROL® XL (glipizide extended release tablets)
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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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