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GLUCOTROL® XL (glipizide extended release tablets)
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GLUCOTROL® XL Quick Finder
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...
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...
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...
4 CONTRAINDICATIONS
Glipizide is contraindicated in patients with:
- •
- Known hypersensitivity to glipizide or any of the product's ingredients.
- •
- Hypersensitivity to sulfonamide derivatives...
5 WARNINGS AND PRECAUTIONS
5.1 Hypoglycemia
All sulfonylurea drugs, including GLUCOTROL XL, are capable of producing severe hypoglycemia [see...
6 ADVERSE REACTIONS
The following serious adverse reactions are discussed in more detail below and elsewhere in the labeling:
- •
- Hypoglycemia [see Warnings and...
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...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data from a...
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...
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...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Glipizide primarily lowers blood glucose by stimulating the release of insulin from the pancreas, an effect...
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...
15 REFERENCES
1. Diabetes, 19, SUPP. 2: 747–830, 1970
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:
...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...
This product's label may have been updated. For full prescribing information, please visit www.pfizer.com.
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.
(800)-332-1088.