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GLIPIZIDE XL Extended Release Tablets (GREENSTONE LLC)

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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.

GLIPIZIDE XL Extended Release Tablets (GREENSTONE LLC) Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

GLIPIZIDE 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

GLIPIZIDE 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

GLIPIZIDE XL (glipizide) Extended Release tablets:

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

5 mg, white and imprinted with "GLIPIZIDE 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 GLIPIZIDE 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

    6.1 Clinical Trials Experience

    ...
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7 DRUG INTERACTIONS

7.1 Drugs Affecting Glucose Metabolism

A number of medications affect glucose metabolism and may require GLIPIZIDE 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 GLIPIZIDE 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

GLIPIZIDE 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

GLIPIZIDE 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 GLIPIZIDE XL including hypoglycemia. Explain...

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For more information, go to www.greenstonellc.com or call 1-800-438-1985.

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