GLYSET® Contraindications (miglitol) | Pfizer Medical Information - US

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CONTRAINDICATIONS

GLYSET Tablets are contraindicated in patients with:

Diabetic ketoacidosis
Inflammatory bowel disease, colonic ulceration, or partial intestinal obstruction, and in patients predisposed to intestinal obstruction
Chronic intestinal diseases associated with marked disorders of digestion or absorption, or with conditions that may deteriorate as a result of increased gas formation in the intestine
Hypersensitivity to the drug or any of its components.

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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Pfizer Safety Reporting Site
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INDICATIONS AND USAGE

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

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DOSAGE AND ADMINISTRATION

There is no fixed dosage regimen for the management of diabetes mellitus with GLYSET Tablets or any other pharmacologic agent. Dosage of GLYSET must be individualized on the basis of both...

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CONTRAINDICATIONS

GLYSET Tablets are contraindicated in patients with:

Diabetic ketoacidosis
Inflammatory bowel disease, colonic ulceration, or partial intestinal obstruction, and in patients predisposed to...

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PRECAUTIONS

Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with GLYSET or any other anti-...

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ADVERSE REACTIONS

Gastrointestinal

Gastrointestinal symptoms are the most common reactions to GLYSET Tablets. In U.S. placebo-controlled trials, the incidences of...

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OVERDOSAGE

Unlike sulfonylureas or insulin, an overdose of GLYSET tablets will not result in hypoglycemia. An overdose may result in transient increases in flatulence, diarrhea, and abdominal discomfort. Because of the lack...

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DESCRIPTION

GLYSET Tablets contain miglitol, an oral alpha-glucosidase inhibitor for use in the management of non-insulin-dependent diabetes mellitus (NIDDM). Miglitol is a desoxynojirimycin derivative, and is chemically...

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CLINICAL PHARMACOLOGY

Miglitol is a desoxynojirimycin derivative that delays the digestion of ingested carbohydrates, thereby resulting in a smaller rise in blood glucose concentration following meals. As a consequence of...

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CLINICAL STUDIES

Clinical Experience in Non-Insulin-Dependent Diabetes Mellitus (NIDDM) Patients on Dietary Treatment Only

GLYSET Tablets were evaluated in two U.S. and...

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HOW SUPPLIED

GLYSET Tablets are available as 25 mg, 50 mg, and 100 mg tablets.

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For Oral Use

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Report Adverse Event

Pfizer Safety

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:

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 or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety 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.