A twenty month study in rats and an eighteen month study in mice at doses up to 75 times the maximum human dose revealed no evidence of drug-related carcinogenicity. Bacterial and in vivo mutagenicity tests were uniformly negative. Studies in rats of both sexes at doses up to 20 times the human dose based on body surface area, showed no effects on fertility.
1. Diabetes, 19, SUPP. 2: 747–830, 1970
Glipizide Extended-Release Tablets are supplied as 2.5 mg, 5 mg, and 10 mg round, unscored, film-coated tablets and are printed with black ink as follows:
2.5 mg tablets are light orange and printed with “WPI ” and “900 ”. They are available in the following package size:
Bottles of 30 NDC 0591-0900-30
5 mg tablets are orange and printed with “WPI ” and “844 ”. They are available in the following package sizes:
Bottles of 100 NDC 0591-0844-01
Bottles of 1000 NDC 0591-0844-10
10 mg tablets are white to off-white and printed with “WPI ” and “845 ”. They are available in the following package sizes:
Bottles of 100 NDC 0591-0845-01
Bottles of 1000 NDC 0591-0845-10
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity.
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Inform patients of the potential adverse reactions of glipizide extended-release tablets including hypoglycemia. Explain the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development to patients and responsible family members. Also inform patients about the importance of adhering to dietary instructions, of a regular exercise program, and of regular testing of glycemic control.
Inform patients that glipizide extended-release tablets should be swallowed whole. Inform patients that they should not chew, divide or crush tablets and they may occasionally notice in their stool something that looks like a tablet. In the glipizide extended-release tablet, the medication is contained within a non-dissolvable shell that has been specially designed to slowly release the drug so the body can absorb it.
Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations (8.1)].
Advise breastfeeding women taking glipizide extended-release tablets to monitor breastfed infants for signs of hypoglycemia (e.g., jitters, cyanosis, hypothermia, excessive sleepiness, poor feeding, seizures) [see Use in Specific Populations (8.2)].
Brands listed are the trademarks of their respective owners.
Teva Pharmaceuticals, USA, Inc.
Parsippany, NJ 07054
Rev. B 12/2020
Glipizide (glip ´ i zide) Extended-Release Tablets
What are glipizide extended-release tablets?
Who should not take glipizide extended-release tablets?
Do not use glipizide extended-release tablets if you:
What should I tell my doctor before taking glipizide extended-release tablets?
Before you take glipizide extended-release tablets, tell your healthcare provider if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Glipizide extended-release tablets may affect the way other medicines work, and other medicines may affect how glipizide extended-release tablets work.
Some medicines can affect how well glipizide extended-release tablets work or may affect your blood sugar level.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take glipizide extended-release tablets?
What should I avoid while taking glipizide extended-release tablets?
What are the possible side effects of glipizide extended-release tablets?
Glipizide extended-release tablets can cause serious side effects, including:
If you have signs or symptoms of low blood sugar, eat or drink something with sugar in it right away. If you do not feel better or your blood sugar level does not go up, call your healthcare provider or go to the nearest emergency room.
The most common side effects of glipizide extended-release tablets include: dizziness, diarrhea, nervousness, tremor, and gas.
These are not all the possible side effects of glipizide extended-release tablets. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How to store glipizide extended-release tablets?
Keep glipizide extended-release tablets and all medicines out of reach of children.
General information about the safe and effective use of glipizide extended-release tablets.
Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use glipizide extended-release tablets for a condition for which it was not prescribed. Do not give glipizide extended-release tablets to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information summarizes the most important information about glipizide extended-release tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about glipizide extended-release tablets that is written for healthcare professionals.
For more information about glipizide extended-release tablets, call Teva Pharmaceuticals USA, Inc. at 1-888-838-2872.
What are the ingredients in glipizide extended-release tablets?
Active ingredient: glipizide
Inactive ingredients: acetyltributyl citrate, ammonia, butyl alcohol, edible black ink, ferrosoferric oxide, hydroxyethyl cellulose, hydroxypropyl cellulose, isopropyl alcohol, lactose monohydrate, magnesium stearate, methacrylic acid copolymer type A, polyethylene glycol, propylene glycol and shellac.
The 2.5 mg and 5 mg tablets also contain FD&C Yellow #6.
Manufactured for: Teva Pharmaceuticals USA, Inc. , Parsippany, NJ 07054
This Patient Information has been approved by the U.S. Food and Drug Administration Rev. B 12/2020
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.