Glipizide XL (Page 4 of 5)
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 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.
15 REFERENCES
1. Diabetes , 19, SUPP. 2: 747–830, 1970
16 HOW SUPPLIED/STORAGE AND HANDLING
GLIPIZIDE XL (glipizide) Extended Release Tablets are supplied as 10 mg round, biconvex tablets and imprinted with black ink as follows:
| Tablet Strength | Tablet Color/Shape | Tablet Markings | Package Size | NDC Code |
|---|---|---|---|---|
| 10 mg | White
Round Biconvex | imprinted with “GXL 10” on one side | Bottles of 30 | NDC
70934-391-30 |
| Bottles of 90 | NDC
70934-391-90 |
Recommended Storage: The tablets should be protected from moisture and humidity. Store at 68–77°F (20–25°C); excursions permitted between 59°F and 86°F (15°C and 30°C) [see USP Controlled Room Temperature].
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 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 XL 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 XL 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.
Pregnancy
Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations (8.1)].
Lactation
Advise breastfeeding women taking GLIPIZIDE XL 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)].
For more information, go to www.greenstonellc.com or call 1-800-438-1985.
LAB-0330-13.0
| This Patient Information has been approved by the U.S. Food and Drug Administration. | Revised 10/2018 | ||
| PATIENT INFORMATION
GLIPIZIDE XL (glipizide) extended release tablets | |||
What is GLIPIZIDE XL?
It is not known if GLIPIZIDE XL is safe and effective in children under 18 years of age. | |||
Who Should Not Take GLIPIZIDE XL?
Do not use GLIPIZIDE XL if you:
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What should I tell my doctor before taking GLIPIZIDE XL?
Before you take GLIPIZIDE XL, 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 XL may affect the way other medicines work, and other medicines may affect how GLIPIZIDE XL works. Some medicines can affect how well GLIPIZIDE XL works or may affect you 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 XL?
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What should I avoid while taking GLIPIZIDE XL?
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What are the possible side effects of GLIPIZIDE XL?
GLIPIZIDE XL can cause serious side effects, including:
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| 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 XL include: dizziness, diarrhea, nervousness, tremor, and gas. These are not all the possible side effects of GLIPIZIDE XL. 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 XL?
Keep GLIPIZIDE XL and all medicines out of reach of children. | |||
| General information about the safe and effective use of GLIPIZIDE XL. Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use GLIPIZIDE XL for a condition for which it was not prescribed. Do not give GLIPIZIDE XL 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 XL. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about GLIPIZIDE XL that is written for healthcare professionals. For more information, go to www.greenstonellc.com or call 1-800-438-1985. | |||
| What are the ingredients in GLIPIZIDE XL? Active ingredient: glipizide Inactive ingredients: polyethylene oxide, hypromellose, magnesium stearate, sodium chloride, red ferric oxide, cellulose acetate, polyethylene glycol, Opadry® blue (OY-LS-20921), (2.5 mg tablets) Opadry® white (YS 2 7063), (5 mg and 10 mg tablet) Opacode® Black Ink (S-1-17823). | |||
LAB-0368-6.0 | |||
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