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:

Table 2. GLIPIZIDE XL Tablet Presentations
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.

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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?
  • GLIPIZIDE XL is a prescription medicine you take by mouth used along with diet and exercise to lower blood sugar in adults with type 2 diabetes mellitus.
  • GLIPIZIDE XL is not for people with type 1 diabetes or people with diabetic ketoacidosis.

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:
  • have a condition called diabetic ketoacidosis
  • have ever had an allergic reaction to glipizide or any of the other ingredients in GLIPIZIDE XL. See the end of this Patient Information for a complete list of ingredients in GLIPIZIDE XL.
What should I tell my doctor before taking GLIPIZIDE XL? Before you take GLIPIZIDE XL, tell your healthcare provider if you:
  • Have ever had a condition called diabetic ketoacidosis
  • Have kidney or liver problems
  • Have had a blockage or narrowing of your intestines due to illness or past surgery
  • Have chronic (continuing) diarrhea
  • Have glucose-6-phosphate dehydrogenase (G6PD) deficiency. This condition usually runs in families. People with G6PD deficiency who take GLIPIZIDE XL may develop hemolytic anemia (fast breakdown of red blood cells).
  • Are pregnant or might be pregnant. It is not known if GLIPIZIDE XL will harm your unborn baby. If you are pregnant, talk to your healthcare provider about the best way to control your blood sugar while you are pregnant. You should not take GLIPIZIDE XL during the last two weeks of pregnancy.
  • Are breastfeeding or plan to breastfeed. It is not known if GLIPIZIDE XL passes into your breast milk. You and your healthcare provider should decide the best way to feed your baby during treatment with GLIPIZIDE XL.

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?
  • Take GLIPIZIDE XL exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will tell you how much GLIPIZIDE XL to take and when to take it.
  • Take GLIPIZIDE XL by mouth, 1 time each day with breakfast or your first meal of the day.
  • Each GLIPIZIDE XL tablet will release the medicine slowly over 24 hours. This is why you take it only 1 time each day.
  • Swallow the GLIPIZIDE XL whole. Do not break, crush, dissolve, chew, or cut the tablet in half. This will damage the tablet and release too much medicine into your body at one time.
  • When you take GLIPIZIDE XL you may see something in your stool that looks like a tablet. This is the empty shell from the tablet. It is normal for the empty shell to pass with your bowel movement after medicine has been absorbed by your body.
  • It is important to take GLIPIZIDE XL every day to help keep your blood sugar level under good control. Your healthcare provider may change your dose depending on your blood sugar test results. If your blood sugar level is not under control, call your healthcare provider. Do not change your dose unless your healthcare provider tells you to.
  • If you take too much GLIPIZIDE XL, call your healthcare provider or go to the nearest emergency room right away.
    Your healthcare provider may tell you to take GLIPIZIDE XL with other diabetes medicines. Low blood sugar can happen more often when GLIPIZIDE XL is taken with other diabetes medicines. See ” What are the possible side effects of GLIPIZIDE XL?
  • Check your blood sugar as your healthcare provider tells you to.
  • Stay on your prescribed diet and exercise program while taking GLIPIZIDE XL.
What should I avoid while taking GLIPIZIDE XL?
  • Do not drink alcohol while taking GLIPIZIDE XL. It can increase your chances of getting serious side effects.
  • Do not drive, operate machinery, or do other dangerous activities until you know how GLIPIZIDE XL affects you.
What are the possible side effects of GLIPIZIDE XL? GLIPIZIDE XL can cause serious side effects, including:
  • Low blood sugar. GLIPIZIDE XL may cause low blood sugar. Signs and symptoms of low blood sugar may include:
  • a cold clammy feeling
  • unusual sweating
  • dizziness
  • weakness
  • trembling
  • shakiness
  • hunger
  • fast heartbeat
  • headache
  • blurred vision
  • slurred speech
  • tingling in the lips or hands
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?
  • Store GLIPIZIDE XL at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store GLIPIZIDE XL in a dry place, in its original container.

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).

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