Glipizide (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 Extended-Release Tablets, 2.5 mg are white to off-white, round, biconvex film-coated tablets imprinted with ‘A’ on one side with black ink.
Bottles of 30 NDC 59651-268-30

Glipizide Extended-Release Tablets, 5 mg are white to off-white, round, biconvex film-coated tablets imprinted with ‘B’ on one side with black ink.
Bottles of 30 NDC 59651-269-30
Bottles of 100 NDC 59651-269-01
Bottles of 500 NDC 59651-269-05

Glipizide Extended-Release Tablets, 10 mg are white to off-white, round, biconvex film-coated tablets imprinted with ‘C’ on one side with black ink.
Bottles of 30 NDC 59651-270-30
Bottles of 100 NDC 59651-270-01
Bottles of 500 NDC 59651-270-05
Bottles of 1,000 NDC 59651-270-99

Recommended Storage: The tablets should be protected from moisture and humidity. Store at 20° to 25°C (68° to 77°F) [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 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.
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 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)].

PATIENT INFORMATION
Glipizide Extended-Release Tablets
(glip’ i zide)

What are glipizide extended-release tablets?

  • Glipizide extended-release tablets are 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 extended-release tablets are not for people with type 1 diabetes or people with diabetic ketoacidosis.

It is not known if glipizide extended-release tablets are safe and effective in children under 18 years of age.

Who Should Not Take glipizide extended-release tablets?

Do not use glipizide extended-release tablets if you:

  • have a condition called diabetic ketoacidosis
  • have ever had an allergic reaction to glipizide or any of the other ingredients in glipizide extended-release tablets. See the end of this Patient Information for a complete list of ingredients in glipizide extended-release tablets.

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:

  • 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 extended-release tablets may develop hemolytic anemia (fast breakdown of red blood cells).
  • Are pregnant or might be pregnant. It is not known if glipizide extended-release tablets 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 extended-release tablets during the last two weeks of pregnancy.
  • Are breastfeeding or plan to breastfeed. It is not known if glipizide passes into your breast milk. You and your healthcare provider should decide the best way to feed your baby during treatment with glipizide extended-release tablets.

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 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 extended-release tablets?

  • Take glipizide extended-release tablets exactly as your healthcare provider tells you to take them.
  • Your healthcare provider will tell you how much glipizide extended-release tablets to take and when to take them.
  • Take glipizide extended-release tablets by mouth, 1 time each day with breakfast or your first meal of the day.
  • Each glipizide extended-release tablet will release the medicine slowly over 24 hours. This is why you take it only 1 time each day.
  • Swallow the glipizide extended-release tablets 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.
  • It is important to take glipizide extended-release tablets 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 extended-release tablets, call your healthcare provider or go to the nearest emergency room right away.

Your healthcare provider may tell you to take glipizide extended-release tablets with other diabetes medicines. Low blood sugar can happen more often when glipizide extended-release tablets are taken with other diabetes medicines. See “What are the possible side effects of glipizide extended-release tablets?

  • Check your blood sugar as your healthcare provider tells you to.
  • Stay on your prescribed diet and exercise program while taking glipizide extended-release tablets.

What should I avoid while taking glipizide extended-release tablets?

  • Do not drink alcohol while taking glipizide extended-release tablets. 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 extended-release tablets affect you.

What are the possible side effects of glipizide extended-release tablets?

Glipizide extended-release tablets can cause serious side effects, including:

  • Low blood sugar. Glipizide extended-release tablets may cause low blood sugar. Signs and symptoms of low blood sugar may include:

● a cold clammy feeling ● hunger
● unusual sweating ● fast heartbeat
● dizziness ● headache
● weakness ● blurred vision
● trembling ● slurred speech
● shakiness ● 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 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?

  • Store glipizide extended-release tablets at room temperature between 20° to 25°C (68° to 77°F).
  • Store glipizide extended-release tablets in a dry place, in its original container.

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. They 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 Aurobindo Pharma USA, Inc. at 1-866-850-2876.

What are the ingredients in glipizide extended-release tablets?

Active ingredient: glipizide

Inactive ingredients: acetyltributyl citrate, ammonium hydroxide, hydroxyethyl cellulose, hydroxypropyl cellulose, iron oxide black, lactose monohydrate, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (1:1), polyethylene glycol, propylene glycol and shellac glaze in ethanol.
This Patient Information has been approved by the U.S. Food and Drug Administration

The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India
Revised: 06/2019

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