Glipizide ER

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Glipizide ER Dosage and Administration

2.1 Recommended Dosing

Glipizide extended-release tablets should be administered orally with breakfast or the first main meal of the day.

The recommended starting dose of glipizide extended-release tablets is 5 mg once daily. Start patients at increased risk for hypoglycemia (e.g. the elderly or patients with hepatic insufficiency) at 2.5 mg [see Use in Specific Population (8.5, 8.6)].

Dosage adjustment can be made based on the patient’s glycemic control. The maximum recommended dose is 20 mg once daily. Patients receiving immediate release glipizide may be switched to glipizide extended-release tablets once daily at the nearest equivalent total daily dose.

2.2 Use with Other Glucose Lowering Agents

When adding glipizide extended-release tablets to other anti-diabetic drugs, initiate glipizide extended-release tablets at 5 mg once daily. Start patients at increased risk for hypoglycemia at a lower dose.

When colesevelam is coadministered with Glipizide ER, maximum plasma concentration and total exposure to glipizide is reduced. Therefore, glipizide extended-release tablets should be administered at least 4 hours prior to colesevelam.

Dosage Forms and Strengths

Glipizide extended-release tablets are supplied as 2.5 mg, 5 mg, and 10 mg round, film-coated tablets and are printed with black ink as follows:

2.5 mg tablets are light orange and printed with “WPI” and “900”.

5 mg tablets are orange and printed with “WPI” and “844”.

10 mg tablets are white to off-white and printed with “WPI” and “845”.

Contraindications

Glipizide is contraindicated in patients with:

Known hypersensitivity to glipizide or any of the product’s ingredients.
Hypersensitivity to sulfonamide derivatives.

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 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 patients with diabetes to inform their healthcare provider if they are pregnant, contemplating pregnancy, breastfeeding, or contemplating breastfeeding.

This product’s label may have been updated. For full prescribing information, please visit www.actavis.com.

Brands listed are the trademarks of their respective owners.

Manufactured by:
Patheon Pharmaceuticals Inc.
Cincinnati, OH 45237 USA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Revised: August 2017

PATIENT INFORMATION

Glipizide (glip´ i zide) Extended-Release Tablets

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 you 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 month 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 if you will take glipizide extended-release tablets or breastfeed. You should not do both.

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?

Take glipizide extended-release tablets exactly as your healthcare provider tells you to take it.
Your healthcare provider will tell you how many glipizide extended-release tablets to take and when to take it.
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.
When you take glipizide extended-release tablets 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 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 many 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
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 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 68° to 77°F (20° to 25°C).
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. 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, you can visit the Actavis internet site at www.actavis.com.

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.