GLUCOTROL® XL (glipizide extended release tablets) 7 DRUG INTERACTIONS

(glipizide extended release tablets)

Prescribing Information

7 DRUG INTERACTIONS

7.1 Drugs Affecting Glucose Metabolism

A number of medications affect glucose metabolism and may require GLUCOTROL XL dose adjustment and close monitoring for hypoglycemia or worsening glycemic control.

The following are examples of medication that may increase the glucose lowering effect of GLUCOTROL XL, increase the susceptibility to and/or intensity of hypoglycemia: antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), sulfonamide antibiotics, nonsteroidal anti-inflammatory agents, chloramphenicol, probenecid, coumarins, voriconazole, H2 receptor antagonists, and quinolones. When these medications are administered to a patient receiving GLUCOTROL XL, monitor the patient closely for hypoglycemia. When these medications are discontinued from a patient receiving GLUCOTROL XL, monitor the patient closely for worsening glycemic control.

The following are examples of medication that may reduce the glucose-lowering effect of GLUCOTROL XL, leading to worsening glycemic control: atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), thyroid hormones, phenytoin, nicotinic acid, and calcium channel blocking drugs. When such drugs are administered to patients receiving GLUCOTROL XL, monitor the patients closely for worsening glycemic control. When these medications are discontinued from patients receiving GLUCOTROL XL, monitor the patient closely for hypoglycemia.

Alcohol, beta-blockers, clonidine, and reserpine may lead to either potentiation or weakening of the glucose-lowering effect. Increased frequency of monitoring may be required when GLUCOTROL XL is co-administered with these drugs.

The signs of hypoglycemia may be reduced or absent in patients taking sympatholytic drugs such as beta-blockers, clonidine, guanethidine, and reserpine. Increased frequency of monitoring may be required when GLUCOTROL XL is co-administered with these drugs.

7.2 Miconazole

Monitor patients closely for hypoglycemia when Glucotrol XL is co-administered with miconazole. A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported [see Clinical Phamacology (12.3)].

7.3 Fluconazole

Monitor patients closely for hypoglycemia when Glucotrol XL is co-administered with fluconazole. Concomitant treatment with fluconazole increases plasma concentrations of glipizide, which may lead to hypoglycemia [see Clinical Pharmacology (12.3)].

7.4 Colesevelam

GLUCOTROL XL should be administered at least 4 hours prior to the administration of colesevelam. Colesevelam can reduce the maximum plasma concentration and total exposure of glipizide when the two are coadministered [see Clinical Pharmacology (12.3)].

Medication Guide

MEDICATION GUIDE

This Patient Information has been approved by the U.S. Food and Drug Administration		Revised 08/2023
PATIENT INFORMATION GLUCOTROL XL (GL'UːKˌOTROL) (glipizide) extended release tablets
What is GLUCOTROL XL? • GLUCOTROL 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. • GLUCOTROL XL is not for people with type 1 diabetes or people with diabetic ketoacidosis. It is not known if GLUCOTROL XL is safe and effective in children under 18 years of age.
Who Should Not Take GLUCOTROL XL? Do not use GLUCOTROL XL if you: • have a condition called diabetic ketoacidosis • have ever had an allergic reaction to glipizide or any of the other ingredients in GLUCOTROL XL. See the end of this Patient Information for a complete list of ingredients in GLUCOTROL XL.
What should I tell my doctor before taking GLUCOTROL XL? Before you take GLUCOTROL 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 GLUCOTROL XL may develop hemolytic anemia (fast breakdown of red blood cells). • Are pregnant or might be pregnant. It is not known if GLUCOTROL 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 GLUCOTROL XL during the last two weeks of pregnancy. • Are breastfeeding or plan to breastfeed. It is not known if GLUCOTROL XL passes into your breast milk. You and your healthcare provider should decide the best way to feed your baby during treatment with GLUCOTROL XL. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. GLUCOTROL XL may affect the way other medicines work, and other medicines may affect how GLUCOTROL XL works. Some medicines can affect how well GLUCOTROL 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 GLUCOTROL XL? • Take GLUCOTROL XL exactly as your healthcare provider tells you to take it. • Your healthcare provider will tell you how much GLUCOTROL XL to take and when to take it. • Take GLUCOTROL XL by mouth, 1 time each day with breakfast or your first meal of the day. • Each GLUCOTROL XL tablet will release the medicine slowly over 24 hours. This is why you take it only 1 time each day. • Swallow the GLUCOTROL 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 GLUCOTROL 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 GLUCOTROL 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 GLUCOTROL XL, call your healthcare provider or go to the nearest emergency room right away. Your healthcare provider may tell you to take GLUCOTROL XL with other diabetes medicines. Low blood sugar can happen more often when GLUCOTROL XL is taken with other diabetes medicines. See "What are the possible side effects of GLUCOTROL XL?" • Check your blood sugar as your healthcare provider tells you to. • Stay on your prescribed diet and exercise program while taking GLUCOTROL XL.
What should I avoid while taking GLUCOTROL XL? • Do not drink alcohol while taking GLUCOTROL 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 GLUCOTROL XL affects you.
What are the possible side effects of GLUCOTROL XL? GLUCOTROL XL can cause serious side effects, including: • Low blood sugar. GLUCOTROL 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 GLUCOTROL XL include: dizziness, diarrhea, nervousness, tremor, and gas. These are not all the possible side effects of GLUCOTROL 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 GLUCOTROL XL? • Store GLUCOTROL XL at room temperature between 68°F to 77°F (20°C to 25°C). • Store GLUCOTROL XL in a dry place, in its original container. Keep GLUCOTROL XL and all medicines out of reach of children.
General information about the safe and effective use of GLUCOTROL XL. Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use GLUCOTROL XL for a condition for which it was not prescribed. Do not give GLUCOTROL 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 GLUCOTROL XL. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about GLUCOTROL XL that is written for healthcare professionals. For more information about GLUCOTROL XL, you can visit the Pfizer internet site at www.pfizer.com.
What are the ingredients in GLUCOTROL 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-0115-8.0

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