x�+� No accumulation of drug was observed in patients with type 2 diabetes mellitus during chronic dosing with GLUCOTROL XL.Administration of GLUCOTROL XL with food has no effect on the 2 to 3 hour lag time in drug absorption. The In studies of GLUCOTROL XL in subjects with type 2 diabete mellitus, once daily administration produced reductions in The absolute bioavailability of glipizide was 100% after single oral doses in patients with The mean relative bioavailability of glipizide in 21 males with type 2 diabetes mellitus after administration of 20 mg GLUCOTROL XL, compared to immediate release Glucotrol (10 mg given twice daily), was 90% at steady-state. Avoid use of GLUCOTROL XL in patients with preexisting severe gastrointestinal narrowing (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. Elderly patients are particularly susceptible to the hypoglycemic action of anti-diabetic agents. 1 0 obj <>stream 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].Distributed by: Pfizer, Roerig Division of Pfizer Inc,NY,NY 10017. endobj Start patients at increased risk for 2.5 mg, blue and imprinted with “GLUCOTROL XL 2.5” or “GXL 2.5” on one side5 mg, white and imprinted with “GLUCOTROL XL 5” or “GXL 5” on one side10 mg, white and imprinted with “GLUCOTROL XL 10” or “GXL 10” on one sideGLUCOTROL XL (glipizide) Extended Release Tablets are supplied as 2.5 mg, 5 mg, and 10 mg round, biconvex tablets and imprinted with black ink as follows:The tablets should be protected from moisture and humidity.

endobj In a Breastfed infants of lactating women using GLUCOTROL XL should be monitored for symptoms of hypoglycemia (see Monitor breastfed infants for signs of hypoglycemia (e.g., jitters, Safety and effectiveness in children have not been established.There were no overall differences in effectiveness or safety between younger and older patients, but greater sensitivity of some individuals cannot be ruled out. When initiating and increasing GLUCOTROL XL in patients who may be predisposed to hypoglycemia (e.g., the elderly, patients with renal impairment, patients on other anti-diabetic medications) start at 2.5 mg. Debilitated or malnourished patients, and those with adrenal, The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. It may harm them.This Patient Information summarizes the most important information about GLUCOTROL XL. It is supplied by Pfizer Inc.. Glucotrol XL is used in the treatment of diabetes, type 2 and belongs to the drug class sulfonylureas.Risk cannot be ruled out during pregnancy. Do not give GLUCOTROL XL to other people, even if they have the same symptoms you have. 4 0 obj <>stream A potential interaction between oral miconazole and oral Monitor patients closely for hypoglycemia when Glucotrol XL is co-administered with fluconazole. 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.These are not all the possible side effects of GLUCOTROL XL. endstream 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. Revised: August 2018The following serious adverse reactions are discussed in more detail below and elsewhere in the labeling:Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.In clinical trials, 580 patients from 31 to 87 years of age received GLUCOTROL XL in doses from 5 mg to 60 mg in both controlled and open trials. Hypoglycemia was not reported for any placebo patients.In clinical trials, allergic skin reactions, i.e., Mild to moderate elevations of ALT, LDH, alkaline phosphatase, The following adverse reactions have been identified during post approval use of GLUCOTROL XL. GLUCOTROL XL is not for people with type 1 diabetes or people with diabetic ketoacidosis. For more information, ask your healthcare provider or pharmacist.Call your doctor for medical advice about side effects.