Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Glipizide is contraindicated in patients with: 1. Known hypersensitivity to the drug. 2. Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.
Glipizide is contraindicated in patients with: 1. Known hypersensitivity to the drug. 2. Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.
SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned to one of four treatment groups (Diabetes, 19, supp. 2: 747-830, 1970). UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2 1 / 2 times that of patients treated with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning. The patient should be informed of the potential risks and advantages of glipizide and of alternative modes of therapy. Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, it is prudent from a safety standpoint to consider that this warning may also apply to other oral hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.
There is no well documented experience with glipizide overdosage. The acute oral toxicity was extremely low in all species tested (LD 50 greater than 4 g/kg). Overdosage of sulfonylureas, including glipizide, can produce hypoglycemia. Mild hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. If hypoglycemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dL. Patients should be closely monitored for a minimum of 24 to 48 hours since hypoglycemia may recur after apparent clinical recovery. Clearance of glipizide from plasma would be prolonged in persons with liver disease. Because of the extensive protein binding of glipizide, dialysis is unlikely to be of benefit.
There is no fixed dosage regimen for the management of diabetes mellitus with glipizide or any other hypoglycemic agent. In addition to the usual monitoring of urinary glucose, the patient's blood glucose must also be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of an adequate blood-glucose-lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels may also be of value in monitoring the patient's response to therapy. Short-term administration of glipizide may be sufficient during periods of transient loss of control in patients usually controlled well on diet. In general, glipizide tablets should be given approximately 30 minutes before a meal to achieve the greatest reduction in postprandial hyperglycemia.
Store at 20˚C to 25˚C (68˚F to 77˚F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. APOTEX INC. GLIPIZIDE TABLETS, USP 5 mg and 10 mg Manufactured by Manufactured for Apotex Inc. Apotex Corp. Toronto, Ontario Weston, Florida Canada M9L 1T9 USA 33326 Revised: May 2017 Rev. 8 Repackaged By: Preferred Pharmaceuticals Inc.
Representative sample of labeling (see HOW SUPPLIED section for complete listing) APOTEX CORP . Repackaged By: Preferred Pharmaceuticals Inc. NDC 68788-0141 Glipizide Tablets, USP 5 mg Rx
Representative sample of labeling (see HOW SUPPLIED section for complete listing) APOTEX CORP . Repackaged By: Preferred Pharmaceuticals Inc. NDC 68788-0142 Glipizide Tablets, USP 10 mg Rx
| Class | Version | Type | Effective |
|---|---|---|---|
| GLIPIZIDE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ec4adfb0-aabc-95b9-ad07-5cb8f8533a09 | Product name | 2 | 20250625 |
| b1de1ca9-d9db-4f4b-2103-09e2014d30d5 | Product name | 5 | 20180912 |
| 2dee091b-3b8c-d27a-b1ba-fcb0d32e776a | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68788-0141-1 | Glipizide | 100 in 1 BOTTLE | TABLET | 100 | 14 | |
| 68788-0141-3 | Glipizide | 30 in 1 BOTTLE | TABLET | 30 | 14 | |
| 68788-0141-6 | Glipizide | 60 in 1 BOTTLE | TABLET | 60 | 14 | |
| 68788-0141-9 | Glipizide | 90 in 1 BOTTLE | TABLET | 90 | 14 | |
| 68788-0142-1 | Glipizide | 100 in 1 BOTTLE | TABLET | 100 | 14 | |
| 68788-0142-3 | Glipizide | 30 in 1 BOTTLE | TABLET | 30 | 14 | |
| 68788-0142-6 | Glipizide | 60 in 1 BOTTLE | TABLET | 60 | 14 | |
| 68788-0142-9 | Glipizide | 90 in 1 BOTTLE | TABLET | 90 | 14 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60505-0141-0 | EA - Each | 60505-0141 | 060fe002-7e4b-48fa-b8ff-db2d3828c7f4 | 1 | 2012-07-24 |
| 60505-0141-1 | EA - Each | 60505-0141 | e7c50d52-216d-49a4-af7f-5c321f139ee5 | 1 | 2012-07-24 |
| 60505-0141-2 | EA - Each | 60505-0141 | f4681913-5f1e-4f36-a5c9-bb72a51d1b76 | 1 | 2012-07-24 |
| 60505-0141-8 | EA - Each | 60505-0141 | 1dbe3016-8158-4460-bb2b-dd466eed8d63 | 1 | 2012-07-24 |
| 60505-0142-0 | EA - Each | 60505-0142 | 7430ab9b-4c91-4c59-abbe-63ea20becaf8 | 1 | 2012-07-24 |
| 60505-0142-1 | EA - Each | 60505-0142 | c6390d90-777b-4d2f-aed3-b9cc9d240e12 | 1 | 2012-07-24 |
| 60505-0142-2 | EA - Each | 60505-0142 | 330e885d-7fd5-4bb5-bbb9-55f37239bf69 | 1 | 2012-07-24 |
| 60505-0142-4 | EA - Each | 60505-0142 | fcca9101-ea92-43fa-a1ee-17d1effb4215 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| GLIPIZIDE | ACTIVE INGREDIENT | X7WDT95N5C | 3 | |
| GLIPIZIDE | ACTIVE MOIETY | X7WDT95N5C | 3 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 3 |
| Product NDC | Package NDC |
|---|---|
| 68788-0141 | 68788-0141-3, 68788-0141-6, 68788-0141-9, 68788-0141-1 |
| 68788-0142 | 68788-0142-3, 68788-0142-6, 68788-0142-9, 68788-0142-1 |
| 60505-0141 | |
| 60505-0142 |
| Name | UNII | Kind |
|---|---|---|
| GLIPIZIDE | X7WDT95N5C | ACTIB |
| ANHYDROUS LACTOSE | 3SY5LH9PMK | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| GLIPIZIDE | X7WDT95N5C | ACTIB |
| ANHYDROUS LACTOSE | 3SY5LH9PMK | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21 H 27 N 5 O 4 S; the molecular weight is 445.55; the structural formula is shown below: Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide tablets, USP for oral use are available in 5 and 10 mg strengths. Inert ingredients are: anhydrous lactose; colloidal silicon dioxide; magnesium stearate; sodium starch glycolate. Meets USP Dissolution Test 2.
Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Glipizide is contraindicated in patients with: 1. Known hypersensitivity to the drug. 2. Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.
SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned to one of four treatment groups (Diabetes, 19, supp. 2: 747-830, 1970). UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2 1 / 2 times that of patients treated with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning. The patient should be informed of the potential risks and advantages of glipizide and of alternative modes of therapy. Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, it is prudent from a safety standpoint to consider that this warning may also apply to other oral hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.
In U.S. and foreign controlled studies, the frequency of serious adverse reactions reported was very low. Of 702 patients, 11.8% reported adverse reactions and in only 1.5% was glipizide discontinued.
There is no well documented experience with glipizide overdosage. The acute oral toxicity was extremely low in all species tested (LD 50 greater than 4 g/kg). Overdosage of sulfonylureas, including glipizide, can produce hypoglycemia. Mild hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. If hypoglycemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dL. Patients should be closely monitored for a minimum of 24 to 48 hours since hypoglycemia may recur after apparent clinical recovery. Clearance of glipizide from plasma would be prolonged in persons with liver disease. Because of the extensive protein binding of glipizide, dialysis is unlikely to be of benefit.
There is no fixed dosage regimen for the management of diabetes mellitus with glipizide or any other hypoglycemic agent. In addition to the usual monitoring of urinary glucose, the patient's blood glucose must also be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of an adequate blood-glucose-lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels may also be of value in monitoring the patient's response to therapy. Short-term administration of glipizide may be sufficient during periods of transient loss of control in patients usually controlled well on diet. In general, glipizide tablets should be given approximately 30 minutes before a meal to achieve the greatest reduction in postprandial hyperglycemia.
Glipizide Tablets, USP are supplied as white to off-white, round, scored tablets, imprinted as follows: 5 mg- “APO” on the side and “GLP” over bisect “5” on the other side; 10 mg- “APO” on one side and “GLP” over bisect “10” on the other side. 5mg bottles Bottle of 30 - 68788-0141-3 Bottle of 60 - 68788-0141-6 Bottle of 90 - 68788-0141-9 Bottle of 100 - 68788-0141-1 10 mg Bottles: Bottle of 30 - 68788-0142-3 Bottle of 60 - 68788-0142-6 Bottle of 90 - 68788-0142-9 Bottle of 100 - 68788-0142
Store at 20˚C to 25˚C (68˚F to 77˚F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. APOTEX INC. GLIPIZIDE TABLETS, USP 5 mg and 10 mg Manufactured by Manufactured for Apotex Inc. Apotex Corp. Toronto, Ontario Weston, Florida Canada M9L 1T9 USA 33326 Revised: May 2017 Rev. 8 Repackaged By: Preferred Pharmaceuticals Inc.
Representative sample of labeling (see HOW SUPPLIED section for complete listing) APOTEX CORP . Repackaged By: Preferred Pharmaceuticals Inc. NDC 68788-0141 Glipizide Tablets, USP 5 mg Rx
Representative sample of labeling (see HOW SUPPLIED section for complete listing) APOTEX CORP . Repackaged By: Preferred Pharmaceuticals Inc. NDC 68788-0142 Glipizide Tablets, USP 10 mg Rx