Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

GLUCOTROL XL is not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

The recommended starting dose of GLUCOTROL XL 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. When adding GLUCOTROL XL to other antidiabetic drugs, initiate GLUCOTROL XL at 5 mg once daily.

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. 

Treatment of patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents, including GLUCOTROL XL, can lead to hemolytic anemia. Avoid use of GLUCOTROL XL in patients with G6PD deficiency. In post marketing reports, hemolytic anemia has also been reported in patients who did not have known G6PD deficiency. 

Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia have been reported with sulfonylureas.

There have been reports of obstructive symptoms in patients with known strictures in association with the ingestion of another drug with this non-dissolvable extended release formulation.

Avoid use of GLUCOTROL XL in patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic).

All sulfonylurea drugs, including GLUCOTROL XL, are capable of producing severe hypoglycemia. Concomitant use of GLUCOTROL XL with other antidiabetic medication can increase the risk of hypoglycemia. A lower dose of GLUCOTROL XL may be required to minimize the risk of hypoglycemia when combining it with other antidiabetic medications.

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.

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.

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.

A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported.

Concomitant treatment with fluconazole increases plasma concentrations of glipizide, which may lead to hypoglycemia.

When colesevelam is co-administered with glipizide ER, maximum plasma concentration and total exposure to glipizide is reduced. Therefore, GLUCOTROL XL should be administered at least 4 hours prior to colesevelam.

Sulfonylureas (including glipizide) cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia. Animal studies: pup mortality was observed in rats administered glipizide from gestation day 15 throughout lactation.

GLUCOTROL XL should be discontinued at least two weeks before expected delivery.

Breastfed infants of lactating women using GLUCOTROL XL should be monitored for symptoms of hypoglycemia. Although glipizide was undetectable in human milk in one small clinical lactation study; this result is not conclusive because of the limitations of the assay used in the study.

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• Use in patients with type 1 diabetes. GoToSource 

• Use in patients under the age of 18. GoToSource

• Use in non-diabetic patients with insulin resistance. GoToSource

• Weight loss. GoToSource

Hypoglycemia (low blood sugar), coma and kidney impairment. GoToSource

Increased risk of death and cardiac events. GoToSource

Hepatitis (inflammation of the liver). GoToSource 

Proximal myopathy (muscle disease), cholestatic jaundice (decreased bile flow), agranulocytosis (deficiency of granulocytes, a type of white blood cell), aplastic and hemolytic anemias (bone marrow disorder), hypersensitivity reactions, neuromuscular and skeletal abnormalities including tremor, myalgia, paresthesia, ocular and dermatological reactions. GoToSource

Coproporphyria-like syndrome. GoToSource

Weight gain. GoToSource

Erythema multiforme (rash), exfoliative dermatitis (severe skin inflammation) and photosensitivity (extreme sensitivity to ultraviolet UV light). GoToSource

Syndrome of inappropriate antidiuretic hormone secretion (body makes too much antidiuretic hormone)    and hyponatremia (low blood sodium level). GoToSource

Increased risk of cancer. GoToSource

Lawsuits filed for death.