Glucotrol XL 10 mg/1
glipizide · TABLET, EXTENDED RELEASE · Roerig
Glucotrol XL is a tablet, extended release containing glipizide at 10 mg/1, taken oral. Manufactured by Roerig.
Key Facts
- Brand Name
- Glucotrol XL
- Generic Name
- glipizide
- NDC Code (Product)
0049-0178- Manufacturer
- Roerig
- Strength
- 10 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA020329
- Drug Class
- Sulfonylurea [EPC]
- Marketing Start
- 05/09/2013
Recall History
Pfizer Inc.
Failed Dissolution Specification; 8 hr stability timepoint
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE GLUCOTROL XL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. GLUCOTROL XL is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis 1.1 Limitations of Use GLUCOTROL XL is not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION ▪ Recommended starting dose is 5 mg once daily. Dose adjustment can be made based on the patient's glycemic control. Maximum recommended dose is 20 mg once daily ( 2.1 ). ▪ Administer with breakfast or the first meal of the day ( 2.1 ). ▪ For combination therapy with other blood-glucose-lowering agents, initiate the agent at the lowest recommended dose, and observe patients for hypoglycemia ( 2.2 ). 2.1 Recommended Dosing GLUCOTROL XL should be administered orally with breakfast or the first main meal of the day. 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 [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 GLUCOTROL XL once daily at the nearest equivalent total daily dose. 2.2 Use with Other Glucose Lowering Agents When adding GLUCOTROL XL to other anti-diabetic drugs, initiate GLUCOTROL XL at 5 mg once daily. Start patients at increase…
Contraindications
4 CONTRAINDICATIONS Glipizide is contraindicated in patients with: • Known hypersensitivity to glipizide or any of the product's ingredients. • Hypersensitivity to sulfonamide derivatives. ▪ Known hypersensitivity to glipizide or any of the product's ingredients ( 4 ). ▪ Hypersensitivity to sulfonamide derivatives ( 4 ).
Drug Interactions
7 DRUG INTERACTIONS ▪ Certain medications may affect glucose metabolism, requiring GLUCOTROL XL dose adjustment and close monitoring of blood glucose ( 7.1 ). ▪ Miconazole: Monitor patients closely. Severe hypoglycemia can occur when GLUCOTROL and oral miconazole are used concomitantly ( 7.2 , 12.3 ). ▪ Fluconazole: Monitor patients closely. An increase in GLUCOTROL AUC was seen after fluconazole administration ( 7.3 , 12.3 ). ▪ Colesevelam: GLUCOTROL XL should be administered at least 4 hours prior to colesevelam ( 7.4 , 12.3 ). 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-inflamma…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail below and elsewhere in the labeling: • Hypoglycemia [see Warnings and Precautions (5.1) ] • Hemolytic anemia [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence > 3%) are dizziness, diarrhea, nervousness, tremor, hypoglycemia and flatulence ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience 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. The dosages above 20 mg are not recommended dosages. In these trials, approximately 180 patients were treated with GLUCOTROL XL for at least 6 months. Table 1 summarizes the incidence of adverse reactions, other than hypoglycemia, that were reported in pooled doub…
Frequently Asked Questions
What is Glucotrol XL used for?
Glucotrol XL contains glipizide. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Glucotrol XL a controlled substance?
Glucotrol XL is not classified as a controlled substance by the DEA.
What is the generic name for Glucotrol XL?
The generic name for Glucotrol XL is glipizide. There are 12 other brand versions of glipizide.
What is the NDC code for Glucotrol XL 10 mg/1?
The NDC (National Drug Code) for Glucotrol XL 10 mg/1 is 0049-0178, listed by Roerig.