"The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called keto"...
GLUCOTROL XL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations Of Use
GLUCOTROL XL is not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
DOSAGE AND ADMINISTRATION
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].
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.
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 increased risk for hypoglycemia at a lower dose.
When colesevelam is coadministered 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.
Dosage Forms And Strengths
GLUCOTROL XL (glipizide) Extended Release tablets:
2.5 mg, blue and imprinted with “GLUCOTROL XL 2.5” or “GXL 2.5” on one side
5 mg, white and imprinted with “GLUCOTROL XL 5” or “GXL 5” on one side
10 mg, white and imprinted with “GLUCOTROL XL 10” or “GXL 10” on one side
Storage And Handling
GLUCOTROL 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:
Table ##. GLUCOTROL XL Tablet Presentations
|Tablet Strength||Tablet Color/ Shape||Tablet Markings||Package Size||NDC Code|
|2.5 mg||Blue Round Biconvex||imprinted with “GLUCOTROL XL 2.5” on one side||Bottles of 30||NDC 00491620-30|
|imprinted with “GXL 2.5” on one side||Bottles of 30||NDC 00490170-01|
|5 mg||White Round Biconvex||imprinted with “GLUCOTROL XL 5” on one side||Bottles of 100 Bottles of 500||NDC 00491550-66
|imprinted with “GXL 5” on one side||Bottles of 100 Bottles of 500||NDC 00490174-02
|10 mg||White Round Biconvex||imprinted with “GLUCOTROL XL 10” on one side||Bottles of 100 Bottles of 500||NDC 00491560-66
|imprinted with “GXL 10” on one side||Bottles of 100 Bottles of 500||NDC 00490178-07
The tablets should be protected from moisture and humidity. 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 : Roerig, Division of Pfizer Inc., NY, NY 10017. Revised 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/1/2015
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