July 1, 2016
Recommended Topic Related To:

Glucotrol XL

"The U.S. Food and Drug Administration today approved Invokana (canagliflozin) tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes.

Type 2 diabetes is the most common form of the disease, affe"...

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Glucotrol XL




Indications
Dosage
How Supplied

INDICATIONS

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

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].

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.

HOW SUPPLIED

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
NDC 0049-1550-73
imprinted with “GXL 5” on one side Bottles of 100 Bottles of 500 NDC 00490174-02
NDC 0049-0174-03
10 mg White Round Biconvex imprinted with “GLUCOTROL XL 10” on one side Bottles of 100 Bottles of 500 NDC 00491560-66
NDC 0049-1560-73
imprinted with “GXL 10” on one side Bottles of 100 Bottles of 500 NDC 00490178-07
NDC 0049-0178-08

Recommended Storage

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 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 12/1/2015

Indications
Dosage
How Supplied

Glucotrol XL - User Reviews

Glucotrol XL User Reviews

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