GLIPIZIDE tablet, film coated, extended release GLIPIZIDE tablet, film coated, extended release GLIPIZIDE ER- glipizide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C)

Available from:

Direct_Rx

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 1.1 Limitations of Use Glipizide extended-release tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Glipizide is contraindicated in patients with: Known hypersensitivity to glipizide or any of the product’s ingredients. Hypersensitivity to sulfonamide derivatives 8.1 Pregnancy Risk Summary Available data from a small number of published studies and postmarketing experience with glipizide extended-release tablets use in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes. However, sulfonylureas (including glipizide) cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia. Therefore, glipizide extended-release tablets should be discontinued at least two weeks before expected deli

Product summary:

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 2: Glipizide extended-release tablet Presentations Tablet Strength Tablet Color/ Shape Tablet Markings Package Size NDC Code 2.5 mg Blue Round Biconvex imprinted with “P 2.5” on one side. Bottles of 30 NDC 64980-279-03 5 mg White Round Biconvex imprinted with “P 5” on one side. Bottles of 100 NDC 64980-280-01 imprinted with “P 5” on one side. Bottles of 500 NDC 64980-280-05 imprinted with “P 5” on one side. Bottles of 1000 NDC 64980-280-10 10 mg White Round Biconvex imprinted with “P 10” on one side. Bottles of 100 NDC 64980-281-01 imprinted with “P 10” on one side. Bottles of 500 NDC 64980-281-05 imprinted with “P 10” on one side. Bottles of 1000 NDC 64980-281-10 Recommended Storage: The tablets should be protected from moisture and humidity. Store at 20° to 25°C (68° to 77º F); [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLIPIZIDE- GLIPIZIDE TABLET, FILM COATED, EXTENDED RELEASE
GLIPIZIDE- GLIPIZIDE TABLET, FILM COATED, EXTENDED RELEASE
GLIPIZIDE ER- GLIPIZIDE TABLET, EXTENDED RELEASE
DIRECT_RX
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GLIPIZIDE
Glipizide extended-release tablets are indicated as an adjunct to diet
and exercise to improve glycemic
control in adults with type 2 diabetes mellitus.
1.1 Limitations of Use
Glipizide extended-release tablets are not recommended for the
treatment of type 1 diabetes mellitus or
diabetic ketoacidosis.
2.1 Recommended Dosing
Glipizide extended-release tablets should be administered orally with
breakfast or the first main meal of
the day.
The recommended starting dose of glipizide extended-release tablets 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
glipizide extended-release tablets
once daily at the nearest equivalent total daily dose.
2.2 Use with Other Glucose Lowering Agents
When adding glipizide extended-release tablets to other anti-diabetic
drugs, initiate glipizide extended-
release tablets at 5 mg once daily. Start patients at increased risk
for hypoglycemia at a lower dose.
When colesevelam is coadministered with glipizide extended-release
tablets, maximum plasma
concentration and total exposure to glipizide is reduced. Therefore,
glipizide extended-release tablets
should be administered at least 4 hours prior to colesevelam.
Glipizide Extended-Release Tablets:
2.5 mg tablets are blue and imprinted with “ P ” on one side.
2.5
5 mg tablets are white and imprinted with “ P ” on one side.
5
10 mg tablets are white and imprinted with “ P ” on one side.
10
Glipizide is contraindicated in patients with:
Known hypersensitivity to glipizide or any of the product’s
ingredients.
Hypers