GLIPIZIDE ER- glipizide tablet, film coated, extended release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

PD-Rx Pharmaceuticals, Inc.

INN (Διεθνής Όνομα):

GLIPIZIDE

Σύνθεση:

GLIPIZIDE 5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 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. 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 delivery (see Clinical Consider

Περίληψη προϊόντος:

Glipizide Extended-Release Tablets are supplied as 5 mg round, unscored, film-coated tablets and are printed with black ink as follows: 5 mg tablets are orange and printed with “ WPI ” and “ 844 ”. They are available in the following package sizes: Bottles of 7 NDC 55289-779-07 Bottles of 30 NDC 55289-779-30 Bottles of 90 NDC 55289-779-90 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

GLIPIZIDE ER- GLIPIZIDE TABLET, FILM COATED, EXTENDED RELEASE
PD-RX PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GLIPIZIDE EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR GLIPIZIDE
EXTENDED-RELEASE TABLETS.
GLIPIZIDE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1994
INDICATIONS AND USAGE
Glipizide extended-release tablets are a sulfonylurea indicated as an
adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes mellitus. (1)
Limitations of Use: Not for treatment of type 1 diabetes or diabetic
ketoacidosis. (1)
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).
DOSAGE FORMS AND STRENGTHS
Tablets: 2.5 mg, 5 mg, 10 mg ( 3).
CONTRAINDICATIONS
Known hypersensitivity to glipizide or any of the product’s
ingredients ( 4)
Hypersensitivity to sulfonamide derivatives ( 4)
WARNINGS AND PRECAUTIONS
Hypoglycemia: May be severe. Ensure proper patient selection, dosing,
and instructions, particularly in
at-risk populations (e.g., elderly, renally impaired) and when used
with other anti-diabetic medications (
5.1).
Hemolytic Anemia: Can occur if glucose 6-phosphate dehydrogenase
(G6PD) deficient. Consider a non-
sulfonylurea alternative ( 5.2).
Potential Increased Risk of Cardiovascular Mortality with
Sulfonylureas: Inform patient of risks, benefits
and treatment alternatives ( 5.3).
Macrovascular Outcomes: No clinical studies have established
conclusive evidence of macrovascular
risk reduction with glipizide extended-release tablets or any other
anti-diabetic drug ( 5.4).
ADVERSE REACT