GLIPIZIDE - glipizide tablet, extended release

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Aurobindo Pharma Limited

INN (nemzetközi neve):

GLIPIZIDE

Összetétel:

GLIPIZIDE 2.5 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 Considerations). Poo

Termék összefoglaló:

Glipizide Extended-Release Tablets, 2.5 mg are light orange, round, biconvex film-coated tablets imprinted with 'A' on one side with black ink.         Bottles of 30                           NDC 65862-888-30 Glipizide Extended-Release Tablets, 5 mg are orange, round, biconvex film-coated tablets imprinted with 'B' on one side with black ink.         Bottles of 30                           NDC 65862-889-30         Bottles of 100                         NDC 65862-889-01         Bottles of 500                         NDC 65862-889-05 Glipizide Extended-Release Tablets, 10 mg are white to off white, round, biconvex film-coated tablets imprinted with 'C' on one side with black ink.         Bottles of 30                           NDC 65862-890-30         Bottles of 100                         NDC 65862-890-01 Recommended Storage: The tablets should be protected from moisture and humidity. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

GLIPIZIDE - GLIPIZIDE TABLET, EXTENDED RELEASE
AUROBINDO PHARMA LIMITED
----------
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 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)
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 REACTIONS
Most common ad