PRANDIN repaglinide pill

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

REPAGLINIDE (UNII: 668Z8C33LU) (REPAGLINIDE - UNII:668Z8C33LU)

Available from:

Gemini Laboratories, LLC

INN (International Name):

REPAGLINIDE

Composition:

REPAGLINIDE 2 mg in 1 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PRANDIN- REPAGLINIDE TABLET
GEMINI LABORATORIES, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRANDIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PRANDIN
PRANDIN ® (REPAGLINIDE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
ADVERSE REACTIONS
To report SUSPECTED ADVERSE REACTIONS, contact Gemini Laboratories,
LLC at [phone] or FDA at 1-800-
FDA-1088 or www.fda.gov/medwatch
REVISED: 2/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
*
FULL PRESCRIBING INFORMATION
PRANDIN® (repaglinide) is an oral blood glucose-lowering drug of the
meglitinide class used in the
management of type 2 diabetes mellitus (also known as non-insulin
dependent diabetes mellitus or
NIDDM). Repaglinide, S(+)2-ethoxy-4(2((3-methyl-1-(2-(1-piperidinyl)
phenyl)-butyl) amino)-2-
oxoethyl) benzoic acid, is chemically unrelated to the oral
sulfonylurea insulin secretagogues.
The structural formula is as shown below:
Repaglinide is a white to off-white powder with molecular formula C27
H36 N2 O4 and a molecular
weight of 452.6. PRANDIN tablets contain 1 mg or 2 mg of repaglinide.
In addition, each tablet contains
the following inactive ingredients: dicalcium phosphate (anhydrous),
microcrystalline cellulose, corn
starch, meglumine, croscarmellose sodium, povidone, poloxamer,
magnesium stearate, and colloidal
silicon dioxide. The 1 mg and 2 mg tablets contain iron oxides (yellow
and red, respectively) as
coloring agents.
Sections or subsections omitted from the full prescribing information
are not listed.
Repaglinide lowers blood glucose levels by stimulating the release of
insulin from the pancreas. This
action is dependent upon functioning beta (ß) cells in the pancreatic
islets. Insulin release is glucose-
dependent and diminishes at low glucose concentrations.
Repaglinide closes ATP-dependent potassium channels in the ß-cell
membrane by binding at
characterizable sites. This potassium channel blockade depolarizes the
ß-cell, which leads to an
op