RX ITEM-Glynase Pres 1.5Mg Tab 100 By Pfizer Pharma

GLYNASE- glyburide tablet
Pharmacia and Upjohn Company


For Oral Use

DESCRIPTION

GLYNASE PresTab Tablets contain micronized (smaller particle size) glyburide, which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide is a white, crystalline compound, formulated as GLYNASE PresTab Tablets of 1.5, 3, and 6 mg strengths for oral administration. Inactive ingredients: colloidal silicon dioxide, corn starch, lactose, magnesium stearate. In addition, the 3 mg strength contains FD&C Blue No. 1 Aluminum Lake, and the 6 mg tablet contains D&C Yellow No. 10 Aluminum Lake. The chemical name for glyburide is 1-[[p-[2-(5-chloro-o-anisamido)ethyl]phenyl]-sulfonyl]-3-cyclohexylurea and the molecular weight is 493.99. The structural formula is represented below:

Chemical Structure
(click image for full-size original)
CLINICAL PHARMACOLOGY

Actions


Glyburide appears to lower the blood glucose acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. The mechanism by which glyburide lowers blood glucose during long-term administration has not been clearly established. With chronic administration in Type II diabetic patients, the blood glucose lowering effect persists despite a gradual decline in the insulin secretory response to the drug. Extrapancreatic effects may be involved in the mechanism of action of oral sulfonylurea hypoglycemic drugs. The combination of glyburide and metformin may have a synergistic effect, since both agents act to improve glucose tolerance by different but complementary mechanisms.

Some patients who are initially responsive to oral hypoglycemic drugs, including glyburide, may become unresponsive or poorly responsive over time. Alternatively, glyburide may be effective in some patients who have become unresponsive to one or more other sulfonylurea drugs.

In addition to its blood glucose lowering actions, glyburide produces a mild diuresis by enhancement of renal free water clearance. Disulfiram-like reactions have very rarely been reported in patients treated with glyburide.

Pharmacokinetics
Single dose studies with GLYNASE PresTab Tablets in normal subjects demonstrate significant absorption of glyburide within one hour, peak drug levels at about two to three hours, and low but detectable levels at twenty-four hours.

Bioavailability studies have demonstrated that GLYNASE PresTab Tablets 3 mg provide serum glyburide concentrations that are not bioequivalent to those from MICRONASE� Tablets 5 mg. Therefore, the patient should be retitrated.

RX ITEM-Glynase Pres 1.5Mg Tab 100 By Pf
NDC 00009-0341-01 UPC/GTIN No.3-00090-34101-5 Mfg.Part No.1551

Glynase Pres 1.5Mg Tab 100 By Pfizer Pha
BRAND: GLYNASE NDC: 00009-0341-01,9034101 UPC: 3-00090-34101-5,300090341015 Pfizer Pharmaceutical

GLYBURIDE,MICRONIZED ORAL
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