MICRONIZED GLYBURIDE- micronized glyburide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

glyburide (UNII: SX6K58TVWC) (glyburide - UNII:SX6K58TVWC)

Available from:

Greenstone Ltd.

INN (International Name):

micronized glyburide

Pharmaceutical form:

TABLET

Composition:

1.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Micronized glyburide tablets are indicated as an adjunct to diet to lower the blood glucose in patients with non-insulin-dependent diabetes mellitus (Type II) whose hyperglycemia cannot be satisfactorily controlled by diet alone. Glyburide may be used concomitantly with metformin when diet and glyburide or diet and metformin alone do not result in adequate glycemic control (see metformin insert). In initiating treatment for non-insulin-dependent diabetes, diet should be emphasized as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. The importance of regular physical activity should also be stressed, and cardiovascular risk factors should be identified and corrective measures taken where possible. If this treatment program fails to reduce symptoms and/or blood glucose, the use of an oral sulfonylurea or insulin should be considered. Use

Product summary:

Micronized glyburide tablets are supplied as follows: 1.5 mg (white, ovoid, imprinted G3781, contour, scored) 3 mg (blue, ovoid, imprinted G3782, contour, scored) 6 mg (yellow, ovoid, imprinted G3783, contour, scored) Rx Only Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Dispensed in well closed containers with safety closures. Keep container tightly closed.

Summary of Product characteristics

MICRONIZED GLYBURIDE- MICRONIZED GLYBURIDE TABLET
GREENSTONE LTD.
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MICRONIZED GLYBURIDE TABLETS
1.5 MG, 3 MG AND 6 MG
DESCRIPTION
Micronized glyburide 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 micronized glyburide 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:
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. Disulf