GLYBURIDE tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC)

Sẵn có từ:

PD-Rx Pharmaceuticals, Inc.

INN (Tên quốc tế):

GLYBURIDE

Thành phần:

GLYBURIDE 2.5 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Glyburide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide is contraindicated in patients: - With known hypersensitivity to the drug or any of its excipients. - With type 1 diabetes mellitus or diabetic ketoacidosis, with or without coma. These conditions should be treated with insulin. - Treated with bosentan.

Tóm tắt sản phẩm:

Glyburide tablets USP are available in the following strengths and package sizes: 2.5 mg (pink, capsule-shaped, flat faced, beveled edge tablet debossed "GLYBUR" on one side and a score line on the other side). Bottles of 30       (NDC 55289-606-30) Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature]. Dispense in well-closed containers with safety closures.

Tình trạng ủy quyền:

New Drug Application Authorized Generic

Đặc tính sản phẩm

GLYBURIDE- GLYBURIDE TABLET
PD-RX PHARMACEUTICALS, INC.
----------
GLYBURIDE TABLETS USP
1.25, 2.5 AND 5 MG
DESCRIPTION
Glyburide is an oral blood-glucose-lowering drug of the sulfonylurea
class. It is a white,
crystalline compound, formulated as tablets of 1.25 mg, 2.5 mg, and 5
mg strengths for
oral administration. Glyburide tablets USP contain the active
ingredient glyburide and the
following inactive ingredients: dibasic calcium phosphate USP,
magnesium stearate NF,
microcrystalline cellulose NF, sodium alginate NF, talc USP. Glyburide
2.5 mg tablets USP
also contain FD&C Red #40 Aluminum Lake. Glyburide 5 mg tablets USP
also contain
FD&C Blue #1 Aluminum Lake. Chemically, Glyburide is identified as
1-[[p-[2-(5-Chloro-o-
anisamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea.
The CAS Registry Number is 10238-21-8.
The structural formula is:
The molecular weight is 493.99. The aqueous solubility of Glyburide
increases with pH as
a result of salt formation.
CLINICAL PHARMACOLOGY
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 play a part in the mechanism of action of
oral sulfonylurea
hypoglycemic drugs.
In addition to its blood glucose lowering actions, Glyburide produces
a mild diuresis by
enhancement of renal free water clearance. Clinical experience to date
indicates an
extremely low incidence of disulfiram-like reactions in patients while
taking Glyburide.
extremely low incidence of disulfiram-like reactions in patients while
taking Glyburide.
PHARMACOKINETICS
Single-dose studies with Glyburide in normal subjects demonstrate
significant absorption
within 1 hour,