GLYBURIDE AND METFORMIN tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

Glyburide (UNII: SX6K58TVWC) (Glyburide - UNII:SX6K58TVWC), Metformin Hydrochloride (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Dostopno od:

Rebel Distributors Corp

INN (mednarodno ime):

Glyburide

Sestava:

Glyburide 2.5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Glyburide and Metformin Hydrochloride Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide and Metformin Hydrochloride Tablets are contraindicated in patients with: - Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥ 1.5 mg/dL [males], ≥ 1.4 mg/dL [females], or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS ). - Known hypersensitivity to metformin hydrochloride or glyburide. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. Glyburide and metformin should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of ren

Povzetek izdelek:

Glyburide and Metformin Hydrochloride Tablets USP, 2.5/500 mg are available as light orange, oval-shaped, beveled-edged, film-coated tablets, debossed and "5711" on one side and "2.5/500" on the other side containing 2.5 mg glyburide USP and 500 mg metformin hydrochloride USP packaged in bottles of 100 and 500 tablets and unit-dose boxes of 100 tablets. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. H 12/2010 Repackaged by: REBEL DISTRIBUTORS CORP Thousand Oaks, CA 91320

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

GLYBURIDE AND METFORMIN- GLYBURIDE AND METFORMIN TABLET, FILM COATED
REBEL DISTRIBUTORS CORP
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GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS USP
RX ONLY
DESCRIPTION
Glyburide and metformin hydrochloride tablets USP contain two oral
antihyperglycemic drugs used in
the management of type 2 diabetes, glyburide USP and metformin
hydrochloride USP.
Glyburide USP is an oral antihyperglycemic drug of the sulfonylurea
class. The chemical name for
glyburide USP is
1-[[_p_-[2-(5-chloro-_o_-anisamido)ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea.
Glyburide
USP is a white to off-white crystalline compound. The glyburide USP
used in glyburide and metformin
hydrochloride tablets USP has a particle size distribution of 25%
undersize value not more than 6 µm,
50% undersize value not more than 7 to 10 µm, and 75% undersize value
not more than 21 µm. The
structural formula is represented below:
C
H ClN O S M.W. 494.01
Metformin hydrochloride USP is an oral antihyperglycemic drug used in
the management of type 2
diabetes. Metformin hydrochloride USP (
_N,N_-dimethylimidodicarbonimidic diamide
monohydrochloride) is not chemically or pharmacologically related to
sulfonylureas,
thiazolidinediones, or α-glucosidase inhibitors. It is a white to
off-white crystalline compound.
Metformin hydrochloride USP is freely soluble in water and is
practically insoluble in acetone, ether,
and chloroform. The pK of metformin USP is 12.4. The pH of a 1%
aqueous solution of metformin
hydrochloride USP is 6.68. The structural formula is as shown:
C H ClN (monohydrochloride) M.W. 165.63
23
28
3
5
a
C H ClN (monohydrochloride) M.W. 165.63
Each glyburide and metformin hydrochloride tablet USP, for oral
administration, contains 1.25 mg
glyburide USP with 250 mg metformin hydrochloride USP, 2.5 mg
glyburide USP with 500 mg
metformin hydrochloride USP, or 5 mg glyburide USP with 500 mg
metformin hydrochloride USP. In
addition, each tablet contains the following inactive ingredients:
copovidone, crospovidone,
hypromellose, magnesium stearate, microcry