GLYBURIDE AND METFORMIN HYDROCHLORIDE- glyburide and metformin hydrochloride tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

GLYBURIDE (UNII: SX6K58TVWC) (GLYBURIDE - UNII:SX6K58TVWC), METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Dostępny od:

Medsource Pharmaceuticals

INN (International Nazwa):

GLYBURIDE

Skład:

GLYBURIDE 5 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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. - Concomitant administration of bosentan. Glyburide and metformin should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such prod

Podsumowanie produktu:

Glyburide and Metformin Hydrochloride Tablets USP, 1.25/250 mg are available as light yellow, oval-shaped, beveled-edged, film-coated tablets, debossed and "5710" on one side and "1.25/250" on the other side containing 1.25 mg glyburide USP and 250 mg metformin hydrochloride USP packaged in bottles of 100 (NDC 0093-5710-01) and 500 (NDC 0093-5710-05). 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 (NDC 0093-5711-01) and 500 (NDC 0093-5711-05). Glyburide and Metformin Hydrochloride Tablets USP, 5/500 mg are available as yellow, oval-shaped, beveled-edged, film-coated tablets, debossed and "5712" on one side and "5/500" on the other side containing 5 mg glyburide USP and 500 mg metformin hydrochloride USP packaged in bottles of 100 (NDC 0093-5712-01) and 500 (NDC 0093-5712-05). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. J 10/2014

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

GLYBURIDE AND METFORMIN HYDROCHLORIDE- GLYBURIDE AND METFORMIN
HYDROCHLORIDE TABLET, FILM COATED
MEDSOURCE PHARMACEUTICALS
----------
GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS USP
5710
5711
5712
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:
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, m