GLYBURIDE AND METFORMIN HYDROCHLORIDE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Preferred Pharmaceuticals Inc.

INN (Διεθνής Όνομα):

GLYBURIDE

Σύνθεση:

GLYBURIDE 5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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:

Περίληψη προϊόντος:

Glyburide and Metformin Hydrochloride Tablets USP, 5 mg/500 mg are pale yellow colored, capsule shaped, biconvex coated tablets, debossed with "655" on one side and plain on the other side and are supplied as follows: NDC 68788-6915-3 in bottles of 30 tablets NDC 68788-6915-6 in bottles of 60 tablets NDC 68788-6915-9 in bottles of 90 tablets NDC 68788-6915-1 in bottles of 100 tablets NDC 68788-6915-8 in bottles of 120 tablets STORAGE Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container (USP). GLUCOPHAGE® is a registered trademark of Merck SantÉ S.A.S., an associate of Merck KGaA of Darmstadt, Germany. Licensed to Bristol-Myers Squibb Company. Micronase® is a registered trademark of Pharmacia & Upjohn Company. Manufactured  by: Cadila Healthcare Ltd. Baddi, India Distributed  by: Zydus  Pharmaceuticals  USA  Inc. Pennington, NJ 08534 Rev.: 04/17

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

GLYBURIDE AND METFORMIN HYDROCHLORIDE- GLYBURIDE AND METFORMIN
HYDROCHLORIDE TABLET
PREFERRED PHARMACEUTICALS INC.
----------
GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Glyburide and Metformin Hydrochloride Tablets, USP contain 2 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 is
1-[[_p_-[2-(5-chloro-_o_-anisamido)ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea.
Glyburide, USP
is a white or almost white, crystalline powder with a molecular
formula of C
H ClN O S and a
molecular weight of 494. The glyburide used in glyburide and metformin
hydrochloride tablets, USP
has a particle size at least 20% are less than 2 micron, at least 80%
are less than 10 micron and 100%
are less than 40 micron. The structural formula is represented below.
Metformin hydrochloride, USP is an oral antihyperglycemic drug used in
the management of type 2
diabetes. Metformin hydrochloride (_N_,_N_-dimethylimidodicarbonimidic
diamide monohydrochloride) is
not chemically or pharmacologically related to sulfonylureas,
thiazolidinediones, or α-glucosidase
inhibitors. It is a white crystals with a molecular formula of C H ClN
(monohydrochloride) and a
molecular weight of 165.62. Metformin hydrochloride, USP is freely
soluble in water, slightly soluble
in ethanol (95%), practically insoluble in acetone and in methylene
chloride. The structural formula is as
shown:
Each glyburide and metformin hydrochloride tablet, USP intended 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 and 5 mg glyburide USP with 500 mg
metformin hydrochloride USP. In
addition, each tablet contains the following inactive ingredients:
calcium carbonate, croscarmellose
sodium, magnesium stearate, microcrystalline cellulose and povidone.
Additionally, 1.25 mg/250 mg table