METFORMIN HYDROCHLORIDE tablet, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Tilgjengelig fra:

AvKARE

INN (International Name):

METFORMIN HYDROCHLORIDE

Sammensetning:

METFORMIN HYDROCHLORIDE 500 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin is 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. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. 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 renal function ( see

Produkt oppsummering:

Metformin hydrochloride extended-release tablets USP are supplied as biconvex-shaped, film-coated extended-release tablets containing 500 mg or 1000 mg of metformin hydrochloride. Metformin hydrochloride extended-release tablets USP 500 mg are extended-release, white to off-white, oval shaped, biconvex coated tablets debossed with "Q21" on one side and "LU" on the other side. NDC 42291-582-60   bottles of 60 Metformin hydrochloride extended-release tablets USP 1000 mg are extended-release, white to off-white, oval shaped, biconvex coated tablets debossed with "Q22" on one side and "LU" on the other side. NDC 42291-583-60    bottles of 60

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
AVKARE
----------
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS
RX ONLY
DESCRIPTION
Metformin hydrochloride extended-release tablets USP contain an oral
antihyperglycemic
drug used in the management of type 2 diabetes. Metformin
hydrochloride (N, N-
dimethylimidodicarbonimidic diamide hydrochloride) is a member of the
biguanide class
of oral antihyperglycemics and is not chemically or pharmacologically
related to any
other class of oral antihyperglycemic agents. The empirical formula of
metformin
hydrochloride is C
H
N
•HCl and its molecular weight is 165.63. Its structural
formula is:
Metformin hydrochloride is a white to off-white crystalline powder
that is freely soluble in
water and is practically insoluble in acetone, ether, and chloroform.
The pKa of
metformin is 12.4. The pH of a 1% aqueous solution of metformin
hydrochloride is 6.68.
Metformin hydrochloride extended-release tablets USP are designed for
once-a-day oral
administration and deliver 500 mg or 1000 mg of metformin
hydrochloride. In addition
to the active ingredient metformin hydrochloride, each tablet contains
the following
inactive ingredients: ammonio methacrylate copolymer type A, ammonio
methacrylate
copolymer type B, colloidal silicone dioxide, crospovidone, dibutyl
sebacate,
hypromellose, magnesium stearate, microcrystalline cellulose and
povidone.
Metformin hydrochloride extended-release tablets USP meets USP
Dissolution Test 12.
SYSTEM COMPONENTS AND PERFORMANCE
Metformin hydrochloride extended-release tablet USP is designed for
once-a-day oral
administration using the swellable matrix coated with a permeable
membrane
technology. The tablet is similar in appearance to other film-coated
oral administered
tablets but it consists of a swellable active core formulation that is
coated by a
permeable membrane. The core formulation is composed primarily of drug
with swellable
matrix excipients. Upon ingestion, water is taken up through the
membrane, which in
turn ca