METFORMIN HYDROCHLORIDE tablet, extended release

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Aidarex Pharmaceuticals LLC

INN (Internationale Bezeichnung):

METFORMIN HYDROCHLORIDE

Zusammensetzung:

METFORMIN HYDROCHLORIDE 500 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Metformin HCl extended-release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. Metformin HCl extended-release tablets, USP are contraindicated in patients with: - 1. 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 ). 1. 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 ). - 2. Known hypersensitivity to metformin HCl, USP. 2. Known hypersensitivity to metformin HCl, USP. - 3. Acute or chronic metabo

Produktbesonderheiten:

Metformin HCl Extended-Release Tablets, USP 500 mg are white, capsule shaped, biconvex tablets debossed "IP 178" on one side and plain on the other side. They are available as follows: Bottles of 30:               NDC 33261-372-30 Bottles of 60:               NDC 33261-372-60 Bottles of 120:             NDC 33261-372-02 Storage Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers as defined in the USP.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
AIDAREX PHARMACEUTICALS LLC
----------
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP
DESCRIPTION
Metformin hydrochloride (HCl) extended-release tablets, USP are oral
antihyperglycemic drugs used in
the management of type 2 diabetes. Metformin HCl, USP
(_N_,_N_-dimethylimidodicarbonimidic diamide
hydrochloride) is not chemically or pharmacologically related to any
other classes of oral
antihyperglycemic agents. The structural formula is as shown:
Metformin HCl, USP is a white to off-white crystalline compound with a
molecular formula of
C H N • HCl and a molecular weight of 165.63. Metformin HCl, USP is
freely soluble in water and
is practically insoluble in acetone, ether, and chloroform. The pK of
metformin is 12.4. The pH of a
1% aqueous solution of metformin HCl, USP is 6.68.
Metformin HCl extended-release tablets, USP contain 500 mg or 750 mg
of metformin HCl, USP as the
active ingredient.
Metformin HCl extended-release tablets, USP 500 mg contain the
inactive ingredients; colloidal silicon
dioxide, hypromellose, magnesium stearate and microcrystalline
cellulose.
Metformin HCl extended-release tablets, USP 750 mg contain the
inactive ingredients; colloidal silicon
dioxide, hypromellose and magnesium stearate.
Dissolution Method: Test 10
SYSTEM COMPONENTS AND PERFORMANCE - Metformin HCl extended-release
tablets, USP comprises a
dual hydrophilic polymer matrix system. Metformin HCl, USP is combined
with a drug release
controlling polymer to form an "inner" phase, which is then
incorporated as discrete particles into an
"external" phase of a second polymer. After administration, fluid from
the gastrointestinal (GI) tract
enters the tablet, causing the polymers to hydrate and swell. Drug is
released slowly from the dosage
form by a process of diffusion through the gel matrix that is
essentially independent of pH. The
hydrated polymer system is not rigid and is expected to be broken up
by normal peristalsis in the GI
tract. The bio