METFORMIN- metformin er 500 mg tablet METFORMIN- metformin er 750 mg tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Granules Pharmaceuticals Inc.

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Metformin hydrochloride 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 hydrochloride extended-release tablets, USP are contraindicated in patients with: 1. Severe Renal Impairment (eGFR below 30mL/min/1.73m2) (see WARNINGS and PRECAUTIONS ). 2.Known hypersensitivity to metformin hydrochloride, USP. 3.Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.

Ringkasan produk:

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Bottles of 30 NDC 70010-491-03 500 mg Bottles of 90 NDC 70010-491-09 500 mg Bottles of 100 NDC 70010-491-01 500 mg Bottles of 500 NDC 70010-491-05 500 mg Bottles of 1000 NDC 70010-491-10 750 mg Bottles of 30 NDC 70010-492-03 750 mg Bottles of 90 NDC 70010-492-09 750 mg Bottles of 100 NDC 70010-492-01 750 mg Bottles of 500 NDC 70010-492-05 750 mg Bottles of 1000 NDC 70010-492-10 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg tablets are white to off-white uncoated, modified capsule shaped tablets debossed with “G7” on one side and plain on the other side. Metformin Hydrochloride Extended-Release Tablets, USP 750 mg tablets are white to off-white uncoated, modified capsule shaped tablets debossed with “G8” on one side and plain on the other side. Storage Store at 20° to 25° C (68° to 77° F); excursions permitted within 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature.] Dispense in light-resistant containers. Dispense with Patient Information available at: https://granulespharma.com/product/metformin-er-tab-500-750/ Manufactured by: Granules India Limited Hyderabad-500 081, India Manufactured for: Granules Pharmaceuticals Inc. Chantilly, VA 20151. Revision date: May 2023

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

METFORMIN- METFORMIN ER 500 MG TABLET
GRANULES PHARMACEUTICALS INC.
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METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG AND 750 MG
DESCRIPTION
Metformin Hydrochloride Extended-Release Tablets, USP
Metformin hydrochloride extended-release tablets, USP are oral
antihyperglycemic drugs
used in the management of type 2 diabetes. Metformin hydrochloride,
USP (N,N-
dimethyl-monohydrochloride,Imidodicarbonimidic diamide) is not
chemically or
pharmacologically related to any other classes of oral
antihyperglycemic agents. The
structural formula is as shown:
Metformin hydrochloride, USP is a white or almost white, crystalline
powder with a
molecular formula of C4H11N5•HCl and a molecular weight of 165.62.
Metformin
hydrochloride is freely soluble in water, slightly soluble in alcohol,
practically insoluble in
acetone and in Methylene chloride. The pKa of metformin is 12.4. The
pH of a 1%
aqueous solution of metformin hydrochloride is 6.35.
Metformin hydrochloride extended-release tablets, USP contain 500 mg
or 750 mg of
metformin hydrochloride as the active ingredient.
Metformin hydrochloride extended-release tablets, USP 500 mg and 750
mg tablets
contain the inactive ingredients hypromellose, magnesium stearate, and
polyvinyl
pyrrolidone.
Dissolution Method: Test 10
System Components and Performance - Metformin hydrochloride
extended-release
tablets, USP comprises a dual hydrophilic polymer matrix system.
Metformin
hydrochloride, 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 biologically
inert components of