METFORMIN HYDROCHLORIDE- metformin hydrochloride tablet, extended release

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Nostrum Laboratories Inc.

INN:

metformin hydrochloride

composition:

metformin hydrochloride 500 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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

leaflet_short:

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg are white, uncoated, oblong tablets, debossed with "NM5" Metformin Hydrochloride Extended-Release Tablets, USP 750 mg are white, uncoated, oblong tablets, debossed with"NM7" Store at 20°–25° C (68°–77° F); excursions permitted to 15°–30° C (59°–86° F). [See USP Controlled Room Temperature.] “Dispense in tight light-resistant containers” in accordance with the USP requirements for this drug product.

authorization_status:

Abbreviated New Drug Application

SPC

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
NOSTRUM LABORATORIES INC.
----------
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP
DESCRIPTION
Metformin hydrochloride extended-release tablets, USP are oral
antihyperglycemic drugs used in the
management of type 2 diabetes. Metformin hydrochloride (
_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 hydrochloride 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 hydrochloride 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 hydrochloride is 6.68.
Metformin hydrochloride extended-release tablets, USP contain 500 mg
or 750 mg of metformin
hydrochloride as the active ingredient. Each tablet contains the
inactive ingredients hypromellose,
silicified microcrystalline cellulose, xanthan gum, maltodextrin,
colloidal silicon dioxide and stearic
acid.
Dissolution Method: USP dissolution test is pending.
SYSTEM COMPONENTS AND PERFORMANCE - Metformin hydrochloride
extended-release tablets, USP
comprises a drug releasing 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 the tablet may
occasionally remain intact during GI transit
and will be eliminated in the feces as a soft, hydrated mass.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Metformin is an antihyperglycemic agent which improves glucose
tolerance in patients with type 2
diabetes, lo