METFORMIN HYDROCHLORIDE - 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:

Citron Pharma LLC

INN (Internationale Bezeichnung):

METFORMIN HYDROCHLORIDE

Zusammensetzung:

METFORMIN HYDROCHLORIDE 500 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Metformin hydrochloride extended-release tablets, USP are 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

Produktbesonderheiten:

Metformin Hydrochloride Extended-Release Tablets USP, 500 mg are white to off-white, capsule shaped, beveled edge, biconvex uncoated tablets debossed with ‘C’ on one side and ‘29’ on the other side.          Bottles of 100               NDC 57237-210-01          Bottles of 500               NDC 57237-210-05 Metformin Hydrochloride Extended-Release Tablets USP, 750 mg are white to off-white, capsule shaped, beveled edge, biconvex uncoated tablets debossed with ‘A’ on one side and ‘19’ on the other side.          Bottles of 100               NDC 57237-211-01          Bottles of 500               NDC 57237-211-05 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 light-resistant containers. Distributed by: Citron Pharma LLC Suite -1101 2 Tower Center Blvd East Brunswick NJ 08816 Code No.: TS/DRUGS/19/1993 Made in India Issued: 04/2016

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
CITRON PHARMA LLC
----------
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP
RX ONLY
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, crystalline powder 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.
Metformin hydrochloride extended-release tablets, USP 500 mg and 750
mg contain the following
inactive ingredients: carbomer, isopropyl alcohol, hydroxy propyl
cellulose, hypromellose, magnesium
stearate, and microcrystalline cellulose.
Meets USP dissolution test 10.
SYSTEM COMPONENTS AND PERFORMANCE - Metformin hydrochloride
extended-release tablets
comprises a hydrophilic polymer matrix system. Metformin hydrochloride
is combined with drug
release – controlling polymers. After administration, fluid from the
gastro intestinal (GI) tract enters the
tablet, causing the polymers to hydrate and swell. Due to hydration
and swelling of the polymer, the
size of the tablet in the stomach increases. As a result, the dosage
may remain in the gastrointestinal
tract for a prolonged period with slow release of the drug. Drug is
released from the dosage form by a
process of diffusion through the gel matrix that is essentially
independent of pH. The hydrated polymer
can be expected to be broken up by normal peristalsis in the GI tract.
The b