METFORMIN HYDROCHLORIDE - metformin hydrochloride tablet, extended release

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

A-S Medication Solutions

INN (Међународно име):

METFORMIN HYDROCHLORIDE

Састав:

METFORMIN HYDROCHLORIDE 750 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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 hydrochloride extended-release tablets are contraindicated in patients with: - Severe renal impairment (eGFR below 30 mL/min/1.73 m2 ) (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.

Резиме производа:

Product: 50090-1981 NDC: 50090-1981-0 90 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 50090-1981-1 60 TABLET, EXTENDED RELEASE in a BOTTLE Product: 50090-2258 NDC: 50090-2258-0 60 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 50090-2258-2 90 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 50090-2258-3 180 TABLET, EXTENDED RELEASE in a BOTTLE

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
A-S MEDICATION SOLUTIONS
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METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP
DESCRIPTION
Metformin hydrochloride extended-release tablets 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 USP as the active ingredient.
Metformin hydrochloride extended-release tablets 500 mg contain the
inactive ingredients xanthan gum,
hypromellose, sodium carbonate, povidone, talc, colloidal silicon
dioxide and magnesium stearate.
Metformin hydrochloride extended-release tablets 750 mg contain the
inactive ingredients xanthan gum,
hypromellose, sodium carbonate, povidone, talc, colloidal silicon
dioxide, magnesium stearate and
ferric oxide (red).
Metformin hydrochloride extended-release tablets meet USP dissolution
test 10.
SYSTEM COMPONENTS AND PERFORMANCE-Metformin hydrochloride
extended-release tablets comprises
a hydrophilic polymer matrix system. Metformin hydrochloride is
combined with a drug release
controlling polymers to form a monophasic matrix system. 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