METFORMIN HYDROCHLORIDE- metformin hydrochloride tablet, extended release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

NuCare Pharmaceuticals, Inc.

INN (mednarodno ime):

METFORMIN HYDROCHLORIDE

Sestava:

METFORMIN HYDROCHLORIDE 500 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 acu

Povzetek izdelek:

Metformin hydrochloride extended release tablets, USP 500 mg are white to off-white, capsule shaped, uncoated tablets debossed with "142" on one side and plain on the other side. tables of 30 NDC 68071-1927-3 tables of 60 NDC 68071-1927-6 tables of 90 NDC 68071-1927-9 tables of 180 NDC 68071-1927-8 tables of 120 NDC 68071-1927-2 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.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
NUCARE PHARMACEUTICALS, INC.
----------
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
C4H11N5•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 po