METFORMIN HYDROCHLORIDE tablet, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Physicians Total Care, Inc.

INN (International Name):

METFORMIN HYDROCHLORIDE

Sammensetning:

METFORMIN HYDROCHLORIDE 500 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

Metformin Hydrochloride Extended - Release Tablets, USP 500 mg Bottles of 60 Bottles of 30 Bottles of 100 Bottles of 180 Bottles of 120 Bottles of 90 NDC 54858-5217-0 NDC 54858-5217-1 NDC 54858-5217-2 NDC 54858-5217-3 NDC 54858-5217-4 NDC 54858-5217-5 750mg Bottles of 30  Bottles of 10 Bottles of 90 Bottles of 180 NDC 54858-5505-0 NDC 54858-5505-1 NDC 54858-5505-2 NDC 54858-5505-3 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. Metformin hydrochloride extended release tablets, USP 750 mg are red colored, biconvex, capsule shaped, uncoated tablets debossed with "143" on one side and plain on the other side. 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.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
PHYSICIANS TOTAL CARE, 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 poly