METFORMIN HYDROCHLORIDE tablet, extended release

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

MedVantx, Inc.

INN (Международно Name):

METFORMIN HYDROCHLORIDE

Композиция:

METFORMIN HYDROCHLORIDE 500 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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: - 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 alte

Каталог на резюме:

Metformin hydrochloride extended-release tablets USP 500 mg, are available as white to off-white oval caplets, debossed with “93” on one side and “7267” on the other side. They are available in bottles of 100 and 1000. Metformin hydrochloride extended-release tablets USP 750 mg, are available as brick red (mottled), oval caplets, debossed with “93” on one side and “7212” on the other side. They are available in bottles of 100. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. AO 4/2010

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
MEDVANTX, INC.
----------
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, 500 MG AND 750
MG
7267
7212
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:
C H N •HCl M.W. 165.63
Metformin hydrochloride is a white to off-white crystalline compound.
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. In addition, each tablet
contains the following inactive
ingredients: ethylcellulose, hypromellose, magnesium stearate and
microcrystalline cellulose. The 750
mg tablet also contains ferric oxide red and ferric oxide yellow.
Metformin hydrochloride extended-release tablets USP meet USP
_Dissolution Test 2_.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Metformin is an antihyperglycemic agent which improves glucose
tolerance in patients with type 2
diabetes, lowering both basal and postprandial plasma glucose. Its
pharmacologic mechanisms of action
are different from other classes of oral antihyperglycemic agents.
Metformin decreases hepatic
glucose production, decreases intestinal absorption of glucose, and
improves insulin sensitivity by
increasing peripheral glucose uptake and utilization. Unlike
sulfonylureas, metformin does not produce
hypoglycemia in either patients with type 2 diabetes or normal
subjects (except in special
circumstances, see PRECAUTIONS) and does not cause hyperinsulinemia.
With metformin therapy,
insulin secretion remains u