METFORMIN HYDROCHLORIDE tablet, film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Blenheim Pharmacal, Inc.

INN (Medzinárodný Name):

METFORMIN HYDROCHLORIDE

Zloženie:

METFORMIN HYDROCHLORIDE 850 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Metformin hydrochloride 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 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 alteration of renal function. (See also PREC

Prehľad produktov:

Metformin hydrochloride tablets, USP Metformin hydrochloride tablets, 500 mg are white to off white, round shaped, biconvex, film coated tablets debossed with ‘I45’ on one side and plain on the other side. Metformin hydrochloride tablets, 850 mg are white to off white, capsule shaped, biconvex, film coated tablets debossed with ‘I46’ on one side and plain on other side. Metformin hydrochloride tablets, 1000 mg are white to off white, oval shaped, biconvex, film coated tablets debossed with ‘I’ and ‘47’ separated by a breakline on one side and the breakline on the other side.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE TABLET, FILM COATED
BLENHEIM PHARMACAL, INC.
----------
RX ONLY
METFORMIN HYDROCHLORIDE TABLETS
(METFORMIN HYDROCHLORIDE TABLETS, USP)
DESCRIPTION
Metformin hydrochloride 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
pKa of metformin is 12.4. The pH of
a 1% aqueous solution of metformin hydrochloride is 6.68.
Metformin hydrochloride tablets contain 500 mg, 850 mg, or 1000 mg of
metformin hydrochloride.
Each tablet contains the inactive ingredients Sodium Starch Glycolate,
Povidone, Corn Starch, Colloidal
Silicon Dioxide and Magnesium Stearate. In addition, the coating for
the 500 mg, 850 mg and 1000 mg
tablets contains Opadry White which contains : Hypromellose, Talc,
Polyethylene glycol and Titanium
dioxide.
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 unchang