METFORMIN HYDROCHLORIDE- metformin tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Amneal Pharmaceuticals

INN (International Nazwa):

METFORMIN HYDROCHLORIDE

Skład:

METFORMIN HYDROCHLORIDE 500 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Metformin HCl Tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Metformin HCl, USP is 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 HCl, USP. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. Metformin HCl, USP 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 PRECAUTIONS .)

Podsumowanie produktu:

Metformin HCl Tablets, USP 500 mg are white to off-white, round, biconvex, film-coated tablets debossed “IP175” on obverse and “500” on the reverse. They are available as follows: Bottles of 100:             NDC 65162-175-10 Bottles of 500:             NDC 65162-175-50 Bottles of 1000:           NDC 65162-175-11 Metformin HCl Tablets, USP 850 mg are white to off-white, round, biconvex, film-coated tablets debossed “IP176” on obverse and “850” on the reverse. They are available as follows: Bottles of 100:             NDC 65162-174-10 Bottles of 500:             NDC 65162-174-50 Bottles of 1000:           NDC 65162-174-11 Metformin HCl Tablets, USP 1000 mg are white to off-white, oval, biconvex, bisected, film-coated tablets debossed “IP177” on obverse and “1000” on the reverse. They are available as follows: Bottles of 100:             NDC 65162-177-10 Bottles of 500:             NDC 65162-177-50 Bottles of 1000:           NDC 65162-177-11 Storage 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 autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

METFORMIN HYDROCHLORIDE - METFORMIN TABLET
AMNEAL PHARMACEUTICALS
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METFORMIN HYDROCHLORIDE TABLETS, USP
DESCRIPTION
Metformin Hydrochloride (HCl) Tablets, USP is an oral
antihyperglycemic drug used in the
management of type 2 diabetes. Metformin HCl, USP
(_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 HCl, USP is a white to off-white crystalline compound with a
molecular formula of
C H N • HCl and a molecular weight of 165.62. Metformin HCl, USP 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 HCl, USP is 6.68.
Metformin HCl Tablets, USP, contains 500 mg, 850 mg, or 1000 mg of
metformin HCl, USP. Each
tablet contains the inactive ingredients povidone, microcrystalline
cellulose, croscarmellose sodium
and magnesium stearate. In addition, the coating for the 500 mg, 850
mg and 1000 mg tablets contain
polyethylene glycol, polyvinyl alcohol, titanium dioxide and talc.
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 unchanged while fasting insulin levels and
day-long plasma insulin response
may actually decrease.
PHARMACOKINETICS
ABSORPTION AND BIOAV