METFORMIN HCL tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Ascend Laboratories, LLC

Designació comuna internacional (DCI):

METFORMIN HYDROCHLORIDE

Composición:

METFORMIN HYDROCHLORIDE 500 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Metformin Hydrochloride 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 Hydrochloride Tablets USP are contraindicated in patients with: 1. 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 ). 2. Known hypersensitivity to metformin hydrochloride 3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. Metformin Hydrochloride Tablets 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.

Resumen del producto:

Metformin Hydrochloride Tablets, USP 500 mg - White to off-white, round, biconvex, film coated tablets debossed with G;10 on one side and plain on the other side. Bottles of 100                                NDC 67877-561-01 Bottles of 500                                NDC 67877-561-05 Bottles of 1000                              NDC 67877-561-10 850 mg -White to off-white, round, biconvex, film coated tablets debossed with G;11 on one side and plain on the other side. Bottles of 100                                 NDC 67877-562-01 Bottles of 500                                 NDC 67877-562-05 Bottles of 1000                               NDC 67877-562-10 1000 mg - White to off-white, oval, biconvex, scored, film coated tablets debossed with G and 12 on either side of the scoreline on one side and plain on the other side. Bottles of 100                                 NDC 67877-563-01 Bottles of 500                                 NDC 67877-563-05 Bottles of 1000                               NDC 67877-563-10 Storage Store at 20°–25° C (68°–77° F); excursions permitted to 15°–30° C (59°–86° F). [See USP Controlled Room Temperature.] Dispense in tight, light-resistant containers with child-resistant closure. Manufactured by: Granules India Limited, Hyderabad-500081, INDIA MADE IN INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Toll Free No.: 1-877-272-7901 Nov 2016

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

METFORMIN HCL - METFORMIN HCL TABLET
ASCEND LABORATORIES, LLC
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METFORMIN HYDROCHLORIDE TABLETS USP
DESCRIPTION
Metformin Hydrochloride 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:
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 USP contain 500 mg, 850 mg, or 1000 mg
of metformin
hydrochloride. Each tablet contains the inactive ingredients povidone
(K-30), povidone (K-90),
pregelatinized starch,and magnesium stearate. In addition, the coating
for the tablets contains artificial
blackberry flavor, hypromellose and polyethylene glycol.
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 Bioavailability