METFORMIN HYDROCHLORIDE TABLETS, USP

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

GRAXCELL PHARMACEUTICAL, LLC.

INN (International Name):

METFORMIN HYDROCHLORIDE

Sammensetning:

METFORMIN HYDROCHLORIDE 1000 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Metformin hydrochloride tablets 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 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.

Produkt oppsummering:

Metformin Hydrochloride Tablets, USP 500 mg - White to off-white, round, biconvex, film coated tablets debossing "G-10" on one side and plain on the other side. Bottles of 60 NDC 70795-1160-6 Bottles of 100 NDC 70795-1160-1 Bottles of 500 NDC 70795-1160-5 Bottles of 1000 NDC 70795-1160-0 850 mg - White to off-white, round, biconvex, film coated tablets debossing "G-11" on one side and plain on the other side. Bottles of 60 NDC 70795-1180-6 Bottles of 100 NDC 70795-1180-1 Bottles of 500 NDC 70795-1180-5 Bottles of 1000 NDC 70795-1180-0 1000 mg - White to off-white, oval, biconvex, scored, film coated tablets debossing "G-12" on either side of score line and plain on the other side. Bottles of 60 NDC 70795-1170-6 Bottles of 100 NDC 70795-1170-1 Bottles of 500 NDC 70795-1170-5 Bottles of 1000 NDC 70795-1170-0 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 for: Graxcell pharmaceutical, llc. 130 knickerbocker ave, bohemia, NY 11716. 1.888-266-8818. Made in India.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
GRAXCELL PHARMACEUTICAL, LLC.
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METFORMIN HYDROCHLORIDE TABLETS, USP
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
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
pKa of Metformin is 12.4. The pH of
a 1% aqueous solution of Metformin hydrochloride is 6.68.
Metformin hydrochloride tablets , USP contains 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, macrogol and titanium dioxide.
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