METFORMIN HYDROCHLORIDE tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Metcure Pharmaceuticals, Inc.

INN (International Name):

METFORMIN HYDROCHLORIDE

Sammensætning:

METFORMIN HYDROCHLORIDE 1000 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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. A Metformin hydrochloride tablets are contraindicated in patients with: - Severe renal impairment (eGFR below 30 mL/min/1.73 m2) (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.

Produkt oversigt:

Metformin Hydrochloride Tablets, USP 500 mg - White to off-white, round, biconvex, film coated tablets debossed with G over 10 on one side and plain on the other side. Bottles of 500 NDC 71709-110-06 850 mg - White to off-white, round, biconvex, film coated tablets debossed with G over 11 on one side and plain on the other side. Bottles of 500 NDC 71709-111-06 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 500 NDC 71709-112-06 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. Distributed By: Metcure Pharmaceuticals, Inc 18 Campus Blvd., Suite 100 Newtown Square, PA 19073 Manufactured by: Granules India Limited Hyderabad-500081, INDIA MADE IN INDIA Jul 2017 M.L.No.: 37/RR/AP/2003/F/R

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
METCURE PHARMACEUTICALS, INC.
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METFORMIN HYDROCHLORIDE
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, USP 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 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
_A