METFORMIN HYDROCHLORIDE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Blenheim Pharmacal, Inc.

INN (Nome Internazionale):

METFORMIN HYDROCHLORIDE

Composizione:

METFORMIN HYDROCHLORIDE 500 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Metformin Hydrochloride Tablets USP, 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 USP is contraindicated in patients with: 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. (See also PRECAUTIONS ).

Dettagli prodotto:

Metformin Hydrochloride Tablets, USP 500 mg - White to off-white, round, biconvex, film coated tablets debossing “H/102” on one side and plain on the other side. Bottles of 30            NDC 10544-133-30 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: Heritage Pharmaceuticals Inc. Edison, NJ 08837 1.866.901.DRUG (3784) Manufactured by: Granules India Limited Ranga Reddy Dist., India 500-043 AP Marketed/ Packaged by: Blenheim Pharmacal, Inc. North Blenheim, NY 12131, (USA) Iss. 04/09

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET
BLENHEIM PHARMACAL, INC.
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METFORMIN HYDROCHLORIDE TABLETS USP
RX ONLY
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 pK
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
_A