METFORMIN HYDROCHLORIDE tablet, extended release

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

NuCare Pharmaceuticals,Inc.

INN (Algemene Internationale Benaming):

METFORMIN HYDROCHLORIDE

Samenstelling:

METFORMIN HYDROCHLORIDE 500 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Metformin hydrochloride extended-release 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 extended-release tablets are contraindicated in patients with: - Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) (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.

Product samenvatting:

Metformin hydrochloride extended-release tablets USP, 500 mg are oval white tablets, with OE debossed on one side and 584 debossed on the other side. They are available as follows: NDC 68071-4270-3 BOTTLES OF 30 NDC 68071-4270-6 BOTTLES OF 60 NDC 68071-4270-9 BOTTLES OF 90 NDC 68071-4270-2 BOTTLES OF 120 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 well-closed, light-resistant containers.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
NUCARE PHARMACEUTICALS,INC.
----------
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP
RX ONLY
DESCRIPTION
Metformin hydrochloride extended-release tablets, USP is an oral
antihyperglycemic drug
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 extended-release tablets, USP contain 500 mg
or 750 mg of
metformin hydrochloride as the active ingredient. In addition, each
tablet contains the
following inactive ingredients: copovidone, carboxymethylcellulose
sodium,
hypromellose, microcrystalline cellulose and magnesium stearate.
The USP dissolution test is pending.
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
4
11
5
a
circumstances, see PRECAUTIONS) and does not cause hyperinsulinemia.
With
metformin therapy, insulin secretion remains unchanged while fasting
insulin levels and
day