METFORMIN HYDROCHLORIDE- metformin hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

metformin hydrochloride (UNII: 786Z46389E) (metformin - UNII:9100L32L2N)

Available from:

Breckenridge Pharmaceutical, Inc.

INN (International Name):

metformin hydrochloride

Composition:

metformin hydrochloride 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: - 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.

Product summary:

Metformin Hydrochloride Tablets, USP Metformin Hydrochloride Tablets, USP, 500 mg are white to off-white, oval, biconvex, film coated tablets with "∧" debossed on one side and "101" debossed on the opposite side. Metformin Hydrochloride Tablets, USP, 850 mg are white to off-white, oval, biconvex, film coated tablets with "∧" debossed on one side and "102" debossed on the opposite side. Metformin Hydrochloride Tablets, USP, 1000 mg are white to off-white, oval, biconvex, film coated tablets with "∧ 103" debossed on one side and a bisect line on both sides. 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 as defined in the USP with a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET
BRECKENRIDGE PHARMACEUTICAL, INC.
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METFORMIN HYDROCHLORIDE [MET FOR' MIN HYE" DROE KLOR' IDE] 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 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
crospovidone, povidone, and stearic acid. In
addition, the coating for the 500 mg, 850 mg and 1000 mg tablets
contains hypromellose, maltodextrin
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.
PHARMACOKI