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:

REMEDYREPACK INC.

INN (International Name):

METFORMIN HYDROCHLORIDE

Composition:

METFORMIN HYDROCHLORIDE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metformin hydrochloride tablets, USP 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. Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) (see  WARNINGS  and PRECAUTIONS ). 2. Known hypersensitivity to metformin hydrochloride tablets, USP. 3. 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 500 mg Bottles of 90 NDC57664-397-59 500 mg Bottles of 100 NDC57664-397-51 500 mg Bottles of 500 NDC57664-397-53 500 mg Bottles of 1000 NDC57664-397-58 850 mg Bottles of 90 NDC57664-435-59 850 mg Bottles of 100 NDC57664-435-51 850 mg Bottles of 500 NDC57664-435-53 850 mg Bottles of 1000 NDC57664-435-58 1000 mg Bottles of 90 NDC57664-474-59 1000 mg Bottles of 100 NDC57664-474-51 1000 mg Bottles of 500 NDC57664-474-53 1000 mg Bottles of 1000 NDC57664-474-58 Metformin hydrochloride 500 mg tablets, USP are round, white to off-white, film coated tablets debossed with “397” on one side and plain on the other side. Metformin hydrochloride 850 mg tablets, USP are round, white to off-white, film coated tablets debossed with “435” on one side and plain on the other side. Metformin hydrochloride 1000 mg tablets, USP are white to off-white colored, oval shaped, film coated tablets debossed with “C” & “474” on one side and scored on both sides. Storage Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in tight, light resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET
REMEDYREPACK INC.
----------
METFORMIN HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Metformin hydrochloride, 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, USP 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, USP
is freely soluble
in water and 4 11 5 is practically insoluble in acetone, ether and
chloroform. The pKa of metformin is
12.4. The pH of a 1% a aqueous solution of metformin hydrochloride,
USP is 6.68.
Metformin hydrochloride tablets USP contain 500 mg, 850 mg and 1000 mg
of metformin
hydrochloride, USP. Each tablet contains the inactive ingredients
povidone, polyethylene glycol and
magnesium stearate. In addition the coating for 500 mg, 850 mg and
1000 mg contains: lactose
monohydrate, hypromellose, titanium dioxide and triacetin.
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 hydrochloride 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.
PHAR