METFORMIN HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals, 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: - Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥ 1.5 mg/dL [males], ≥ 1.4 mg/dL [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (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.    Metformin 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 alte

Product summary:

Metformin hydrochloride tablets, USP are supplied as: 500 mg Tablets: White, biconvex, circular shaped film coated tablets with A debossed on one side and 12 debossed on the other side. Bottles of 100 NDC 68071-3212-1 Storage 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 light-resistant containers.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
NUCARE PHARMARMACEUTICALS, INC.
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METFORMIN HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Metformin hydrochloride tablets 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, for oral administration, contains 500
mg, 850 mg, or 1000 mg of
metformin hydrochloride. Each tablet contains the inactive ingredients
povidone and magnesium
stearate. In addition, the coating for the 500 mg, 850 mg, and 1000 mg
contains 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
ABSORPTION AND BIOA