METFORMIN HYDROCHLORIDE- 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:

Teva Pharmaceuticals USA, 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 500 mg, are available as white to off-white film-coated oval-shaped tablets, debossed with “93” on one side and “48” on the other side. They are available in bottles of 100 (NDC 0093-1048-01) and 1000 (NDC 0093-1048-10). Metformin Hydrochloride Tablets USP 850 mg, are available as white to off-white film-coated oval-shaped tablets, debossed with “93” on one side and “49” on the other side. They are available in bottles of 100 (NDC 0093-1049-01) and 1000 (NDC 0093-1049-10). Metformin Hydrochloride Tablets USP 1000 mg, are available as white to off-white film-coated oval-shaped tablets, scored on two sides, debossed with “9” on the left side of the score and “3” on the right side of the score on one side and “72” on the left side of the score and “14” on the right side of the score on the other side. They are available in bottles of 100 (NDC 0093-7214-01) and 1000 (NDC 0093-7214-10). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Czech Republic By: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic Manufactured For: North Wales, PA 19454 Rev. AO 4/2017

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
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METFORMIN HYDROCHLORIDE TABLETS USP
DESCRIPTION
Metformin Hydrochloride Tablets USP are oral antihyperglycemic drugs
used in the management of
type 2 diabetes. Metformin hydrochloride, USP
(_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:
C H N •HCl M.W. 165.63
Metformin hydrochloride, USP is a white to off-white crystalline
compound. Metformin hydrochloride,
USP 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, USP is 6.68.
Metformin Hydrochloride Tablets USP contain 500 mg, 850 mg, or 1000 mg
of metformin
hydrochloride, USP. In addition, each tablet contains the following
inactive ingredients: colloidal
silicon dioxide, hypromellose, magnesium stearate, polyethylene
glycol, povidone and titanium dioxide.
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 BIOAVAILABILITY
The absolute bioavailability of a metformin hyd