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:

Glenmark Pharmaceuticals Inc., USA

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:

Product summary:

Metformin Hydrochloride Tablets USP 500 mg Bottles of 90 NDC 68462-159-90 500 mg Bottles of 100 NDC 68462-159-01 500 mg Bottles of 180 NDC 68462-159-18 500 mg Bottles of 500 NDC 68462-159-05 500 mg Bottles of 1000 NDC 68462-159-10 850 mg Bottles of 90 NDC 68462-160-90 850 mg Bottles of 100 NDC 68462-160-01 850 mg Bottles of 180 NDC 68462-160-18 850 mg Bottles of 500 NDC 68462-160-05 850 mg Bottles of 1000 NDC 68462-160-10 1000 mg Bottles of 90 NDC 68462-161-90 1000 mg Bottles of 100 NDC 68462-161-01 1000 mg Bottles of 180 NDC 68462-161-18 1000 mg Bottles of 500 NDC 68462-161-05 1000 mg Bottles of 1000 NDC 68462-161-10 Metformin hydrochloride tablets USP 500 mg are white, round shaped, biconvex, film coated tablets debossed with “G 45” on one side & “500” on the other side. Metformin hydrochloride tablets USP 850 mg are white, round shaped, biconvex, film coated tablets debossed with “G 45” on one side & “850” on the other side. Metformin hydrochloride tablets USP 1000 mg are white, capsule shaped, biconvex, film coated tablets with breakline on both sides & debossed with “G/45” on one side and “1000” on the other side.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET
GLENMARK PHARMACEUTICALS INC., USA
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METFORMIN HYDROCHLORIDE TABLETS USP
RX ONLY
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:
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 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, for oral administration, contain
500 mg, 850 mg, or 1000 mg of
metformin hydrochloride, USP. Each tablet contains the inactive
ingredients microcrystalline cellulose,
magnesium stearate and povidone. In addition, the coating for the 500
mg, 850 mg and 1000 mg tablets
contains Opadry YS-1R-7006 Clear. The components of Opadry YS-1R-7006
Clear are hydroxypropyl
methylcellulose, polyethylene glycol 400 and polyethylene glycol 6000.
USP Dissolution test 1 is used.
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