METFORMIN HYDROCHLORIDE tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

State of Florida DOH Central Pharmacy

SNN (starptautisko nepatentēto nosaukumu):

METFORMIN HYDROCHLORIDE

Kompozīcija:

METFORMIN HYDROCHLORIDE 850 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients 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 hydrochloride tablets 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 alteration of renal function. (See also PRECAUTIONS. )

Produktu pārskats:

Metformin hydrochloride tablets USP 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 one side & debossed with “G/45” on one side and “1000” on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows:

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
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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 is 6.68.
Metformin hydrochloride tablets USP, for oral administration, contains
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 hyp