METFORMIN HYDROCHLORIDE tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Cambridge Therapeutics Technologies, LLC

INN (שם בינלאומי):

METFORMIN HYDROCHLORIDE

הרכב:

METFORMIN HYDROCHLORIDE 850 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Metformin hydrochloride tablets USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Metformin hydrochloride is 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 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 .

leaflet_short:

Metformin hydrochloride tablets USP: Metformin hydrochloride tablets 850 mg are white to off-white, round shape, biconvex coated tablets debossed with "228" on one side and plain on the other side. NDC 70882-125-30, Package of 30 tablets (3 x 10 unit-of-dose blister) Store at 20°–25° C (68°–77° F); excursions permitted to 15°–30° C (59°–86° F). [See USP Controlled Room Temperature.]  Dispense in light-resistant containers. Manufactured by: Alkem Laboratories Limited ALKEM HOUSE, Lower Parel, Mumbai – 400 013, INDIA Distributed by Cambridge Therapeutic Technologies, LLC Teaneck, NJ 07666 Packaged by Legacy Pharmaceutical Packaging, LLC Earth City, MO 63045 Revised: May 2017 20657

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
CAMBRIDGE THERAPEUTICS TECHNOLOGIES, LLC
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METFORMIN HYDROCHLORIDE TABLETS USP
DESCRIPTION
Metformin hydrochloride tablets USP are 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 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 contain 850 mg of metformin
hydrochloride USP. Each tablet
contains the inactive ingredients corn starch, povidone and magnesium
stearate. In addition, the coating
for each tablet contains hypromellose, talc, titanium dioxide,
polyethylene glycol, and propylene
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 B