METFORMIN HYDROCHLORIDE tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Lake Erie Medical DBA Quality Care Products LLC

INN (nemzetközi neve):

METFORMIN HYDROCHLORIDE

Összetétel:

METFORMIN HYDROCHLORIDE 850 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 alteration of renal function. (See also PRECAUTIONS .)

Termék összefoglaló:

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. 850 mg Tablets: White, biconvex, circular shaped film coated tablets with ‘A’ debossed on one side and ‘13’ debossed on the other side. NDC: 35356-922-30  Bottles of 30 NDC: 35356-922-60  Bottles of 60 NDC: 35356-922-90  Bottles of 90 1000 mg Tablets: ​White, biconvex, oval shaped film coated tablets with a score line in between ‘1’ and ‘4’ on one side and ‘A’ debossed on the other side. NDC: 35356-886-30  Bottles of 30 NDC: 35356-886-60  Bottles of 60 NDC: 35356-886-90  Bottles of 90 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.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
METFORMIN HYDROCHLORIDE TABLETS, USP
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 a