METFORMIN HYDROCHLORIDE tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

PuraCap Laboratories LLC dba Blu Pharmaceuticals

INN (International namn):

METFORMIN HYDROCHLORIDE

Sammansättning:

METFORMIN HYDROCHLORIDE 500 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Metformin hydrochloride tablets USP 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 USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride tablets are contraindicated in patients with: 1. 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). 2. Known hypersensitivity to metformin hydrochloride. 3. 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 underg

Produktsammanfattning:

Metformin Hydrochloride Tablets USP, for oral administration, are available as: 500 mg: white to off-white, round, biconvex, beveled edge, film-coated tablets, debossed “ E ” over “213” on one side and plain on the other side and supplied as: NDC 24658-790-01 Bottles of 100 NDC 24658-790-10 Bottles of 1000 850 mg: white to off-white, round, biconvex, beveled edge, film-coated tablets, debossed “ E ” over “215” on one side and plain on the other side and supplied as: NDC 24658-791-05 Bottles of 500 1000 mg: white to off-white, oval, biconvex, film-coated tablets, debossed “ E 221” on one side and bisected on both sides and supplied as: NDC 24658-792-05 Bottles of 500 Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant containers as defined in the USP with a child-resistant closure, as required.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
----------
METFORMIN TABLETS, USP
RX ONLY
DESCRIPTION
Metformin hydrochloride is an 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 is a white to off-white crystalline compound
with a molecular formula of
C4H11N5•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 pKa
of metformin is 12.4. The pH of
a 1% aqueous solution of metformin hydrochloride is 6.68.
Each metformin hydrochloride tablet USP, intended for oral
administration, contains 500 mg or 850 mg
or 1000 mg metformin hydrochloride. In addition, each metformin
hydrochloride tablet USP contains
the following inactive ingredients: colloidal silicon dioxide,
hypromellose, magnesium stearate,
polyethylene glycol and povidone.
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
_ABS