METFORMIN HYDROCHLORIDE tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

QPharma Inc

INN (Rahvusvaheline Nimetus):

METFORMIN HYDROCHLORIDE

Koostis:

METFORMIN HYDROCHLORIDE 500 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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:

Toote kokkuvõte:

Metformin hydrochloride tablets, USP are supplied as: Metformin Hydrochloride Tablets USP, 500 mg: White, biconvex, circular shaped film coated tablets with ‘A’ debossed on one side and ‘12’ debossed on the other side.              Bottles of 60                          NDC 42708-040-60 Metformin Hydrochloride Tablets USP, 1000 mg: 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.              Bottles of 30                          NDC 42708-039-30 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.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
QPHARMA INC
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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 (_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 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 AND BI