METFORMIN HYDROCHLORIDE tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Legacy Pharmaceutical Packaging, LLC

INN (Nama Internasional):

METFORMIN HYDROCHLORIDE

Komposisi:

METFORMIN HYDROCHLORIDE 1000 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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: 1. Severe renal impairment (eGFR below 30 mL/min/1.73 m ) (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.

Ringkasan produk:

Metformin hydrochloride tablets, USP are supplied as: 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 60                     NDC68645-300-59 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.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
LEGACY PHARMACEUTICAL PACKAGING, LLC
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METFORMIN HYDROCHLORIDE TABLETS, USP
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