METFORMIN HYDROCHLORIDE tablet, film coated METFORMIN HYDROCHORIDE- metformin tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

NCS HealthCare of KY, LLC dba Vangard Labs

INN (International Name):

METFORMIN HYDROCHLORIDE

구성:

METFORMIN HYDROCHLORIDE 500 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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: - Severe renal impairment (eGFR below 30 mL/min/1.73 m2 ) (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.

제품 요약:

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.         Blistercards of 30                     NDC 0615-8015-39         Blistercards of 28                     NDC 0615-8015-28         Blistercards of 15                     NDC 0615-8015-05         Unit dose boxes of 30              NDC 0615-8015-30 Metformin Hydrochloride Tablets, USP 850 mg : White, biconvex, circular shaped film coated tablets with ‘A’ debossed on one side and ‘13’ debossed on the other side.         Blistercards of 30                     NDC 0615-8105-39          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.        Blistercards of 30                     NDC 0615-7982-39        Blistercards of 15                     NDC 0615-7982-05        Unit dose boxes of 30              NDC 0615-7982-30        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.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
METFORMIN HYDROCHORIDE- METFORMIN TABLET, FILM COATED
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
---------- METFORMIN HYDROCHLORIDE TABLETS, USP
500 MG, 850 MG & 1000 MG
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
4
11
5
a
circumstances, see PRECAUTIONS) and does not cause hyperinsulinemia.
With
metformin therapy, insulin secretion remains unchanged whi