metformin hydrochloride- Metformin Hydrochloride tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

metformin hydrochloride (UNII: 786Z46389E) (metformin - UNII:9100L32L2N)

제공처:

Provident Pharmaceutical, Inc

INN (국제 이름):

Metformin Hydrochloride

약제 형태:

TABLET, FILM COATED

구성:

500 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Metformin hydrochloride tablets, as monotherapy, are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Metformin hydrochloride is indicated in patients 10 years of age and older. Metformin hydrochloride may be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults (17 years of age and older). Metformin hydrochloride is 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 hydrochloride should be temporarily discontinued in

제품 요약:

Metformin Hydrochloride Tablets 500 mg Bottles of 100           NDC 20091-531-01 500 mg Bottles of 500           NDC 20091-531-05 500 mg Bottles of 1000         NDC 20091-531-10 850 mg Bottles of 100           NDC 20091-533-01 850 mg Bottles of 500           NDC 20091-533-05 850 mg Bottles of 1000         NDC 20091-533-10 1000 mg Bottles of 100         NDC 20091-535-01 1000 mg Bottles of 500         NDC 20091-535-05 1000 mg Bottles of 1000       NDC 20091-535-10 Metformin Hydrochloride 500 mg tablets are white colored, round shape, film coated tablets debossed with "P531" on one side and "500" on the other side. Metformin Hydrochloride 850 mg tablets are white colored, round shape, film coated tablets debossed with "P533" on one side and "850" on the other side. Metformin Hydrochloride 1000 mg tablets are white colored, oval shape, film coated tablets debossed with "P" bisect "535" on one side and "10" bisect "00" on the other side. Store at 20° - 25° C (68° - 77° F); excursion permitted to 15° - 30° C (59° - 86° F). Dispense in tight, light-resistant container with child-resistant closure as defined in the USP.

제품 특성 요약

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
PROVIDENT PHARMACEUTICAL, INC
----------
METFORMIN HYDROCHLORIDE TABLETS, USP
RX ONLY
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, contain 500
mg, 850 mg, or 1000 mg of
metformin hydrochloride. Each tablet contains the inactive ingredients
carnauba wax, crospovidone,
hypromellose, magnesium stearate, polydextrose, polyethylene glycol,
povidone, pregelatinized starch,
titanium dioxide, and triacetin.
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
A