METFORMIN HYDROCHLORIDE tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

MedVantx, Inc.

INN (Kansainvälinen yleisnimi):

METFORMIN HYDROCHLORIDE

Koostumus:

METFORMIN HYDROCHLORIDE 500 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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: - 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 tablets should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function (see also PRE

Tuoteyhteenveto:

Metformin hydrochloride tablets USP 500 mg, are available as white to off-white film-coated oval-shaped tablets, debossed with “93” on one side and “48” on the other side. They are available in bottles of 90, 100, 500 and 1000. Metformin hydrochloride tablets USP 850 mg, are available as white to off-white film-coated oval-shaped tablets, debossed with “93” on one side and “49” on the other side. They are available in bottles of 90, 100 and 1000. Metformin hydrochloride tablets USP 1000 mg, are available as white to off-white film-coated oval-shaped tablets, scored on two sides, debossed with “9” on the left side of the score and “3” on the right side of the score on one side and “72” on the left side of the score and “14” on the right side of the score on the other side. They are available in bottles of 90, 100 and 1000. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured In India By: EMCURE PHARMACUETICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. AM 9/2009

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
MEDVANTX, INC.
----------
METFORMIN HYDROCHLORIDE TABLETS USP, 500 MG, 850 MG, AND 1000 MG
1048
1049
7214
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:
C H N •HCl M.W. 165.63
Metformin hydrochloride is a white to off-white crystalline compound.
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 USP contain 500 mg, 850 mg, or 1000 mg
of metformin
hydrochloride. In addition, each tablet contains the following
inactive ingredients: colloidal silicon
dioxide, hypromellose, magnesium stearate, polyethylene glycol,
povidone and titanium dioxide.
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 Bioavailability
The absolute bioavailability of a me