METFORMIN HYDROCHLORIDE EXTENDED RELEASE- metformin hydrochloride tablet, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Direct_Rx

INN (International Name):

METFORMIN HYDROCHLORIDE

Sammensetning:

METFORMIN HYDROCHLORIDE 500 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Metformin hydrochloride extended release tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride 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 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 PRECAUTION

Produkt oppsummering:

Metformin Hydrochloride Extended Release Tablets USP 500 mg Bottles of 100 NDC 67877-159-01 500 mg Bottles of 500 NDC 67877-159-05 500 mg Bottles of 1000 NDC 67877-159-10 Metformin hydrochloride extended release tablets USP 500 mg are white to off-white, capsule shaped, biconvex, beveled edge tablet, with occasionally mottled appearance, debossed with "˥L 001" on one side and plain on other side. 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.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

METFORMIN HYDROCHLORIDE EXTENDED RELEASE- METFORMIN HYDROCHLORIDE
TABLET,
EXTENDED RELEASE
DIRECT_RX
----------
METFORMIN HCL ER
Lactic Acidosis:
Lactic acidosis is a rare, but serious, metabolic complication that
can occur due to metformin
accumulation during treatment with metformin hydrochloride extended
release tablets USP when it
occurs, it is fatal in approximately 50% of cases. Lactic acidosis may
also occur in association
with a number of pathophysiologic conditions, including diabetes
mellitus, and whenever there is
significant tissue hypoperfusion and hypoxemia. Lactic acidosis is
characterized by elevated
blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte
disturbances with an increased
anion gap, and an increased lactate/pyruvate ratio. When metformin is
implicated as the cause of
lactic acidosis, metformin plasma levels >5 μg/mL are generally
found.
The reported incidence of lactic acidosis in patients receiving
metformin hydrochloride is very
low (approximately 0.03 cases/1000 patient-years, with approximately
0.015 fatal cases/1000
patient-years). In more than 20,000 patient-years exposure to
metformin in clinical trials, there
were no reports of lactic acidosis. Reported cases have occurred
primarily in diabetic patients
with significant renal insufficiency, including both intrinsic renal
disease and renal
hypoperfusion, often in the setting of multiple concomitant
medical/surgical problems and
multiple concomitant medications. Patients with congestive heart
failure requiring pharmacologic
management, in particular those with unstable or acute congestive
heart failure who are at risk of
hypoperfusion and hypoxemia, are at increased risk of lactic acidosis.
The risk of lactic acidosis
increases with the degree of renal dysfunction and the patient's age.
The risk of lactic acidosis
may, therefore, be significantly decreased by regular monitoring of
renal function in patients
taking metformin hydrochloride extended release tablets USP and by use
of the minimum effective
dose of metform