METFORMIN HYDROCHLORIDE E/R- 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:

DirectRX

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 extended release tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Safety and effectiveness of metformin hydrochloride extended release tablets USP in pediatric patients have not been established. Geriatric Use Controlled clinical studies of metformin hydrochloride did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients, although other reported clinical experience has not identified differences in responses between the elderly and younger patients. Metformin is known to be substantially excreted by the kidney and because the risk of serious adverse reactions to the drug is greater in patients with impaired renal function, metformin hydrochloride should only be used in patie

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

METFORMIN HYDROCHLORIDE E/R- METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
DIRECTRX
----------
METFORMIN HYDROCHLORIDE
BOXED WARNING SECTION
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