METFORMIN HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Direct RX

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- -

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET
DIRECT RX
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METFROMIN HCL
DESCRIPTION
CLINICAL PHARMACOLOGY
CLINICAL STUDIES
INDICATIONS AND USAGE
CONTRAINDICATIONS
WARNINGS
Lactic acidosis is a rare, but serious, metabolic complication that
can occur due to Metformin
accumulation during treatment with Metformin Hydrochloride 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 mcg/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 Tablets USP
and by use of the minimum
effective d