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Glyhart

Glyhart Overdosage

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Overdosage
Dapagliflozin administered at single doses of up to 500 mg [50 times the maximum recommended human dose (MRHD)] in healthy subjects showed no toxicity. Glucose was detected in the urine of these subjects for a dose-related period of time (at least 5 days for the 500 mg dose), with no reports of dehydration, hypotension, or electrolyte imbalance. In addition, no clinically significant effect on QTc interval was observed. The incidence of hypoglycemia was similar to placebo. In clinical studies, dapagliflozin given at once a day doses of up to 100 mg (10 times the MRHD) for 2 weeks in healthy subjects and patients with type 2 diabetes mellitus, had similar rates of adverse events including dehydration or hypotension compared with placebo. There were also no clinically significant dose-related changes in laboratory parameters including serum electrolytes and biomarkers of renal function. The incidence of hypoglycemia was slightly higher than placebo and was not dose-related.
Initiate appropriate supportive treatment dictated by the patient's clinical signs and symptoms if overdose occurs. The removal of dapagliflozin by hemodialysis has not been studied.
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