<p><strong>Lactic Acidosis</strong>: Postmarketing cases of Metformin Hydrochloride-associated lactic acidosis. If lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of this combination.<br />
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<strong>Hypotension</strong>: Before initiating this combination assess and correct volume status in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms of hypotension after initiating therapy and increase monitoring in clinical situations where volume contraction is expected.<br />
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<strong>Ketoacidosis</strong>: Before initiating this combination assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue this combination, evaluate and treat promptly.<br />
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<strong>Acute kidney injury &amp; impairment in renal function</strong>: Consider temporarily discontinuing this combination in settings of reduced oral intake or fluid losses. If acute kidney injury occurs, discontinue this combination promptly and institute treatment.<br />
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<strong>Urosepsis, Pyelonephritis, Fournier&rsquo;s gangrene &amp; Genital mycotic infections</strong>: Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.<br />
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<strong>Hypoglycemia</strong>: Consider lowering the dose of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating this combination.<br />
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<strong>Vitamin B12 Deficiency</strong>: Metformin Hydrochloride may lower vitamin B12 levels. Monitor hematologic parameters annually.<br />
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<strong>Increased LDL-C</strong>: Monitor and treat as appropriate.<br />
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<strong>Macrovascular Outcomes</strong>: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with this combination.</p>