Ertoxa tablet is a sodium glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use : Ertoxa tablet is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Ertugliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, ertugliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
Assess renal function prior to initiation of Ertugliflozin and periodically thereafter Use of Ertugliflozin is contraindicated in patients with an eGFR less than 30 mL/minute/1.73 m2 Initiation of Ertugliflozin is not recommended in patients with an eGFR of 30 mL/minute/1.73 m2 to less than 60 mL/minute/1.73 m2 Continued use of Ertugliflozin is not recommended when eGFR is persistently between 30 and less than 60 mL/minute/1.73 m2. Hepatic impairment : No dose adjustment of ertugliflozin is necessary in patients with mild or moderate hepatic impairment. Ertugliflozin has not been studied in patients with severe hepatic impairment and is not recommended for use in these patients. Pediatric population : The safety and efficacy of ertugliflozin in children under 18 years of age have not been established. No data are available.
Always consult a registered doctor before taking any medicine. This information is for general knowledge only.
Side effects may include: cough (with or without phlegm), stuffy or runny nose, sore throat, mouth ulcers, diarrhea, nausea and vomiting, abdominal pain, constipation, weight loss, headache/dizziness, back pain joint pain, muscle pain, feeling weak, tremor etc.
Severe renal impairment, end-stage renal disease (ESRD), or dialysis. History of a serious hypersensitivity reaction to Ertugliflozin.
Concomitant Use with Insulin And Insulin Secretogogues : Ertoxa may increase the risk of hypoglycemia when used in combination with insulin and/or an insulin secretogogue. Therefore, a lower dose of insulin or insulin secretogogue may be required to minimize the risk of hypoglycemia when used in combination with Ertoxa. Positive Urine Glucose Test : Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control. Interference With 1,5-anhydroglucitol (1,5-AG) Assay : Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.
Ketoacidosis : Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization, have been identified in clinical trials and post marketing surveillance in patients with type 1 and type 2 diabetes mellitus receiving sodium glucose co-transporter-2 (SGLT2) inhibitors and cases have been reported in Ertoxa treated patients in clinical trials. Across the clinical program, ketoacidosis was identified in 3 of 3,409 (0.1%) of Ertoxa treated patients and 0% of comparator-treated patients. Fatal cases of ketoacidosis have been reported in patients taking SGLT2 inhibitors. Patients treated with Ertoxa who present with signs and symptoms consistent with severe metabolic acidosis should be assessed for ketoacidosis regardless of presenting blood glucose levels, as ketoacidosis associated with Ertoxa may be present even if blood glucose levels are less than 250 mg/dL. If ketoacidosis is suspected, Ertoxa should be discontinued, patient should be evaluated, and prompt treatment should be instituted. Treatment of ketoacidosis may require insulin, fluid and carbohydrate replacement. General : Ertoxa is not indicated for the treatment of patients with type 1 diabetes mellitus. Hypotension : Ertoxa causes intravascular volume contraction. Therefore, symptomatic hypotension may occur after initiating Ertoxa particularly in patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2) [see Use In Specific Populations], elderly patients (>65 years), in patients with low systolic blood pressure, and in patients on diuretics. Before initiating Ertoxa, volume status should be assessed and corrected if indicated. Monitor for signs and symptoms of hypotension after initiating therapy. Acute Kidney Injury And Impairment In Renal Function : Ertoxa causes intravascular volume contraction and can cause renal impairment. There have been post marketing reports of acute kidney injury some requiring hospitalization and dialysis in patients receiving SGLT2 inhibitors. Before initiating Ertoxa, consider factors that may predispose patients to acute kidney injury including hypovolemia, chronic renal insufficiency, congestive heart failure and concomitant medications (diuretics, ACE inhibitors, ARBs, NSAIDs). Consider temporarily discontinuing Ertoxa in any setting of reduced oral intake (such as acute illness or fasting) or fluid losses (such as gastrointestinal illness or excessive heat exposure); monitor patients for signs and symptoms of acute kidney injury. If acute kidney injury occurs, discontinue Ertoxa promptly and institute treatment. Ertoxa increases serum creatinine and decreases eGFR. Patients with moderate renal impairment (eGFR 30 to less than 60 mL/min/1.73 m2) may be more susceptible to these changes. Renal function abnormalities can occur after initiating Ertoxa. Renal function should be evaluated prior to initiating Ertoxa and periodically thereafter. Use of Ertoxa is not recommended when eGFR is persistently between 30 and less than 60 mL/min/1.73 m2 and is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m2 Hypoglycemia With Concomitant Use With Insulin And Insulin Secretogogues Insulin and insulin secretogogues (e.g., sulfonylurea) are known to cause hypoglycemia. Ertoxa may increase the risk of hypoglycemia when used in combination with insulin and/or an insulin secretogogue. Therefore, a lower dose of insulin or insulin secretogogue may be required to minimize the risk of hypoglycemia when used in combination with Ertoxa. Increases In Low-Density Lipoprotein Cholesterol (LDL-C) : Dose-related increases in LDL-C can occur with Ertoxa. Monitor and treat as appropriate. Macrovascular Outcomes : There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Ertoxa.