Ertoxa

Eltero 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
: Eltero tablet is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

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.

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 Eltero treated patients in clinical trials. Across the clinical program, ketoacidosis was identified in 3 of 3,409 (0.1%) of Eltero treated patients and 0% of comparator-treated patients. Fatal cases of
ketoacidosis have been reported in patients taking SGLT2 inhibitors.
Patients treated with Eltero 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 Eltero may be present even if blood glucose levels are less than 250 mg/dL. If ketoacidosis is suspected, Eltero should be discontinued, patient should be evaluated, and prompt treatment should be instituted. Treatment of ketoacidosis may require insulin, fluid and carbohydrate replacement.
General
: Eltero is not indicated for the treatment of patients with type 1 diabetes mellitus.
Hypotension
: Eltero causes intravascular volume contraction. Therefore, symptomatic hypotension may occur after initiating Eltero 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 Eltero, 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
: Eltero 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 Eltero, 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 Eltero 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 Eltero promptly and institute treatment. Eltero 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 Eltero. Renal function should be evaluated prior to initiating Eltero and periodically thereafter. Use of Eltero 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. Eltero 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 Eltero.
Increases In Low-Density Lipoprotein Cholesterol (LDL-C)
: Dose-related increases in LDL-C can occur with Eltero. Monitor and treat as appropriate.
Macrovascular Outcomes
: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Eltero.

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.