ElteroTM(Ertugliflozin)
Therapeutic Group: Anti Diabetic
Presentation
Eltero 5: Each film-coated tablet contains Ertugliflozin L Pyroglutamic Acid INN, equivalent to Ertugliflozin 5 mg.
Eltero 15: Each film-coated tablet contains Ertugliflozin L Pyroglutamic Acid INN, equivalent to Ertugliflozin 15 mg.
Description
SGLT2 is the predominant transporter responsible for the 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, lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
Indications
Ertugliflozin 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.
Dosage & Administration
The recommended starting dose is 5 mg once daily, taken in the morning, with or without food. Increase the dose to 15 mg once daily for those tolerating Ertugliflozin and needing additional glycemic control. Assess renal function before initiating Ertugliflozin and periodically thereafter.
• Do not use in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m2
• Initiation is not recommended in patients with an eGFR of 30 to less than 60 mL/minute/1.73 m2
• Continued use is not recommended in patients with an eGFR persistently between 30 and less than 60 mL/min/1.73 m2.
Side Effects
Dehydration, vaginal yeast infection, yeast infection of the penis, urinary tract infection, female genital mycotic infections, diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, headache, etc.
Precautions
• Hypotension: may occur particularly in patients with renal impairment, the elderly, or patients on diuretics. Before initiating, assess and correct the volume status. Monitor for signs and symptoms during therapy.
• Ketoacidosis: Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue, evaluate, and treat promptly. Before initiating, consider risk factors for ketoacidosis. Patients may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.
• Acute Kidney Injury and Impairment in Renal Function: Consider temporarily discontinuing in settings of reduced oral intake or fluid losses. If an acute kidney injury occurs, discontinue and promptly treat it. Monitor renal function.
• Urosepsis and Pyelonephritis: Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.
• Lower Limb Amputation: Before initiating, consider factors that may increase the risk of amputation. Monitor patients for infections or ulcers of the lower limbs, and discontinue treatment if these occur.
• Hypoglycemia: Consider a lower dose of insulin or insulin secretagogue to reduce the risk of hypoglycemia when used in combination.
• Genital Mycotic Infections: Monitor and treat if indicated.
• Increased LDL-C: Monitor and treat as appropriate.
Use in Pregnancy & Lactation
• Pregnancy: advise females of the potential risk to a fetus, especially during the second and third trimesters.
• Lactation: Breastfeeding not recommended.
• Geriatrics: higher incidence of adverse reactions related to reduced intravascular volume.
• Renal impairment: higher incidence of adverse reactions related to reduced intravascular volume and renal function.
Drug Interaction
Concomitant use with Insulin and Insulin Secretagogues Ertugliflozin may increase the risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. Therefore, a-lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with Ertugliflozin.
Over Dose
In the event of an overdose with Ertugliflozin, contact the Poison Control Center. Employ the usual supportive measures as dictated by the patient’s clinical status. Removal of Ertugliflozin by hemodialysis has not been studied.
Storage
Do not store above 30 °C. Keep away from light and out of the reach of children.
Commercial Pack
Eltero 5: Each box contains 3 blister strips of 10 tablets.
Eltero 15: Each box contains 2 blister strips of 10 tablets.