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Other brands with the same active ingredient
These brands contain the same active ingredient (Ertugliflozin). Same strength and form. Confirm the switch with your doctor or pharmacist.
Indications & Uses
Ertuglif 5 is indicated for:
Pharmacology
SGLT2 is the main transporter that takes glucose from the glomerular filtrate back into the blood. Ertugliflozin blocks SGLT2. With this transporter inhibited, the kidney reabsorbs less of the filtered glucose and the renal threshold for glucose drops, so more glucose leaves the body in the urine.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
The recommended starting dose of Ertugliflozin is 5 mg once daily, taken in the morning, with or without food. If a patient tolerates 5 mg once daily and needs additional glycemic control, the dose may be raised to the maximum recommended dose of 15 mg once daily.
Patients with renal impairment
Assess renal function before initiation of Ertugliflozin, and then periodically. Using Ertugliflozin is contraindicated in patients with an eGFR less than 30 mL/minute/1.73 m2. Initiation is not recommended when the eGFR is 30 mL/minute/1.73 m2 to less than 60 mL/minute/1.73 m2. Continued use is also not recommended when the eGFR stays 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. It has not been studied in patients with severe hepatic impairment, so it is not recommended for them.
Pediatric population
The safety and efficacy of ertugliflozin in children under 18 years of age have not been established. No data are available.
Side Effects
Ertugliflozin can cause a few side effects. These include cough (with or without phlegm), a stuffy or runny nose, sore throat and mouth ulcers. Some people get diarrhea, nausea and vomiting, abdominal pain or constipation. Others notice weight loss, headache or dizziness, back pain, joint pain, muscle pain, feeling weak, tremor and similar problems.
Cautions & Contraindications
Warnings & Precautions
Ketoacidosis Ketoacidosis is a serious, life-threatening condition that needs urgent hospital treatment. It has been reported in clinical trials and in post marketing surveillance among patients with type 1 and type 2 diabetes mellitus who were taking sodium glucose co-transporter-2 (SGLT2) inhibitors. Cases also occurred in patients treated with Ertugliflozin (Ertuglif) in clinical trials. Across the clinical program, ketoacidosis was identified in 3 of 3,409 (0.1%) of Ertuglif treated patients and 0% of comparator-treated patients. Fatal cases have been reported in patients taking SGLT2 inhibitors. If a patient on Ertuglif shows signs and symptoms that fit severe metabolic acidosis, ketoacidosis should be checked for whatever the blood glucose level is. Ketoacidosis linked to Ertuglif may be present even when blood glucose is less than 250 mg/dL. If ketoacidosis is suspected, stop Ertuglif, evaluate the patient and start treatment promptly. Treatment may need insulin, fluid and carbohydrate replacement. General Ertuglif is not indicated for the treatment of patients with type 1 diabetes mellitus. Hypotension Ertuglif causes intravascular volume contraction, so symptomatic hypotension may occur after starting it. The risk is higher in patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2) [see Use In Specific Populations], in elderly patients (over 65 years), in patients with low systolic blood pressure and in patients on diuretics. Before starting Ertuglif, assess volume status and correct it if needed. After starting therapy, watch for signs and symptoms of hypotension. Acute Kidney Injury And Impairment In Renal Function Ertuglif causes intravascular volume contraction and can cause renal impairment. After marketing, there have been reports of acute kidney injury, some needing hospitalization and dialysis, in patients receiving SGLT2 inhibitors. Before starting Ertuglif, consider what may make a patient prone to acute kidney injury. These include hypovolemia, chronic renal insufficiency, congestive heart failure and concomitant medicines (diuretics, ACE inhibitors, ARBs, NSAIDs). Consider stopping Ertuglif temporarily whenever oral intake is reduced (such as acute illness or fasting) or fluid is being lost (such as gastrointestinal illness or excessive heat exposure), and monitor the patient for signs and symptoms of acute kidney injury. If acute kidney injury occurs, stop Ertuglif promptly and start treatment. Ertuglif 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 appear after starting Ertuglif, so renal function should be evaluated before starting it and periodically after that. Ertuglif is not recommended when eGFR is persistently between 30 and less than 60 mL/min/1.73 m2, and it 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. Ertuglif may increase the risk of hypoglycemia when it is used with insulin and/or an insulin secretogogue. A lower dose of the insulin or insulin secretogogue may therefore be needed to reduce that risk when it is combined with Ertuglif. Increases In Low-Density Lipoprotein Cholesterol (LDL-C) Dose-related increases in LDL-C can occur with Ertuglif. Monitor and treat as appropriate. Macrovascular Outcomes No clinical studies have established conclusive evidence that Ertuglif reduces macrovascular risk.
Contraindications
Ertugliflozin must not be used in severe renal impairment, end-stage renal disease (ESRD) or dialysis. It is also not for anyone with a history of a serious hypersensitivity reaction to Ertugliflozin.
Pregnancy & Breastfeeding
Pregnancy: There isn't enough data on Ertugliflozin in pregnant women to say whether it carries a risk of harm to the baby's development. Poorly controlled diabetes in pregnancy is itself a risk to both the mother and the fetus. In rats, adverse kidney changes were seen when ertugliflozin was given during the period of kidney development that matches the late second and third trimesters of human pregnancy. Doses approximately 13 times the maximum clinical dose caused dilatation of the renal pelvis and tubules and renal mineralization, and these changes were not fully reversible. No fetal harm was seen in rats or rabbits at exposures approximately 300 times higher than the maximal clinical dose of 15 mg/day, when it was given during organogenesis. Because of the adverse kidney effects in animals, Ertugliflozin is not recommended during the second and third trimesters of pregnancy.
Lactation: Nobody knows yet whether Ertugliflozin passes into human milk, what it does to a breastfed infant, or whether it affects milk production. It is present in the milk of lactating rats. Human kidneys mature in the womb and during the first 2 years of life, which is when exposure through breast milk may happen, so there may be a risk to the developing kidney. Because a breastfed infant could have serious adverse reactions, women should be advised that Ertugliflozin is not recommended while breastfeeding.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatrics (<18 years of age)
Safety and effectiveness of Ertugliflozin in patients under 18 years of age have not been established.
Geriatrics
No dosage adjustment of Ertugliflozin is recommended based on age. Across the clinical program, 876 patients (25.7%) treated with Ertugliflozin were 65 years and older, and 152 patients (4.5%) treated with Ertugliflozin were 65 years and older and had a higher incidence of adverse reactions related to volume depletion compared to younger patients. These events were reported in 1.1%, 2.2% and 2.6% of patients treated with comparator, Ertugliflozin 5 mg, and Ertugliflozin 15 mg, respectively. Ertugliflozin is expected to have diminished efficacy in elderly patients with renal impairment.
Overdose
If someone takes too much Ertugliflozin, contact the Poison Control Center. Give the usual supportive care, based on the patient's clinical condition. Whether Ertugliflozin can be removed by hemodialysis has not been studied.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Take Ertugliflozin only as your doctor advises. It can be dispensed only on the prescription of a registered physician. Store it in a dry place at 30°C or below.
Drug Interactions
Common questions about Ertuglif 5 5 mg
What is Ertuglif 5 5 mg Tablet?
Ertuglif 5 5 mg Tablet is a medicine that contains Ertugliflozin. It is made by Navana Pharmaceuticals Ltd. It belongs to the Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors group of medicines.
What is Ertuglif 5 used for?
Ertuglif 5 is used for: Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus, Diabetes Mellitus.
What are the side effects of Ertuglif 5?
Ertugliflozin can cause a few side effects. These include cough (with or without phlegm), a stuffy or runny nose, sore throat and mouth ulcers.
Can I take Ertuglif 5 during pregnancy or while breastfeeding?
Pregnancy: There isn't enough data on Ertugliflozin in pregnant women to say whether it carries a risk of harm to the baby's development. Poorly controlled diabetes in pregnancy is itself a risk to both the mother and the fetus. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Ertuglif 5?
If someone takes too much Ertugliflozin, contact the Poison Control Center. Give the usual supportive care, based on the patient's clinical condition. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Ertuglif 5?
Take Ertugliflozin only as your doctor advises. It can be dispensed only on the prescription of a registered physician.
Can I take other medicines with Ertuglif 5?
Some medicines can interact with Ertugliflozin, for example: Insulin (Human) 30/70. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Ertuglif 5?
Ertuglif 5 is a prescription (Rx) medicine. Take it as your doctor advises.