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Ertu5 mg
Synovia Pharma PLC
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Ertugliflozin: Brands, Price & Uses in Bangladesh
Ertugliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor used in the management of type 2 diabetes mellitus.
About Ertugliflozin
Indications of Ertugliflozin
Ertugliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor used in the management of type 2 diabetes mellitus.
Established / FDA-approved indication
- As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Combination use
Ertugliflozin may be used alone or in combination with other antidiabetic agents such as metformin, sulfonylureas, DPP-4 inhibitors, or insulin, when glycemic control is not achieved with a single agent, under physician supervision.
Not indicated for
- Type 1 diabetes mellitus
- Treatment of diabetic ketoacidosis
Cardiovascular outcomes
In a large cardiovascular outcomes trial, Ertugliflozin showed cardiovascular safety (non-inferiority for major adverse cardiovascular events) in patients with type 2 diabetes and established atherosclerotic cardiovascular disease, but a cardiovascular risk-reduction benefit has not been established; Ertugliflozin is therefore not indicated specifically for cardiovascular risk reduction.
Off-label use: Ertugliflozin is not commonly prescribed off-label. Any use outside the above should be individualized by a physician.
Dosage & Administration of Ertugliflozin
Adults
| Indication | Starting Dose | Maintenance / Maximum Dose |
|---|---|---|
| Type 2 diabetes mellitus (adjunct to diet and exercise) | 5 mg orally once daily in the morning | May be increased to 15 mg once daily if additional glycemic control is needed and the dose is tolerated. Maximum dose: 15 mg/day. |
Renal impairment
Assess renal function before starting Ertugliflozin and periodically thereafter. Ertugliflozin is not recommended for use in patients with an eGFR persistently below 45 mL/min/1.73m² and is contraindicated in severe renal impairment, end-stage renal disease, or in patients on dialysis (see Contraindications).
Hepatic impairment
No dose adjustment is required in mild-to-moderate hepatic impairment. Ertugliflozin has not been studied in severe hepatic impairment and is not recommended in this population.
Pediatric dosing
Safety and efficacy of Ertugliflozin in patients under 18 years have not been established; pediatric dosing is not defined.
Missed dose
If a dose of Ertugliflozin is missed, it should be taken as soon as remembered on the same day; the missed dose should be skipped if it is almost time for the next dose. Doses should not be doubled.
Side Effects of Ertugliflozin
Common side effects
- Genital mycotic (yeast) infections
- Urinary tract infections
- Headache
- Vaginal pruritus
- Increased urination
- Mild increase in LDL cholesterol
Serious side effects (seek prompt medical attention)
- Euglycemic diabetic ketoacidosis — can occur even with normal or near-normal blood glucose; symptoms include nausea, vomiting, abdominal pain, fatigue, and difficulty breathing.
- Necrotizing fasciitis of the perineum (Fournier's gangrene) — a rare but life-threatening infection; seek emergency care for perineal/genital pain, swelling, redness, or fever.
- Lower limb amputation risk associated with the SGLT2 inhibitor class (see Precautions and Warnings).
- Volume depletion, dehydration, and hypotension.
- Hypersensitivity reactions.
- Urosepsis and pyelonephritis.
Contraindications of Ertugliflozin
- Known hypersensitivity to Ertugliflozin or any component of the formulation (e.g., anaphylaxis or angioedema has been reported).
- Severe renal impairment, end-stage renal disease, or patients on dialysis.
Frequently Asked Questions about Ertugliflozin
What is Ertugliflozin used for?
Ertugliflozin is used along with diet and exercise to help control blood sugar levels in adults with type 2 diabetes mellitus. It is not used for type 1 diabetes or diabetic ketoacidosis.
How should I take Ertugliflozin?
Ertugliflozin is usually taken once daily in the morning, with or without food. It should be swallowed whole and taken at the same time each day for best results.
What are the most serious risks of Ertugliflozin?
Ertugliflozin can rarely cause a serious condition called euglycemic diabetic ketoacidosis, in which blood glucose may not be very high but the body becomes acidic; it can also rarely cause a severe genital/perineal infection called Fournier's gangrene, and may increase the risk of lower limb amputation. Seek immediate medical attention for symptoms such as severe abdominal pain, nausea, vomiting, unusual tiredness, or severe genital/perineal pain, swelling, or redness with fever.
Can Ertugliflozin cause low blood sugar (hypoglycemia)?
Ertugliflozin alone has a low risk of causing hypoglycemia, but the risk increases when it is combined with insulin or sulfonylurea medicines. Your doctor may lower the dose of those medicines when starting Ertugliflozin.
Is Ertugliflozin safe during pregnancy or breastfeeding?
Ertugliflozin is not recommended during pregnancy, especially in the second and third trimesters, or during breastfeeding, because of potential effects on the developing kidneys of the fetus or infant. It should be used in pregnancy only if clearly needed and after consulting a physician.
Who should not take Ertugliflozin?
Ertugliflozin should not be used by people with a known hypersensitivity to it, or by people with severe kidney impairment, end-stage renal disease, or those on dialysis.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.