Medication info

Steglatro Tablets 5 Milligrams (Ertugliflozin L-Pyroglutamic Acid)

Prescription medicationTablet경구Approval revoked
Ingredient · strength
Ertugliflozin L-Pyroglutamic Acid›6.477mg / 1 tablet
Manufacturer / importer
한국엠에스디(주)
Appearance
Pink, bilaterally convex, triangular film-coated tablet with '701' engraved on one side.
Packaging
28 tablets
Approval status
Approval revoked

MFDS item code 201803367 · Approved 2018.08.17

This product's status changed to Approval revoked on 2025.10.13. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Blood sugar control and cardiovascular event prevention effect
Who takes it
Adults
Adult dose
The recommended starting dose of this medication is 5 mg once daily for monotherapy and in combination therapy with other hypoglycemic agents such as metformin. This medication should be administered orally once daily in the morning regardless of meals. If patients tolerate the 5 mg dose well and additional blood sugar control is needed, the dose may be increased to 15 mg once daily.

Ingredients

Importer
한국엠에스디(주)

Efficacy & effects

Blood sugar control and cardiovascular event prevention effect

  • Poor blood sugar control in adult patients with type 2 diabetes
  • cardiovascular disease
View approved original text

This medication is used in conjunction with dietary and exercise therapy to help control blood sugar in adult patients with type 2 diabetes. It can be used alone or in combination with other medications. Particularly, for patients with poor blood sugar management who have cardiovascular disease, it is essential to verify the precautions related to the occurrence of cardiovascular events. This medication effectively controls blood sugar levels and helps improve diabetes management.

How to take

Adult dose

The recommended starting dose of this medication is 5 mg once daily for monotherapy and in combination therapy with other hypoglycemic agents such as metformin. This medication should be administered orally once daily in the morning regardless of meals. If patients tolerate the 5 mg dose well and additional blood sugar control is needed, the dose may be increased to 15 mg once daily.

Precautions

This medication should not be administered to certain patients. First, it is not used in patients who have had severe allergic reactions to the main ingredient or excipients of this drug, type 1 diabetes patients, patients with diabetic ketoacidosis, patients with significantly impaired kidney function or those undergoing dialysis. Additionally, this medication contains lactose, so patients with genetic conditions such as lactose intolerance or galactose intolerance should not take it. Patients at risk of reduced blood volume or low blood pressure should use this medication with caution. In particular, patients with poor kidney function, elderly patients, and those taking diuretics should carefully monitor their blood status before treatment and closely observe during treatment as they may experience blood volume reduction and hypotension. In cases of severe congestive heart failure, the use of this medication is not recommended. This medication can cause a serious metabolic disorder known as ketoacidosis, so if symptoms such as vomiting, abdominal pain, or difficulty breathing occur, consult a doctor immediately. There may be a tendency for fungal infections to occur in the genital area, so it's important to seek treatment if there are signs of infection. While taking this medication, side effects such as headaches, urinary tract infections, vulvar itching, increased urination, and thirst may occur, so it's important to be aware of these symptoms. Regular kidney function tests are necessary to ensure that there are no abnormalities. Additionally, this medication may increase the risk of hypoglycemia, requiring careful monitoring of blood sugar levels. Women who are pregnant or breastfeeding should not use this medication and should stop taking it immediately if pregnancy is confirmed. The safety of this medication in children and adolescents has not been established, so it is advisable not to use it. Elderly patients should take caution as they may experience side effects related to reduced blood volume more frequently. Patients with severe impairment of kidney or liver function should not use this medication or should use it cautiously. In the event of an overdose, appropriate treatment should be given according to the symptoms, and it is not clear whether this medication can be removed by dialysis. Finally, this medication should be stored out of reach of children, not transferred to other containers, and handled safely.

Side effects and when to seek care immediately

Serious side effects

Hypotension due to decreased blood volume, syncope, orthostatic hypotension, ketoacidosis, acute kidney injury, renal impairment, acute generalized renal failure, limb amputation, urosepsis, pyelonephritis, necrotizing fasciitis of the perineum (Fournier's gangrene), severe urinary tract infection

Mild side effects

Fungal infection in the female genital area, fungal infection in the male genital area, urinary tract infection, headache, vulvar itching, increased urination, nasopharyngitis, back pain, weight loss, thirst, increase in low-density lipoprotein cholesterol (LDL-C), rise in hemoglobin, rise in serum phosphate, hypoglycemia

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pink, bilaterally convex, triangular film-coated tablet with '701' engraved on one side.

Package unit

28 tablets

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.