Medication info

Empagliflozin/Metformin Extended-Release Tablets 25/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›25mg / 1 tabletMetformin Hydrochloride with Colloidal Anhydrous Silica›1010mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
Dark orange oval extended-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202500781 · Approved 2025.04.03

Summary

Main use
Control of blood sugar in adults with type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The dosage of this medication in antidiabetic therapy should be determined considering each component's maximum daily recommended dosage of 25 mg of empagliflozin and extended-release metformin hydrochloride not exceeding 2000 mg, based on each patient's current treatment, effectiveness, and tolerability. This medication should be taken once daily in the evening with food to reduce gastrointestinal side effects associated with metformin. Related to metformin usage.

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

Control of blood sugar in adults with type 2 diabetes and prevention of cardiovascular events

  • Difficulty controlling blood sugar
  • type 2 diabetes
  • cardiovascular disease
View approved original text

This medication helps control blood sugar in adults with type 2 diabetes when used in conjunction with diet and exercise. It is particularly effective in patients whose blood sugar is not well controlled, and caution is required when there is pre-existing cardiovascular disease. This medication improves blood sugar control, aiding in the treatment of diabetes.

How to take

Adult dose

The dosage of this medication in antidiabetic therapy should be determined considering each component's maximum daily recommended dosage of 25 mg of empagliflozin and extended-release metformin hydrochloride not exceeding 2000 mg, based on each patient's current treatment, effectiveness, and tolerability. This medication should be taken once daily in the evening with food to reduce gastrointestinal side effects associated with metformin. Related to metformin usage.

Precautions

This medication is used for the treatment of type 2 diabetes and helps to control blood sugar levels. However, it can rarely cause a serious condition known as lactic acidosis. Lactic acidosis can lead to excessive accumulation of lactic acid in the body, which can be a dangerous state; therefore, if symptoms appear, you should consult a doctor immediately. In addition, there is a risk of hypoglycemia if taken together with insulin or sulfonylureas, so caution is advised. This medication should not be used in patients with severely impaired kidney function or acute renal injury. It should be discontinued for a certain period before and after surgery, and resumed only after kidney function has returned to normal. This medication should also be avoided or used with caution in cases of severe infections, dehydration, heart failure, or hepatic dysfunction. It should be discontinued for a period before and after any tests using iodinated contrast media to minimize the risk of kidney injury and lactic acidosis. This medication can increase the risk of genital infections and urinary tract infections, so immediate treatment should be received if any symptoms of infection appear. During use, vitamin B12 levels may decrease, so it is advisable to check regularly through blood tests. Alcohol can increase the risk of side effects, so it is important not to overindulge while taking this medication. It is preferable not to use this medication in pregnant or potentially pregnant women, as well as in breastfeeding women. Elderly patients or those with weak kidney function should have their dosages adjusted and kidney function assessed regularly. This medication should be swallowed whole without breaking or chewing the tablets, and while the coating may be excreted in stool, this is normal. In cases of overdose, the risk is more towards lactic acidosis than toxicity, and appropriate treatment should be received in a hospital. Finally, this medication should be stored out of the reach of children and kept in its original container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), necrosis of perineum, ketoacidosis, lactic acidosis, angioedema, high fever with severe rash, blisters, skin peeling, pain in oral/ocular mucosa, difficulty breathing, asthma attacks, respiratory disturbances accompanied by cough and fever, yellowing of skin or eyes (jaundice), severe lethargy, sudden and severe headache, seizures, confusion of consciousness, visual disturbances, paralysis, significantly reduced urine output.

Mild side effects

  • Hypoglycemia
  • urinary tract infection
  • genital infection
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • abnormal liver function tests
  • hepatitis
  • altered taste
  • erythema
  • increased serum lipids
  • increased blood creatinine
  • increased hematocrit
  • decreased vitamin B12 and deficiency
  • weight loss
  • dizziness
  • headache
  • weakness
  • chest discomfort
  • chest pain
  • fever
  • fatigue
  • peripheral edema
  • facial swelling
  • vascular stent stenosis
  • vascular stenting.

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

Storage

This medication should be stored in a tightly closed container, avoiding exposure to air or moisture, and kept at room temperature between 1 to 30 degrees Celsius. Storing it this way helps to maintain its effectiveness and ensure safe use.

Appearance and packaging

Appearance

Dark orange oval extended-release film-coated tablet

Package unit

30 tablets/bottle

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.

Questions about this medicine

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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.