Medication info

Empagmet Extended-Release Tablets 10/1000 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›10mg / 1 tabletMetformin Hydrochloride with Colloidal Anhydrous Silica›1010mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
Dark orange oval extended-release film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202500782 · Approved 2025.04.03

Summary

Main use
Blood sugar control in adults with type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The dosage for this medication is determined by considering each patient's current treatment, efficacy, and tolerance within the maximum daily limits of 25 mg of empagliflozin and 2000 mg of extended-release metformin hydrochloride. This medication is taken once daily at dinner time along with food. The dose of metformin hydrochloride should be increased gradually, and the tablets should be swallowed whole without splitting, crushing, or chewing. Initial recommended doses

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

Blood sugar control in adults with type 2 diabetes and prevention of cardiovascular events

  • Abnormal blood sugar control in adults with type 2 diabetes
  • risk of cardiovascular events
View approved original text

This medication is helpful for adults with type 2 diabetes who have difficulty managing blood sugar with diet and exercise, and is used to improve blood sugar control. Particularly, caution should be taken when administering this medication to patients with type 2 diabetes who have cardiovascular disease, referencing expert clinical trial information if blood sugar is not adequately controlled. This medication can assist in diabetes management by improving blood sugar control and may also contribute to reducing the risk of cardiovascular complications.

How to take

Adult dose

The dosage for this medication is determined by considering each patient's current treatment, efficacy, and tolerance within the maximum daily limits of 25 mg of empagliflozin and 2000 mg of extended-release metformin hydrochloride. This medication is taken once daily at dinner time along with food. The dose of metformin hydrochloride should be increased gradually, and the tablets should be swallowed whole without splitting, crushing, or chewing. Initial recommended doses

Precautions

This medication is used to control blood sugar, and should not be taken by patients with impaired kidney function or severe renal disease. This medication should also not be used in the presence of acute conditions such as severe infections, dehydration, decreased cardiac function, or acute myocardial infarction. Women who are pregnant or may become pregnant should not take this medication, and discontinuation during breastfeeding is also advisable. This medication may rarely cause a serious side effect called lactic acidosis; therefore, if symptoms such as difficulty breathing, muscle pain, abdominal pain, or weakness occur, medical consultation should be sought immediately. Additionally, if this medication is taken with insulin or sulfonylureas, there is a risk of hypoglycemia, so careful monitoring of blood sugar changes is necessary. Urinary or genital infections may occur, so prompt treatment should be sought if infection symptoms appear. When undergoing surgery or tests using iodine-based contrast agents, the use of this medication should be temporarily halted, and it should be resumed only after confirming normal kidney function. Elderly patients or those at risk of fluid loss should be cautious about dehydration and decreased blood pressure, and regular monitoring of kidney function is recommended. This medication should be swallowed whole and not crushed or chewed, and it is normal for the tablet coating to be expelled in the stool. It is advisable to avoid alcohol consumption during treatment, and since vitamin B12 deficiency may occur, blood tests should be performed if necessary. Regular consultation with medical professionals regarding blood sugar control and adverse reactions is essential while on this medication, and any abnormal symptoms should be reported immediately.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, necrosis of the perineum, ketoacidosis, lactic acidosis, urosepsis, pyelonephritis, abnormal liver function tests, hepatitis, cerebral infarction, myocardial infarction, fever, chest pain, chest discomfort, vascular stent thrombosis, acute kidney injury, acute cholecystitis, autoimmune hepatitis, cholelithiasis, shock, cardiopulmonary disease, sepsis, pneumonia, acute congestive heart failure, acute myocardial infarction, hypoglycemia (including severe and significant hypoglycemia), difficulty breathing

Mild side effects

  • Hypoglycemia
  • urinary infections
  • genital infections
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • decreased vitamin B12
  • taste disturbances
  • itching
  • erythema
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
  • headache
  • vascular stent stenosis
  • vascular stent thrombosis
  • fatigue
  • peripheral edema
  • facial swelling
  • edema
  • weight loss
  • vulvar pruritis
  • benign prostatic hyperplasia
  • diabetic retinopathy

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 to 30 degrees Celsius room temperature, which helps preserve the efficacy of the medication for a longer time.

Appearance and packaging

Appearance

Dark orange oval extended-release film-coated tablets

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.