Medication info

Empagliflozin/Metformin Tablet 12.5/500 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
동화약품(주)
Appearance
Oval film-coated tablet that is convex on both sides, purplish with light brown tint
Packaging
10 tablets/box [10 tablets/PTPX1], 60 tablets/box [10 tablets/PTPX6], 30 tablets/bottle, 60 tablets/bottle
Approval status
Active

MFDS item code 202302634 · Approved 2023.09.05

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 1 tablet, twice daily. It should be determined within the maximum daily recommended limits for each ingredient, which is 25 mg for empagliflozin and 2000 mg for metformin, considering each patient's treatment regimen, efficacy, and tolerance. If taken in combination with metformin alone or other medications such as insulin, the recommended dosage is 5 mg of empagliflozin twice daily (total of 10 mg) and the existing dose of metformin.

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

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

  • Blood sugar control issues in adult patients with type 2 diabetes
  • cardiovascular diseases
View approved original text

This medication aids in blood sugar control for adult patients with type 2 diabetes through a combination therapy of empagliflozin and metformin, alongside dietary management and exercise therapy. It is particularly effective for those whose blood sugar is not adequately controlled, and patients with cardiovascular diseases should refer to specialist advice. This medication improves the blood sugar levels of diabetic patients, aiding in health management.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet, twice daily. It should be determined within the maximum daily recommended limits for each ingredient, which is 25 mg for empagliflozin and 2000 mg for metformin, considering each patient's treatment regimen, efficacy, and tolerance. If taken in combination with metformin alone or other medications such as insulin, the recommended dosage is 5 mg of empagliflozin twice daily (total of 10 mg) and the existing dose of metformin.

Precautions

This medication is an antidiabetic agent that helps manage blood sugar levels. During usage, there may be a risk of severe lactic acidosis, a dangerous condition, so patients should be vigilant for symptoms. Caution is needed particularly when used with insulin or sulfonylureas as hypoglycemia may occur. Patients with severely impaired kidney function or acute kidney impairment should not take this medication. Moreover, this medication should not be used by patients with type 1 diabetes or a history of lactic acidosis or diabetic ketoacidosis. Patients scheduled for surgery or those receiving radiocontrast containing iodine should temporarily discontinue this medication for a certain period, resuming it only after kidney function recovery. Pregnant or breastfeeding women are also advised against taking this medication. Regular monitoring of kidney function is necessary during treatment to confirm no abnormalities, and particular caution is needed for the elderly or those with weakened kidney function. This medication may cause side effects such as hypoglycemia, urinary tract infections, genital infections, and increased urination, so if symptoms occur, immediate consultation with healthcare professionals is necessary. Furthermore, if signs of fluid loss or dehydration occur, the medication may be temporarily discontinued. Vitamin B12 levels may decrease, so regular blood tests are recommended if necessary. Alcohol may increase the risk of side effects from this medication, so it is best to avoid drinking during treatment. This medication may interact with other drugs, so if taking any other medications, always inform your doctor or pharmacist. Elderly patients should have dose adjustments and regular monitoring due to the risk of side effects from decreased kidney function. In case of overdose, seek immediate medical care, as some components can be removed by hemodialysis. This medication is not recommended for children, and it should be kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme drowsiness, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

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
  • taste disturbance
  • itching
  • rash
  • hives
  • erythema
  • angioedema
  • difficulty urinating
  • interstitial nephritis
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
  • decreased and deficiency of Vitamin B12
  • headache
  • dizziness
  • weight loss
  • vulvar pruritus
  • insomnia
  • discomfort

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

Storage

This medication should be stored in a tightly closed container to protect it from exposure to air and moisture. It is important to maintain a storage temperature between 1°C and 30°C. This way, the components of the medication remain unchanged and can be used safely.

Appearance and packaging

Appearance

Oval film-coated tablet that is convex on both sides, purplish with light brown tint

Package unit

10 tablets/box [10 tablets/PTPX1], 60 tablets/box [10 tablets/PTPX6], 30 tablets/bottle, 60 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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.