Medication info

Mgliduon Tablet 5/500 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
한국프라임제약(주)
Appearance
Orange-yellow, bilaterally convex, oval film-coated tablet
Packaging
10 tablets/box [10 tablets/PTP x 1], 60 tablets/box [10 tablets/PTP x 6], 60 tablets/bottle
Approval status
Active

MFDS item code 202201735 · Approved 2022.04.28

Summary

Main use
Effectiveness in blood sugar control for Type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 1 tablet per dose, twice a day. The dosage should be determined considering each patient’s current treatment regimen, efficacy, and tolerance, within the maximum recommended ranges of 25 mg of empagliflozin and 2000 mg of metformin. In cases where adequate blood sugar control is not achievable with metformin alone or in combination with insulin and other medications, the recommended dosage will be 5 mg of empagliflozin twice a day (total daily amount of 10 mg) along with the existing metformin dosage.

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

Effectiveness in blood sugar control for Type 2 diabetes and prevention of cardiovascular events

  • Type 2 diabetes
  • abnormal blood sugar control
  • cardiovascular diseases
  • cardiovascular events
View approved original text

This medication is used as an adjunct to diet and exercise to improve blood sugar control in adults with Type 2 diabetes. It helps effectively lower blood sugar levels when empagliflozin and metformin are administered in combination, especially in patients whose blood sugar is not adequately controlled. Moreover, in patients with Type 2 diabetes who have established cardiovascular disease, it is important to follow professional guidance due to the risk of cardiovascular events. This medication aids in blood sugar management and the improvement of cardiovascular health.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet per dose, twice a day. The dosage should be determined considering each patient’s current treatment regimen, efficacy, and tolerance, within the maximum recommended ranges of 25 mg of empagliflozin and 2000 mg of metformin. In cases where adequate blood sugar control is not achievable with metformin alone or in combination with insulin and other medications, the recommended dosage will be 5 mg of empagliflozin twice a day (total daily amount of 10 mg) along with the existing metformin dosage.

Precautions

This medicine is used for the treatment of Type 2 diabetes to help control blood sugar levels. It may cause a rare side effect known as severe lactic acidosis; therefore, it should not be used in patients with poor kidney function, severe infections, dehydration, or heart failure. Moreover, when taken together with other diabetes medications such as insulin or sulfonylureas, there is a risk of hypoglycemic symptoms, so caution is advised. Patients with moderate to severe renal impairment, those with acute cardiac issues or severe infections, and pregnant or nursing women should not take this medication. Patients scheduled for surgery or those undergoing tests involving iodinated contrast agents should discontinue this medication for a specified period and can resume after normal kidney function is restored. While taking this medication, patients should regularly monitor their kidney function, and if dehydration, severe vomiting, or diarrhea occurs, they should consult a physician immediately. Possible side effects include hypoglycemia, urinary tract infections, genital infections, increased urination, gastrointestinal disturbances (nausea, vomiting, diarrhea), so any symptoms should be reported to healthcare providers. Particularly, if symptoms of lactic acidosis such as fatigue, muscle pain, dyspnea, abdominal pain appear, immediate medical treatment is needed, and this medication can be removed in emergencies through hemodialysis. Alcohol consumption may increase the risk of lactic acidosis, so patients should avoid excessive drinking while taking this medication. Elderly patients or those with impaired kidney function should start with a lower dose and must be monitored regularly for blood sugar and kidney function. This medication should not be taken by pregnant women or those who may become pregnant, nor is it recommended for children due to lack of established safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, mouth/eye mucosal pain, severe skin reactions, asthma attacks, respiratory symptoms with cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headaches, lightning-like headache, seizures, confusion, visual disturbances, paralysis.

Mild side effects

  • Hypoglycemia
  • urinary tract infections
  • genital infections
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • abnormal liver function tests
  • hepatitis
  • taste disturbances
  • itching
  • rashes
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • decreased serum creatinine
  • vitamin B12 decrease and deficiency
  • headache
  • dizziness
  • orthostatic dizziness
  • weakness
  • chest discomfort
  • chest pain
  • weight loss
  • vulvar pruritus
  • insomnia
  • fever
  • fatigue.

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained in a room temperature range of 1 to 30 degrees Celsius to safely maintain the drug's effectiveness.

Appearance and packaging

Appearance

Orange-yellow, bilaterally convex, oval film-coated tablet

Package unit

10 tablets/box [10 tablets/PTP x 1], 60 tablets/box [10 tablets/PTP x 6], 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.