Medication info

Empadown Duo Tablet 5/500 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
제이더블유신약(주)
Appearance
Orange-yellow, oval film-coated tablet with a biconvex shape
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 202201341 · Approved 2022.04.04

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage for this drug is 1 tablet, taken twice daily. Each patient's current treatment regimen, efficacy, and tolerability should be considered to ensure that the total daily maximum recommended doses of empagliflozin 25 mg and metformin 2000 mg are not exceeded. Patients who cannot achieve adequate blood sugar control with metformin alone or in combination with other medications like insulin are recommended to take empagliflozin 5 mg twice daily (total of 10 mg).

Ingredients

Manufacturer
제이더블유신약(주)

Efficacy & effects

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

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

This drug is used to help control blood sugar in adult patients with type 2 diabetes who also follow dietary and exercise regimens. It is particularly suitable for patients whose blood sugar is not adequately controlled, and additional caution is needed for those with cardiovascular disease. The combination treatment helps improve blood sugar management and is effective for diabetes treatment.

How to take

Adult dose

The recommended dosage for this drug is 1 tablet, taken twice daily. Each patient's current treatment regimen, efficacy, and tolerability should be considered to ensure that the total daily maximum recommended doses of empagliflozin 25 mg and metformin 2000 mg are not exceeded. Patients who cannot achieve adequate blood sugar control with metformin alone or in combination with other medications like insulin are recommended to take empagliflozin 5 mg twice daily (total of 10 mg).

Precautions

This drug is used for diabetes treatment, where the two components work together to control blood sugar. There is a risk of a rare side effect known as severe lactic acidosis while taking this drug, so if symptoms occur, consult a doctor immediately. Caution is needed when used with other diabetes medications as hypoglycemia may occur. Patients with significantly reduced kidney function or acute kidney issues, severe infections, or congestive heart failure should not use this drug. Before undergoing tests that use iodine contrast agents, this drug should be temporarily discontinued, and it should be resumed only after kidney function is confirmed to be normal. If scheduled for surgery, discontinue this drug 48 hours prior to the procedure and resume only after confirming normal kidney function post-surgery. Those with poor liver function or excessive alcohol intake should be cautious when using this drug. It is safer for women who are pregnant or breastfeeding not to take this drug. Elderly patients or those with reduced kidney function should have regular kidney function tests and may require dosage adjustments. This drug may increase urinary output, so patients at risk of dehydration or hypotension should closely monitor their fluid status. During treatment, symptoms of genital or urinary tract infections may occur, and appropriate treatment should be sought if symptoms arise. Vitamin B12 levels may decrease, so it is advisable to regularly check vitamin B12 levels during long-term use. Hypoglycemic symptoms may occur, especially when taken with other blood sugar-lowering agents, so blood sugar levels should be carefully monitored. In cases of overdose, serious side effects may occur, so the drug should be taken according to the doctor's instructions for accurate dosing. This drug is not recommended for children or teenagers under 18 years of age. Regular consultations with a physician during treatment are necessary, and any unusual symptoms should be reported to healthcare providers immediately. To store this drug safely, keep it out of the reach of children and store it in its original container.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, necrosis of the perineum, ketoacidosis, lactic acidosis, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, yellowing of skin or eyes (jaundice), systemic severe allergic reactions.

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
  • altered taste
  • itching
  • rash
  • erythema
  • headache
  • dizziness
  • orthostatic dizziness
  • weakness
  • chest discomfort
  • chest pain
  • thirst
  • increased serum lipids
  • elevated serum creatinine
  • decreased glomerular filtration rate
  • increased hematocrit
  • decreased and deficiency of vitamin B12
  • weight loss
  • insomnia
  • adverse effects.

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

Storage

This drug may be sensitive to air and moisture and should be stored in a tightly sealed container. It is important to maintain storage temperatures between 1 and 30 degrees Celsius. Proper storage will help ensure the drug's effectiveness.

Appearance and packaging

Appearance

Orange-yellow, oval film-coated tablet with a biconvex shape

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.