Medication info
Empa Duo Tablet 5/500 mg (Empagliflozin, Metformin Hydrochloride)

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

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
(주)동구바이오제약
Appearance
Orange-yellow, oval, bi-convex film-coated tablets
Packaging
10 tablets/box [10 tablets/PTP x 1], 60 tablets/box [10 tablets/PTP x 6], 30 tablets/bottle, 60 tablets/bottle
Approval status
Active

MFDS item code 202201297 · Approved 2022.04.04 · Insurance code 657309070

Summary

Main use
Efficacy in blood glucose control for type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dose of this medication is 1 tablet once daily, twice a day. The dosage should be decided based on each patient's treatment regimen, efficacy, and tolerance, ensuring that it does not exceed Empagliflozin 25 mg and Metformin 2000 mg. If blood glucose control is insufficient, take 1 tablet of Empagliflozin 5 mg twice a day along with the existing dose of Metformin. If Empagliflozin has good tolerance while additional blood glucose control is needed, the daily total amount can be adjusted.

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

Efficacy in blood glucose control for type 2 diabetes and prevention of cardiovascular events

  • Type 2 diabetes
  • abnormal blood glucose control
  • cardiovascular disease
  • cardiovascular events
View approved original text

This medication is used in conjunction with diet and exercise to effectively control blood sugar for patients with type 2 diabetes. It combines Empagliflozin and Metformin, particularly for adult type 2 diabetes patients whose blood sugar is not adequately controlled and who may have cardiovascular disease, as indicated in the professional information regarding cardiovascular event caution. Therefore, this drug helps improve blood sugar control, along with cardiovascular risk management in adult patients with type 2 diabetes.

How to take

Adult dose

The recommended dose of this medication is 1 tablet once daily, twice a day. The dosage should be decided based on each patient's treatment regimen, efficacy, and tolerance, ensuring that it does not exceed Empagliflozin 25 mg and Metformin 2000 mg. If blood glucose control is insufficient, take 1 tablet of Empagliflozin 5 mg twice a day along with the existing dose of Metformin. If Empagliflozin has good tolerance while additional blood glucose control is needed, the daily total amount can be adjusted.

Precautions

This medication is helpful for controlling blood sugar; however, certain important precautions must be followed when taking it. First, this medication can cause a dangerous condition known as lactic acidosis. Lactic acidosis occurs when there is an excessive buildup of lactic acid in the body, which can be very serious and may sometimes lead to death. Thus, it is safe not to use this drug in patients with impaired kidney function or problems with the heart, liver, or lungs. Additionally, there is a risk of hypoglycemia when using this drug together with insulin or other blood glucose-lowering agents. Hypoglycemia can cause dizziness, cold sweats, and in severe cases, loss of consciousness. This drug should only be administered to patients with normal kidney function, and patients with moderate to severe impaired kidney function should not take it. Since kidney function can vary, it is important to monitor kidney status through regular blood tests. If surgery is planned or if a test involves iodine contrast agents, this medication should be discontinued for a certain period before and after the test. This is because it can put stress on the kidneys and increase the risk of lactic acidosis. Pregnant or breastfeeding women are advised not to use this drug. During pregnancy, insulin therapy is recommended for blood glucose control. During the use of this medication, if conditions such as dehydration, severe infection, or heart failure occur, you should immediately consult a doctor and discontinue the drug. Additionally, alcohol consumption should be avoided as it can increase the risk of lactic acidosis. This medication may increase the risk of urinary tract infections and genital infections, so treatment should be sought promptly if infection symptoms arise. Moreover, this medication can decrease vitamin B12 levels, so it is advisable to have regular testing for vitamin B12 levels if taken long-term. Elderly patients or those with weak kidney function should adjust the dosage of this drug, and regular kidney function tests are necessary. In cases of overdose, serious side effects such as lactic acidosis may occur, so the dosage must be carefully adhered to, and hospital visits should be made immediately if unusual symptoms occur. Finally, this medication should be stored out of reach of children, and kept in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweats, pallor, severe allergic reaction
  • Severe rash accompanied by high fever, blisters, peeling skin, pain in oral/ocular mucosa, severe skin reactions
  • Asthma attack, respiratory difficulties accompanied by cough + fever
  • Yellowing of skin or eyes (jaundice), extreme fatigue, liver abnormalities (jaundice)
  • Sudden and severe headache, lightning-like headache, seizures, loss of consciousness

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
  • itching
  • rash
  • increased serum lipids
  • increased serum creatinine
  • increased hematocrit
  • decreased and deficiency of vitamin B12
  • headache
  • dizziness
  • weakness
  • chest discomfort
  • chest pain
  • fever
  • insomnia
  • weight loss
  • vulvar itching
  • anxiety
  • facial swelling
  • peripheral edema

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. It is best to keep it at room temperature between 1 to 30 degrees Celsius. This way, the drug's effectiveness and safety can be maintained for a long time.

Appearance and packaging

Appearance

Orange-yellow, oval, bi-convex film-coated tablets

Package unit

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