Medication info

Empagduo Tablet 5/850 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
명문제약(주)
Appearance
White film-coated tablets that are convex on both sides with a yellowish tint
Packaging
10 tablets/box [10 tablets/PTPX1], 60 tablets/box [10 tablets/PTPX6], 60 tablets/bottle
Approval status
Active

MFDS item code 202201374 · Approved 2022.04.04

Summary

Main use
Blood glucose control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dose of this medication is 1 tablet once, 2 times a day. The treatment regimen, efficacy, and tolerability of each patient should be considered and should not exceed empagliflozin 25 mg and metformin 2000 mg total daily maximum dose. If blood glucose control is difficult when metformin is used alone or in combination with other drugs, empagliflozin 5 mg should be taken 2 times a day (total 10 mg) along with the existing metformin dosage. If tolerability is good and additional blood glucose control is needed, empagliflozin 25 mg (total daily dose) can be increased.

Ingredients

Manufacturer
명문제약(주)

Efficacy & effects

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

  • Type 2 diabetes with difficult blood glucose control
  • cardiovascular diseases
View approved original text

This medication assists dietary and exercise management to improve blood glucose control in adult patients with type 2 diabetes. It is particularly suitable for adult patients with type 2 diabetes whose blood glucose is not adequately controlled, and careful use is necessary in patients with cardiovascular diseases. This medication effectively manages blood sugar through the combination of empagliflozin and metformin, improving health status.

How to take

Adult dose

The recommended dose of this medication is 1 tablet once, 2 times a day. The treatment regimen, efficacy, and tolerability of each patient should be considered and should not exceed empagliflozin 25 mg and metformin 2000 mg total daily maximum dose. If blood glucose control is difficult when metformin is used alone or in combination with other drugs, empagliflozin 5 mg should be taken 2 times a day (total 10 mg) along with the existing metformin dosage. If tolerability is good and additional blood glucose control is needed, empagliflozin 25 mg (total daily dose) can be increased.

Precautions

This medication may cause a rare but serious side effect called severe lactic acidosis, so caution is needed, especially in patients with impaired kidney function or in cases of severe infection or dehydration. Additionally, the risk of hypoglycemia may increase when taken with insulin or sulfonylurea medications, so close monitoring of blood sugar levels is necessary. This medication should not be used in patients with moderate to severe renal impairment, acute cardiac problems or heart failure, acute infections, severe trauma, before or after surgery, and requires dose adjustment according to renal function and regular monitoring of renal function tests. Caution is also required in patients at risk of fluid loss or those with irregular meals or engaging in strenuous exercise. While taking this medication, side effects may occur such as urinary tract infections or genital infections and increased urination; if any abnormal symptoms occur, immediate consultation with healthcare professionals is advised. Moreover, vitamin B12 levels may decrease over time, so regular blood tests are recommended during prolonged use. Pregnant or breastfeeding women should not take this medication, and dosage for the elderly should be adjusted according to renal function. In cases of overdose, hypoglycemia or lactic acidosis may occur, requiring immediate hospital treatment. This medication is not recommended for children or adolescents under 18 years of age. It is important to avoid alcohol while taking this medication, maintain proper hydration, and regularly undergo examinations as directed by a physician.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • necrosis of the perineum
  • ketoacidosis
  • lactic acidosis
  • cerebral infarction
  • myocardial infarction
  • acute kidney injury
  • acute pyelonephritis
  • urosepsis
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  • heart failure
  • worsening heart failure
  • severe allergic reactions
  • severe skin adverse reactions
  • severe edema
  • severe central nervous system symptoms
  • difficulty breathing
  • difficulty in breathing
  • liver abnormalities (jaundice)
  • sudden and very severe headache
  • thunderclap headache
  • seizures
  • altered consciousness
  • visual disturbances
  • paralysis
  • urine output

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
  • erythema
  • thirst
  • increased serum creatinine
  • decreased glomerular filtration rate
  • decreased and deficiency of vitamin B12
  • decreased fluid volume
  • altered taste
  • headache
  • dizziness
  • insomnia
  • chest discomfort
  • chest pain
  • weakness
  • weight loss
  • vulvar pruritus
  • genital pruritus

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 preferred storage temperature is between 1 to 30 degrees Celsius at room temperature. Proper storage will help maintain the effectiveness of the medication for a long time.

Appearance and packaging

Appearance

White film-coated tablets that are convex on both sides with a yellowish tint

Package unit

10 tablets/box [10 tablets/PTPX1], 60 tablets/box [10 tablets/PTPX6], 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.