Medication info
Empagliflozin/Metformin Tablets 5/1000 mg (Empagliflozin, Metformin Hydrochloride)

Empagliflozin/Metformin Tablets 5/1000 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
(주)메디카코리아
Appearance
Yellow film-coated tablets that are convex on both sides with a brownish tint.
Packaging
10 tablets/box[(10 tablets/PTP x 1)], 60 tablets/box[(10 tablets/PTP x 6)], 60 tablets/bottle, 30 tablets/bottle
Approval status
Active

MFDS item code 202201399 · Approved 2022.04.04 · Insurance code 646005530

Summary

Main use
Effect on blood sugar 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, twice a day. The dosage should be determined taking into consideration the current treatment regimen, efficacy, and tolerance of each patient without exceeding empagliflozin 25 mg and metformin 2000 mg. For patients who cannot achieve sufficient blood sugar control with metformin alone or in combination with other medications like insulin, the recommended dose is 5 mg of empagliflozin twice a day (total daily amount 10 mg).

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

Effect on blood sugar control in type 2 diabetes and prevention of cardiovascular events

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

This medication is primarily used to improve blood sugar control in adults with type 2 diabetes. It is administered as an adjunct to diet and exercise therapy using a combination of empagliflozin and metformin. It is particularly effective in patients whose blood sugar is not well controlled. Caution is also required when administering this medication to type 2 diabetic patients with cardiovascular disease. This medication helps improve blood sugar control and aids in overall diabetes management.

How to take

Adult dose

The recommended dose of this medication is 1 tablet once, twice a day. The dosage should be determined taking into consideration the current treatment regimen, efficacy, and tolerance of each patient without exceeding empagliflozin 25 mg and metformin 2000 mg. For patients who cannot achieve sufficient blood sugar control with metformin alone or in combination with other medications like insulin, the recommended dose is 5 mg of empagliflozin twice a day (total daily amount 10 mg).

Precautions

This medication contains two components that help control blood sugar and is used for diabetes treatment. However, caution is needed as rare side effects such as severe lactic acidosis may occur. Lactic acidosis can lead to a dangerous condition caused by the excessive accumulation of lactic acid in the body and can sometimes be life-threatening. Additionally, caution is necessary since hypoglycemia, or very low blood sugar, may occur when used with other diabetes medications. This medication should not be administered to patients with moderate to severe renal impairment, acute renal problems, severe infections, heart failure, or acute myocardial infarction. Moreover, the use of this medication should be temporarily halted before and after undergoing examinations that utilize iodinated contrast agents, and it should be resumed only after renal function is confirmed to be normal. It is advisable that women who are pregnant or may become pregnant, and those who are nursing, avoid taking this medication. Regular kidney function tests should be performed while on this medication, especially in situations where there is a risk of reduced fluid volume due to dehydration, severe vomiting or diarrhea. This medication can increase the risk of urinary and genital infections, so immediate consultation with a doctor is necessary if any symptoms of infection appear. Also, this medication may lower vitamin B12 levels, so it is advisable to monitor for vitamin B12 levels during long-term use. Alcohol intake can increase the risk of lactic acidosis, so excessive drinking should be avoided while on this medication. In elderly patients, the dosage should be adjusted and condition monitored regularly considering the risks of decreased kidney function and loss of fluid volume. Hypoglycemia may occur, so careful monitoring of blood sugar changes is particularly important when taken together with insulin or other blood sugar-lowering agents. In case of suspected drug overdose, immediate medical attention should be sought for appropriate treatment, especially if lactic acidosis is suspected. While taking this medication, it is important to undergo regular tests as directed by a doctor and consult immediately if any unusual symptoms arise.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • perineal necrosis
  • lactic acidosis
  • ketoacidosis
  • severe allergic reactions
  • severe skin reactions
  • liver abnormalities (jaundice)
  • severe neurological symptoms
  • significant edema or urination problems
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  • urosepsis
  • pyelonephritis
  • myocardial infarction
  • cerebral infarction
  • acute kidney injury
  • acute cholecystitis
  • autoimmune hepatitis
  • gallstones
  • pneumonia
  • sepsis
  • acute pyelonephritis
  • worsening heart failure
  • severe infections
  • shock
  • acute myocardial infarction.

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
  • urticaria
  • erythema multiforme
  • difficulty urinating
  • interstitial nephritis
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
  • increased hematocrit
  • decreased and deficiency of vitamin B12
  • headache
  • dizziness
  • insomnia
  • weakness
  • chest pain.

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. Moreover, it is best to avoid extremely hot or cold places and store it at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow film-coated tablets that are convex on both sides with a brownish tint.

Package unit

10 tablets/box[(10 tablets/PTP x 1)], 60 tablets/box[(10 tablets/PTP x 6)], 60 tablets/bottle, 30 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.