Medication info
Empagliflozin 12.5/1000mg (Empagliflozin, Metformin Hydrochloride)

Empagliflozin 12.5/1000mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
(주)메디카코리아
Appearance
Biconvex oval film-coated tablets with a dark brownish purple color.
Packaging
60 tablets/box [10 tablets/PTP x 6], 10 tablets/box [10 tablets/PTP x 1], 60 tablets/bottle, 30 tablets/bottle
Approval status
Active

MFDS item code 202302588 · Approved 2023.08.30 · Insurance code 646005760

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 medication is 1 tablet per dose, taken 2 times a day. Dosage is determined within the range that does not exceed 25 mg of empagliflozin and 2000 mg of metformin. When used in combination with metformin alone or with insulin, the recommended dosage is to take 5 mg of empagliflozin twice daily, and in cases where additional blood glucose control is needed, the dose can be increased to 25 mg of empagliflozin. This medication is designed to minimize gastrointestinal side effects related to metformin.

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

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

  • Type 2 diabetes with poor glucose control
  • cardiovascular disease
View approved original text

This medicine is used as an adjunct to diet and exercise to help control blood sugar in adults with type 2 diabetes. It is especially administered to patients whose blood sugar is not adequately controlled, and should be used cautiously in those with cardiovascular disease. This medicine effectively improves blood glucose levels to assist in diabetes management.

How to take

Adult dose

The recommended dosage for this medication is 1 tablet per dose, taken 2 times a day. Dosage is determined within the range that does not exceed 25 mg of empagliflozin and 2000 mg of metformin. When used in combination with metformin alone or with insulin, the recommended dosage is to take 5 mg of empagliflozin twice daily, and in cases where additional blood glucose control is needed, the dose can be increased to 25 mg of empagliflozin. This medication is designed to minimize gastrointestinal side effects related to metformin.

Precautions

This medicine may cause a rare but serious side effect called lactic acidosis. It should be avoided particularly in patients with poor kidney function, dehydration, severe infections, or heart issues. Additionally, there is an increased risk of hypoglycemia when used with other antidiabetic medications that lower blood sugar, such as insulin or sulfonylureas, so caution is needed. It should not be administered to patients with allergies to ingredients in this medication, severe kidney impairment, type 1 diabetes, acute or chronic metabolic acidosis, acute heart failure, or those undergoing tests using contrast agents. While on treatment, it is essential to regularly monitor kidney function, especially in elderly patients or those with diminished kidney function. In situations where there is a risk of fluid loss, temporarily discontinuing this medication may be necessary, and caution should also be taken in cases of gastrointestinal disorders, liver dysfunction, excessive alcohol consumption, or malnutrition. This medication may increase the risk of urinary tract infections and genital infections, so patients should consult their doctor immediately if symptoms of infection occur. It is advisable for women who are pregnant or may become pregnant and nursing mothers to avoid using this medication, and it is not recommended for children since safety and effectiveness have not been established. In case of overdose, hemodialysis may be required, so patients must adhere to the prescribed dosage when taking the medication. Regular blood tests and monitoring of physical condition are vital while taking this medication, and patients should inform their healthcare provider immediately if any unusual symptoms occur.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor → severe allergic reactions.
  • Severe rash with high fever accompanied by blisters, skin peeling, oral/ocular mucosal pain → severe skin adverse reactions.
  • Shortness of breath or difficulty breathing, asthma attack, combined cough + fever respiratory issues → respiratory problems.
  • Jaundice or yellowing of the skin or eyes, severe lethargy → liver issues (jaundice).
  • Sudden symptoms.

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
  • taste disturbance
  • itching
  • rash
  • hives
  • erythema
  • angioedema
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
  • urinary difficulty
  • abnormal diagnostic tests
  • decreased absorption of vitamin B12
  • reduced body fluid volume
  • headache
  • dizziness
  • weakness
  • chest discomfort
  • 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 must be stored in a tightly closed container. The recommended storage temperature is between 1 to 30 degrees Celsius at room temperature to maintain its efficacy and safety over time.

Appearance and packaging

Appearance

Biconvex oval film-coated tablets with a dark brownish purple color.

Package unit

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