Medication info
Empagliflozin/Metformin Extended-Release Tablets 25/1000 mg (Empagliflozin, Metformin)

Empagliflozin/Metformin Extended-Release Tablets 25/1000 mg (Empagliflozin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›25mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
아주약품(주)
Appearance
Pink rectangular extended-release film-coated tablet
Packaging
Bottle packaging - 30 tablets/bottle
Approval status
Active

MFDS item code 202501578 · Approved 2025.06.26 · Insurance code 654006250

Summary

Main use
Effect on blood sugar control in adults with type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
For diabetes therapy, the dosage of this medication is determined considering each ingredient's maximum recommended daily dosage of 25 mg of Empagliflozin and 2000 mg of extended-release Metformin Hydrochloride based on each patient's current treatment, efficacy, and tolerability. This medication is taken once daily in the evening with meals to reduce gastrointestinal adverse reactions due to Metformin. Increase the dose of Metformin Hydrochloride gradually.

Ingredients

Manufacturer
아주약품(주)

Efficacy & effects

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

  • Blood sugar control disorders
  • type 2 diabetes
View approved original text

This medication is used as an adjunct to dietary and exercise therapy to improve blood sugar control in adults with type 2 diabetes through the combined administration of empagliflozin and metformin. Clinical trial information should be referenced to manage the occurrence of cardiovascular events cautiously, especially in patients whose blood sugar is inadequately controlled and who have established cardiovascular disease. This medication is effective in controlling blood sugar levels and aids in managing type 2 diabetes.

How to take

Adult dose

For diabetes therapy, the dosage of this medication is determined considering each ingredient's maximum recommended daily dosage of 25 mg of Empagliflozin and 2000 mg of extended-release Metformin Hydrochloride based on each patient's current treatment, efficacy, and tolerability. This medication is taken once daily in the evening with meals to reduce gastrointestinal adverse reactions due to Metformin. Increase the dose of Metformin Hydrochloride gradually.

Precautions

This medication helps control blood sugar levels and is used in the treatment of diabetes. This medication may rarely cause lactic acidosis, which is a dangerous condition, so it should not be used in patients with impaired kidney function, severe infection, or dehydration. Additionally, caution is advised when using this medication in conjunction with insulin or other diabetes medications, as hypoglycemia may occur. Patients with moderate to severe renal impairment, acute renal issues, severe heart failure, or those undergoing certain contrast imaging tests should not use this medication. Women who are pregnant or breastfeeding and patients with severe liver or lung dysfunction should also not take this medication. This medication increases urination and can raise the risk of urinary tract infections or genital infections; any related symptoms should be discussed with a healthcare professional immediately. Long-term use may lower vitamin B12 levels; therefore, regular monitoring of blood vitamin B12 concentrations is advisable. Alcohol consumption can increase the risk of lactic acidosis, so avoid excessive drinking while taking this medication. Patients scheduled for surgery should stop taking this medication 48 hours before surgery and resume only after confirming normal renal function post-surgery. During treatment with this medication, adequate fluid intake and monitoring of the condition are essential to prevent dehydration or fluid loss. Symptoms of hypoglycemia may occur, so blood sugar levels should be monitored carefully, especially after irregular meals or vigorous exercise. This medication must be swallowed whole and should not be crushed or chewed. It is normal for the tablet coating to appear in the stool. Elderly or patients with reduced renal function may require dosage adjustments and regular renal function tests. In the case of overdose, serious side effects such as lactic acidosis may occur, and immediate medical attention is necessary, which may include hemodialysis. Finally, this medication should be stored out of reach of children and kept in its original container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, angioedema, brown skin changes (jaundice), liver dysfunction, lactic acidosis, ketoacidosis, severe allergic reactions, severe rash, blistering, skin peeling, pain in oral/ocular mucosa, breathing difficulties, asthmatic attacks, respiratory abnormalities with cough and fever, severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, decreased urine output, severe swelling, urinary abnormalities, perineal necrosis, urosepsis

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
  • altered taste
  • itching
  • rash
  • erythema
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  • vulvovaginitis
  • balanitis
  • genital infections
  • hypoglycemia
  • decreased vitamin B12
  • decreased fluid volume
  • increased urination
  • urination difficulties
  • increased serum creatinine
  • headache
  • dizziness
  • weight loss
  • insomnia
  • fatigue
  • pain
  • increased blood pressure
  • musculoskeletal pain
  • urinary stones
  • scrotal pain
  • fever
  • facial swelling
  • facial edema

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

Storage

Store this medication in a tightly sealed container to prevent exposure to air or moisture, and keep it at room temperature between 1 and 30 degrees Celsius for safety.

Appearance and packaging

Appearance

Pink rectangular extended-release film-coated tablet

Package unit

Bottle packaging - 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.