Medication info
Empagazamet Tablet 5/850 mg (Empagliflozin 2L-Proline, Metformin)

Empagazamet Tablet 5/850 mg (Empagliflozin 2L-Proline, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin 2L-Proline›7.55mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
(주)경보제약
Appearance
Oval film-coated tablet with a white color with a yellowish tint
Packaging
30 tablets/bottle, 60 tablets/bottle
Approval status
Active

MFDS item code 202502921 · Approved 2025.11.12

Summary

Main use
Blood glucose control in adults with 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, twice a day. It should be determined considering each patient's current treatment regimen, effectiveness, and tolerance without exceeding the maximum recommended daily doses of empagliflozin 25 mg and metformin 2000 mg. The recommended dosage for patients who are unable to achieve sufficient blood glucose control through monotherapy with metformin or combination therapy with other drugs, including insulin, is:

Ingredients

Manufacturer
(주)경보제약

Efficacy & effects

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

  • Blood glucose control problems in adults with type 2 diabetes
  • cardiovascular disease
  • risk of occurrence of cardiovascular events
View approved original text

This medication helps improve blood glucose control in adults with type 2 diabetes when used in combination with empagliflozin and metformin. It is administered as an adjunct to diet and exercise therapy for patients whose blood glucose is not adequately controlled, and it is particularly effective for those patients. Additionally, caution is advised for adults with type 2 diabetes and cardiovascular disease regarding the occurrence of cardiovascular events, and the directions of professionals must be closely followed. This medication is used to enhance blood glucose management and is utilized in the treatment of diabetes.

How to take

Adult dose

The recommended dosage for this medication is 1 tablet per dose, twice a day. It should be determined considering each patient's current treatment regimen, effectiveness, and tolerance without exceeding the maximum recommended daily doses of empagliflozin 25 mg and metformin 2000 mg. The recommended dosage for patients who are unable to achieve sufficient blood glucose control through monotherapy with metformin or combination therapy with other drugs, including insulin, is:

Precautions

This medication assists in lowering blood glucose and is used for diabetes treatment. However, it can cause a rare complication called severe lactic acidosis, which requires caution. Lactic acidosis is a dangerous condition where lactic acid accumulates excessively in the body, which can lead to death. Additionally, when taken in conjunction with other diabetes medications such as insulin or sulfonylureas, hypoglycemia may occur, so care should be taken. This medication should not be used in patients with severe renal impairment or in patients with acute infections, heart problems, or liver function disorders. It is also safer for women who are pregnant or breastfeeding not to take this medication. Before taking the medication, renal function must be checked, and regular blood tests should be conducted to monitor kidney status. Consult a doctor immediately if dehydration or severe vomiting, diarrhea occurs while taking the medication. This medication may increase the risk of urinary tract infections or genital infections, so quick treatment is necessary if any infection symptoms emerge. Additionally, it may lower vitamin B12 levels, so it is advisable to check blood levels while taking it for an extended period. Alcohol consumption can increase the risk of lactic acidosis, so it is best to avoid it. If surgery is approaching or undergoing tests using iodine contrast agents, the medication should be paused for a certain period, and it should be restarted only after confirming normal renal function. Elderly patients or those at risk of fluid volume loss should take greater care when taking this medication, and immediate measures should be taken if hypoglycemic symptoms arise. In case of overdose, serious side effects such as lactic acidosis may occur, so take exactly as prescribed by your doctor. Regular check-ups and symptom observation are very important while taking this medication.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • lactic acidosis
  • ketoacidosis
  • urosepsis
  • pyelonephritis
  • necrotizing fasciitis of the perineum
  • severe edema
  • myocardial infarction
  • cerebral infarction
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  • acute kidney injury
  • seizures
  • confusion
  • vision disturbances
  • paralysis
  • hypertension
  • chest tightness
  • difficulty breathing
  • asthma attacks
  • cold sweat
  • pallor
  • hepatitis
  • liver abnormalities
  • severe allergic reactions
  • severe skin adverse reactions
  • severe neurological symptoms
  • respiratory problems
  • severe edema.

Mild side effects

  • Hypoglycemia
  • urinary tract infections
  • genital infections
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • decreased appetite
  • constipation
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  • abnormal liver function tests
  • taste disturbances
  • erythema
  • itching
  • increased blood creatinine
  • increased hematocrit
  • decreased and deficiency of vitamin B12
  • weight loss
  • dizziness
  • headache
  • insomnia
  • weakness
  • chest discomfort
  • chest pain
  • fever
  • edema
  • dermal cysts
  • seborrheic dermatitis
  • atopic dermatitis
  • diabetic foot
  • and circular lesions.

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

Oval film-coated tablet with a white color with a yellowish tint

Package unit

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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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.