Medication info
Empagagmet 5/500 mg (Empagliflozin 2L-Proline, Metformin)

Empagagmet 5/500 mg (Empagliflozin 2L-Proline, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin 2L-Proline›7.55mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
(주)경보제약
Appearance
Pale yellow oval film-coated tablet
Packaging
30 tablets/bottle, 60 tablets/bottle
Approval status
Active

MFDS item code 202502920 · Approved 2025.11.12

Summary

Main use
Effectiveness in blood sugar control for Type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 1 tablet, twice a day. The maximum recommended dosage per day for each ingredient is determined not to exceed Empagliflozin 25 mg and Metformin 2000 mg. In cases where sufficient blood sugar control is difficult with Metformin alone or in combination therapy with insulin or other medications, administer Empagliflozin 5 mg twice a day (total daily dosage of 10 mg) along with the existing Metformin dosage. Tolerability

Ingredients

Manufacturer
(주)경보제약

Efficacy & effects

Effectiveness in blood sugar control for Type 2 diabetes and prevention of cardiovascular events

  • Abnormal blood sugar control in adult patients with Type 2 diabetes
  • cardiovascular disease
View approved original text

This medication is used as a combination therapy of Empagliflozin and Metformin to improve blood sugar control in adult patients with Type 2 diabetes, as an adjunct to diet and exercise. It can also be used in adult diabetic patients with cardiovascular disease when blood sugar is not adequately controlled. However, information regarding events related to cardiovascular events should be referenced from clinical trial data for professionals. This medication helps effectively manage blood sugar and prevent complications associated with diabetes.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet, twice a day. The maximum recommended dosage per day for each ingredient is determined not to exceed Empagliflozin 25 mg and Metformin 2000 mg. In cases where sufficient blood sugar control is difficult with Metformin alone or in combination therapy with insulin or other medications, administer Empagliflozin 5 mg twice a day (total daily dosage of 10 mg) along with the existing Metformin dosage. Tolerability

Precautions

This medication works by the combined action of its two components to help control blood sugar. First, it helps lower blood sugar by facilitating the excretion of glucose in urine through the kidneys. Additionally, the other component suppresses excessive glucose production in the liver and improves insulin action, contributing to blood sugar control. However, this medication should not be used in patients with poor kidney function. In particular, it is prohibited to administer in cases of moderate to severe decreased kidney function. It should also be avoided in acute illnesses such as severe infections, dehydration, congestive heart failure, and acute myocardial infarction. This medication is not administered to pregnant or breastfeeding women. During the use of this drug, symptoms of hypoglycemia may occur; hence, caution should be exercised regarding the risk of hypoglycemia when used in conjunction with insulin or other hypoglycemic agents. Additionally, this medication can cause a rare but serious side effect called lactic acidosis, so if symptoms such as sudden breathing difficulty, muscle pain, weakness, or abdominal pain occur, consult a doctor immediately. Urinary tract infections or genital infections can arise, so seek prompt treatment if related symptoms occur. This drug can cause a decrease in fluid volume; thus, caution is necessary if symptoms of dehydration or low blood pressure present themselves. Also, patients with liver impairment or those who consume excessive alcohol should be cautious when taking this medication. Before and after surgery or exams using iodine contrast agents, the use of this medication should be temporarily discontinued and resumed only after kidney function returns to normal. Elderly patients may have an increased risk of decreased kidney function; thus, renal function should be regularly monitored and dosages adjusted. This drug may lower vitamin B12 levels; therefore, monitoring serum vitamin B12 concentrations periodically during long-term use is advisable. In case of overdose, treatments like dialysis may be required, so dosage must be strictly adhered to. Finally, this medication has not been established for safety and efficacy in children under 18 years old and is not recommended for pediatrics.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, lactic acidosis, ketoacidosis, urinary sepsis, pyelonephritis, necrotizing fasciitis of the perineum, myocardial infarction, cerebral infarction, stroke-like episodes, acute kidney injury, liver dysfunction (hepatitis, acute cholecystitis, autoimmune hepatitis), acute cholecystitis, hypertension accompanied by severe edema, sudden and very severe headache, seizures, confusion, visual disturbances, paralysis,

Mild side effects

  • Hypoglycemia
  • urinary tract infection
  • genital infection
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • decreased appetite
  • constipation
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  • altered taste
  • itching
  • rash
  • erythema
  • thirst
  • decreased and deficiency of vitamin B12
  • headache
  • dizziness
  • insomnia
  • weakness
  • chest discomfort
  • increased serum creatinine
  • abnormal urine
  • vulvar pruritus
  • genital pruritus
  • hypertension
  • back pain

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

Storage

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly closed container. Additionally, it is advisable to store it at room temperature between 1 to 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Pale yellow oval film-coated tablet

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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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.