Medication info
Empagagliptin 2L-Proline/Metformin Tablets 5/1000 mg

Empagagliptin 2L-Proline/Metformin Tablets 5/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin 2L-Proline›7.55mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
(주)경보제약
Appearance
Dark yellow oval film-coated tablets
Packaging
30 tablets/bottle, 60 tablets/bottle
Approval status
Active

MFDS item code 202502938 · Approved 2025.11.13

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dose for this medication is 1 tablet once daily, taken twice a day. The maximum recommended daily dose for empagagliptin is 25 mg, and for metformin, it should not exceed 2000 mg. For patients on monotherapy with metformin or combined with other medications, empagagliptin can be taken at 5 mg twice a day (total daily dose of 10 mg), and can be increased to a total of 25 mg daily if tolerance is good and additional blood sugar control is needed.

Ingredients

Manufacturer
(주)경보제약

Efficacy & effects

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

  • Poor blood sugar control in patients with type 2 diabetes
  • cardiovascular disease
View approved original text

This medication is used in conjunction with dietary and exercise therapy to improve blood sugar control in patients with type 2 diabetes. By using empagagliptin and metformin together, blood sugar can be effectively controlled. It can also provide assistance when blood sugar control is insufficient, and caution is needed when used in patients with cardiovascular disease. For some patients, consideration of the impact on cardiovascular events is essential, so it is important to receive guidance from a specialist. Overall, this medication is used to enhance blood sugar control and support diabetes management.

How to take

Adult dose

The recommended dose for this medication is 1 tablet once daily, taken twice a day. The maximum recommended daily dose for empagagliptin is 25 mg, and for metformin, it should not exceed 2000 mg. For patients on monotherapy with metformin or combined with other medications, empagagliptin can be taken at 5 mg twice a day (total daily dose of 10 mg), and can be increased to a total of 25 mg daily if tolerance is good and additional blood sugar control is needed.

Precautions

This medication is helpful in controlling blood sugar. However, it may cause a dangerous condition known as severe lactic acidosis, so caution is needed. When used with other diabetes medications, hypoglycemia may occur, so it should be used carefully. Patients with significantly impaired kidney function, acute infections, dehydration, or cardiac issues should not use this medication. Also, it is safe for pregnant or breastfeeding women to avoid this medication. Kidney function should be monitored regularly during treatment, and special caution should be taken if symptoms of dehydration or gastrointestinal discomfort occur. Urinary tract infections or genital infections may occur, so any symptoms should be reported to healthcare providers immediately. If sudden fatigue, muscle pain, difficulty breathing, or abdominal pain occurs while taking this medication, it could be a sign of lactic acidosis and immediate medical attention should be sought. It may be necessary to consult with a doctor about temporarily stopping the medication before surgery or radiological examinations. Taking this medication with alcohol can be dangerous, so it is best to avoid drinking. Elderly or patients with weak kidney function may require dose adjustments and regular monitoring. There is a risk of hypoglycemia, so caution should be exercised in skipping meals or after vigorous exercise. Monitoring vitamin B12 levels during the medication period is advisable. Following these precautions can ensure safe therapeutic effects.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, necrotizing fasciitis of the perineum, lactic acidosis, ketoacidosis, urosepsis, pyelonephritis, severe edema, liver dysfunction (jaundice), severe allergic reactions, severe skin adverse reactions, difficulty breathing, asthma attacks, heart problems (myocardial infarction, angina), cerebral infarction, seizures, confusion, visual disturbances, paralysis, significantly reduced urine output, potential worsening of diseases due to increased urine output, severe edema or urination.

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
  • altered taste
  • itching
  • rash
  • erythema
  • increased blood creatinine
  • decreased glomerular filtration rate
  • reduced and deficient vitamin B12
  • thirst
  • increased serum lipids
  • headache
  • dizziness
  • insomnia
  • cough
  • difficulty breathing
  • weight loss
  • vulvar pruritus
  • genital pruritus
  • hypertension
  • anxiety
  • etc.

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

Storage

This medication may be sensitive to air and light, so it should be stored in a sealed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius. By storing it this way, the effects of the medication can be safely maintained.

Appearance and packaging

Appearance

Dark yellow oval film-coated tablets

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.