Medication info

Empagliflozin 25/5 mg (Empagliflozin, Linagliptin)

Prescription medicationTablet경구
Ingredient · strength
Linagliptin Micronized›5mg / 1 tabletEmpagliflozin Amorphous›25mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
Pink, round, biconvex film-coated tablet
Packaging
Bottle - 30 tablets/bottle, Bottle - 100 tablets/bottle
Approval status
Active

MFDS item code 202502185 · Approved 2025.08.22

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
The recommended starting dose is 10 mg of empagliflozin and 5 mg of linagliptin once daily. If additional blood sugar control is needed and the patient tolerates the initial dose, the dose may be increased to 25/5 mg once daily. Continue with the existing dosing regimen. This medication can be taken regardless of meals, and the tablet should be swallowed whole. If a dose is missed, it should be taken as soon as remembered, but if the next scheduled dose is within 12 hours, skip the missed dose and continue with the normal schedule.

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication assists in blood sugar control when used along with dietary and exercise therapy for patients with type 2 diabetes who have difficulty controlling blood sugar levels. The two ingredients, empagliflozin and linagliptin, work together to effectively lower blood sugar levels. Therefore, this medication is used to improve blood sugar management in type 2 diabetes.

How to take

Adult dose

The recommended starting dose is 10 mg of empagliflozin and 5 mg of linagliptin once daily. If additional blood sugar control is needed and the patient tolerates the initial dose, the dose may be increased to 25/5 mg once daily. Continue with the existing dosing regimen. This medication can be taken regardless of meals, and the tablet should be swallowed whole. If a dose is missed, it should be taken as soon as remembered, but if the next scheduled dose is within 12 hours, skip the missed dose and continue with the normal schedule.

Precautions

This medication contains two ingredients, empagliflozin and linagliptin, and is primarily used for the treatment of diabetes. First, this medication should not be used by patients with allergies to empagliflozin or linagliptin, or to other ingredients contained in the medication, nor should it be used by patients with type 1 diabetes, diabetic ketoacidosis, or those on dialysis. Caution should be exercised when using in patients with impaired kidney function, heart failure, a history of pancreatitis, or suspected bullous pemphigoid, a skin condition. The most common side effect associated with this medication during usage is urinary tract infection, while rare but serious side effects including ketoacidosis, pancreatitis, hypersensitivity reactions, and hypoglycemia may also occur. Particularly, there is a risk of hypoglycemia when this medication is taken with insulin or sulfonylureas; caution is warranted. Also, symptoms of low blood pressure or dehydration due to fluid loss may emerge, so those being treated for hypertension, elderly patients, and individuals with a history of low blood pressure should exercise additional caution when taking this medication. This medication may increase the risk of urinary tract infections and genital fungal infections, so if infection symptoms appear, immediate consultation with healthcare providers is recommended. Women who are pregnant or breastfeeding are advised not to use this medication unless specifically instructed; it is recommended to stop breastfeeding during treatment. Use in children under 18 years is not recommended due to the lack of established safety and efficacy.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • ketoacidosis
  • pancreatitis
  • bullous pemphigoid
  • pneumonia
  • acute kidney injury
  • acute pyelonephritis
  • sepsis
  • heart failure
Show 14 more
  • cardiac arrest
  • angina
  • acute myocardial infarction
  • congestive heart failure
  • shortness of breath
  • asthma attack
  • perineal necrosis
  • urosepsis
  • increased blood creatinine
  • systemic disorders
  • altered consciousness
  • paralysis
  • visual disturbances
  • severe swelling (edema)

Mild side effects

  • Urinary tract infection
  • vaginitis
  • vulvitis
  • balanitis
  • nasopharyngitis
  • cough
  • constipation
  • mouth ulcers
  • itching
  • rash
Show 20 more
  • hypoglycemia
  • thirst
  • increased urination
  • increased blood creatinine
  • decreased glomerular filtration rate
  • increased amylase
  • increased lipase
  • increased hematocrit
  • increased serum lipids
  • increased blood creatinine
  • headache
  • dizziness
  • drowsiness
  • fatigue
  • weakness
  • chest discomfort
  • fever
  • nosebleeds
  • oropharyngeal pain
  • asthma

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. The proper storage temperature is room temperature between 1°C and 30°C. Avoid storage in excessively hot or cold places.

Appearance and packaging

Appearance

Pink, round, biconvex film-coated tablet

Package unit

Bottle - 30 tablets/bottle, Bottle - 100 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.