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

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

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride›1000mg / 1 tabletEmpagliflozin Amorphous›25mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
Pink oblong extended-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202500764 · Approved 2025.04.01 · Insurance code 645211070

Summary

Main use
Effect on blood glucose control and prevention of cardiovascular events in adults with type 2 diabetes
Who takes it
Adults
Adult dose
This medication is administered as one tablet containing 25 mg of empagliflozin and 1000 mg of metformin hydrochloride (extended-release) once daily with meals. To maintain the extended-release properties, it should not be broken, crushed, chewed, or taken apart but swallowed whole. When converting from immediate-release metformin to extended-release formulations, close monitoring of blood glucose control is required, and dosage adjustments should be made accordingly. Dosage adjustments are necessary depending on renal function, and mild renal impairment patients should take care.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

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

  • Blood glucose disorder
  • type 2 diabetes
  • cardiovascular disease
View approved original text

This medication is used to help control blood glucose levels in adults with type 2 diabetes in conjunction with dietary and physical exercise therapies. It is particularly suitable for patients whose blood glucose is not adequately controlled, and some patients with cardiovascular diseases should refer to the physician's notes. This medication effectively improves blood glucose control by administering empagliflozin and metformin together.

How to take

Adult dose

This medication is administered as one tablet containing 25 mg of empagliflozin and 1000 mg of metformin hydrochloride (extended-release) once daily with meals. To maintain the extended-release properties, it should not be broken, crushed, chewed, or taken apart but swallowed whole. When converting from immediate-release metformin to extended-release formulations, close monitoring of blood glucose control is required, and dosage adjustments should be made accordingly. Dosage adjustments are necessary depending on renal function, and mild renal impairment patients should take care.

Precautions

This medication is used for the treatment of type 2 diabetes, acting with two components to control blood glucose. While taking this medication, a rare side effect called lactic acidosis may occur, so if symptoms such as shortness of breath, muscle pain, and fatigue arise, immediate consultation with a physician is necessary. Also, when taken with insulin or sulfonylurea medications, there is a risk of hypoglycemia, so blood glucose levels should be carefully monitored. Patients with impaired kidney function or acute renal failure should not use this medication and should undergo regular kidney function tests. Avoid administration in cases of acute infections, dehydration, severe heart failure, and liver dysfunction, and temporary discontinuation is necessary when surgery is planned or contrast agent examinations are to be conducted. This medication may increase the risk of genital and urinary tract infections; hence, rapid treatment should be sought if infection symptoms occur. Vitamin B12 levels may decrease, so monitoring through blood testing is recommended when used long-term. Pregnant or breastfeeding women should not take this medication, particularly if there is a possibility of pregnancy. Elderly patients or those at risk of fluid loss should carefully monitor for dehydration or hypotension symptoms and be well aware of hypoglycemia symptoms. Do not crush, chew, or break the tablets but swallow them whole; it is normal for the tablet coating to be excreted in stool. If an overdose occurs, immediately visit a medical institution for appropriate treatment as there is a risk of lactic acidosis. It is advisable to avoid alcohol consumption during the use of this medication and to inform the physician of any other medications being taken due to potential interactions. No special effects have been reported when operating vehicles or machinery; however, caution is necessary due to possible hypoglycemia or dizziness. To use this medication safely, regular blood tests and strict adherence to the physician's instructions are required.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, perineal necrosis, ketoacidosis, lactic acidosis, urosepsis and pyelonephritis, severe allergic reactions, severe skin adverse reactions, severe edema, acute kidney injury, liver abnormalities (jaundice), myocardial infarction, cerebral infarction, concussion, severe neurological symptoms (headache, seizures, consciousness confusion, vision disturbances, paralysis), heart failure, shock, sepsis, acute myocardial infarction, acute cholecystitis, autoimmune hepatitis, cholelithiasis,

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
  • taste disturbances
  • itching
  • rash
  • increased serum creatinine
  • increased serum lipids
  • decreased vitamin B12
  • decreased fluid volume
  • headache
  • dizziness
  • weakness
  • chest pain
  • fever
  • weight loss
  • insomnia
  • fatigue
  • edema
  • increased blood pressure
  • dryness
  • anxiety
  • back pain
  • joint pain
  • musculoskeletal pain

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 to 30 degrees Celsius. This will help maintain the effectiveness and safety of the medication over time.

Appearance and packaging

Appearance

Pink oblong extended-release film-coated tablet

Package unit

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.