Medication info
Zepazinduo Tablet 5/850 mg (Empagliflozin, Metformin Hydrochloride)

Zepazinduo Tablet 5/850 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
제일약품(주)
Appearance
White, oval, double-sided, convex film-coated tablet with a yellow tint
Packaging
Bottle - 60 tablets/bottle, PTP - 60 tablets/box [(10 tablets/PTP x 6)]
Approval status
Active

MFDS item code 202501740 · Approved 2025.07.10 · Insurance code 645406550

Summary

Main use
Blood sugar control in adults with type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 1 tablet, twice daily. The dose is decided considering each patient’s current therapeutic regimen, efficacy, and tolerance within the maximum recommended daily limits of empagliflozin 25 mg and metformin 2000 mg. For patients not achieving adequate blood sugar control with monotherapy of metformin or in combination with other medications such as insulin, the recommended dose is 5 mg of empagliflozin twice daily (a total of 10 mg/day) along with the existing dose of metformin.

Ingredients

Manufacturer
제일약품(주)

Efficacy & effects

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

  • Failure to control blood sugar
  • type 2 diabetes
  • cardiovascular disease
View approved original text

This medication helps adult patients with type 2 diabetes improve blood sugar control together with diet and exercise therapy. It is particularly effective in patients whose blood sugar is not adequately controlled, and can be used cautiously in the presence of cardiovascular diseases. This medication effectively lowers blood sugar through the actions of empagliflozin and metformin, aiding in diabetes management. When used safely under the guidance of a specialist according to the patient's condition, it can improve blood sugar control.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet, twice daily. The dose is decided considering each patient’s current therapeutic regimen, efficacy, and tolerance within the maximum recommended daily limits of empagliflozin 25 mg and metformin 2000 mg. For patients not achieving adequate blood sugar control with monotherapy of metformin or in combination with other medications such as insulin, the recommended dose is 5 mg of empagliflozin twice daily (a total of 10 mg/day) along with the existing dose of metformin.

Precautions

This medication is used to help control blood sugar in diabetes patients. When using this medication, caution is necessary as rare side effects such as severe lactic acidosis may occur. Lactic acidosis can lead to serious conditions due to excessive accumulation of lactic acid in the body, which can be life-threatening. Furthermore, caution is needed as there is a risk of hypoglycemia when used with other diabetes medications such as insulin or sulfonylureas. This medication should not be used in patients with moderate to severe renal dysfunction or in those with acute renal problems. In patients with severe heart failure or acute heart issues, severe infections, or dehydration, taking this medication may pose risks and should be avoided. When undergoing examinations using radiographic iodine contrast agents, this medication should be discontinued for a certain period before and after the exam, and it should only be resumed after confirming normal kidney function. Pregnant women, women who may become pregnant, and nursing mothers should avoid taking this medication. This medication can increase urination, potentially causing fluid loss or blood pressure drop, so special caution should be exercised in the elderly or those at risk of dehydration. While taking this medication, vitamin B12 levels may decrease, so it is advisable to check through blood tests if necessary. Alcohol consumption may worsen the effects of this medication on lactic acid metabolism, so excessive drinking should be avoided while taking this medication. This medication may cause hypoglycemic symptoms, so further caution is needed when meals are skipped or exercise levels are high, and in case of hypoglycemic symptoms, immediate consultation with medical personnel is essential. While taking this medication, genital or urinary tract infections may occur, so related symptoms should be reported immediately. If surgery is planned, this medication should be discontinued 48 hours prior to the surgery, and it should be resumed only after confirming the recovery of normal kidney function. Elderly patients are at higher risk for kidney function decline, so regular monitoring of kidney function is necessary, and dosage adjustments may be needed. In case of overdose, severe side effects may occur, so it is crucial to adhere to the prescribed dosage, and if unusual symptoms arise, immediate medical attention should be sought. Finally, this medication is not to be used in children, as its safety and efficacy in this population have not been established. Lastly, this medication should be stored out of reach of children and kept in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, chest tightness, difficulty breathing, pallor, severe swelling, severe rash with fever, blistering, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanying cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, decrease in urine output.

Mild side effects

  • Hypoglycemia
  • urinary tract infection
  • genital infection
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • decrease and deficiency of vitamin B12
  • taste disturbance
  • rash
  • erythema
  • itching
  • abnormal liver function tests
  • hepatitis
  • increased blood creatinine levels
  • increased serum lipids
  • headache
  • thirst
  • weight loss
  • dizziness
  • weakness
  • chest discomfort
  • chest pain
  • insomnia
  • anxiety
  • fatigue
  • orthostatic dizziness
  • weight gain
  • abnormal electrocardiogram.

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. Additionally, it is best to store the medication at room temperature between 1°C and 30°C. This way, the medication's effectiveness is maintained for a longer duration and can be used safely.

Appearance and packaging

Appearance

White, oval, double-sided, convex film-coated tablet with a yellow tint

Package unit

Bottle - 60 tablets/bottle, PTP - 60 tablets/box [(10 tablets/PTP x 6)]

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.