Medication info
Zepazine Duo Tablets 12.5/850 mg (Empagliflozin, Metformin Hydrochloride)

Zepazine Duo Tablets 12.5/850 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
제일약품(주)
Appearance
Biconvex oval film-coated tablet with a pinkish white color
Packaging
Bottle - 60 tablets/bottle, PTP - 60 tablets/box [(10 tablets/PTP x 6)]
Approval status
Active

MFDS item code 202501819 · Approved 2025.07.17 · Insurance code 645406580

Summary

Main use
Effect on blood sugar control and cardiovascular event prevention in adults with type 2 diabetes
Who takes it
Adults
Adult dose
The recommended dose of this medication is 1 tablet once, twice a day. The maximum daily recommended dose for each ingredient should not exceed 25 mg of empagliflozin and 2000 mg of metformin, and should be determined based on each patient's current treatment regime, efficacy, and tolerability. For patients who do not achieve adequate blood sugar control with metformin alone or in combination with other medications such as insulin, a dose of 5 mg of empagliflozin twice a day may be prescribed.

Ingredients

Manufacturer
제일약품(주)

Efficacy & effects

Effect on blood sugar control and cardiovascular event prevention in adults with type 2 diabetes

View approved original text

This medication is used to improve blood sugar control in adult patients with type 2 diabetes by complementing dietary and exercise therapy through the combination of empagliflozin and metformin. It is particularly effective for patients whose blood sugar is not well controlled, and may also be used with caution in patients with cardiovascular disease to prevent cardiovascular events. This medication helps enhance overall blood sugar management.

How to take

Adult dose

The recommended dose of this medication is 1 tablet once, twice a day. The maximum daily recommended dose for each ingredient should not exceed 25 mg of empagliflozin and 2000 mg of metformin, and should be determined based on each patient's current treatment regime, efficacy, and tolerability. For patients who do not achieve adequate blood sugar control with metformin alone or in combination with other medications such as insulin, a dose of 5 mg of empagliflozin twice a day may be prescribed.

Precautions

This medication is used for the treatment of diabetes and aids in blood sugar control. When taking this medication, kidney function should be regularly monitored to ensure it is normal, and it should not be used if kidney function is severely impaired. This medication should not be taken in cases of severe infections, dehydration, or acute heart disease. It is advisable that pregnant women or women of childbearing potential, and breastfeeding women, refrain from using this medication. This medication can cause hypoglycemia, so caution is necessary when taken alongside insulin or other hypoglycemic agents, and dose adjustments may be required. Rare but serious side effects such as lactic acidosis may occur; if symptoms such as malaise, muscle pain, difficulty breathing, or abdominal pain arise, immediate consultation with a physician is necessary. Moreover, this medication may increase the risk of urinary tract infections or genital infections, so rapid treatment is required if infection symptoms are present. When undergoing surgery or iodine contrast imaging tests, this medication should be temporarily discontinued and resumed only after ensuring normal kidney function post-testing. Alcohol consumption may increase the risk of lactic acidosis, so excessive drinking should be avoided while taking this medication. Elderly patients or those at risk of fluid loss should be vigilant about dehydration and hypotension, and regular blood tests and kidney function assessments are important. This medication is not recommended for children, and any unusual reactions should be reported to healthcare personnel immediately. Finally, 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, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in mucous membranes of mouth/eyes, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by coughing and fever, yellowing of skin or eyes, extreme lethargy, sudden severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, markedly reduced urine output

Mild side effects

  • Hypoglycemia
  • urinary tract infection
  • genital infection
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • appetite loss
  • constipation
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  • abnormal liver function tests
  • hepatitis
  • taste disturbances
  • itching
  • rash
  • erythema
  • increased serum lipid levels
  • increased serum creatinine
  • thirst
  • decreased vitamin B12 levels
  • dizziness
  • headache
  • weakness
  • chest discomfort
  • chest pain
  • weight loss
  • insomnia
  • vulvar itching
  • shortness of breath
  • cough
  • fever
  • facial swelling
  • edema
  • pain

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. The recommended storage temperature is at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Biconvex oval film-coated tablet with a pinkish white color

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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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.