Medication info
Zadium Duo Tablet 12.5/500 mg (Empagliflozin, Metformin Hydrochloride)

Zadium Duo Tablet 12.5/500 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
Light brownish purple, oval, biconvex film-coated tablet
Packaging
60 tablets/box (10 tablets/PTP x 6), 10 tablets/box (10 tablets/PTP x 1), 60 tablets/bottle, 30 tablets/bottle
Approval status
Active

MFDS item code 202302747 · Approved 2023.09.13 · Insurance code 694004430

Summary

Main use
Blood glucose control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage for this medication is 1 tablet per dose, taken twice a day. The dosing should be determined considering the current treatment regimen, efficacy, and tolerability of each patient, ensuring that the maximum recommended daily dosages of empagliflozin 25 mg and metformin 2000 mg are not exceeded. For patients unable to achieve adequate blood glucose control with metformin alone or in combination with other medications such as insulin, the recommended dose is empagliflozin 5 mg twice daily (total daily amount 10 mg) along with the existing metformin dosage.

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

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

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

This medication is used to improve blood glucose control in adults with type 2 diabetes, as an adjunct to dietary and exercise therapy. It particularly enhances blood glucose control when empagliflozin and metformin are used in combination. Special caution is advised for patients with cardiovascular diseases whose blood glucose is inadequately controlled, and clinical trial information from specialists should be referenced. This medication effectively improves blood glucose control in type 2 diabetes patients.

How to take

Adult dose

The recommended dosage for this medication is 1 tablet per dose, taken twice a day. The dosing should be determined considering the current treatment regimen, efficacy, and tolerability of each patient, ensuring that the maximum recommended daily dosages of empagliflozin 25 mg and metformin 2000 mg are not exceeded. For patients unable to achieve adequate blood glucose control with metformin alone or in combination with other medications such as insulin, the recommended dose is empagliflozin 5 mg twice daily (total daily amount 10 mg) along with the existing metformin dosage.

Precautions

This medication is used for diabetes management and contains two active components. Firstly, metformin hydrochloride lowers blood glucose but may lead to a rare side effect known as severe lactic acidosis, requiring caution. Secondly, empagliflozin increases glucose excretion in the urine, which may elevate the risk of urinary tract infections or genital infections. This medication should not be used in patients with severely impaired kidney function, acute infections, heart failure, or other serious conditions. It is also not recommended for pregnant or nursing women or patients with impaired liver function. During treatment, kidney function should be regularly monitored, especially in elderly patients or those with mildly impaired kidney function, who require closer observation. Caution must be taken to avoid fluid loss due to dehydration, severe vomiting, or diarrhea during treatment; if such symptoms occur, discontinue the medication and consult a physician. If taken alongside other diabetes medications such as insulin or sulfonylureas, there may be an increased risk of hypoglycemia, necessitating dosage adjustments. Serious metabolic disturbances such as lactic acidosis and ketoacidosis may occur. If symptoms like malaise, muscle pain, shortness of breath, or abdominal pain arise, inform healthcare personnel immediately. It is advisable to avoid alcohol consumption during treatment for blood glucose control, and to temporarily suspend use before surgeries or tests involving iodine contrast agents. Increased urination or symptoms of urinary tract infections or genital infections may occur during treatment; notify healthcare personnel if these symptoms appear. The safety of this medication in pediatric patients has not been established and is not recommended for those under 18. Furthermore, elderly patients require careful management due to the risks of kidney function decline and fluid loss. In cases of overdose, there is a risk of hypoglycemia or lactic acidosis, requiring immediate hospital treatment, and possible blood dialysis. This medication should be stored out of reach of children and kept in its original container for safety.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, severe swelling, urinary sepsis, pyelonephritis, perineal necrosis, lactic acidosis, ketoacidosis, severe skin reactions (such as severe rash with fever, blisters, skin peeling, mouth/eye mucosa pain), shortness of breath, asthma attacks, respiratory distress, liver dysfunction (jaundice, yellowing of skin or eyes, general malaise), sudden and severe headache, seizures, altered consciousness, visual disturbances, paralysis.

Mild side effects

  • Hypoglycemia
  • urinary tract infections
  • genital infections
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • abnormal liver function tests
  • hepatitis
  • taste disturbances
  • itching
  • rash
  • urticaria
  • erythema
  • angioedema
  • difficulty urinating
  • thirst
  • increased serum lipids
  • elevated serum creatinine
  • increased hematocrit
  • reduced fluid volume
  • oral discomfort
  • dizziness
  • headache
  • insomnia
  • chest discomfort
  • chest pain
  • weakness
  • weight loss
  • vulvar symptoms.

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

Storage

This medication must be stored in a sealed container to avoid exposure to air or moisture, and the storage temperature should be maintained between 1 to 30 degrees Celsius (room temperature). This is essential to preserve the medication's effectiveness and ensure its safe use.

Appearance and packaging

Appearance

Light brownish purple, oval, biconvex film-coated tablet

Package unit

60 tablets/box (10 tablets/PTP x 6), 10 tablets/box (10 tablets/PTP x 1), 60 tablets/bottle, 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.