Medication info
Zadium Duo Tablet 5/1000 mg (Empagliflozin, Metformin Hydrochloride)

Zadium Duo Tablet 5/1000 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
A yellow, brownish, oval-shaped, 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 202201385 · Approved 2022.04.04 · Insurance code 694004470

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dose of this medication is 1 tablet per dose, taken twice a day. The maximum recommended daily dose of empagliflozin is 25 mg, and for metformin it should not exceed 2000 mg. When using metformin alone or in combination with other medications, continue the existing metformin dosage while administering empagliflozin 5 mg twice daily (a total of 10 mg). If tolerance is excellent and additional blood sugar control is needed, empagliflozin

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

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

View approved original text

This medication is used to help control blood sugar in adults with type 2 diabetes using a combination of empagliflozin and metformin. It can effectively manage blood sugar levels when used alongside dietary and exercise regimens. It is particularly suitable for patients who do not have sufficient blood sugar control, and caution is warranted in patients with cardiovascular diseases. This medication helps maintain stable blood sugar levels for diabetes management.

How to take

Adult dose

The recommended dose of this medication is 1 tablet per dose, taken twice a day. The maximum recommended daily dose of empagliflozin is 25 mg, and for metformin it should not exceed 2000 mg. When using metformin alone or in combination with other medications, continue the existing metformin dosage while administering empagliflozin 5 mg twice daily (a total of 10 mg). If tolerance is excellent and additional blood sugar control is needed, empagliflozin

Precautions

This medication may cause a very dangerous condition called lactic acidosis, so caution is necessary, especially in individuals with impaired kidney function or those with serious infections, dehydration, or heart problems. Patients with allergies to the main ingredients or components of this medication, those with moderate to severe kidney impairment, type 1 diabetes patients, or those with acute metabolic acidosis should not take this medication. Furthermore, when undergoing tests that use iodinated contrast agents, this medication should be discontinued before and after the test and resumed only after kidney function has recovered. There is a risk of hypoglycemia when taken in conjunction with insulin or sulfonylurea medications, so blood sugar levels and symptoms should be closely monitored when using these medications together. Patients with compromised kidney function or elderly individuals should have regular kidney function tests and consider dosage adjustments or discontinuation if necessary. This medication may cause side effects such as urinary infections or genital infections, increased urination, so any related symptoms should be reported to healthcare professionals immediately. It is advisable to avoid alcohol consumption during treatment, and temporary discontinuation may be necessary during acute illnesses or surgeries. Women who are pregnant, may become pregnant, or are breastfeeding should not use this medication due to safety concerns. This medication can lower vitamin B12 levels, so periodic monitoring of vitamin B12 levels is necessary when used for extended periods. Serious side effects, such as lactic acidosis, may occur in cases of overdose, requiring immediate emergency treatment. This medication has not been established as safe or effective for use in children and is not recommended for individuals under the age of 18. Additionally, during use of this medication, care should be taken to prevent wounds on the feet and maintain foot health.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • perineal necrosis
  • ketoacidosis
  • lactic acidosis
  • pyelonephritis
  • urosepsis
  • liver dysfunction
  • hepatitis
  • acute kidney injury
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  • acute renal failure
  • cerebral infarction
  • myocardial infarction
  • heart failure
  • angina
  • cardiac disorders
  • stroke
  • severe allergic reactions
  • severe skin reactions
  • respiratory difficulties
  • difficulty breathing
  • severe edema or urination abnormalities
  • severe headache
  • confusion
  • seizures
  • vision abnormalities
  • paralysis
  • perineal necrosis.

Mild side effects

  • Urinary infections
  • genital infections
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
  • taste abnormalities
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  • itching
  • rash
  • erythema
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
  • vitamin B12 decrease and deficiency
  • fluid volume decrease
  • headache
  • dizziness
  • weakness
  • chest discomfort
  • chest pain
  • fever
  • fatigue
  • insomnia
  • weight loss
  • weight gain
  • anxiety
  • vulvar pruritus
  • genital pruritus

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

Storage

This medication should be stored in a tightly sealed container to protect it from exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the medication's efficacy over time.

Appearance and packaging

Appearance

A yellow, brownish, oval-shaped, 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.