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

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

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride›850mg / 1 tabletEmpagliflozin›5mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
White, oval-shaped film-coated tablet with a yellowish hue, double convex
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 202201387 · Approved 2022.04.04 · Insurance code 694004460

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage is 1 tablet once, twice a day. The maximum recommended daily dosage for each ingredient should not exceed 25 mg of Empagliflozin and 2000 mg of Metformin, based on the individual patient's current treatment regimen, efficacy, and tolerability. For patients not achieving adequate blood sugar control with Metformin alone or in combination therapies with insulin or other medications, the recommended dose is 5 mg of Empagliflozin twice a day (total daily amount)

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

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

  • Inadequately controlled blood sugar
  • type 2 diabetes
  • cardiovascular disease
View approved original text

This medicine is used to assist in blood sugar control for patients with type 2 diabetes. It is especially effective as an adjunct to dietary and exercise therapy when Empagliflozin and Metformin are used together. It is suitable for adult patients whose blood sugar is not adequately controlled, and careful evaluation is necessary for patients with cardiovascular disease. Management should be referenced based on clinical trial information for safe use. This medicine improves blood sugar control and helps the health of patients.

How to take

Adult dose

The recommended dosage is 1 tablet once, twice a day. The maximum recommended daily dosage for each ingredient should not exceed 25 mg of Empagliflozin and 2000 mg of Metformin, based on the individual patient's current treatment regimen, efficacy, and tolerability. For patients not achieving adequate blood sugar control with Metformin alone or in combination therapies with insulin or other medications, the recommended dose is 5 mg of Empagliflozin twice a day (total daily amount)

Precautions

This medicine may cause a rare but serious side effect called severe lactic acidosis, so it should not be administered to patients with impaired kidney function, severe infections, or dehydration. Care should be taken if used together with other diabetes medications such as insulin or sulfonylureas as there is a risk of hypoglycemia. Patients with impaired kidney function, acute heart failure, pregnant women, breastfeeding women, and patients with severe liver dysfunction should not take this medicine. If undergoing tests using iodine contrast agents, this medicine should be discontinued before the test and can be resumed only after confirming that kidney function returns to normal. This medicine may increase the risk of urinary tract infections and genital infections, so immediate consultation with healthcare professionals is required if related symptoms occur. Patients at risk of decreased fluid volume, such as those with dehydration or cardiovascular disease, should be carefully monitored for blood pressure and fluid status while taking this medicine. Vitamin B12 levels may decrease, so patients taking this medicine for a long period are advised to regularly check their vitamin B12 levels. Excessive alcohol consumption should be avoided while taking this medicine, as alcohol can increase the risk of lactic acidosis. Elderly patients or those with deteriorating kidney function may require dose adjustment and regular kidney function tests. During treatment, blood sugar control levels should be monitored consistently, and immediate action should be taken if hypoglycemic symptoms occur. If surgery is planned or prolonged fasting is needed due to acute illness, the use of this medicine should be temporarily halted, and restarted once the condition stabilizes. This medicine has not been confirmed for safety and efficacy in children, so it is not recommended for those under the age of 18. If symptoms such as fever, pain in the groin or perineum, swelling, skin rashes occur while taking this medicine, immediate medical attention is required, especially concerning severe infection symptoms like perineal necrosis. In case of overdose, swift medical attention is necessary, and for Metformin, the medication can be removed via hemodialysis. This medicine should be kept out of the reach of children and stored in its original container for safety.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, perineal necrosis, ketoacidosis, lactic acidosis, cerebral infarction, myocardial infarction, heart failure, acute kidney injury, acute renal failure, urosepsis, pyelonephritis, liver abnormalities (hepatitis, acute cholecystitis, autoimmune hepatitis), severe allergic reactions, severe skin adverse reactions, severe rash with fever, blistering, skin peeling, pain in oral/ocular mucosa, difficulty breathing, asthma attacks, cough accompanied by fever

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
  • altered taste
  • itching
  • rash
  • erythema
  • angioedema
  • urinary difficulty
  • interstitial nephritis
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • reduced glomerular filtration rate
  • decreased and deficient vitamin B12
  • headache
  • dizziness
  • orthostatic dizziness
  • drowsiness
  • anxiety
  • insomnia
  • weight gain

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

Storage

This medicine may be sensitive to air and moisture, so it must be stored in a tightly sealed container. Ideally, store at room temperature between 1°C and 30°C. Proper storage will help maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

White, oval-shaped film-coated tablet with a yellowish hue, double convex

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.