Medication info
Zadim Duo Tablet 5/500 mg (Empagliflozin, Metformin Hydrochloride)

Zadim Duo Tablet 5/500 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
Orange-yellow, 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 202201386 · Approved 2022.04.04 · Insurance code 694004450

Summary

Main use
Effective in blood glucose control and prevention of cardiovascular events in type 2 diabetes
Who takes it
Adults
Adult dose
The recommended dose of this medication is 1 tablet once, twice a day. The dose is determined within the range not exceeding 25 mg of empagliflozin and 2000 mg of metformin, depending on each patient's treatment regimen and tolerability. If blood glucose control is insufficient with metformin alone or in combination with other medications, take 5 mg of empagliflozin twice daily (total 10 mg) with the existing dose of metformin. If tolerability is good and additional blood glucose control is needed, the dose may be escalated to 25 mg of empagliflozin daily.

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

Effective in blood glucose control and prevention of cardiovascular events in type 2 diabetes

  • Type 2 diabetes
  • blood glucose control abnormalities
  • cardiovascular diseases
  • cardiovascular events
View approved original text

This medication effectively assists in blood glucose control for adult patients with type 2 diabetes through the combination therapy of empagliflozin and metformin. When used junto with diet and exercise therapy, it improves blood glucose levels and is particularly suitable for patients whose blood glucose control is insufficient. Caution is required in patients with cardiovascular disease, and it is essential to refer to relevant clinical information. This medication enhances blood glucose control and aids in diabetes management.

How to take

Adult dose

The recommended dose of this medication is 1 tablet once, twice a day. The dose is determined within the range not exceeding 25 mg of empagliflozin and 2000 mg of metformin, depending on each patient's treatment regimen and tolerability. If blood glucose control is insufficient with metformin alone or in combination with other medications, take 5 mg of empagliflozin twice daily (total 10 mg) with the existing dose of metformin. If tolerability is good and additional blood glucose control is needed, the dose may be escalated to 25 mg of empagliflozin daily.

Precautions

This medication can cause severe lactic acidosis; thus, if symptoms of lactic acidosis such as malaise, muscle pain, difficulty breathing, weakness, or abdominal pain occur, consult a physician immediately. When used in conjunction with other diabetes treatments such as insulin or sulfonylureas, there is a rare risk of hypoglycemia, so close monitoring of blood glucose changes is essential. This medication should not be administered to individuals with allergies to its ingredients or with moderate to severe impaired renal function, or conditions that may induce acute renal injury. Patients in serious conditions such as acute infections, heart failure, myocardial infarction, shock, etc., should temporarily discontinue using this medication before and after surgery and resume after kidney function recovery. Pregnant women, those who may become pregnant, or nursing mothers should not use this medication; particularly during pregnancy, insulin treatment is recommended for blood glucose management. This medication affects renal function, so regular kidney function tests are necessary, and if abnormal findings occur, consultation with a physician is advised. Caution is needed for patients at risk of fluid loss, such as those with cardiovascular disease, elderly individuals, and those with dehydration symptoms. During treatment with this medication, urinary tract infections and genital infections may occur; immediately inform healthcare professionals if infection symptoms develop. Vitamin B12 levels may decrease, so it is advised to monitor vitamin B12 concentrations during prolonged use. Alcohol consumption can increase the risk of lactic acidosis, so excessive drinking should be avoided while taking this medication. If hypoglycemia symptoms occur, immediately consume sugar; if symptoms persist, seek medical assistance. This medication has not been established for safety and efficacy in children, so it is recommended that individuals under 18 years of age do not take it. Elderly patients need dose adjustments and regular monitoring due to higher risks of renal function decline and fluid loss. In cases of overdose, severe side effects such as lactic acidosis may occur, so immediate medical treatment should be sought.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, necrosis of the perineum, lactic acidosis, severe allergic reactions, ketoacidosis, urosepticemia, pyelonephritis, severe edema, liver abnormalities (jaundice), severe neurological symptoms (headaches, seizures, confusion, visual disturbances, paralysis), severe dermatological adverse reactions (rash, blisters, skin peeling, mucosal pain), acute kidney injury, acute cholecystitis, autoimmune hepatitis, cholelithiasis, myocardial infarction, cerebral infarction, sepsis, shock

Mild side effects

  • Hypoglycemia
  • urinary tract infections
  • genital infections
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
Show 22 more
  • abnormal liver function tests
  • hepatitis
  • altered taste
  • itching
  • rash
  • erythema
  • increased serum lipids
  • increased blood creatinine
  • decreased glomerular filtration rate
  • decreased and deficiency of vitamin B12
  • thirst
  • hypoglycemia
  • dyspepsia
  • headache
  • dizziness
  • weight loss
  • weight gain
  • insomnia
  • anxiety
  • chest discomfort
  • chest pain
  • weakness

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

Storage

This medication must be stored in a tightly sealed container to avoid exposure to air and moisture. It is best to keep it at room temperature between 1 to 30 degrees Celsius. Storing it this way will safely maintain its effectiveness.

Appearance and packaging

Appearance

Orange-yellow, 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.