Medication info

Zadiel Tablet 25 mg (Empagliflozin)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Empagliflozin›25mg / 1 tablet
Manufacturer / importer
지엘파마(주)
Appearance
Pale yellow oval film-coated tablet
Packaging
10 tablets/PTP [10 tablets/PTP×1], 30 tablets/PTP [10 tablets/PTP×3]
Approval status
Approval withdrawn

MFDS item code 202105979 · Approved 2021.08.17

This product's status changed to Approval withdrawn on 2026.01.23. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of 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 once daily 10 mg in monotherapy and as add-on therapy with other blood glucose-lowering agents including insulin. When additional blood sugar control is needed and well tolerated, the dose can be increased to 25 mg once daily. When used in combination with sulfonylureas or insulin, consideration of dose reductions for those agents may be necessary to reduce the risk of hypoglycemia. This medication is administered regardless of meals, with the tablets taken whole.

Ingredients

Manufacturer
지엘파마(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes and prevention of cardiovascular events

  • Abnormal blood sugar control in patients with type 2 diabetes
  • cardiovascular disease
View approved original text

This medication is used as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes. It can be used alone or in combination with other medications. Additionally, for patients with type 2 diabetes who are not adequately controlled and have cardiovascular disease, caution is necessary regarding the risk of cardiovascular events, hence clinical trial information from a professional should be considered. This medication is effectively used in diabetes management.

How to take

Adult dose

The recommended dose of this medication is once daily 10 mg in monotherapy and as add-on therapy with other blood glucose-lowering agents including insulin. When additional blood sugar control is needed and well tolerated, the dose can be increased to 25 mg once daily. When used in combination with sulfonylureas or insulin, consideration of dose reductions for those agents may be necessary to reduce the risk of hypoglycemia. This medication is administered regardless of meals, with the tablets taken whole.

Precautions

This medication should not be used in certain patients. Firstly, individuals with allergic reactions to any components of this medication should not take it. Secondly, patients with type 1 diabetes or diabetic ketoacidosis should not use this medication. Thirdly, patients with severely impaired renal function or those on dialysis should also avoid this medication. Fourthly, patients with genetic lactose intolerance or lactase deficiency, and glucose-galactose malabsorption should avoid this medication. This medication should be used with caution in patients with impaired renal function, and if renal function drops below a certain level, the medication should be discontinued. Particularly, in patients with end-stage renal disease or those on dialysis, the expected effect of this medication is not anticipated, so it is not used. In patients with mild to moderate heart failure, this medication should be used with caution, while it is not recommended for patients with severe heart failure. When this medication is used in conjunction with insulin or insulin secretagogues, there is a risk of hypoglycemia, necessitating the adjustment of dosages of these medications. During treatment, side effects such as hypoglycemia, infections, increased urination, and decreased fluid volume may occur, so caution is advised. In particular, genital infections and urinary tract infections may increase, so if symptoms occur, it is crucial to consult a doctor immediately. This medication can cause severe ketoacidosis; if suspected symptoms occur, immediate treatment should be sought, and medication discontinuation should follow if necessary. Elderly patients or those at risk for fluid volume loss should be cautious of dehydration or hypotension, with regular fluid status checks being important. Pregnant women are advised to avoid this medication, and if pregnancy is confirmed, it should be discontinued immediately. Breastfeeding women are also recommended to cease nursing during the use of this medication. Children and adolescents should not use this medication as its safety and efficacy have not been established. No specific toxicity has been reported for overdose, but if abnormal symptoms occur, immediate medical attention should be sought for appropriate treatment. Lastly, this medication may interact with other drugs, so it's important to inform healthcare professionals of any other medications being taken. Finally, this medication should be stored out of reach of children, and transferring it to another container should be avoided.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (angioedema)
  • ketoacidosis
  • urinary sepsis
  • pyelonephritis
  • perineal necrosis

Mild side effects

Hypoglycemia, vulvovaginal candidiasis, balanitis, and other genital infections, increased urination, rash, itching, increased serum creatinine, reduced glomerular filtration rate, increased serum lipids, decreased blood pressure, dehydration, hypotension, decreased blood volume, orthostatic hypotension, increased urine output, interstitial nephritis, increased serum lipids in diagnostic tests, increased hematocrit, thirst, and hypoglycemia related to blood sugar control during driving or machine operation.

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

Storage

This medication must be stored in an airtight container to prevent exposure to air or moisture, and it is best kept at room temperature between 1 to 30 degrees Celsius. Therefore, it should be securely stored away from overly hot or cold places.

Appearance and packaging

Appearance

Pale yellow oval film-coated tablet

Package unit

10 tablets/PTP [10 tablets/PTP×1], 30 tablets/PTP [10 tablets/PTP×3]

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.

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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.