Medication info

Empagliflozin 10 mg (Empagliflozin)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Empagliflozin›10mg / 1 tablet
Manufacturer / importer
(주)킵스바이오파마
Appearance
Yellowish-colored, bilaterally convex, round, film-coated tablets
Packaging
10 tablets/box [10 tablets/PTP*1], 30 tablets/box [10 tablets/PTP*3], 30 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202102034 · Approved 2021.03.04

This product's status changed to Approval withdrawn on 2025.03.21. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Effectiveness in blood sugar control for type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage for this medication is once daily 10 mg for monotherapy and adjunctive therapy with other glucose-lowering medications such as insulin. If the 10 mg dose is well-tolerated, the dose may be increased to 25 mg once daily for additional blood sugar control. When used in combination with sulfonylureas or insulin, a reduction in the dose of sulfonylureas or insulin should be considered to reduce the risk of hypoglycemia.

Ingredients

Manufacturer
(주)킵스바이오파마

Efficacy & effects

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

  • Type 2 diabetes
  • difficulty controlling blood sugar
  • inability to control blood sugar
  • cardiovascular disease
  • occurrence of cardiovascular events
View approved original text

This medication is used to improve blood sugar control in adults with type 2 diabetes and serves as an adjunct to diet and exercise. It can be used alone when blood sugar control is difficult and may be combined with medications such as metformin, pioglitazone, sulfonylureas, insulin, or the DPP-4 inhibitor linagliptin, as needed. It plays an important role in blood sugar control, particularly for patients with cardiovascular disease, thus should be used with caution according to expert guidance. This medication is used to enhance blood sugar control and assist in diabetes management.

How to take

Adult dose

The recommended dosage for this medication is once daily 10 mg for monotherapy and adjunctive therapy with other glucose-lowering medications such as insulin. If the 10 mg dose is well-tolerated, the dose may be increased to 25 mg once daily for additional blood sugar control. When used in combination with sulfonylureas or insulin, a reduction in the dose of sulfonylureas or insulin should be considered to reduce the risk of hypoglycemia.

Precautions

This medication should not be used by patients with allergic reactions to the active ingredient or other components. Patients with type 1 diabetes or diabetic ketoacidosis should not take this medication. It is not suitable for patients with severely impaired kidney function, end-stage renal disease, or undergoing dialysis. Due to the presence of lactose in this medication, patients with genetic issues such as lactose intolerance, lactase deficiency, or glucose-galactose malabsorption should also avoid taking it. Patients with mildly impaired kidney function should use this medication cautiously, and dosage adjustments or discontinuation may be needed based on kidney function. Patients with mild to moderate heart failure should use it carefully, and it is not recommended for patients with severe heart failure. When taken concurrently with medications such as insulin or sulfonylureas, there may be a risk of hypoglycemia, so dose adjustments may be necessary. Patients should be cautious of side effects such as hypoglycemia, genital infections, urinary tract infections, increased urination, and fluid volume depletion while taking this medication. Particularly, elderly patients or those at risk of fluid volume depletion should be vigilant for dehydration or hypotension, and regular monitoring of kidney function is required. This medication can cause a serious metabolic disturbance known as ketoacidosis, so any related symptoms should be promptly discussed with healthcare professionals. Pregnant women should avoid using this medication, and it should also be avoided during breastfeeding. Caution is needed during driving or operating machinery due to the risk of hypoglycemia while taking this medication. No specific toxic symptoms are known in the case of overdose, but appropriate treatment may be required based on clinical status. This medication has not been established as safe or effective for use in children and adolescents, so it should not be administered to them. When storing this medication, it should be kept out of the reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), angioedema, ketoacidosis, urinary sepsis, pyelonephritis, rash, necrotizing fasciitis, liver injury (no reports of liver dysfunction or jaundice-related adverse reactions, but liver injury has been noted), urinary sepsis and pyelonephritis, ketoacidosis, necrotizing fasciitis, increased serum creatinine, decreased glomerular filtration rate, acute kidney injury, acute cholecystitis, autoimmune hepatitis, cholelithiasis, deep vein thrombosis, serious allergic reactions

Mild side effects

  • Hypoglycemia
  • genital mycotic infection
  • vulvovaginitis
  • balanitis
  • other genital infections
  • increased urination
  • rash
  • urticaria
  • angioedema
  • fluid volume depletion
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  • increased serum creatinine
  • decreased glomerular filtration rate
  • itching
  • vomiting
  • diarrhea
  • nausea
  • headache
  • dizziness
  • fatigue
  • peripheral edema
  • facial edema
  • fever
  • swelling
  • pain
  • decreased blood pressure
  • dehydration
  • hypotension
  • reduced blood volume
  • orthostatic hypotension
  • nocturia
  • blood and lymphatic system disorders

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 air and moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius to ensure the medication remains effective and safe to use.

Appearance and packaging

Appearance

Yellowish-colored, bilaterally convex, round, film-coated tablets

Package unit

10 tablets/box [10 tablets/PTP*1], 30 tablets/box [10 tablets/PTP*3], 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.