Medication info

Innoen Empagliflozin 25 mg

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

MFDS item code 202105730 · Approved 2021.08.04

Summary

Main use
Treatment of type 2 diabetes by improving blood sugar control
Who takes it
Adults
Adult dose
The recommended dosage for this medication is 10 mg once daily for monotherapy and for additional combination therapy with other glucose-lowering agents such as insulin. If the 10 mg dose is well tolerated and additional blood sugar control is required, the dose can be increased to 25 mg once daily. This medication can be taken regardless of meals. The tablet should be swallowed whole. Do not take double the dose in one day.

Ingredients

Manufacturer
에이치케이이노엔(주)

Efficacy & effects

Treatment of type 2 diabetes by improving blood sugar control

  • Type 2 diabetes
  • impaired blood sugar control
  • 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. In particular, in patients with type 2 diabetes whose blood sugar is not adequately controlled and who have cardiovascular disease, caution is needed for the occurrence of cardiovascular events, and guidance from a specialist should be sought. This medication helps with diabetes management by improving blood sugar control.

How to take

Adult dose

The recommended dosage for this medication is 10 mg once daily for monotherapy and for additional combination therapy with other glucose-lowering agents such as insulin. If the 10 mg dose is well tolerated and additional blood sugar control is required, the dose can be increased to 25 mg once daily. This medication can be taken regardless of meals. The tablet should be swallowed whole. Do not take double the dose in one day.

Precautions

This medication should not be used in certain patients. Patients with allergies to the main ingredient or components, individuals with type 1 diabetes or diabetic ketoacidosis should not be administered this drug. Patients with severely impaired kidney function or end-stage renal disease, and patients undergoing dialysis should also not take this medication. Additionally, it should not be administered to patients with genetic metabolic disorders such as lactase intolerance. In patients with mild kidney impairment, it should be administered with caution, and regular kidney function tests are important. If kidney function continuously worsens, this medication should be discontinued. It is not recommended for severely ill patients with heart failure. When taken with blood glucose-lowering medications such as insulin or sulfonylureas, there is a risk of hypoglycemia, and dosage adjustments may be necessary. Adverse reactions that may occur while taking this medication include hypoglycemia, genital infections, urinary tract infections, increased urination, and decreased blood volume, with special caution being necessary for the elderly due to a higher risk of fluid loss. Severe metabolic disturbances such as ketoacidosis may occur, so if symptoms appear, immediate treatment should be sought, and this medication is not to be used in the treatment of type 1 diabetes. Reports of liver damage have also been made, so patients with liver dysfunction should exercise caution, and special attention is needed for the elderly or those at risk of fluid loss. There is a significant risk of severe urinary tract infections such as urosepsis and pyelonephritis, so immediate treatment should be sought if symptoms of infection arise. There is also an increased risk of genital fungal infections, so patients with a history of infections should be closely monitored. This medication may show positive results in urine glucose tests, so be mindful when interpreting test results. Caution is needed when driving or operating machinery due to the risk of hypoglycemia, especially when taken in combination with insulin or sulfonylureas. While no specific toxicities have been reported from overdose, appropriate treatment is needed depending on the clinical condition. Use during pregnancy is not recommended, and if pregnancy is confirmed, the medication should be discontinued. It is safest to stop breastfeeding while taking this medication. Safety and efficacy in pediatric patients have not been established, so it should not be administered to patients under 18 years of age. Regular kidney function tests and monitoring for symptoms of infection are needed during the course of this medication, and any abnormal symptoms should prompt immediate consultation with healthcare professionals.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • ketoacidosis
  • urosepsis
  • pyelonephritis
  • perineal necrosis.

Mild side effects

  • Hypoglycemia
  • vulvovaginal candidiasis
  • vulvitis
  • balanitis
  • urinary tract infection
  • rash
  • itching
  • increased urination
  • increased serum creatinine
  • decreased glomerular filtration rate
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  • decreased blood volume
  • decreased blood pressure
  • dehydration
  • hypotension
  • decreased blood volume
  • orthostatic hypotension
  • syncope
  • interstitial nephritis
  • thirst
  • increased serum lipids
  • increased blood creatinine
  • increased hematocrit.

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air and moisture, and it is best stored at room temperature between 1°C and 30°C. Storing it this way helps to maintain the medication's effectiveness.

Appearance and packaging

Appearance

Pale yellow oval film-coated tablet

Package unit

30 tablets - 30 tablets/PTP[(10 tablets/PTP×3)], 10 tablets - 10 tablets/PTP[(10 tablets/PTP×1)]

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.