Medication info
Empagliflozin 10 mg Tablet

Empagliflozin 10 mg Tablet

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

MFDS item code 202105849 · Approved 2021.08.11 · Insurance code 643508890

Summary

Main use
Treatment for type 2 diabetes blood sugar control and reduction of cardiovascular disease risk in chronic heart failure and kidney disease
Who takes it
Adults
Adult dose
For type 2 diabetes, take 10 mg once daily as monotherapy and in addition to other hypoglycemic agents like insulin. If tolerance is good and further blood sugar control is needed, the dosage can be increased to 25 mg once daily. For chronic heart failure and chronic kidney disease, take 10 mg once daily. This medication can be taken irrespective of meals and should be swallowed whole.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Treatment for type 2 diabetes blood sugar control and reduction of cardiovascular disease risk in chronic heart failure and kidney disease

  • Type 2 diabetes
  • chronic heart failure
  • chronic kidney disease
View approved original text

This medication is primarily used in conjunction with dietary and exercise regimens to help control blood sugar in adults with type 2 diabetes. It also helps reduce the risk of death and hospitalization due to cardiovascular disease in patients with chronic heart failure. Additionally, it is effective in reducing the risk of deterioration of kidney function or death due to cardiovascular disease in patients with chronic kidney disease. Therefore, this medication plays an important role not only in diabetes management but also in managing heart failure and kidney disease, thereby improving health status.

How to take

Adult dose

For type 2 diabetes, take 10 mg once daily as monotherapy and in addition to other hypoglycemic agents like insulin. If tolerance is good and further blood sugar control is needed, the dosage can be increased to 25 mg once daily. For chronic heart failure and chronic kidney disease, take 10 mg once daily. This medication can be taken irrespective of meals and should be swallowed whole.

Precautions

This medication should not be used by those who are allergic to the active ingredient or any of the components. It should not be administered to type 1 diabetes patients or those with diabetic ketoacidosis, and patients who genetically cannot digest lactose should not take this medication. For patients with poor kidney function, kidney function should be regularly monitored while using this medication, and it is not recommended for patients with severely low kidney function. There is a risk of hypoglycemia when taken with insulin or insulin-secreting medications, so dose adjustment may be necessary. Patients should be carefully monitored for side effects such as hypoglycemia, infections, especially genital and urinary tract infections, decreased fluid volume, and increased urination while taking this medication. Rarely, severe metabolic abnormalities known as ketoacidosis may occur, and if symptoms appear, immediate consultation with medical professionals is necessary. Elderly patients or those at risk of fluid volume loss should be cautious of dehydration or hypotension, and monitoring of fluid status is recommended. This medication has been reported to cause liver damage, so liver health should also be carefully monitored. Caution is required during driving or operating machinery due to the risk of hypoglycemia, especially when used in conjunction with insulin and similar products. Women who are pregnant or breastfeeding should avoid taking this medication, and it should be immediately discontinued upon confirmation of pregnancy. Children should not use this medication as safety and efficacy have not been established. No specific toxic symptoms have been reported in cases of overdose, but appropriate treatment is needed based on clinical status. This medication should be kept out of the reach of children, and transferring it to another container should be avoided to maintain quality and safety.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • ketoacidosis
  • urinary tract sepsis
  • pyelonephritis
  • perineal necrosis
  • severe allergic reactions
  • severe skin adverse reactions
  • severe edema or urination abnormalities
  • liver abnormalities (jaundice)
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  • serious neurological symptoms
  • respiratory problems
  • acute kidney injury
  • fever
  • deep vein thrombosis
  • angina
  • Prinzmetal angina
  • coronary artery disease
  • acute cholecystitis
  • autoimmune hepatitis
  • gallstones
  • sepsis
  • pneumonia
  • pulmonary tuberculosis

Mild side effects

Constipation, itching, rash, hypoglycemia, vulvovaginal candidiasis, vulvitis, glans inflammation and other genital infections, increased urination, difficulty urinating, interstitial nephritis, thirst, increased serum lipids, increased serum creatinine, decreased glomerular filtration rate, increased hematocrit, diarrhea, nausea, gastric ulcer, colitis, vomiting, ischemic colitis, gastrointestinal bleeding, soft tissue infection, appendiceal abscess, appendicitis, chronic otitis media, peritonsillar abscess

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

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture ingress and should be kept at a temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain its effectiveness for a longer period.

Appearance and packaging

Appearance

Pale yellow, round film-coated tablet

Package unit

30 tablets/box [(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.

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.