Medication info
Empagliflozin 25 mg (Empagliflozin)

Empagliflozin 25 mg (Empagliflozin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›25mg / 1 tablet
Manufacturer / importer
삼천당제약(주)
Appearance
Pale yellow, round, biconvex, film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202102076 · Approved 2021.03.05 · Insurance code 651206180

Summary

Main use
Improvement of blood sugar control in adults with type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this drug is 10 mg once daily for monotherapy and additional combination therapy with insulin or other antihyperglycemic agents. If tolerability is excellent and additional blood sugar control is needed, the dose may be increased to 25 mg once daily. This drug can be taken without regard to food. The tablet should be swallowed whole. If a dose is missed, take it as soon as remembered, but do not take a double dose in one day.

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

Improvement of blood sugar control in adults with 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 drug is used in conjunction with diet and exercise therapy to help control blood sugar in adult patients with type 2 diabetes. It can be used as monotherapy and, if blood sugar control is insufficient, can be combined with metformin, pioglitazone, sulfonylureas, or insulin. It can also be used in combination with the DPP-4 inhibitor linagliptin. Special caution is necessary for patients with type 2 diabetes who have cardiovascular disease regarding the occurrence of cardiovascular events. Overall, this drug is used to improve blood sugar control effects in conjunction with various treatment options.

How to take

Adult dose

The recommended dosage of this drug is 10 mg once daily for monotherapy and additional combination therapy with insulin or other antihyperglycemic agents. If tolerability is excellent and additional blood sugar control is needed, the dose may be increased to 25 mg once daily. This drug can be taken without regard to food. The tablet should be swallowed whole. If a dose is missed, take it as soon as remembered, but do not take a double dose in one day.

Precautions

This drug should not be used in patients who are allergic to the active ingredient or any components. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. This drug is not to be used in patients with severely impaired kidney function, end-stage renal disease, or those on dialysis. This drug contains lactose, so patients with lactose intolerance or related genetic disorders should not take it. Patients with mildly impaired kidney function require dosage adjustment, and if kidney function worsens, administration should be discontinued. Due to the expected lack of efficacy in end-stage renal disease or dialysis patients, this drug should not be used in these groups. Mild cases in patients with heart failure should use this medication cautiously, while it is not advisable for severe cases. When used with insulin or insulin secretagogues, there may be a risk of hypoglycemia, so dosage adjustments may be necessary. During treatment with this drug, side effects such as hypoglycemia, infections, and increased urination may occur, so symptoms should be monitored. Particularly for women, genital infections may occur more frequently, and immediate treatment is needed if symptoms develop. There may be a reduction in fluid volume or blood pressure, so caution is advised for the elderly or those with low blood pressure. Serious side effects, such as liver dysfunction or ketoacidosis, have been reported, so if symptoms occur, immediate consultation with a healthcare professional is necessary. This drug may have a mild effect when driving or operating machinery, so caution is required, especially in cases with a risk of hypoglycemia. It is recommended that pregnant or nursing women avoid this drug and discontinue use if pregnancy is confirmed. Safety and efficacy in children under 18 years of age have not been established, so it is not to be used in this population. No specific toxic symptoms have been reported in cases of overdose, but in the event of an overdose, immediate healthcare consultation is advised to receive appropriate treatment. This drug should be stored out of reach of children, and it is safe not to transfer it to another container. Regular kidney function tests are essential during the use of this drug, and any abnormal symptoms should be discussed with a healthcare professional immediately.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, ketoacidosis, urosepsis, pyelonephritis, perineal necrosis, severe allergic reactions, severe cutaneous adverse reactions, severe neurological symptoms (headache, stroke, intracranial aneurysm), liver abnormalities (jaundice), acute cholecystitis, autoimmune hepatitis, cholelithiasis, angina, Prinzmetal angina, coronary artery disease, deep vein thrombosis, severe edema, acute renal injury, ureteral stone disease, sudden and very

Mild side effects

  • Hypoglycemia
  • vulvovaginal candidiasis
  • vulvitis
  • glans inflammation
  • and other genital infections
  • increased urination
  • rash
  • itching
  • increased serum creatinine
  • decreased glomerular filtration rate
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  • thirst
  • reduced fluid volume
  • headache
  • dizziness
  • fatigue
  • peripheral edema
  • facial edema
  • weight gain
  • ECG abnormalities
  • decreased hemoglobin
  • hematuria
  • constipation
  • diarrhea
  • dyspepsia
  • abdominal pain
  • nausea
  • vomiting
  • cough
  • shortness of breath
  • anxiety
  • insomnia
  • vulvar pruritis

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

Storage

This drug may be sensitive to air or moisture, so it should be stored in a sealed container. It is advisable to maintain a room temperature between 1 and 30 degrees Celsius for storage. Storing it this way helps to safely preserve the drug's efficacy.

Appearance and packaging

Appearance

Pale yellow, round, biconvex, film-coated tablets

Package unit

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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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.