Medication info
Empagliflozin 25mg (Empagliflozin)

Empagliflozin 25mg (Empagliflozin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›25mg / 1 tablet
Manufacturer / importer
(주)팜젠사이언스
Appearance
Light yellow, double convex, oval film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202102046 · Approved 2021.03.05 · Insurance code 670105200

Summary

Main use
Improvement of blood sugar control and prevention of cardiovascular events in type 2 diabetes
Who takes it
Adults
Adult dose
The recommended dosage for this medication is 10 mg once daily for monotherapy and in addition to other antidiabetic agents like insulin. If the 10 mg dosage of this medication is well tolerated but additional blood sugar control is necessary, the dosage may be increased to 25 mg once daily. This medication can be administered regardless of meals. Tablets should be swallowed whole. Do not take double the dose in one day.

Ingredients

Manufacturer
(주)팜젠사이언스

Efficacy & effects

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

  • Type 2 diabetes
  • difficulty in blood sugar control
  • cardiovascular disease
View approved original text

This medication is used to improve blood sugar control in adult patients with type 2 diabetes, in conjunction with dietary and exercise therapies. It can be administered alone and may be used in combination with other antidiabetic agents such as metformin when monotherapy does not provide adequate blood sugar control. Additionally, if blood sugar control is insufficient with metformin alone or other combinations, this medication can be added to help control blood sugar. Caution is needed regarding the occurrence of cardiovascular events in patients with type 2 diabetes and cardiovascular disease while using this medication. In summary, this medication is used to enhance blood sugar control in patients with type 2 diabetes.

How to take

Adult dose

The recommended dosage for this medication is 10 mg once daily for monotherapy and in addition to other antidiabetic agents like insulin. If the 10 mg dosage of this medication is well tolerated but additional blood sugar control is necessary, the dosage may be increased to 25 mg once daily. This medication can be administered regardless of meals. Tablets should be swallowed whole. Do not take double the dose in one day.

Precautions

This medication should not be used in certain patients. First, patients who are allergic to the active ingredient or components of this medication should not be administered this drug. Additionally, it is contraindicated for patients with type 1 diabetes or diabetic ketoacidosis. Patients with severely impaired kidney function, specifically with a glomerular filtration rate of less than 30 mL/min/1.73m2, or those undergoing dialysis due to end-stage renal disease should not take this medication. This medication contains lactose and should not be provided to patients with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Patients with mildly impaired kidney function should use this medication with caution. Particularly, it is recommended that this medication is not started in patients with a glomerular filtration rate of less than 60 mL/min/1.73m2, and if already being used, the dosage may need to be reduced or discontinued. Since the effectiveness of this medication is not expected in patients with end-stage renal disease or those on dialysis, it should not be used. It is important to regularly monitor kidney function before and during treatment since this medication is affected by kidney function. Patients with heart failure, especially those with mild to moderate heart failure, should have this medication used cautiously, while in patients with severe heart failure, its use is not recommended. Additionally, when used with insulin or insulin secretagogues, the risk of hypoglycemia may increase, potentially requiring dosage adjustments. Possible adverse reactions during the use of this medication include hypoglycemia, genital infections, urinary tract infections, increased urination, dehydration, and hypotension. The risk of hypoglycemia is particularly increased when combined with insulin or sulfonylureas, necessitating caution. Genital infections are more common in females and are mostly mild to moderate. Dehydration and hypotension symptoms may occur more frequently, especially in the elderly, so hydration status should be carefully monitored. This medication can induce severe metabolic acidosis (ketoacidosis), so treatment should be discontinued immediately and medical advice sought if symptoms arise. Symptoms of ketoacidosis may include nausea, vomiting, abdominal pain, malaise, and difficulty breathing. Additionally, caution is recommended in the presence of risk factors for ketoacidosis such as acute illness, surgery, reduced insulin dosage, calorie restriction, or alcohol abuse. This medication may cause liver damage, so caution is needed in cases of suspected liver dysfunction. Elderly patients, particularly those over 75 years old, have a higher risk of fluid loss; thus, they should be carefully monitored for dehydration symptoms or changes in blood pressure while taking this medication. Safety data for individuals over 85 years of age are limited, so initiation of treatment is not recommended. This medication can cause serious urinary tract infections such as urosepsis and pyelonephritis, so immediate treatment should be sought if symptoms of infection appear. There is also an increased risk of genital fungal infections, so patients with a history of infection should carefully observe symptoms and seek treatment when necessary. This medication may impact urination function, so patients with bladder conditions should take care as their condition may worsen. This medication may lead to glucose detection in urine tests, which should be considered when interpreting test results. Mild effects may be observed when driving or operating machinery, particularly due to hypoglycemia risk when combined with insulin or sulfonylureas. Patients with diabetes have an increased risk of lower limb amputation and should take care in foot management, while also being aware of the rare possibility of serious infections such as perineal necrosis, thus needing to inform healthcare professionals immediately if related symptoms arise. This medication may interact with other drugs, and dosage adjustments and monitoring are needed, especially when taken with diuretics, insulin, or sulfonylureas. Use of this medication during pregnancy is not recommended, and it should be discontinued immediately upon confirmation of pregnancy. It is also safer to cease breastfeeding while taking this medication if nursing. Safety and efficacy in children under 18 years old have not been established, therefore it should not be used in this age group. No specific toxic symptoms have been reported in the case of overdose, but appropriate treatment based on clinical condition is necessary. Keep out of reach of children, and do not transfer tablets to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, ketoacidosis, urosepsis, pyelonephritis, perineal necrosis, severe allergic reactions, worsening heart failure, signs of suspected liver damage, symptoms of severe ketoacidosis (nausea, vomiting, abdominal pain, malaise, difficulty breathing), severe skin reactions (severe rash, blisters, skin peeling, mucosal pain), acute kidney injury, angina, deep vein thrombosis, acute pyelonephritis, fever, elevated blood pressure, and severe swelling.

Mild side effects

  • Hypoglycemia
  • itching
  • rash
  • increased urination
  • genital mycotic infection
  • vulvovaginitis
  • balanitis
  • urinary tract infection
  • decreased fluid volume
  • increased serum creatinine
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  • headache
  • dizziness
  • cough
  • nasal bleeding
  • chest pain
  • fatigue
  • swelling
  • constipation
  • dyspepsia
  • abdominal pain
  • nausea
  • gastritis
  • anxiety
  • insomnia
  • etc.

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. The medication should also be kept at room temperature, neither too hot nor too cold, between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Light yellow, double convex, oval film-coated tablet

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.