Medication info
Empagliflozin 25 mg Tablets

Empagliflozin 25 mg Tablets

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

MFDS item code 202102033 · Approved 2021.03.04 · Insurance code 693202690

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage for this medication is 10 mg once daily for monotherapy and in addition to insulin or other glucose-lowering agents. If a patient can tolerate the 10 mg dosage but requires further blood sugar control, the dose may be increased to 25 mg once daily. This medication can be administered regardless of meals. The tablet should be swallowed whole. If a dose is missed, it should be taken as soon as remembered.

Ingredients

Manufacturer
(주)킵스바이오파마

Efficacy & effects

Blood sugar control in type 2 diabetes and prevention of cardiovascular events

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

This medication is used in conjunction with diet and exercise to assist in blood sugar control for adults with type 2 diabetes. It can also be administered as monotherapy, but is used in combination therapy when sufficient blood sugar control is difficult with other diabetes medications, such as metformin. It improves blood sugar control effects when used in combination with metformin, pioglitazone, sulfonylureas, insulin, or the DPP-4 inhibitor linagliptin. Particularly for patients with cardiovascular disease, it should be used cautiously based on clinical trial information from specialists. This medication effectively improves 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 insulin or other glucose-lowering agents. If a patient can tolerate the 10 mg dosage but requires further blood sugar control, the dose may be increased to 25 mg once daily. This medication can be administered regardless of meals. The tablet should be swallowed whole. If a dose is missed, it should be taken as soon as remembered.

Precautions

This medication should not be administered to certain patients. For example, patients with hypersensitivity to the active ingredient, type 1 diabetes patients, patients with diabetic ketoacidosis, patients with significantly impaired kidney function, and those with genetic issues such as lactose intolerance or galactose intolerance should not take this medication. In patients with slightly impaired kidney function, this medication should be administered cautiously, with regular testing of kidney function while adjusting the dose or discontinuing if necessary. Additionally, this medication is not used in patients with end-stage renal disease or those on dialysis, as its effectiveness cannot be expected. In patients with heart failure, especially those with severe heart failure, experience with this medication is limited, thus caution is required. When used with insulin or other insulin secretagogues such as sulfonylureas, the risk of hypoglycemia may increase, so dose adjustments may be necessary. While taking this medication, side effects such as hypoglycemia, genital infections, urinary tract infections, increased urination, decreased fluid volume, increased serum creatinine, etc., may occur, and patients should consult healthcare professionals if symptoms arise. Particularly, serious metabolic disturbances such as ketoacidosis may occur, so if symptoms like nausea, vomiting, abdominal pain, or difficulty breathing appear, patients should immediately visit a healthcare facility for evaluation. Elderly patients or those at risk of fluid loss must be cautious of dehydration or hypotension, and their physical condition should be closely monitored while taking this medication. This medication can increase the risk of dehydration and hypotension when used with other diuretics, and the risk of hypoglycemia may increase when used with insulin secretagogues, thus caution is warranted for combination therapy. Pregnant women should avoid taking this medication, and nursing mothers are advised to discontinue breastfeeding while on this medication. Its safety and effectiveness in pediatric patients under 18 years of age has not been established, so it is not recommended for this age group. There have been no reported specific toxic symptoms from overdose, but in cases of excessive intake, the patient's condition should be closely monitored and appropriate treatment should be provided. This medication should be kept out of reach of children, and transferring it to another container could adversely affect its quality, so caution is advised.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • ketoacidosis
  • urosepsis
  • pyelonephritis
  • perineal necrosis
  • severe allergic reactions
  • severe skin reactions
  • liver abnormalities (jaundice)
  • severe edema or urination changes
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  • difficulty breathing
  • asthma attacks
  • respiratory distress
  • severe neurological symptoms

Mild side effects

  • Hypoglycemia
  • vulvovaginitis
  • balanitis
  • other genital infections
  • increased urination
  • rash
  • itching
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
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  • thirst
  • diarrhea
  • nausea
  • stomach ulcers
  • colitis
  • vomiting
  • ischemic colitis
  • gastrointestinal bleeding
  • soft tissue infection
  • appendiceal abscess
  • appendicitis
  • chronic otitis media
  • peritonsillar abscess
  • pneumonia
  • pulmonary tuberculosis
  • acute pyelonephritis
  • sepsis
  • subcutaneous abscess
  • cervical cancer

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or humidity. It is important to maintain storage temperatures between 1 to 30 degrees Celsius. Proper storage ensures the medication retains its effectiveness over time.

Appearance and packaging

Appearance

Pale yellow, oval-shaped, biconvex 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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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.