Medication info
Empagliflozin 10 mg Tablet (Empagliflozin)

Empagliflozin 10 mg Tablet (Empagliflozin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›10mg / 1 tablet
Manufacturer / importer
동화약품(주)
Appearance
Light yellow, double convex, round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202102364 · Approved 2021.03.16 · Insurance code 642707100

Summary

Main use
Improvement of Type 2 Diabetes (Blood Sugar Control)
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 10 mg once daily for monotherapy and additional combination therapy with other antihyperglycemic agents such as insulin. If there is excellent tolerance and additional blood sugar control is required, the dosage may be increased to 25 mg once daily. This medication can be taken regardless of meals, and the tablet should be swallowed whole. If a dose is missed, take it as soon as remembered; do not take double the dose in one day.

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

Improvement of Type 2 Diabetes (Blood Sugar Control)

  • Difficulty in blood sugar control in patients with type 2 diabetes
  • blood sugar control failure
  • cardiovascular disease
View approved original text

This medication is used in combination with dietary and exercise therapy to improve blood sugar control in adults with type 2 diabetes. It may initially be administered as monotherapy, but if blood sugar control is insufficient with monotherapy, it will be used in conjunction with metformin or other diabetes medications. It can particularly be used alongside metformin, pioglitazone, sulfonylureas, insulin, or the DPP-4 inhibitor linagliptin. In patients with type 2 diabetes accompanied by cardiovascular disease, administration should be based on expert guidance. This medication is used to enhance blood sugar control and improve diabetes treatment effectiveness.

How to take

Adult dose

The recommended dosage of this medication is 10 mg once daily for monotherapy and additional combination therapy with other antihyperglycemic agents such as insulin. If there is excellent tolerance and additional blood sugar control is required, the dosage may be increased to 25 mg once daily. This medication can be taken regardless of meals, and the tablet should be swallowed whole. If a dose is missed, take it as soon as remembered; do not take double the dose in one day.

Precautions

This medication should not be used in patients with an allergic reaction to the active ingredient or any of its components. Do not administer this medication to patients with type 1 diabetes or diabetic ketoacidosis. This medication is not to be used in patients with severely impaired renal function, that is, those with a glomerular filtration rate of less than 30 mL/min/1.73m² or in those with end-stage renal disease or undergoing dialysis. This medication contains lactose, so it should not be given to patients with genetic conditions such as galactose intolerance, lactose deficiency, or glucose-galactose malabsorption. Caution is needed in patients with somewhat impaired renal function, and it is advisable not to initiate this medication in patients with a glomerular filtration rate of less than 60 mL/min/1.73m². If renal function continues to fall below 60 mL/min/1.73m², dosage adjustment or discontinuation of the medication is necessary. This medication is not expected to be effective in patients with end-stage renal disease or those on dialysis. As this medication can affect kidney function, it is important to regularly monitor renal function before and during administration. In patients with heart failure, especially those with mild to moderate severity (NYHA class I-II), careful administration is required, and it is not recommended in patients of severe severity (NYHA class III-IV). When used in combination with insulin or insulin secretagogues such as sulfonylureas, there may be an increased risk of hypoglycemia, so dosage adjustment may be necessary in these cases. Patients should be aware of hypoglycemic symptoms while taking this medication, especially when used with insulin or insulin secretagogues. This medication may lead to side effects such as genital infections, urinary tract infections, and increased urination, so if any unusual symptoms occur, immediate consultation with medical personnel is necessary. This medication may cause hypotension or dehydration related to decreased fluid volume, thus caution should be exercised particularly in the elderly or those with low blood pressure. In severe cases, metabolic acidosis known as ketoacidosis may occur, so prompt treatment is required if symptoms occur, necessitating quick testing. It is advisable for pregnant women not to take this medication, and treatment should be discontinued upon confirmation of pregnancy. Breastfeeding women are also recommended to stop nursing if they are taking this medication. The safety and efficacy of this medication have not been established in children under 18 years of age, so it is not used in this population. No specific toxic symptoms have been reported in cases of overdose, but appropriate treatment is necessary depending on the clinical condition. This medication should be stored out of reach of children and it is advisable not to transfer it to another container. There is a risk of hypoglycemia when operating machinery or driving, particularly when used with insulin, so caution is advised. Regular monitoring of kidney function and blood sugar levels during treatment with this medication is important. Additionally, foot care should be emphasized, and if symptoms such as pain, redness, or swelling in the perineum occur, medical personnel should be informed immediately.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • ketoacidosis
  • rash
  • perineal necrosis
  • urosepticemia
  • pyelonephritis
  • severe allergic reactions
  • severe skin adverse reactions
  • respiratory issues
Show 4 more
  • liver abnormalities (jaundice)
  • severe neurological symptoms
  • severe edema
  • or urination abnormalities.

Mild side effects

  • Hypoglycemia
  • Vulvovaginitis
  • Balinitis
  • other genital infections
  • increased urination
  • urinary tract infections
  • fluid volume loss
  • increased serum creatinine
  • decreased glomerular filtration rate
  • diarrhea
Show 18 more
  • nausea
  • gastric ulcer
  • colitis
  • vomiting
  • ischemic colitis
  • colon bleeding
  • soft tissue infection
  • appendiceal abscess
  • appendicitis
  • meningitis
  • chronic otitis media
  • peritonsillar abscess
  • pneumonia
  • pulmonary tuberculosis
  • acute pyelonephritis
  • sepsis
  • subcutaneous abscess
  • and ovarian abscess.

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 recommended to keep it at room temperature between 1 and 30 degrees Celsius. Storing it this way can maintain the effectiveness of the medication and prevent degradation.

Appearance and packaging

Appearance

Light yellow, double convex, round 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.