Medication info

Empagliflozin 25 mg Tablets (Empagliflozin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›25mg / 1 tablet
Manufacturer / importer
진양제약(주)
Appearance
Light yellow biconvex oval film-coated tablet
Packaging
10 tablets/box [(10 tablets/PTP x 1)], 30 tablets/box [(10 tablets/PTP x 3)], 30 tablets/bottle
Approval status
Active

MFDS item code 202102263 · Approved 2021.03.12

Summary

Main use
Improvement of 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 additional combination therapy with insulin and other blood glucose-lowering agents. If a patient tolerates 10 mg well but requires additional blood sugar control, the dosage can 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.

Ingredients

Manufacturer
진양제약(주)

Efficacy & effects

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

  • Difficulty controlling blood sugar
  • inability to control blood sugar
  • type 2 diabetes
  • cardiovascular disease
View approved original text

This medication is used as an adjunct to diet and exercise to help control blood sugar in adults with type 2 diabetes. It can be administered alone, and if blood sugar control is inadequate, it may be used in combination with metformin, pioglitazone, sulfonylureas, insulin, or the DPP-4 inhibitor linagliptin. Particularly, patients with type 2 diabetes confirmed to have cardiovascular disease need to be cautious about the occurrence of cardiovascular events. This medication is used to improve blood sugar control and assist in the management of the patient's health.

How to take

Adult dose

The recommended dosage for this medication is 10 mg once daily for monotherapy and additional combination therapy with insulin and other blood glucose-lowering agents. If a patient tolerates 10 mg well but requires additional blood sugar control, the dosage can 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.

Precautions

This medication should not be used in patients with an allergy to the active ingredient or any components. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. It should not be used in patients with severely impaired kidney function or end-stage kidney disease or during dialysis. This medication contains lactose and should not be taken by patients with genetic disorders such as lactose intolerance, lactase deficiency, or glucose-galactose malabsorption. In patients with mild renal impairment, this medication should be used with caution, and dosage adjustments or discontinuation may be necessary. In patients with mild to moderate heart failure, it should be used cautiously, and it is not recommended for those with severe heart failure. When used together with blood glucose-lowering agents such as insulin or sulfonylureas, there is a risk of hypoglycemia, so the doses of these medications may need to be reduced. During the use of this medication, there may be side effects such as hypoglycemia, urinary tract infections, genital infections, and increased urination, so caution is advised. Especially, serious metabolic abnormalities such as ketoacidosis may occur. Therefore, if symptoms such as vomiting, abdominal pain, or difficulty breathing appear, immediate consultation with a healthcare professional is necessary. In elderly patients or those at risk of fluid volume depletion or hypotension, careful administration is required, and fluid status should be checked frequently. This medication may cause serious urinary infections such as urosepsis or pyelonephritis, so rapid treatment is required if infection symptoms occur. Pregnant or breastfeeding women are advised not to use this medication and should discontinue use upon confirmation of pregnancy. The safety and efficacy in children under the age of 18 have not been established. There have been no reported special toxicities in case of overdose, but appropriate treatment should be administered according to clinical condition. During the use of this medication, it should be kept out of the reach of children and care should be taken not to transfer to other containers. Caution is necessary when driving or operating machinery due to the risk of hypoglycemia, especially when taken together with insulin or sulfonylureas. Diabetic patients should seek medical attention immediately if they experience pain or swelling in the perineum or other areas during regular foot care.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, necrotizing fasciitis, ketoacidosis, urosepsis and pyelonephritis, liver damage (signs of liver abnormality), severe allergic reactions, acute kidney injury, deep vein thrombosis, severe skin reactions, severe edema or urinary anomalies, severe neurological symptoms (headache, cerebral infarction, memory abnormalities, confusion, etc.), difficulty breathing and asthma attacks, jaundice, sudden and severe headache, severe fever along with severe

Mild side effects

  • Hypoglycemia
  • vulvovaginal candidiasis
  • vulvitis and other genital infections
  • increased urination
  • rash
  • itching
  • serum lipid increase
  • elevated serum creatinine
  • decreased glomerular filtration rate
  • thirst
Show 21 more
  • headache
  • dizziness
  • fatigue
  • fever
  • chills
  • dyspepsia
  • abdominal pain
  • vomiting
  • diarrhea
  • constipation
  • rhinitis
  • bronchitis
  • cough
  • nasal bleeding
  • asthma
  • allergic rhinitis
  • drowsiness
  • musculoskeletal pain
  • unstable angina
  • anxiety
  • sleep disturbance

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The recommended storage temperature is between 1 and 30 degrees Celsius at room temperature. This will help maintain the efficacy of the medication safely.

Appearance and packaging

Appearance

Light yellow biconvex oval film-coated tablet

Package unit

10 tablets/box [(10 tablets/PTP x 1)], 30 tablets/box [(10 tablets/PTP x 3)], 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.