Medication info
Empagliflozin 25 mg Tablet (Empagliflozin)

Empagliflozin 25 mg Tablet (Empagliflozin)

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

MFDS item code 202102078 · Approved 2021.03.05 · Insurance code 645907230

Summary

Main use
Blood sugar control in Type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dose of this medication is 10 mg once daily. If additional blood sugar control is needed with good tolerability, it may be increased to 25 mg once daily. This medication can be taken irrespective of meals and the tablet should be swallowed whole. If a dose is missed, it should be taken as soon as remembered, but do not take two doses in one day.

Ingredients

Manufacturer
동광제약(주)

Efficacy & effects

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

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

This medication is used in conjunction with diet and exercise to help control blood sugar in adult patients with Type 2 diabetes. It can be administered as monotherapy or in combination with other diabetes medications such as metformin, pioglitazone, sulfonylureas, insulin, or DPP-4 inhibitors if blood sugar control is insufficient. Particularly, information regarding the prevention of cardiovascular events in Type 2 diabetes patients with cardiovascular disease should refer to professional guidelines. This medication is effective in improving blood sugar control and should be adjusted based on the individual patient's condition.

How to take

Adult dose

The recommended dose of this medication is 10 mg once daily. If additional blood sugar control is needed with good tolerability, it may be increased to 25 mg once daily. This medication can be taken irrespective of meals and the tablet should be swallowed whole. If a dose is missed, it should be taken as soon as remembered, but do not take two doses in one day.

Precautions

This medication should not be used in patients with a known allergy to the active ingredient or any of its components. It is not to be administered in patients with Type 1 diabetes or diabetic ketoacidosis. Patients with severely impaired renal function, end-stage renal disease, or those on dialysis should not use this medication. It should not be used in patients with a genetic disorder that prevents lactose breakdown. Patients with mildly impaired renal function should use this medication with caution, and dosage adjustments or discontinuation may be necessary. Some patients with heart failure may require careful monitoring due to the lack of safety data. If taken with medications that pose a risk of hypoglycemia, such as insulin or sulfonylureas, dosage adjustments may be necessary to reduce the risk of hypoglycemia. Adverse effects may include hypoglycemia, urinary tract infections, genital infections, increased urination, dehydration, hypotension, and liver function abnormalities. Particularly, elderly patients or those at risk of fluid loss should be cautious of dehydration symptoms. This medication can cause a serious metabolic disorder called ketoacidosis, so if symptoms appear, immediate consultation with healthcare professionals is required. Due to potential liver damage, caution should be exercised if liver function abnormalities are present. Moreover, the risk of urinary and genital infections may be increased, so appropriate treatment is necessary if infection symptoms occur. This medication may affect lithium levels in the blood, so patients taking lithium should frequently monitor their blood levels. Pregnant women are advised not to use this medication, and it should also be avoided during breastfeeding. Safety and efficacy in pediatric patients under 18 years of age have not been established. There are no specific toxic symptoms reported in case of overdose, but appropriate medical intervention should be sought in the event of an overdose. This medication should be stored out of the reach of children and it is important not to transfer it to another container to maintain product quality.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • ketoacidosis
  • urosepsis
  • pyelonephritis
  • rash
  • perineal necrosis
  • severe metabolic acidosis
  • nausea
  • vomiting
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  • abdominal pain
  • fatigue
  • dyspnea
  • liver damage
  • fluid volume loss
  • hypotension
  • orthostatic hypotension
  • fainting
  • acute kidney injury
  • ureteral stones
  • hematuria
  • renal mass
  • urinary retention
  • vascular stent thrombosis
  • angina
  • Prinzmetal angina
  • deep vein thrombosis
  • headache
  • cerebral infarction
  • intracranial aneurysm

Mild side effects

  • Hypoglycemia
  • diarrhea
  • nausea
  • gastric ulcer
  • colitis
  • vomiting
  • ischemic colitis
  • colon bleeding
  • vaginitis
  • vulvitis
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  • balanitis
  • genital infections
  • increased urination
  • difficulty urinating
  • interstitial nephritis
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
  • increased hematocrit
  • rash
  • itching
  • urticaria
  • angioedema
  • decreased fluid volume
  • dehydration
  • hypotension
  • decreased blood volume
  • orthostatic hypotension

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

A pale yellow, oval, 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.