Medication info
Pharma Empaglow 25 mg (Empagliflozin)

Pharma Empaglow 25 mg (Empagliflozin)

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

MFDS item code 202102824 · Approved 2021.03.31 · Insurance code 653007130

Summary

Main use
Improvement in blood sugar control for type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dose for this medication as monotherapy or as an adjunct with other blood glucose-lowering agents, such as insulin, is 10 mg once daily. If additional blood sugar control is needed and the patient tolerates it well, the dose may be increased to 25 mg once daily. When co-administering with sulfonylureas or insulin, consider reducing the dose of sulfonylureas or insulin to decrease the risk of hypoglycemia. It can be taken without regard to meals.

Ingredients

Manufacturer
(주)한국파마

Efficacy & effects

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

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

This medication helps adults with type 2 diabetes control their blood sugar levels and is used in conjunction with diet and exercise. It can be used alone, but in cases where blood sugar control is difficult, it can be administered in combination with other diabetes medications such as Metformin, Pioglitazone, Sulfonylureas, Insulin, or Linagliptin. Caution should be taken when being used in patients with cardiovascular disease, referencing clinical trial information regarding cardiovascular events. This medication is effective for improving blood sugar control and is used effectively in diabetes treatment.

How to take

Adult dose

The recommended dose for this medication as monotherapy or as an adjunct with other blood glucose-lowering agents, such as insulin, is 10 mg once daily. If additional blood sugar control is needed and the patient tolerates it well, the dose may be increased to 25 mg once daily. When co-administering with sulfonylureas or insulin, consider reducing the dose of sulfonylureas or insulin to decrease the risk of hypoglycemia. It can be taken without regard to meals.

Precautions

This medication should not be given to certain patients. First, patients with allergic reactions to this medication's active ingredient or any of its components should not take it. Secondly, it is not to be used in patients with type 1 diabetes or diabetic ketoacidosis. Thirdly, patients with severely impaired kidney function, specifically those with a glomerular filtration rate of less than 30 mL/min/1.73m2, or those with end-stage renal disease or on dialysis should not take this medication. Fourthly, patients with genetic issues such as lactose intolerance or galactose intolerance should also avoid this medication. This medication should be used with caution in patients with mild kidney impairment. For those with a glomerular filtration rate of less than 60 mL/min/1.73m2, treatment initiation should be avoided, and if already on the medication, dosage adjustment or discontinuation may be necessary. It is not effective and not to be used in patients with end-stage renal disease or who are on dialysis. In patients with heart failure, especially mild to moderate cases, it should be used cautiously, and it is not recommended for those with severe heart failure. When combined with insulin or sulfonylureas, which stimulate insulin secretion, there is a risk of hypoglycemia, so dosage adjustments of these medications may be necessary. This medication may cause side effects including hypoglycemia, genital infections, increased urination, urinary tract infections, and decreased fluid volume. If any unusual symptoms appear, patients should consult a healthcare professional immediately. Especially, serious metabolic acidosis known as ketoacidosis may occur, so if symptoms such as nausea, vomiting, abdominal pain, or respiratory distress occur, patients should visit a hospital immediately. Elderly patients or those at risk of fluid loss should be cautious about dehydration and hypotension, and the administration of this medication may be temporarily suspended if necessary. This medication may affect kidney function, so regular kidney function tests are important. Additionally, it is advisable to avoid the use of this medication during pregnancy and to cease breastfeeding if currently nursing. Safety and efficacy have not been established for children and adolescents under 18, so it should not be used in these populations. No specific toxic reactions have been reported in cases of overdose, but appropriate treatment may be required based on clinical conditions. This medication may interact with other drugs, so patients taking other medications should inform their healthcare provider, especially when taking diuretics, insulin, or sulfonylureas. Finally, this medication should be kept out of reach of children, and it is safer not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, ketoacidosis, urosepsis, pyelonephritis, necrotizing fasciitis, liver damage (including signs of liver dysfunction), sudden and severe headache, intracranial aneurysm, seizures, confusion, vision changes, paralysis, significant decrease in urine output, generalized edema, hypertension, deep vein thrombosis, angina, unstable angina, stent thrombosis, acute kidney injury, acute cholecystitis.

Mild side effects

  • Hypoglycemia
  • vulvovaginal candidiasis
  • balanitis
  • other genital infections
  • increased urination
  • urinary tract infections
  • decreased fluid volume
  • increased blood creatinine
  • decreased glomerular filtration rate
  • rash
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  • itching
  • angioedema
  • headache
  • dizziness
  • facial swelling
  • edema
  • fever
  • fatigue
  • dyslipidemia
  • hyperglycemia
  • hyponatremia
  • weight gain
  • ECG abnormalities
  • hemoglobin decrease
  • weight loss
  • constipation
  • indigestion
  • abdominal pain.

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

Storage

This medication should be stored in a closed container to protect it from air and moisture. The appropriate storage temperature is room temperature between 1°C and 30°C. Avoid storing in excessively hot or cold places.

Appearance and packaging

Appearance

Light yellow, biconvex, 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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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.