Medication info

Empori Tablets 10 mg (Empagliflozin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›10mg / 1 tablet
Manufacturer / importer
삼익제약(주)
Appearance
Pale yellow, double convex, round film-coated tablets
Packaging
Box - 10 tablets/box [10 tablets/PTP x 1], Box - 30 tablets/box [10 tablets/PTP x 3], Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 202102083 · Approved 2021.03.05

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 dose of this medication is 10 mg once daily for monotherapy and additional combination therapy with insulin and other hypoglycemic agents. If the 10 mg dose is well tolerated but additional blood sugar control is needed, the dose can be increased to 25 mg once daily. This medication can be administered regardless of meals, and the tablet should be swallowed whole. If a dose is missed, take it as soon as remembered.

Ingredients

Manufacturer
삼익제약(주)

Efficacy & effects

Improvement of 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 help control blood sugar levels in adults with type 2 diabetes. It can be administered alone but may also be taken in combination with metformin or other diabetic medications if blood sugar control is difficult. Specifically, it is added to treatment when metformin alone is insufficient, or when blood sugar control is challenging even during insulin therapy, to enhance therapeutic efficacy. Additionally, it may help with blood sugar control and prevent cardiovascular events in patients with type 2 diabetes who have cardiovascular disease, thus it should be used with caution. This medication can be used flexibly depending on various treatment situations, improving blood sugar management for patients.

How to take

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and additional combination therapy with insulin and other hypoglycemic agents. If the 10 mg dose is well tolerated but additional blood sugar control is needed, the dose can be increased to 25 mg once daily. This medication can be administered 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 by certain patients. Firstly, patients allergic to any of the components in this medication should not take it. Secondly, patients with type 1 diabetes or experiencing diabetic ketoacidosis should also avoid using this medication. Thirdly, patients with severely reduced kidney function or end-stage renal disease, as well as those undergoing dialysis, should not take this medication. Fourthly, patients with genetic lactose-related problems should also not use this medication. For patients with slightly reduced kidney function, this medication should be used cautiously. In particular, patients whose glomerular filtration rate falls below a certain threshold may require dosage adjustment or discontinuation. Patients with end-stage renal disease or those on dialysis should not use this medication as its efficacy is not expected. For patients with heart failure, those with mild to moderate cases should use the medication with caution, while severe heart failure patients are advised against using it. Moreover, when taken together with insulin or medications that stimulate insulin secretion, the risk of hypoglycemia may increase, necessitating dosage adjustments for these medications when using this drug. During treatment with this medication, various adverse reactions may occur. The most common adverse reaction is hypoglycemia, which occurs when taken in combination with insulin or sulfonylureas. Symptoms such as genital infections, urinary tract infections, increased urination, and decreased fluid volume have also been reported, so caution is required. Additionally, serious adverse reactions such as ketoacidosis, urosepsis, pyelonephritis, and perineal necrosis have been reported, and immediate consultation with medical staff is necessary if symptoms occur. Elderly patients, especially those over 75 years old, are at higher risk of fluid volume loss, so they should be monitored closely while using this medication. This medication may affect body hydration and lower blood pressure, so patients with a history of hypotension or cardiovascular disease should use it cautiously. Use of this drug is not recommended during pregnancy, and it should be discontinued if pregnancy is confirmed. In breastfeeding cases, as this medication may be secreted in breast milk, it is advisable to stop breastfeeding. The safety and efficacy of this medication in children under the age of 18 have not been established, so it should not be used in pediatric patients. No specific toxic symptoms have been reported in cases of overdose, but in the event of an overdose, immediate medical attention should be sought for appropriate treatment. This medication should be kept out of the reach of children and should not be transferred to other containers for safety. Finally, there is a risk of hypoglycemia while driving or operating machinery during treatment with this medication, so caution is advisable, especially when used together with insulin or sulfonylureas.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, perineal necrosis, ketoacidosis, vulvovaginitis, balanitis, and other genital infections, urosepsis, pyelonephritis, severe allergic reactions, severe skin reactions, shortness of breath, liver abnormalities (jaundice), serious neurological symptoms, acute kidney injury, severe edema accompanied by increased blood pressure, heart failure, limb amputation

Mild side effects

  • Hypoglycemia
  • itching
  • rash
  • increased urination
  • urinary tract infection
  • dehydration
  • hypotension
  • increased blood creatinine
  • decreased glomerular filtration rate
  • increased serum lipids
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  • headache
  • dizziness
  • fatigue
  • fever
  • weight gain
  • constipation
  • dyspepsia
  • abdominal pain
  • vomiting
  • diarrhea
  • dry mouth
  • muscle pain
  • joint pain
  • dry eyes
  • cough
  • nosebleed
  • anxiety
  • insomnia
  • scrotal pain
  • vaginal discharge
  • etc.
  • mild to moderate adverse reactions

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

Storage

This medication must be kept in a tightly sealed container to prevent exposure to air or moisture. It is recommended to store at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow, double convex, round film-coated tablets

Package unit

Box - 10 tablets/box [10 tablets/PTP x 1], Box - 30 tablets/box [10 tablets/PTP x 3], Bottle - 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.