Medication info

Empagmet® 5/500 milligrams

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
삼성제약(주)
Appearance
Orange-yellow, biconvex, oval film-coated tablets
Packaging
10 tablets/box [10 tablets/PTP×1], 60 tablets/box [10 tablets/PTP×6], 60 tablets/bottle
Approval status
Active

MFDS item code 202201367 · Approved 2022.04.04

Summary

Main use
Effectiveness in blood sugar control for type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 1 tablet at a time, 2 times a day. The dosage is determined considering each patient's treatment regimen, effectiveness, and tolerance, not exceeding the maximum recommended doses of empagliflozin 25 mg and metformin 2000 mg. For patients not achieving sufficient blood sugar control with metformin alone or combined with other medications, the recommended dosage is 5 mg of empagliflozin twice daily along with the existing dosage of metformin. Empagliflozin

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

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

  • Poor blood sugar control in adult patients with type 2 diabetes
  • cardiovascular diseases
  • cardiovascular events
View approved original text

This medication effectively aids in blood sugar control for adult patients with type 2 diabetes in conjunction with dietary and exercise therapy through the combined administration of empagliflozin and metformin. It is particularly used by patients whose blood sugar is not sufficiently controlled and should be used with caution in those with cardiovascular diseases. It helps to improve blood sugar levels and reduce the risk of complications. Patients can expect significant assistance in blood sugar control when taken safely under professional guidance.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet at a time, 2 times a day. The dosage is determined considering each patient's treatment regimen, effectiveness, and tolerance, not exceeding the maximum recommended doses of empagliflozin 25 mg and metformin 2000 mg. For patients not achieving sufficient blood sugar control with metformin alone or combined with other medications, the recommended dosage is 5 mg of empagliflozin twice daily along with the existing dosage of metformin. Empagliflozin

Precautions

This medication is an antidiabetic agent that helps in controlling blood sugar levels. However, caution is necessary due to the potential for a rare side effect called severe lactic acidosis. When taken in combination with other antidiabetic medications, hypoglycemia may occur. Patients with moderate to severe renal impairment, acute kidney issues, serious infections, or heart problems should not take this medication. It should also not be used by women who are pregnant or nursing. Regular kidney function tests should be conducted during treatment to check for abnormalities. Additionally, it may be necessary to temporarily stop taking the medication during gastrointestinal disturbances or dehydration, and serious infections. Side effects such as hypoglycemia, urinary tract infections, genital infections, and increased urination may occur; any unusual symptoms should be reported to a doctor immediately. Elderly patients or those at higher risk of fluid loss should be especially cautious. Alcohol consumption may increase the risk of lactic acidosis and should be avoided during treatment. Before and after surgery or when undergoing imaging tests with iodinated contrast, the medication should be temporarily stopped and should only be resumed after confirming normal kidney function. This medication is not recommended for children, and dosage adjustments should be made for the elderly based on kidney function. In case of an overdose, treatments such as hemodialysis may be required, so caution is advised. Finally, store this medication in a place inaccessible to children and in its original container for safety.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • angioedema
  • necrosis of the perineum
  • ketoacidosis
  • lactic acidosis
  • severe rash with high fever
  • blisters
  • skin peeling
  • pain in oral/ocular mucous membranes
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  • difficulty breathing
  • asthma attacks
  • chest tightness
  • shortness of breath
  • confusion
  • visual disturbances
  • paralysis
  • severe headache
  • cerebral infarction
  • concussion
  • acute kidney injury
  • acute cholecystitis
  • autoimmune hepatitis
  • gallstones
  • hepatitis
  • acute pyelonephritis
  • urinary sepsis

Mild side effects

  • Hypoglycemia
  • urinary tract infection
  • genital infection
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
Show 20 more
  • abnormal liver function test
  • hepatitis
  • altered taste
  • itching
  • rash
  • increased serum creatinine
  • decreased glomerular filtration rate
  • decreased and deficiency of vitamin B12
  • thirst
  • increased blood lipids
  • dermal cyst
  • seborrheic dermatitis
  • atopic dermatitis
  • diabetic foot
  • circular dermatitis
  • heat rash
  • sebaceous gland hyperplasia
  • dizziness
  • headache
  • insomnia

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

Storage

This medication may be sensitive to air or humidity and should be stored in a tightly sealed container. It is best to keep the storage temperature between 1 to 30 degrees Celsius at room temperature. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Orange-yellow, biconvex, oval film-coated tablets

Package unit

10 tablets/box [10 tablets/PTP×1], 60 tablets/box [10 tablets/PTP×6], 60 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.