Medication info

Empagliflozin and Metformin Tablets 5/500 mg (Empagliflozin, Metformin Hydrochloride)

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

MFDS item code 202201443 · Approved 2022.04.05

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 one tablet twice daily. The maximum recommended daily dosage for each ingredient is 25 mg of empagliflozin and 2000 mg of metformin. Patients who cannot achieve sufficient blood sugar control with metformin alone or in combination with insulin or other medications should take empagliflozin 5 mg twice daily (total daily dose of 10 mg) along with the standard metformin dosage. For patients who tolerate 10 mg of empagliflozin (total daily dose), a dose increase to 25 mg (total daily dose) can be considered if additional blood sugar control is needed.

Ingredients

Manufacturer
동국제약(주)

Efficacy & effects

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

  • Blood sugar control abnormalities
  • type 2 diabetes
  • cardiovascular disease
View approved original text

This medication is used as an adjunct to diet and exercise to improve blood sugar control in patients with type 2 diabetes. It is particularly effective in adult patients who are suitable for dual therapy with empagliflozin and metformin. Furthermore, if adult patients with type 2 diabetes have not had sufficient blood sugar control, especially those with confirmed cardiovascular disease, it should be used with caution according to clinical trial information. This medication helps manage blood sugar effectively for diabetes treatment.

How to take

Adult dose

The recommended dosage of this medication is one tablet twice daily. The maximum recommended daily dosage for each ingredient is 25 mg of empagliflozin and 2000 mg of metformin. Patients who cannot achieve sufficient blood sugar control with metformin alone or in combination with insulin or other medications should take empagliflozin 5 mg twice daily (total daily dose of 10 mg) along with the standard metformin dosage. For patients who tolerate 10 mg of empagliflozin (total daily dose), a dose increase to 25 mg (total daily dose) can be considered if additional blood sugar control is needed.

Precautions

This medication can cause a rare but serious side effect known as lactic acidosis, therefore it should not be used in patients with poor kidney function, acute kidney issues, severe infections, or dehydration. Additionally, the risk of hypoglycemia may increase if this medication is used in conjunction with insulin or sulfonylureas, so blood sugar levels should be monitored carefully in such cases. It is best to avoid this medication in pregnant women or those who may become pregnant, breastfeeding mothers, and patients with severely impaired liver function. Since this medication is influenced by kidney function, regular kidney function tests should be performed before and during treatment, and the medication should be discontinued if kidney function falls below a certain level. Before and after procedures utilizing iodinated contrast media, this medication should be temporarily discontinued, and resumed only after kidney function has returned to normal. This medication can lead to fluid loss, so it should be used carefully in elderly patients, those with low blood pressure, or symptoms of dehydration, with the option to interrupt treatment if necessary. During treatment, urinary tract infections or genital infections may occur, thus any infections should be reported to healthcare professionals immediately. Since vitamin B12 levels may decrease, it is advisable to check blood vitamin B12 levels in patients receiving long-term treatment. It is crucial to avoid alcohol consumption while taking this medication, and be cautious of irregular eating habits or excessive exercise, as well as potential interactions with other medications that may increase the risk of hypoglycemia or ketoacidosis. Elderly patients have a higher risk of renal function decline and fluid loss; therefore, dosage adjustments and regular monitoring are necessary during treatment. In the event of an overdose of this medication, it is essential to seek medical attention promptly, especially if symptoms of lactic acidosis occur, as immediate emergency treatment is required.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, necrotizing fasciitis of the perineum (Fournier's gangrene), ketoacidosis, lactic acidosis, urosepsis, pyelonephritis, severe allergic reactions, serious skin adverse reactions, severe neurological symptoms, liver abnormalities (jaundice), severe edema or urination issues, severe lactic acidosis, severe hypoglycemia, acute renal failure, severe liver damage, exacerbation of heart failure, acute renal failure related to iodinated contrast media, dehydration and hypotension due to increased urine output

Mild side effects

  • Hypoglycemia
  • urinary tract infections
  • genital infections
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • decreased appetite
  • constipation
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  • abnormal liver function tests
  • hepatitis
  • altered taste
  • itching
  • rash
  • increased serum creatinine
  • decreased glomerular filtration rate
  • decreased and deficient vitamin B12
  • thirst
  • abnormal diagnostic tests
  • headache
  • dizziness
  • fever
  • chest discomfort
  • chest pain
  • weakness
  • weight loss
  • perineal itching
  • cough
  • insomnia
  • anxiety
  • pain
  • posture

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

Storage

Store this medication in a tightly closed container, ensuring it does not come into contact with air or moisture, and keep it at a safe temperature between 1 degree and 30 degrees Celsius. Storing it this way can help maintain its efficacy for a longer duration.

Appearance and packaging

Appearance

Orange-yellow, bilaterally convex oval film-coated tablets

Package unit

10 tablets/box [(10 tablets/PTP x 1)], 60 tablets/box [(10 tablets/PTP x 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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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.