Medication info

Empagliflozin/Metformin Tablet 5/850 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
동화약품(주)
Appearance
White, oval-shaped film-coated tablets with a convex shape and a yellowish tint
Packaging
10 tablets/box[10 tablets/PTPX1], 60 tablets/box[10 tablets/PTPX6], 30 tablets/bottle, 60 tablets/bottle
Approval status
Active

MFDS item code 202201662 · Approved 2022.04.22

Summary

Main use
Effect on controlling blood sugar levels in type 2 diabetes and preventing cardiovascular events
Who takes it
Adults
Adult dose
The recommended dose of this medication is 1 tablet, twice daily. The total daily maximum recommended doses of empagliflozin 25 mg and metformin 2000 mg should not be exceeded, and should be determined based on each patient's current treatment regimen, efficacy, and tolerability. Patients with sufficient glycemic control using metformin alone or in combination with other medications such as insulin should take empagliflozin 5 mg twice a day (total daily amount 10 mg) and their usual metformin dosage.

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

Effect on controlling blood sugar levels in type 2 diabetes and preventing cardiovascular events

  • Type 2 diabetes
  • impaired glycemic control
  • cardiovascular disease
View approved original text

This medication is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes through the combination of empagliflozin and metformin. Particularly, patients with cardiovascular disease whose glycemic control is not adequate should take this medication carefully under the direction of a specialist. This medication effectively helps manage blood sugar levels and is used in the treatment of type 2 diabetes.

How to take

Adult dose

The recommended dose of this medication is 1 tablet, twice daily. The total daily maximum recommended doses of empagliflozin 25 mg and metformin 2000 mg should not be exceeded, and should be determined based on each patient's current treatment regimen, efficacy, and tolerability. Patients with sufficient glycemic control using metformin alone or in combination with other medications such as insulin should take empagliflozin 5 mg twice a day (total daily amount 10 mg) and their usual metformin dosage.

Precautions

This medication helps to control blood sugar levels. However, a rare and serious condition known as lactic acidosis may occur while using this medication, so caution is advised. It should not be used in patients with significantly impaired kidney function or in cases of acute infection or dehydration. Additionally, there is a risk of hypoglycemia when used in conjunction with insulin or other anti-diabetic medications. Before using iodinated contrast agents, this medication should be temporarily discontinued and resumed only after confirming normal kidney function. It is advisable for pregnant or lactating women not to take this medication. This medication may cause side effects such as urinary tract infections or genital infections, increased urination, so any symptoms should be reported to a healthcare professional. Regular monitoring is necessary as it may reduce vitamin B12 levels. Elderly patients may experience decreased kidney function, so dose adjustments and regular kidney function tests are important. During treatment, excessive alcohol should be avoided, and if dietary intake or fluid intake is irregular or insufficient, there is a risk of hypoglycemia or lactic acidosis. In case of overdose, seek medical attention immediately, and this medication can be removed by hemodialysis. This medication is not recommended for children under 18 years.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, perineal necrosis, ketoacidosis, lactic acidosis, urosepsis and pyelonephritis, liver abnormalities (hepatitis and acute cholecystitis), myocardial infarction, cerebral infarction, acute renal failure, acute kidney injury, acute cholecystitis, severe edema, severe allergic reactions, severe skin adverse reactions, serious neurological symptoms, respiratory issues, hypertension, hypoglycemia (severe hypoglycemia), heart failure, shock, seizures, confusion, visual disturbances,

Mild side effects

  • Hypoglycemia
  • urinary tract infections
  • genital infections
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • abnormal liver function tests
  • hepatitis
  • altered taste
  • itching
  • rash
  • increased serum lipids
  • elevated serum creatinine
  • headache
  • dizziness
  • orthostatic dizziness
  • drowsiness
  • weakness
  • chest discomfort
  • chest pain
  • fever
  • fatigue
  • edema
  • weight loss
  • insomnia
  • anxiety
  • erectile dysfunction
  • vulvar itching
  • genital itching

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage ensures the safe preservation of the medication's effectiveness.

Appearance and packaging

Appearance

White, oval-shaped film-coated tablets with a convex shape and a yellowish tint

Package unit

10 tablets/box[10 tablets/PTPX1], 60 tablets/box[10 tablets/PTPX6], 30 tablets/bottle, 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.