Medication info

Empagliflozin/Metformin Tablet 5/850 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
삼성제약(주)
Appearance
White oval film-coated tablets that are convex on both sides with a yellow tint.
Packaging
10 tablets/box [(10 tablets/PTP×1)], 60 tablets/box [(10 tablets/PTP×6)], 60 tablets/bottle
Approval status
Active

MFDS item code 202201368 · Approved 2022.04.04

Summary

Main use
Effect on 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 1 tablet once or twice a day. The maximum recommended daily dose of empagliflozin is 25 mg, and for metformin, it should not exceed 2000 mg, determined based on each patient's current treatment regimen, efficacy, and tolerability. For patients who cannot achieve adequate blood glucose control with metformin alone or in combination with other medications such as insulin, the recommended dose is 5 mg of empagliflozin twice daily (total daily dose 10 mg).

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Effect on blood sugar control in type 2 diabetes and prevention of cardiovascular events

  • Type 2 diabetes
  • abnormal blood sugar control
  • cardiovascular diseases
View approved original text

This medication is used to assist in blood sugar control for adult patients with type 2 diabetes through the combined use of empagliflozin and metformin. Taking it alongside dietary and exercise therapy can enhance blood sugar management. It is particularly suitable for adult patients with type 2 diabetes whose blood sugar is not adequately controlled, and for patients with cardiovascular diseases, it is necessary to consult clinical trial information from professionals when using this medication. This drug improves blood sugar control and aids in diabetes management.

How to take

Adult dose

The recommended dose of this medication is 1 tablet once or twice a day. The maximum recommended daily dose of empagliflozin is 25 mg, and for metformin, it should not exceed 2000 mg, determined based on each patient's current treatment regimen, efficacy, and tolerability. For patients who cannot achieve adequate blood glucose control with metformin alone or in combination with other medications such as insulin, the recommended dose is 5 mg of empagliflozin twice daily (total daily dose 10 mg).

Precautions

This drug is used to treat diabetes and contains two components that help control blood sugar. It can cause a rare side effect known as severe lactic acidosis, so special caution should be taken, especially by patients with impaired kidney function or those with heart diseases. Additionally, if taken with other diabetes medications such as insulin or sulfonylureas, there is a risk of hypoglycemia, so dosage adjustments may be necessary when using these medications together. This medication should not be administered to patients with moderate to severe renal impairment or to those in serious conditions such as acute infections, dehydration, heart failure, or acute myocardial infarction. If undergoing tests involving iodinated contrast agents, the medication should be discontinued for a certain period before and after the examination, and can only be resumed once normal kidney function is verified. Women who are pregnant or nursing should not take this medication, and it is not recommended for children or adolescents under the age of 18. This drug may increase the risk of urinary tract infections and genital infections, so any signs of infection should be reported to a healthcare provider immediately. During treatment, kidney function and blood sugar levels should be monitored regularly, and vitamin B12 levels may also need to be checked. Additionally, this medication can cause fluid loss, so elderly patients or those at risk of dehydration should be carefully observed. In cases of overdose, blood dialysis may be required, and the reported side effects of this medication include nausea, vomiting, diarrhea, abdominal pain, hypoglycemia, and liver function abnormalities. Lastly, it is advisable to avoid alcohol consumption while taking this medication, and the decision to continue use during surgery or serious illness should be made in consultation with healthcare providers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), lactic acidosis, ketoacidosis, angioedema, perineal necrosis, urosepsis, pyelonephritis, headache (severe headache, thunderclap headache), cerebral infarction, acute kidney injury, jaundice (yellowing of skin or eyes), acute cholecystitis, autoimmune hepatitis, cholelithiasis, severe allergic reactions, severe skin adverse reactions, serious neurological symptoms, difficulty breathing, severe swelling or urination abnormalities,

Mild side effects

  • Hypoglycemia
  • urinary tract infection
  • genital infection
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
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  • abnormal liver function tests
  • hepatitis
  • taste abnormalities
  • itching
  • rash
  • elevated serum lipids
  • increased serum creatinine
  • elevated hematocrit
  • decreased vitamin B12
  • fluid volume depletion
  • taste disorders
  • dermal cysts
  • seborrheic dermatitis
  • atopic dermatitis
  • ring-shaped eczema
  • prickly heat
  • sebaceous gland hyperplasia
  • back pain
  • headache
  • dizziness

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

Storage

This drug may be sensitive to air or moisture, so it should be stored in a sealed container. It is important to maintain storage temperatures between 1 and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

White oval film-coated tablets that are convex on both sides with a yellow tint.

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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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.