Medication info

Empagliflozin/Metformin Duo Tablets 5/850 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
(주)테라젠이텍스
Appearance
White, oval, biconvex, film-coated tablets with a yellow tint
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 202201396 · 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 per dose, taken twice daily. Dosages should be determined considering each patient's current therapy, efficacy, and tolerability, without exceeding 25 mg of empagliflozin and 2000 mg of metformin. For patients who cannot achieve adequate blood glucose control with metformin alone or in combination with other medications such as insulin, the recommended dosage is 5 mg of empagliflozin twice daily (

Ingredients

Manufacturer
(주)테라젠이텍스

Efficacy & effects

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

  • Abnormal blood sugar control
  • type 2 diabetes
  • cardiovascular disease
View approved original text

This medication is used as an adjunct to diet and exercise to assist in blood sugar control for patients with type 2 diabetes. It is particularly suitable for adult patients who do not achieve sufficient blood sugar control and can also be administered to patients with accompanying cardiovascular disease. However, it is important to refer to specialist recommendations concerning the risk of cardiovascular events. This medication helps improve blood sugar control, aiding in diabetes treatment.

How to take

Adult dose

The recommended dose of this medication is 1 tablet per dose, taken twice daily. Dosages should be determined considering each patient's current therapy, efficacy, and tolerability, without exceeding 25 mg of empagliflozin and 2000 mg of metformin. For patients who cannot achieve adequate blood glucose control with metformin alone or in combination with other medications such as insulin, the recommended dosage is 5 mg of empagliflozin twice daily (

Precautions

This medication helps control blood sugar levels. It may cause a rare side effect known as lactic acidosis, which is a serious condition where lactic acid builds up excessively in the body. Lactic acidosis is severe and can sometimes be fatal, so immediate consultation with a physician is necessary if symptoms occur. Additionally, the risk of hypoglycemia may increase when this medication is taken with other diabetes medications such as insulin or sulfonylureas. Symptoms of hypoglycemia include dizziness, cold sweat, and severe fatigue. This medication should not be used in patients with significantly impaired kidney function or in acute conditions such as infections, dehydration, heart failure, or acute myocardial infarction. Women who are pregnant or may become pregnant and nursing mothers should also avoid this medication. During treatment, regular monitoring of kidney function is necessary, as treatment may be stopped if there is a decline in kidney function. When undergoing imaging tests with iodine contrast agents, this medication should be suspended for a certain period before and after the test, and it should be resumed only after confirming normal kidney function. This medication may lead to fluid loss, so patients at risk for dehydration or low blood pressure should use caution. Elderly patients or those with cardiovascular conditions should be especially careful. During treatment, urinary and genital infections may occur, and any related symptoms should be reported to a physician immediately. The metformin component may cause gastrointestinal disturbances (diarrhea, nausea, vomiting, etc.) and may lower vitamin B12 levels, so regular monitoring may be required. Alcohol use can increase the risk of lactic acidosis; therefore, it is advisable to avoid drinking alcohol while on this medication. Women who are pregnant or nursing should not take this medication, and if they are currently taking it, they should consult their doctor. This medication is not recommended for children under 18 years of age. In the case of overdose, there is a risk of lactic acidosis or hypoglycemia, and immediate medical attention is required, possibly needing treatment via hemodialysis. Patients should have their blood sugar and kidney function, as well as vitamin B12 levels, regularly monitored during treatment, and should consult their doctor immediately if any abnormal symptoms occur. Additionally, this medication may interact with other drugs, so it is essential to inform healthcare providers of other medications being taken.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, perineal necrosis, ketoacidosis, lactic acidosis, urosepsis, pyelonephritis, myocardial infarction, cerebral infarction, acute kidney injury, liver abnormalities (hepatitis, autoimmune hepatitis, acute cholecystitis, cholelithiasis), sudden and severe headache, seizures, confusion, visual disturbances, paralysis, difficulty breathing, asthma attacks, severe edema, increased blood pressure, heart failure, shock, acute congestive heart failure, acute myocardial infarction, acute

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
  • increased serum creatinine
  • decreased glomerular filtration rate
  • thirst
  • headache
  • dizziness
  • fatigue
  • peripheral edema
  • facial edema
  • fever
  • swelling
  • weight loss
  • insomnia
  • cough
  • breathing difficulties
  • anxiety
  • musculoskeletal pain
  • back pain
  • fever

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

Storage

This medication may be sensitive to air or humidity, so it must be stored in a tightly sealed container. It is important to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature to preserve the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

White, oval, biconvex, film-coated tablets with a yellow tint

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.