Medication info

Empagliflozin Metformin Duo Tablet 5/850 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
신풍제약(주)
Appearance
Biconvex oval film-coated tablet that is white with a yellow tint
Packaging
10 tablets/box [10 tablets/PTP x 1], 60 tablets/box [10 tablets/PTP x 6], 30 tablets/bottle, 60 tablets/bottle
Approval status
Active

MFDS item code 202201362 · Approved 2022.04.04

Summary

Main use
Effectiveness in controlling blood sugar in type 2 diabetes and preventing cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 1 tablet, twice a day. The dosage should be determined within the limits of a daily maximum of 25 mg of empagliflozin and 2000 mg of metformin, considering each patient's treatment regimen, efficacy, and tolerance. If adequate blood sugar control is not achieved with monotherapy of metformin or in combination with other drugs such as insulin, the recommended dosage is 5 mg of empagliflozin twice daily (totaling 10 mg) along with the existing dosage of metformin.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

Effectiveness in controlling blood sugar in type 2 diabetes and preventing cardiovascular events

  • Type 2 diabetes
  • poor blood sugar control
  • cardiovascular disease
View approved original text

This drug is used to improve glycemic control in adult patients with type 2 diabetes who are suitable for the combination use of empagliflozin and metformin. It helps manage blood sugar effectively when taken in conjunction with dietary and exercise regimens. It is particularly important to consult with a healthcare professional about the potential impact on cardiovascular events in adults with type 2 diabetes who do not achieve adequate blood sugar control and have existing cardiovascular conditions. This medication aids in the treatment of type 2 diabetes by improving blood sugar control.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet, twice a day. The dosage should be determined within the limits of a daily maximum of 25 mg of empagliflozin and 2000 mg of metformin, considering each patient's treatment regimen, efficacy, and tolerance. If adequate blood sugar control is not achieved with monotherapy of metformin or in combination with other drugs such as insulin, the recommended dosage is 5 mg of empagliflozin twice daily (totaling 10 mg) along with the existing dosage of metformin.

Precautions

This medication helps control blood sugar levels. However, there is a risk of a serious condition known as lactic acidosis, so caution is required when using this medication. Particular care should be taken in conjunction with insulin or sulfonylurea medications, as hypoglycemia may occur. This drug should not be used in patients with moderate to severe renal impairment, acute renal status, type 1 diabetes, or acute or chronic metabolic acidosis. Additionally, use should be avoided or temporarily discontinued in situations such as acute myocardial infarction, heart failure, severe infections, and before or after surgery. While taking this medication, renal function should be regularly monitored for abnormalities, and if dehydration, severe vomiting, or diarrhea occurs, medication should be temporarily paused. Also, there may be a risk of hypoglycemia when used in combination with insulin or sulfonylureas, necessitating dosage adjustments. Common side effects include hypoglycemia, urinary tract infections, genital infections, and increased urination. Serious side effects such as liver function abnormalities, skin rashes, interstitial nephritis, and necrotizing fasciitis have been reported; if symptoms occur, consult a doctor immediately. Women who are pregnant or breastfeeding should not take this medication, and the elderly or those with poor nutritional status should use it more cautiously. This medication may interact with other drugs, so if you are taking other medications, be sure to inform your doctor or pharmacist. In the event of an overdose, serious side effects such as lactic acidosis may occur, so if an overdose is suspected, seek immediate medical care. Lastly, this medication should be kept out of reach of children and stored in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), necrotizing fasciitis, lactic acidosis, ketoacidosis, angioedema, urosepsis, pyelonephritis, severe allergic reactions, severe skin adverse reactions, serious nervous system symptoms, liver dysfunction (jaundice), severe edema or urinary abnormalities, sudden severe headache, thunderclap headache, seizure, confusion, visual disturbances, paralysis, breathing difficulties, asthma attacks, respiratory issues accompanied by cough and fever, high fever and

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
  • altered taste
  • itching
  • rash
  • increased serum lipids
  • elevated blood creatinine
  • decreased glomerular filtration rate
  • decreased vitamin B12 and deficiency
  • low blood pressure
  • dehydration
  • hypotension
  • reduced blood volume
  • orthostatic hypotension
  • syncope
  • fatigue
  • facial edema
  • peripheral edema
  • facial swelling
  • headache
  • dizziness

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. Additionally, it is advisable to store the medication at room temperature, specifically between 1 to 30 degrees Celsius, avoiding places that are too hot or too cold.

Appearance and packaging

Appearance

Biconvex oval film-coated tablet that is white with a yellow tint

Package unit

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