Medication info

Empaglin Duo Tablet 12.5/500 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
진양제약(주)
Appearance
Brownish-purple, bilaterally convex oval film-coated tablet
Packaging
10 tablets/box [(10 tablets/PTP×1)], 60 tablets/box [(10 tablets/PTP×6)], 60 tablets/bottle
Approval status
Active

MFDS item code 202302757 · Approved 2023.09.14

Summary

Main use
Blood glucose control and cardiovascular event prevention effects in adult patients with type 2 diabetes
Who takes it
Adults
Adult dose
The recommended dose is 1 tablet once, twice daily. The dose should be determined based on the patient’s treatment regimen, efficacy, and tolerability within the range not exceeding 25 mg of empagliflozin and 2000 mg of metformin. If blood glucose control is insufficient with monotherapy of metformin or in combination with insulin, it is recommended to take 5 mg of empagliflozin twice daily and to continue with the usual dose of metformin. If tolerability is good and additional blood glucose control is necessary...

Ingredients

Manufacturer
진양제약(주)

Efficacy & effects

Blood glucose control and cardiovascular event prevention effects in adult patients with type 2 diabetes

  • Abnormal blood glucose control
  • type 2 diabetes
View approved original text

This medication is used in conjunction with diet and exercise to assist in blood glucose control in adults with type 2 diabetes. It is particularly suitable for patients whose blood glucose control has been inadequate. It can also be used in patients with type 2 diabetes who have cardiovascular diseases, but the clinical trial information and precautions from professionals should be referred to upon use. This medication effectively controls blood glucose and assists in diabetes management.

How to take

Adult dose

The recommended dose is 1 tablet once, twice daily. The dose should be determined based on the patient’s treatment regimen, efficacy, and tolerability within the range not exceeding 25 mg of empagliflozin and 2000 mg of metformin. If blood glucose control is insufficient with monotherapy of metformin or in combination with insulin, it is recommended to take 5 mg of empagliflozin twice daily and to continue with the usual dose of metformin. If tolerability is good and additional blood glucose control is necessary...

Precautions

This medication helps control blood glucose and is used for diabetes treatment. However, during its use, a rare complication called lactic acidosis may occur, so caution is advised. Lactic acidosis is a serious condition that arises when too much lactic acid accumulates in the body, with symptoms including fatigue, muscle pain, difficulty breathing, and abdominal pain. This medication should not be administered to patients with poor kidney function, acute infections, dehydration, or severe heart disease. Additionally, it is also advised that patients with type 1 diabetes or women who are pregnant or nursing do not use this medication for safety. When used alongside other diabetes treatments, hypoglycemia may occur, so dosage adjustment is necessary if insulin or sulfonylurea medications are taken together. During treatment, regular monitoring of kidney function is essential to ensure the safe use of the medication. This medication may cause side effects such as urinary tract infections, genital infections, and increased urination, so if symptoms appear, consult with a doctor. Also, gastrointestinal disturbances, liver function abnormalities, hypoglycemia, fluid loss, and other adverse reactions have been reported, so caution is required. Prior to surgery or radiological examinations, this medication should be temporarily halted, and after confirming normal kidney function following the examination, it can be resumed. Alcohol consumption should be avoided as it may increase the risk of lactic acidosis. Elderly patients or those at risk for fluid loss should use this medication with increased caution and require regular health assessments. Women who are pregnant or may become pregnant and those who are nursing should not take this medication. In case of overdose, seek immediate medical attention for proper treatment, which may include hemodialysis. This medication is not recommended for children and should be kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • ketoacidosis
  • lactic acidosis
  • angioedema
  • perineal necrosis
  • urosepsis
  • pyelonephritis
  • severe allergic reactions
  • severe skin reactions
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  • difficulty breathing
  • asthma attacks
  • liver abnormalities (jaundice)
  • severe neurological symptoms
  • severe edema or urination abnormalities
  • acute kidney failure
  • cerebral infarction
  • myocardial infarction
  • sepsis
  • shock
  • acute congestive heart failure
  • acute myocardial infarction
  • severe infections
  • severe traumatic reactions

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
  • altered taste
  • rash
  • itching
  • hives
  • angioedema
  • difficulty urinating
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
  • decreased fluid volume
  • weight loss
  • hypercholesterolemia
  • dyslipidemia
  • vitamin D deficiency
  • nasopharyngitis
  • soft tissue infections
  • pneumonia
  • none

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Brownish-purple, bilaterally convex oval film-coated tablet

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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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.