Medication info

Empagduo Tablet 12.5/850 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
구주제약(주)
Appearance
Pinkish white, biconvex, oval-shaped film-coated tablet
Packaging
60 tablets/bottle, 10 tablets/box [10 tablets/PTP x 1], 60 tablets/PTP [10 tablets/PTP x 6]
Approval status
Active

MFDS item code 202302648 · Approved 2023.09.05

Summary

Main use
Effect of controlling blood sugar in type 2 diabetes and preventing cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage for this medication is 1 tablet per dose, taken twice a day. The dosage should be determined by considering each patient’s treatment regimen, efficacy, and tolerability, not exceeding 25 mg of Empagliflozin and 2000 mg of Metformin. In cases where blood sugar control is insufficient with Metformin alone or in combination with other medications such as insulin, the recommended dosage is 5 mg of Empagliflozin twice a day (total of 10 mg) along with existing Metformin dosages.

Ingredients

Manufacturer
구주제약(주)

Efficacy & effects

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

View approved original text

This medication is used to assist in controlling blood sugar for adult patients with type 2 diabetes who are following a dietary regimen and exercise program. It is particularly suitable for patients whose blood sugar is not adequately controlled. Patients with cardiovascular disease should refer to professional guidance and caution. This medication effectively improves blood sugar levels to help manage diabetes.

How to take

Adult dose

The recommended dosage for this medication is 1 tablet per dose, taken twice a day. The dosage should be determined by considering each patient’s treatment regimen, efficacy, and tolerability, not exceeding 25 mg of Empagliflozin and 2000 mg of Metformin. In cases where blood sugar control is insufficient with Metformin alone or in combination with other medications such as insulin, the recommended dosage is 5 mg of Empagliflozin twice a day (total of 10 mg) along with existing Metformin dosages.

Precautions

This medication helps to control blood sugar levels. However, there is a risk of a rare side effect called severe lactic acidosis, which can be life-threatening and therefore requires caution. Additionally, if taken in combination with insulin or sulfonylureas, there is a risk of hypoglycemia. Patients with moderate to severe renal impairment, acute kidney problems, serious infections, heart failure, acute myocardial infarction, and certain health conditions should not take this medication. It is also safest for pregnant or nursing women to avoid this medication. Before and during taking this medication, regular kidney function tests are essential, especially for the elderly or those with impaired kidney function. In situations with a risk of fluid loss, such as dehydration, severe vomiting, or diarrhea, the medication may need to be temporarily discontinued. This medication may increase the risk of urinary or genital infections, so if any infection symptoms appear, consult a healthcare professional immediately. Increased urination may occur, and symptoms of low blood pressure due to decreased fluid volume may also be present. During use, be cautious of hypoglycemia symptoms, and if taken with insulin or other blood sugar-lowering agents, dosage adjustments may be necessary to reduce the risk of hypoglycemia. This medication is not recommended for patients with liver dysfunction, and if liver damage symptoms arise, contact healthcare professionals immediately. Prior to and following exams or surgeries using iodine contrast agents, this medication should be temporarily discontinued and resumed only after the restoration of normal kidney function. Alcohol intake may increase the risk of lactic acidosis, so avoid excessive drinking during treatment. Elderly patients are at a higher risk of renal dysfunction, so dosage adjustments and regular monitoring are necessary. It is crucial to consult healthcare providers promptly if any changes in symptoms or adverse reactions occur during the course of this medication.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough + fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headaches, thunderclap headache, seizures, altered consciousness, 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
  • hives
  • erythema
  • angioedema
  • thirst
  • increased serum lipids
  • elevated serum creatinine
  • decreased glomerular filtration rate
  • increased hematocrit
  • vulvar vaginitis
  • vulvitis
  • balanitis
  • decreased fluid volume
  • headache
  • dizziness
  • orthostatic dizziness
  • insomnia
  • anxiety

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

Storage

Store this medication in a tightly sealed container to prevent contact with air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Pinkish white, biconvex, oval-shaped film-coated tablet

Package unit

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

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.