Medication info

EMPLDM Met Tablet 5/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
동화약품(주)
Appearance
Biconvex oval film-coated tablet that is yellow with a brownish tint
Packaging
10 tablets/box [10 tablets/PTP × 1], 60 tablets/box [10 tablets/PTP × 6], 30 tablets/bottle, 60 tablets/bottle
Approval status
Active

MFDS item code 202201664 · Approved 2022.04.22

Summary

Main use
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, twice daily. The dosage should not exceed the total of 25 mg of empagliflozin and 2000 mg of metformin. For patients using metformin alone or in combination with other medications, the recommended dose is 5 mg of empagliflozin twice daily, along with the existing metformin dose. If tolerance is good, the dose of empagliflozin can be increased from 10 mg to 25 mg. This medication should be taken with food.

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

Blood sugar control in type 2 diabetes and prevention of cardiovascular events

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

This medication is used to assist adults with type 2 diabetes in controlling their blood sugar levels, in conjunction with dietary and exercise therapy. It is especially effective for patients whose blood sugar is not adequately controlled, as the combined effects of empagliflozin and metformin contribute to effectively lowering blood sugar. Furthermore, for patients with cardiovascular diseases, there are precautions regarding the risk of cardiovascular events, so it should be used under the guidance of a healthcare professional. Overall, this medication plays a crucial role in improving blood sugar management in patients with type 2 diabetes.

How to take

Adult dose

The recommended dose of this medication is 1 tablet, twice daily. The dosage should not exceed the total of 25 mg of empagliflozin and 2000 mg of metformin. For patients using metformin alone or in combination with other medications, the recommended dose is 5 mg of empagliflozin twice daily, along with the existing metformin dose. If tolerance is good, the dose of empagliflozin can be increased from 10 mg to 25 mg. This medication should be taken with food.

Precautions

This medication helps to regulate blood sugar. However, it is important to adhere to various precautions when taking this medication. Firstly, this medication may cause a rare side effect known as severe lactic acidosis, which can be life-threatening, so caution is warranted. Lactic acidosis is a condition that occurs when there is an excessive accumulation of lactic acid in the body, with symptoms including malaise, muscle aches, difficulty breathing, weakness, and abdominal pain. In addition, when taken with insulin or sulfonylurea, there is a risk of hypoglycemia, so it’s important to be aware of hypoglycemic symptoms. Symptoms of hypoglycemia include dizziness, cold sweat, trembling, and headache. Patients with moderate to severe renal dysfunction, acute kidney problems, severe infections, unstable heart function, type 1 diabetes, and pregnant or breastfeeding women should not use this medication. This medication can affect kidney function, so regular kidney function tests should be conducted before and during treatment. Extreme caution is also advised during episodes of dehydration or severe vomiting and diarrhea, as these can increase the risk of worsening kidney function. The use of iodinated contrast media before and after certain examinations requires a temporary discontinuation of this medication, and it should be resumed only after confirming normal kidney function. During the course of this medication, urinary tract or genital infections may occur; hence, any signs of infection must be reported to healthcare providers immediately. Gastrointestinal disturbances (such as diarrhea, nausea, vomiting), skin rash, itching, increased urination, fluid loss, hypoglycemia, vitamin B12 deficiency, and other adverse reactions may occur; any abnormal symptoms should be discussed with a healthcare professional. Consumption of alcohol may increase the risk of side effects associated with this medication; therefore, alcohol should be avoided during use. Elderly patients or those with impaired kidney function should be especially cautious and require dose adjustments and regular monitoring. Pregnant women or those who may become pregnant, as well as breastfeeding women, should not take this medication, and alternative treatments should be considered if necessary. In case of overdose, serious side effects may occur, so the prescribed dose must be strictly adhered to, and immediate medical attention should be sought in the event of an overdose. It is essential to regularly monitor blood sugar and kidney function during the course of this medication. Additionally, consult a healthcare professional regarding possible interactions with other drugs when taking this medication.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • perineal necrosis
  • ketoacidosis
  • lactic acidosis
  • pyelonephritis
  • urosepsis
  • liver dysfunction (jaundice)
  • acute kidney injury
  • acute cholecystitis
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  • autoimmune hepatitis
  • cholelithiasis
  • hepatitis
  • cerebral infarction
  • concussion
  • intracranial aneurysm
  • myocardial infarction
  • acute renal failure
  • severe edema
  • hypertension
  • severe allergic reactions
  • severe skin reactions
  • dyspnea
  • asthma attacks
  • difficulty breathing
  • acute cholecystitis
  • acute

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 creatinine
  • increased hematocrit
  • decreased vitamin B12
  • thirst
  • headache
  • dizziness
  • insomnia
  • chest discomfort
  • chest pain
  • weakness
  • dyslipidemia
  • weight loss
  • vulvar pruritus
  • dyspnea
  • cough
  • orthostatic dizziness
  • drowsiness

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

Storage

This medication should be stored in a sealed container to avoid exposure to air or moisture. The recommended storage temperature is at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

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

Package unit

10 tablets/box [10 tablets/PTP × 1], 60 tablets/box [10 tablets/PTP × 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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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.