Medication info

Empadown Duo Tablet 5/850 mg (Empagliflozin, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
제이더블유신약(주)
Appearance
Biconvex oval film-coated tablets that are white with a yellowish hue
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 202201340 · Approved 2022.04.04

Summary

Main use
Blood sugar control and prevention of cardiovascular events in adult patients with type 2 diabetes
Who takes it
Adults
Adult dose
The recommended dosage for this medication is 1 tablet once, twice a day. The dosage is determined based on the treatment regimen, efficacy, and tolerability of the patient, not exceeding 25 mg of empagliflozin and 2000 mg of metformin. If blood sugar control is insufficient, administer 5 mg of empagliflozin twice daily along with the current dose of metformin. If tolerated well, the total daily dose of empagliflozin can be increased to 25 mg.

Ingredients

Manufacturer
제이더블유신약(주)

Efficacy & effects

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

  • Adult patients with type 2 diabetes who find it difficult to control blood sugar levels
  • patients with cardiovascular disease
View approved original text

This medication is suitable for adult patients with type 2 diabetes that are treated with a combination of empagliflozin and metformin. It helps improve blood sugar control when used as an adjunct therapy along with meal planning and exercise therapy. In cases where cardiovascular disease is present among patients with type 2 diabetes whose blood sugar is not adequately controlled, the impact of this medication on the occurrence of cardiovascular events should be referenced from expert guidelines. Overall, it is used to facilitate diabetes management by enhancing blood sugar control.

How to take

Adult dose

The recommended dosage for this medication is 1 tablet once, twice a day. The dosage is determined based on the treatment regimen, efficacy, and tolerability of the patient, not exceeding 25 mg of empagliflozin and 2000 mg of metformin. If blood sugar control is insufficient, administer 5 mg of empagliflozin twice daily along with the current dose of metformin. If tolerated well, the total daily dose of empagliflozin can be increased to 25 mg.

Precautions

This medication contains two components, empagliflozin and metformin hydrochloride, both of which lower blood sugar and are used for the treatment of type 2 diabetes. Care should be taken when taking this medication as it may lead to a serious condition known as lactic acidosis. Lactic acidosis is a condition where lactate builds up excessively in the body, which can be severe and potentially fatal. Additionally, using this medication with insulin or sulfonylureas can raise the risk of hypoglycemia, so blood sugar levels should be closely monitored. This medication is not administered to patients with severely impaired renal function or conditions such as acute infection, dehydration, severe heart failure, or acute myocardial infarction. Before and after tests using iodine contrast agents, this medication should be temporarily suspended due to the risk of worsening kidney function and lactic acidosis. Resuming the medication should occur after confirming that kidney function has returned to normal. It is contraindicated for women who are pregnant or may become pregnant, as well as for lactating women; patients with liver impairment should also avoid this medication. Regular kidney function tests should be conducted to verify safety during treatment, and especially elderly patients or those with slightly impaired kidney function should be tested more frequently. This medication may cause side effects such as gastrointestinal disturbances, hypoglycemia, urinary tract infections, genital infections, increased urination, decreased fluid volume, and should be reported to healthcare personnel if symptoms occur. Alcohol consumption may increase the risk of lactic acidosis, therefore it is important to avoid excessive drinking during treatment. Additionally, during treatment with this medication, irregular meals, intense exercise, and taking other medications may pose risks for hypoglycemia or ketoacidosis, so caution is advised. Notify a doctor immediately if pain, swelling, redness, etc., occurs in the genital or perineal area, as severe cases may require surgical treatment. In case of overdose, dialysis may be required, so the prescribed dosage must be strictly adhered to according to the physician’s instructions. Lastly, keep out of reach of children, and store in the original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweats, pallor, severe allergic reactions
  • Severe rashes accompanied by high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions
  • Shortness of breath or difficulty breathing, asthmatic attacks, abnormal breathing with coughing and fever
  • Jaundice (yellowing of the skin or eyes), extreme lethargy, liver abnormalities (jaundice)
  • Sudden and severe headaches

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
  • erythema
  • headache
  • dizziness
  • orthostatic dizziness
  • drowsiness
  • fatigue
  • increased serum lipids
  • increased hematocrit
  • increased serum creatinine
  • decreased serum creatinine
  • thirst
  • abnormal test results
  • weight loss
  • fatigue
  • facial swelling
  • fever
  • unusual

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

Storage

This medication must be stored in a tightly sealed container to prevent air or moisture from entering. It is advisable to store at room temperature, between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Biconvex oval film-coated tablets that are white with a yellowish hue

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.