Medication info
Jardiance Duo Tablets 12.5/500 mg (Empagliflozin, Metformin)

Jardiance Duo Tablets 12.5/500 mg (Empagliflozin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
Light brownish-purple, biconvex oval film-coated tablet
Packaging
60 tablets/box [10 tablets/PTP x 6], 30 tablets/bottle, 10 tablets/box [10 tablets/PTP x 1], 60 tablets/bottle
Approval status
Active

MFDS item code 202302787 · Approved 2023.09.20 · Insurance code 657808060

Summary

Main use
Effect on 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 per administration, taken twice a day. The dose should be determined based on each patient's treatment regimen, efficacy, and tolerability, within the maximum daily doses of empagliflozin 25 mg and metformin 2000 mg. In cases where blood sugar control is insufficient with metformin alone or combined with other medications such as insulin, empagliflozin 5 mg should be taken twice daily (total daily dose of 10 mg), along with the existing dose of metformin.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Effect on blood sugar control in type 2 diabetes and prevention of cardiovascular events

  • Difficulty in blood sugar control
  • type 2 diabetes
  • cardiovascular diseases
  • risk of cardiovascular events
View approved original text

This medication is used to help manage blood sugar in adults with type 2 diabetes who do not receive sufficient blood sugar control with diet and exercise alone. The combination of empagliflozin and metformin enhances blood sugar control and should be used cautiously in patients with cardiovascular disease. This drug helps improve blood sugar levels consistently, aiding in diabetes management.

How to take

Adult dose

The recommended dose of this medication is 1 tablet per administration, taken twice a day. The dose should be determined based on each patient's treatment regimen, efficacy, and tolerability, within the maximum daily doses of empagliflozin 25 mg and metformin 2000 mg. In cases where blood sugar control is insufficient with metformin alone or combined with other medications such as insulin, empagliflozin 5 mg should be taken twice daily (total daily dose of 10 mg), along with the existing dose of metformin.

Precautions

This medication is used for diabetes treatment and contains two active ingredients: empagliflozin and metformin. While taking this medication, there is a risk of developing a rare side effect known as severe lactic acidosis. Lactic acidosis can lead to the accumulation of lactic acid in the body, which can be dangerous, especially in patients with impaired kidney function or those with acute infections, dehydration, or heart problems. Moreover, this medication may cause hypoglycemia (low blood sugar) when used with other diabetes treatments, so careful monitoring of blood sugar levels is necessary. Patients with moderate to severe renal impairment, acute kidney problems, severe liver dysfunction, acute heart failure, type 1 diabetes, or pregnant or breastfeeding women should not use this medication. Before and after the use of iodine contrast for examinations, the intake of this medication should be stopped and resumed only after ensuring normal kidney function. This drug can cause fluid loss, so special caution is required for patients at risk of dehydration or elderly patients undergoing hypertension treatment. During treatment, side effects such as symptoms of hypoglycemia, urinary tract infections, genital infections, increased urination, gastrointestinal disorders (nausea, vomiting, diarrhea, etc.) may occur; if any unusual symptoms arise, consult a doctor immediately. Vitamin B12 levels may decrease, so regular blood tests should be conducted to assess levels and supplementation may be needed. Alcohol consumption may increase the risk of lactic acidosis; hence, avoid excessive drinking during treatment. Elderly patients often have decreased renal function, so renal function tests should be conducted before use and monitored regularly, ensuring not to exceed maximum dosages. In preparation for surgery, the medication should be discontinued 48 hours prior and should be resumed only after a return to normal kidney function post-surgery. This medication is not for use in pregnant women or those who may become pregnant, as well as breastfeeding women. Regular blood tests and renal function checks are required during the treatment, with adjustments to dosage as directed by a physician based on symptoms. Finally, this medication should be kept out of the reach of children and stored in its original container.

Side effects and when to seek care immediately

Serious side effects

  • Severe lactic acidosis
  • severe hypoglycemia
  • hives
  • angioedema
  • severe swelling (edema)
  • rash
  • perineal necrosis
  • ketoacidosis
  • urinary sepsis
  • pyelonephritis
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  • severe skin reactions
  • hepatitis
  • liver dysfunction (jaundice)
  • sudden and severe headache
  • cerebrovascular accident
  • stroke
  • seizures
  • confusion
  • visual disturbances
  • paralysis
  • nephrolithiasis
  • acute kidney injury
  • acute renal failure
  • myocardial infarction
  • congestive heart failure
  • angina
  • deep vein thrombosis

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 test
  • hepatitis
  • taste alteration
  • rash
  • itching
  • hives
  • erythema
  • angioedema
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
  • increased hematocrit
  • decreased fluid volume
  • hypotension
  • decreased systolic blood pressure
  • decreased blood volume
  • orthostatic hypotension
  • syncope
  • Vitamin B12 absorption impairment

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

Storage

This medication should be stored in a tightly closed container to prevent air and moisture from entering. A storage temperature of 1 to 30 degrees Celsius at room temperature is recommended.

Appearance and packaging

Appearance

Light brownish-purple, biconvex oval film-coated tablet

Package unit

60 tablets/box [10 tablets/PTP x 6], 30 tablets/bottle, 10 tablets/box [10 tablets/PTP x 1], 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.

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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.