Medication info
Jardiance Duo Tablet 12.5/500 mg

Jardiance Duo Tablet 12.5/500 mg

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

MFDS item code 201600388 · Approved 2016.01.21 · Insurance code 653501530

Summary

Main use
Blood glucose control for type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage for this medication is 1 tablet once daily, twice daily. The dosage should be determined considering the current therapy, efficacy, and tolerability of each patient, while not exceeding the maximum daily recommended doses of empagliflozin 25 mg and metformin 2000 mg. - For patients who are unable to achieve adequate blood glucose control with metformin alone or other drugs including insulin, the recommended dosage is empagliflozin 5 mg once daily, twice daily.

Ingredients

Importer
한국베링거인겔하임(주)

Efficacy & effects

Blood glucose control for type 2 diabetes and prevention of cardiovascular events

  • Abnormal blood glucose control in adults with type 2 diabetes
  • inadequately controlled blood glucose
  • cardiovascular diseases
View approved original text

This medication is used in combination with empagliflozin and metformin to improve blood glucose control in adults with type 2 diabetes. It is administered as an adjunct to dietary and exercise therapy for patients whose blood glucose levels are not adequately controlled. It is also effective for patients with type 2 diabetes who have cardiovascular diseases, although caution is needed regarding the potential for cardiovascular events. For detailed information related to this, please refer to the information for healthcare professionals. Therefore, this medication primarily helps in managing blood glucose levels and maintaining cardiovascular health in patients with type 2 diabetes.

How to take

Adult dose

The recommended dosage for this medication is 1 tablet once daily, twice daily. The dosage should be determined considering the current therapy, efficacy, and tolerability of each patient, while not exceeding the maximum daily recommended doses of empagliflozin 25 mg and metformin 2000 mg. - For patients who are unable to achieve adequate blood glucose control with metformin alone or other drugs including insulin, the recommended dosage is empagliflozin 5 mg once daily, twice daily.

Precautions

This medication aids in blood glucose control but could rarely cause serious side effects like lactic acidosis, requiring caution. When taken with other diabetes medications, there is a risk of hypoglycemia, so blood glucose levels should be closely monitored. It should not be administered to patients with moderate to severe renal impairment, acute kidney issues, severe infections, heart failure, or acute myocardial infarction. Medication should be discontinued before and after tests using iodine-containing contrast agents, resuming only when kidney function is confirmed to be normal. It is not recommended for use in pregnant or breastfeeding women, nor in children under 18 years of age. During treatment, attention should be paid to signs of fluid loss or dehydration, liver dysfunction, hypoglycemia symptoms, urinary tract infections, and genital infections. Elderly patients or those with reduced kidney function should have regular kidney function tests and may require dose adjustments when used with insulin or sulfonylurea due to hypoglycemia risk. Moreover, this medication may reduce vitamin B12 levels, so monitoring vitamin B12 status during prolonged use is advised. In cases of overdose, the risk of lactic acidosis is present, requiring immediate notification to healthcare providers, with treatment potentially involving dialysis. Alcohol consumption should be avoided during treatment, and medication may need to be discontinued based on symptoms. Finally, if symptoms such as fever, pain in the genitals or perineum, redness, or swelling occur during treatment, immediate consultation with healthcare providers is necessary, as this can indicate a serious infection needing prompt treatment.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, ketoacidosis, lactic acidosis, urosepsis, pyelonephritis, necrotizing fasciitis of the perineum, severe swelling, chest tightening, difficulty breathing, pallor, severe allergic reactions, high fever with severe rash, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, breathing irregularities accompanied by cough and fever, yellowing of skin or eyes, jaundice

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
  • angioedema
  • dysuria
  • thirst
  • increased serum lipids
  • elevated serum creatinine
  • altered taste
  • headache
  • dizziness
  • orthostatic dizziness
  • fatigue
  • chest discomfort
  • chest pain
  • weakness
  • weight loss
  • vulvar itching
  • insomnia
  • rash
  • cough

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature. This will ensure that the chemical composition remains stable and safe for use.

Appearance and packaging

Appearance

Light brownish-purple, oval-shaped, biconvex film-coated tablet

Package unit

60 tablets/box [10 tablets/PTP × 6 packs]

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.