Medication info
Jardiance Duo Tablet 12.5/1000 mg (Empagliflozin, Metformin)

Jardiance Duo Tablet 12.5/1000 mg (Empagliflozin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›12.5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
Biconvex, oval-shaped, film-coated tablet with a dark brownish-purple color
Packaging
60 tablets/bottle [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 202302786 · Approved 2023.09.20 · Insurance code 657808050

Summary

Main use
Effectiveness in blood sugar control for type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 1 tablet, taken twice a day. Dosage should be determined considering the patient's treatment regimen, effectiveness, and tolerance, not exceeding 25 mg of empagliflozin and 2000 mg of metformin. For patients receiving metformin alone or in combination with other drugs, the recommended dosage is 5 mg of empagliflozin twice a day (total daily dose of 10 mg) along with their existing dose of metformin. For those with good tolerance requiring additional blood sugar control, the dosage of empagliflozin can be increased to 25 mg (total daily dose). For patients transitioning to this medication from a combination of empagliflozin (total daily dose of 10 mg or 25 mg) and metformin, dosing should be done based on their existing doses of empagliflozin and metformin. When used in conjunction with sulfonylureas or insulin, dosage reductions of sulfonylureas or insulin can be considered to reduce the risk of hypoglycemia (see warnings and interactions). This medication should be taken with meals to reduce gastrointestinal side effects associated with metformin. If a dose is missed, it should be taken as soon as remembered but should not be doubled. If so, the missed dose should be skipped.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Effectiveness in blood sugar control for type 2 diabetes and prevention of cardiovascular events

  • Difficulty in blood sugar control
  • type 2 diabetes
  • cardiovascular disease
View approved original text

This medication works by combining empagliflozin and metformin to effectively enhance blood sugar control in patients with type 2 diabetes in conjunction with diet and exercise. It is particularly suitable for adult patients with type 2 diabetes whose blood sugar control is insufficient and may also be considered for patients with cardiovascular disease. However, caution regarding the occurrence of cardiovascular events should be detailed in clinical trial information for professionals. This medication supports the management of patients' health by improving blood sugar control.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet, taken twice a day. Dosage should be determined considering the patient's treatment regimen, effectiveness, and tolerance, not exceeding 25 mg of empagliflozin and 2000 mg of metformin. For patients receiving metformin alone or in combination with other drugs, the recommended dosage is 5 mg of empagliflozin twice a day (total daily dose of 10 mg) along with their existing dose of metformin. For those with good tolerance requiring additional blood sugar control, the dosage of empagliflozin can be increased to 25 mg (total daily dose). For patients transitioning to this medication from a combination of empagliflozin (total daily dose of 10 mg or 25 mg) and metformin, dosing should be done based on their existing doses of empagliflozin and metformin. When used in conjunction with sulfonylureas or insulin, dosage reductions of sulfonylureas or insulin can be considered to reduce the risk of hypoglycemia (see warnings and interactions). This medication should be taken with meals to reduce gastrointestinal side effects associated with metformin. If a dose is missed, it should be taken as soon as remembered but should not be doubled. If so, the missed dose should be skipped.

Precautions

This medication can cause severe lactic acidosis, which is very rare but can be fatal, so caution is advised. Symptoms of hypoglycemia may occur when used with other diabetes medications, so caution is necessary. Patients with moderate to severe renal impairment or acute kidney issues should not use this medication. Patients in serious conditions such as acute infections, heart disease, or sepsis should also avoid administration. It is not suitable for patients with type 1 diabetes or a history of ketoacidosis. Before and after tests using radiographic contrast agents, renal function should be checked, and the medication should be discontinued if necessary. Patients scheduled for surgery should stop taking this medication 48 hours prior to surgery and resume afterward. Patients with liver dysfunction, severe lung disease, excessive alcohol intake, or dehydration symptoms should also be cautious. Women who are pregnant or breastfeeding should not take this medication. Elderly patients are at higher risk of fluid loss, requiring increased caution when taking this medication and regular monitoring of renal function. This medication may cause side effects such as hypoglycemia, urinary tract infections, genital infections, and increased urination, so if symptoms appear, patients should consult healthcare professionals immediately. Regular blood tests are recommended as vitamin B12 levels may decrease. Alcohol consumption may increase the risk of lactic acidosis, so it is advisable to avoid it during treatment. Patients are particularly advised to be cautious of irregular meals, excessive exercise, and taking other medications during treatment. Since there may be a possibility of drug interactions, patients should inform healthcare professionals of any other medications they are taking. This medication is not recommended for children and adolescents under 18 years old, as its safety and efficacy have not been established. In the case of overdose, patients should immediately visit a medical institution for appropriate treatment, and dialysis may be required. This medication should be stored out of reach of children and kept in its original container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), ketoacidosis, lactic acidosis, urosepsis, pyelonephritis, perineal necrosis, severe skin adverse reactions (severe rash, blisters, skin peeling, mucosal pain in mouth/eyes), severe allergic reactions, severe edema, or urination abnormalities (significant decrease in urine volume, severe swelling throughout the body, accompanied by elevated blood pressure), difficulty breathing, asthma attacks, respiratory issues (coughing with fever), liver abnormalities (jaundice, skin

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
  • altered taste
  • itching
  • rash
  • erythema
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  • hives
  • angioedema
  • hypoglycemia
  • vulvovaginal candidiasis
  • vulvitis
  • balanitis
  • and other genital infections
  • urinary tract infections
  • increased urination
  • urination difficulties
  • thirst
  • increased serum lipids
  • increased blood creatinine
  • decreased glomerular filtration rate
  • increased hematocrit
  • weakness
  • chest discomfort
  • chest pain
  • weight loss
  • dizziness
  • headache

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 contact with air or moisture. Additionally, it is best to store the medication at room temperature between 1°C and 30°C. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Biconvex, oval-shaped, film-coated tablet with a dark brownish-purple color

Package unit

60 tablets/bottle [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.

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.