Medication info
Jardiance 10 mg (Empagliflozin)

Jardiance 10 mg (Empagliflozin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›10mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
Light yellow, double-sided, convex, round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202102090 · Approved 2021.03.05 · Insurance code 657808330

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 for monotherapy and additional combination therapy with insulin or other hypoglycemics is 10 mg once daily. If the patient has good tolerance to the 10 mg dose and requires additional blood sugar control, the dosage may be increased to 25 mg once daily. When this medication is used in combination with sulfonylureas or insulin, dosage reduction of sulfonylureas or insulin may be considered to reduce the risk of hypoglycemia.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

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

  • Type 2 diabetes
  • difficulty in blood sugar control
  • cardiovascular diseases
View approved original text

This medication is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. It can also be administered as monotherapy, and in cases where patients have never been treated with diabetes medications or have difficulty controlling blood sugar with monotherapy, it can be used in combination with metformin. Additionally, it may be combined with other treatments such as metformin alone, pioglitazone, sulfonylureas, or insulin therapy for patients whose blood sugar control is insufficient. Caution is needed regarding the impact of this medication on cardiovascular event occurrence in patients with cardiovascular diseases and type 2 diabetes; therefore, refer to professional guidance. Overall, this medication is effectively used to improve blood sugar control in various situations.

How to take

Adult dose

The recommended dose of this medication for monotherapy and additional combination therapy with insulin or other hypoglycemics is 10 mg once daily. If the patient has good tolerance to the 10 mg dose and requires additional blood sugar control, the dosage may be increased to 25 mg once daily. When this medication is used in combination with sulfonylureas or insulin, dosage reduction of sulfonylureas or insulin may be considered to reduce the risk of hypoglycemia.

Precautions

This medication should not be used in patients who are allergic to the active ingredient or any component of this medication. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. This medication is not used in patients with severely impaired renal function or end-stage kidney disease, as well as those undergoing dialysis. Since this medication contains lactose, patients with genetic metabolic disorders such as lactose intolerance or galactose intolerance should not take it. Patients with mild renal impairment should be administered this medication with caution and renal function must be monitored before administration and regularly thereafter. For patients with severe heart failure, this medication is not recommended, while mild patients should use it cautiously. When used together with insulin or sulfonylureas, the risk of hypoglycemia may increase, so dosage adjustments may be required. During administration, patients should carefully observe for symptoms such as hypoglycemia, infections, increased urination, urinary tract infections, or decreased fluid volume, among other side effects. Particular attention should be given to severe infection symptoms such as genital infections and necrotizing fasciitis, and related symptoms require immediate consultation with medical personnel. This medication can induce ketoacidosis, so if symptoms such as vomiting, abdominal pain, or breathing difficulties occur, immediate medical attention is required. Elderly patients or those at risk of fluid loss should take precautions against dehydration and low blood pressure, and may temporarily discontinue use if necessary. Patients taking this medication should use alternative methods for monitoring blood sugar levels, as 1,5-AG tests are unreliable. Women who are pregnant or planning to become pregnant should avoid this medication, and breastfeeding women should refrain from taking it. Children under 18 years of age should not use this medication as its safety and efficacy have not been established for this age group. There have been no reports of specific toxic symptoms from overdose, but clinical condition should be meticulously monitored, and appropriate treatment should be provided as necessary. Store this medication out of the reach of children, and do not transfer it to other containers for safety. This medication may have a slight impact on driving or operating machinery, especially for patients at risk of hypoglycemia, so caution is advised. Diabetes patients should pay attention to routine foot care and it is important to consult medical personnel regarding the possibility of lower limb amputation.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, necrotizing fasciitis, ketoacidosis, urosepsis and pyelonephritis, severe edema or urination issues (including urinary retention), asthma attacks, serious allergic reactions (hives, angioedema), severe skin reactions (including rash), liver issues (jaundice symptoms are not explicitly stated but reports of liver damage exist), severe neurological symptoms (headaches, reported strokes), respiratory problems

Mild side effects

  • Hypoglycemia
  • vulvovaginal candidiasis
  • vulvar vaginitis
  • balanitis and other genital infections
  • increased urination
  • rash
  • itching
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
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  • headache
  • dizziness
  • decreased fluid volume
  • fatigue
  • fever
  • facial swelling
  • edema
  • cough
  • breathing difficulties
  • diarrhea
  • indigestion
  • abdominal pain
  • nausea
  • gastritis
  • constipation
  • anxiety
  • insomnia
  • weight loss
  • vulvar pruritus
  • genital pruritus
  • lower back pain

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. By doing so, the medication's efficacy can be well maintained, ensuring safe use.

Appearance and packaging

Appearance

Light yellow, double-sided, convex, round film-coated tablet

Package unit

30 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.