Medication info
Jardiance 10 mg Tablet (Empagliflozin)

Jardiance 10 mg Tablet (Empagliflozin)

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

MFDS item code 202102270 · Approved 2021.03.12 · Insurance code 644915040

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 10 mg once daily for monotherapy and for additional combination therapy with insulin and other blood glucose-lowering agents. If well tolerated and additional blood sugar control is needed, the dosage can be increased to 25 mg once daily. This medication can be taken without regard to meals and should be swallowed whole. If a dose is missed, take it as soon as remembered, but do not take two doses at once.

Ingredients

Manufacturer
제이더블유중외제약(주)

Efficacy & effects

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

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

This medication is used in conjunction with diet and exercise to help control blood sugar levels in adults with type 2 diabetes. It may be used alone, but if blood sugar control is insufficient, it may be administered in combination with metformin, pioglitazone, sulfonylureas, insulin, or DPP-4 inhibitors. It is especially important to use this medication with caution in patients with type 2 diabetes who have cardiovascular disease, and to refer to the relevant clinical trial information. This drug is effective in improving blood sugar management and preventing complications in patients.

How to take

Adult dose

The recommended dosage of this medication is 10 mg once daily for monotherapy and for additional combination therapy with insulin and other blood glucose-lowering agents. If well tolerated and additional blood sugar control is needed, the dosage can be increased to 25 mg once daily. This medication can be taken without regard to meals and should be swallowed whole. If a dose is missed, take it as soon as remembered, but do not take two doses at once.

Precautions

This medication should not be used in certain patients. First, individuals allergic to the active ingredient or any component of this medication should avoid taking it. Additionally, it should not be administered to patients with type 1 diabetes or those experiencing diabetic ketoacidosis. Patients with severely impaired renal function, defined as a glomerular filtration rate of less than 30 mL/min/1.73m2 or those with end-stage renal disease or who are undergoing dialysis should also refrain from using this medication. This medication contains lactose, so it should not be given to patients with lactose intolerance or genetic lactose enzyme deficiency. Patients with mildly impaired renal function should use this medication with caution. Patients with a glomerular filtration rate of less than 60 mL/min/1.73m2 should not initiate treatment with this medication and those already receiving it may need dosage adjustment or discontinuation. In cases of end-stage renal disease or undergoing dialysis, this medication is not expected to be effective and should not be used. Regular monitoring of renal function prior to and during treatment is essential. Patients with heart failure classified as mild to moderate by the New York Heart Association (Class I-II) should use it cautiously, whereas it is not recommended for those classified as severe (Class III-IV). Additionally, when taken with insulin or sulfonylureas, which are insulin secretagogues, there is a risk of hypoglycemia, and dosage adjustments of those medications may be necessary. Adverse reactions that may occur while taking this medication include hypoglycemia, genital infections, urinary tract infections, increased urination, and reduced fluid volume. In particular, the risk of hypoglycemia may be heightened when taken concurrently with insulin or sulfonylureas, so caution is advised. Serious side effects reported include ketoacidosis, Fournier's gangrene (perineal necrotizing fasciitis), and acute pyelonephritis; if symptoms occur, it is important to consult a physician immediately. This medication may cause fluid volume loss, necessitating caution in elderly patients or those with hypotension or cardiovascular disease during administration. Pregnant women are advised to avoid taking this medication, and it should be discontinued immediately if pregnancy is confirmed. Nursing mothers are also advised to discontinue breastfeeding while using this medication. It should not be used in pediatric patients under 18 years of age, as safety and efficacy have not been established. No specific toxic symptoms have been reported in cases of overdose, but appropriate treatment should be sought in the event of overdose. Store this medication out of reach of children and do not transfer it to other containers for safety. Caution is advised when driving or operating machinery, especially when taken in conjunction with insulin or sulfonylureas due to the risk of hypoglycemia. Regular monitoring of renal function and observation of unusual symptoms during treatment is important, and if any unusual symptoms occur, medical consultation should be sought immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, ketoacidosis, urosepsis, pyelonephritis, Fournier's gangrene, chest tightness, difficulty breathing, cold sweat, pallor, severe swelling (edema), interstitial nephritis, acute kidney injury, sudden and severe headache, seizures, confusion, visual disturbances, paralysis, significant reduction in urine output, severe swelling accompanied by increased blood pressure, chest pain, angina, Prinzmetal's angina, deep vein thrombosis

Mild side effects

  • Hypoglycemia
  • vulvovaginal candidiasis
  • vulvitis
  • glansitis
  • other genital infections
  • itching
  • rash
  • increased urination
  • urinary difficulty
  • thirst
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  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
  • fever
  • headache
  • hives
  • angioedema
  • reduced fluid volume
  • edema
  • facial swelling
  • peripheral edema
  • rash
  • fatigue
  • facial swelling
  • chills
  • unusual sensations
  • pain
  • pain at injection site
  • vascular stent stenosis
  • vascular spasm

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

Storage

This medication should be stored tightly sealed to prevent exposure to air and moisture. It is best kept at room temperature between 1 degree and 30 degrees.

Appearance and packaging

Appearance

Light yellow, double-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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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.