Medication info

Idian Tablet 25mg (Empagliflozin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›25mg / 1 tablet
Manufacturer / importer
일양약품(주)
Appearance
Light yellow, oval-shaped film-coated tablet with both sides convex
Packaging
10 tablets/box [10 tablets/PTP x 1], 30 tablets/box [10 tablets/PTP x 3], 30 tablets/bottle
Approval status
Active

MFDS item code 202102071 · Approved 2021.03.05

Summary

Main use
Improvement of blood sugar control and prevention of cardiovascular events in adult patients with type 2 diabetes
Who takes it
Adults
Adult dose
The recommended dose is 10 mg once daily for monotherapy or in combination with other antidiabetic agents such as insulin. If additional blood sugar control is needed and tolerability is good, the dose may be increased to 25 mg once daily. This medication can be taken regardless of meals, and the tablets should be swallowed whole. If a dose is missed, take it as soon as you remember but do not take double the dose within a day.

Ingredients

Manufacturer
일양약품(주)

Efficacy & effects

Improvement of blood sugar control and prevention of cardiovascular events in adult patients with type 2 diabetes

  • Difficulty in controlling blood sugar levels in patients with type 2 diabetes
  • and conditions where blood sugar is not adequately controlled
View approved original text

This medication is used in conjunction with dietary control and exercise to help manage blood sugar levels in adult patients with type 2 diabetes. It can be administered alone, and if adequate control is not achieved with monotherapy, it may be combined with metformin, pioglitazone, sulfonylureas, insulin, or DPP-4 inhibitors like linagliptin. It can also be used in patients with type 2 diabetes who have cardiovascular diseases, but in this case, it is important to refer to the precautions provided by specialists. This medicine effectively controls blood sugar across various therapeutic combinations, improving diabetes management.

How to take

Adult dose

The recommended dose is 10 mg once daily for monotherapy or in combination with other antidiabetic agents such as insulin. If additional blood sugar control is needed and tolerability is good, the dose may be increased to 25 mg once daily. This medication can be taken regardless of meals, and the tablets should be swallowed whole. If a dose is missed, take it as soon as you remember but do not take double the dose within a day.

Precautions

This medication should not be administered to certain patients. First, those with allergic reactions to the active ingredient or any component of this medication should not take it. Second, patients with type 1 diabetes or diabetic ketoacidosis should not use this medication. Third, those with severely impaired kidney function, that is, with a glomerular filtration rate of less than 30 mL/min/1.73m2 or those with end-stage renal disease or undergoing dialysis should not take this medication. Fourth, individuals with lactose intolerance, galactose intolerance, or genetic lactase deficiency should not receive this medication as it contains lactose. Patients with slightly impaired kidney function should use this medication cautiously. If the glomerular filtration rate is less than 60 mL/min/1.73m2, it is best to avoid using this medication from the start, and if already in use, dosage adjustments or discontinuation may be necessary. This medication is not used in patients with end-stage renal disease or those undergoing dialysis as efficacy cannot be expected. For patients with heart failure classified as mild to moderate (NYHA class I-II), it should be used with caution, whereas its use is not recommended for those with severe heart failure (NYHA class III-IV). When taken alongside insulin or sulfonylureas, the risk of hypoglycemia may increase, so dosage reductions of insulin or secretagogues may be necessary. Attention should be paid to adverse reactions while taking this medication. Hypoglycemia, genital infections, urinary tract infections, increased urination, decrease in fluid volume, interstitial nephritis, and others may occur. Particularly, serious metabolic acidosis known as ketoacidosis might develop, so if symptoms arise, immediate consultation with medical personnel is essential. Elderly patients, particularly those over 75 years old, are at higher risk of fluid loss, thus caution is advised. This medication can affect liver or kidney function; therefore, periodic kidney function tests are required before and during administration. Women who are pregnant are advised to avoid taking this medication, and upon confirmation of pregnancy, discontinuation of use is recommended. Breastfeeding women are advised to cease breastfeeding while taking this medication. This medication has not been established for safety and efficacy in children under 18 years of age, so it should not be used. No specific toxic symptoms have been reported in the event of overdose; however, in case of overdose, immediate consultation with a medical institution for appropriate treatment is necessary. This medication may interact with other drugs, particularly with diuretics, insulin, and sulfonylureas, thus caution is needed when co-administered. While taking this medication, patients should be careful while driving or operating machinery due to the risk of hypoglycemia. Finally, this medication should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, ketoacidosis, urosepsis, pyelonephritis, rash, necrosis of the perineum, sudden and severe headache, confusion, visual disturbances, paralysis, liver abnormalities (jaundice), profound lethargy, significantly reduced urination, severe generalized edema with elevation of blood pressure, dyspnea or difficulties in breathing, asthma attacks, cough accompanied by respiratory abnormalities and fever

Mild side effects

  • Hypoglycemia
  • vulvovaginitis
  • external genital inflammation
  • balanitis
  • and other genital infections
  • increased urination
  • urinary tract infections
  • fluid volume loss
  • increased blood creatinine
  • decreased glomerular filtration rate
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  • rash
  • itching
  • urination difficulties
  • interstitial nephritis
  • thirst
  • increased serum lipids
  • increased hematocrit
  • headache
  • dizziness
  • drowsiness
  • facial paralysis
  • fatigue
  • peripheral edema
  • facial swelling
  • fever
  • facial swelling
  • chills
  • edema
  • pain

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

Storage

This medication must be stored in an airtight container to prevent exposure to air or moisture, and it is important to maintain storage temperatures between 1 and 30 degrees Celsius. By adhering to these storage conditions, the medication's effectiveness and safety can be well maintained.

Appearance and packaging

Appearance

Light yellow, oval-shaped film-coated tablet with both sides convex

Package unit

10 tablets/box [10 tablets/PTP x 1], 30 tablets/box [10 tablets/PTP x 3], 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.