Medication info
Mglie Tablets 25 mg (Empagliflozin)

Mglie Tablets 25 mg (Empagliflozin)

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

MFDS item code 202101970 · Approved 2021.03.03 · Insurance code 663608380

Summary

Main use
Blood sugar control for type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dose of this medication is 10 mg once daily for both monotherapy and additional combination therapy with insulin and other hypoglycemic agents. If a patient tolerates this 10 mg dose well and requires additional blood sugar control, the dose may be increased to 25 mg once daily. This medication can be taken regardless of meals, and the tablet should be swallowed whole. If a dose is missed, take it as soon as remembered.

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

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

  • Difficulty in blood sugar control
  • inability to control blood sugar
  • type 2 diabetes
View approved original text

This medication is used to improve blood sugar control in adult patients with type 2 diabetes. Initially, it can be administered as monotherapy, and if blood sugar control is insufficient with monotherapy, it may be used in combination with metformin, pioglitazone, sulfonylureas, insulin, DPP-4 inhibitors, etc. In particular, patients with concomitant cardiovascular disease should be carefully administered according to the specialist's instructions. This medication helps in blood sugar control in conjunction with dietary and exercise therapies and contributes to the improvement of the patient's health.

How to take

Adult dose

The recommended dose of this medication is 10 mg once daily for both monotherapy and additional combination therapy with insulin and other hypoglycemic agents. If a patient tolerates this 10 mg dose well and requires additional blood sugar control, the dose may be increased to 25 mg once daily. This medication can be taken regardless of meals, and the tablet should be swallowed whole. If a dose is missed, take it as soon as remembered.

Precautions

This medication should not be administered to certain patients. Firstly, it should not be used in patients who are allergic to the active ingredient or any of the components of this medication. Additionally, it should not be given to patients with type 1 diabetes or those with diabetic ketoacidosis. Patients with severely impaired kidney function, i.e. glomerular filtration rate below 30 mL/min/1.73m2, end-stage renal disease, or those undergoing dialysis should also not use this medication. Since this medication contains lactose, it should be avoided in patients with lactose intolerance or genetic galactose metabolism disorders. In patients with slightly impaired kidney function, this medication should be administered cautiously. In cases where glomerular filtration rate is less than 60 mL/min/1.73m2, the dosage of this medication may need to be adjusted or discontinued. This medication is not recommended for patients with end-stage renal disease or those on dialysis, as its effects are not expected. Regular monitoring of kidney function before and during treatment is essential. In patients with mild to moderate heart failure, caution should be exercised, and it is not recommended in patients with severe heart failure. This medication may increase the risk of hypoglycemia when used in conjunction with drugs that can cause hypoglycemia such as insulin or sulfonylureas, so dosage adjustments of insulin or these medications may be necessary when used together. Possible adverse reactions that can occur while taking this medication include hypoglycemia, genitourinary infections, urinary tract infections, increased urination, fluid volume depletion, etc. In particular, genitourinary fungal infections may occur more commonly in women, requiring caution. Serious metabolic derangements such as ketoacidosis can rarely occur, so if symptoms such as vomiting, abdominal pain, breathing difficulties, or fatigue appear, immediate consultation with healthcare personnel is required. This medication can lead to fluid loss, so it must be used more cautiously in situations with a risk of dehydration or in elderly patients. Serious urinary tract infections such as urosepsis or pyelonephritis have been reported, so prompt evaluation and treatment are necessary if urinary tract infection symptoms occur. This medication increases the risk of genitourinary fungal infections, so patients with a history of such infections should be monitored closely. There is a risk of hypoglycemia when driving or operating machinery, especially when used in combination with insulin or sulfonylureas. Its use is not recommended during pregnancy, and if pregnancy is confirmed, it should be discontinued. During breastfeeding, it is also advisable to discontinue breastfeeding, as this medication may be excreted in breast milk. It is not used in children under 18 years of age, as safety and efficacy have not been established. In the case of overdose, the patient's condition should be closely monitored, and appropriate treatment should be provided; the effectiveness of removal through dialysis is not known. This medication should be stored out of reach of children, and transferring it to another container is not advisable as it may affect quality.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, ketoacidosis, urosepsis, pyelonephritis, perineal necrosis, severe allergic reactions, severe ketoacidosis, serious urinary infections including urosepsis and pyelonephritis, perineal necrosis, acute kidney injury, liver damage (including jaundice), deep vein thrombosis, acute cholecystitis, autoimmune hepatitis, cholelithiasis, severe rash with high fever, blisters, skin peeling, mucosal pain in the mouth/eyes, thunderclap headache, and other

Mild side effects

Hypoglycemia, vulvovaginitis, vulvar inflammation, balanitis and other genitourinary infections, increased urination, rash, itching, increased serum creatinine, decreased glomerular filtration rate, headache, dizziness, fatigue, facial swelling, peripheral edema, fluid volume depletion, vomiting, diarrhea, indigestion, abdominal pain, dry mouth, fever, vascular stent stenosis, vascular stent thrombosis, otalgia, orthostatic dizziness, anxiety, insomnia, constipation, vulvar pruritus, genital

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. Additionally, it is best to store it at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness safely.

Appearance and packaging

Appearance

Light yellow, biconvex, oval film-coated tablet

Package unit

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.