Medication info
Mglirijeng 10 mg (Empagliflozin)

Mglirijeng 10 mg (Empagliflozin)

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

MFDS item code 202101971 · Approved 2021.03.03 · Insurance code 663608390

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 for both monotherapy and additional combination therapy with insulin or other blood sugar-lowering agents is 10 mg once daily. If additional blood sugar control is needed and tolerance is good, the dosage can be increased to 25 mg once daily. It can be administered regardless of meals, and the tablet should be swallowed whole. If a dose is missed, take it as soon as remembered, but do not take double the dosage in one day.

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

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

  • Type 2 diabetes
  • difficulty in blood sugar control
  • inability to control blood sugar
  • cardiovascular diseases
  • occurrence of cardiovascular events
View approved original text

This medication is used to help control blood sugar in adult patients with type 2 diabetes. It can be effective as monotherapy for blood sugar control, but if necessary, it can be combined with other blood sugar-lowering medications such as Metformin to enhance treatment effects. For instance, combination therapy is recommended for patients who have never used diabetes medications before or are insufficiently controlled with monotherapy. Additionally, combination therapy may be necessary for those not controlled with Metformin monotherapy or in combination with other drugs (such as Pioglitazone, Sulfonylureas, DPP-4 inhibitors, etc.). This medication can also be added for patients who are receiving insulin treatment but still have inadequate blood sugar control. Caution is required when using this medication in patients with cardiovascular diseases, and it should be administered under professional guidance. Therefore, this medication is effectively used to improve blood sugar control in patients with type 2 diabetes.

How to take

Adult dose

The recommended dosage of this medication for both monotherapy and additional combination therapy with insulin or other blood sugar-lowering agents is 10 mg once daily. If additional blood sugar control is needed and tolerance is good, the dosage can be increased to 25 mg once daily. It can be administered regardless of meals, and the tablet should be swallowed whole. If a dose is missed, take it as soon as remembered, but do not take double the dosage in one day.

Precautions

This medication should not be used in certain patients. First, it should not be administered to patients allergic to the active ingredient or components of this medication. Second, it is not suitable for patients with type 1 diabetes or diabetic ketoacidosis. Third, it should not be given to patients with severely impaired kidney function, end-stage renal disease, or those on dialysis. Fourth, it should not be used in patients with genetic lactose intolerance, galactose intolerance, or lactose enzyme deficiency. For patients with some degree of impaired kidney function, this medication should be administered with caution. Especially in patients with a glomerular filtration rate of less than 60 ml/min/1.73m2, it is advisable not to use this medication from the start. Even if the tolerance to this medication is good, the dose should be adjusted or maintained. If the glomerular filtration rate continues to drop below 45 ml/min/1.73m2, this medication should be discontinued. This medication is not expected to be effective in patients with end-stage renal disease or those on dialysis. For patients with heart failure, especially those with mild to moderate (NYHA class I-II) symptoms, caution should be exercised. It is not recommended for severe (NYHA class III-IV) patients due to a lack of clinical trial experience. The risk of hypoglycemia may increase when this medication is used with insulin or sulfonylureas, so the doses of these medications may need to be reduced. Possible adverse reactions that may occur with this medication include hypoglycemia, genital infections (vulvovaginitis, vulvar infections, balanitis, etc.), urinary tract infections, increased urination, skin rash, urticaria, angioedema, decreased fluid volume, increased serum creatinine, etc. Hypoglycemia, in particular, may occur more frequently when used in combination with insulin or sulfonylureas. This medication can potentially cause serious ketoacidosis, so if symptoms such as nausea, vomiting, abdominal pain, fatigue, or shortness of breath appear, you should immediately notify a doctor and undergo a ketone test regardless of blood sugar levels. Elderly patients, especially those over 75 years of age, are at a higher risk of fluid loss, so caution is needed. In situations where fluid loss is a concern, it is advisable to temporarily discontinue this medication. This medication can cause serious infections such as urinary sepsis, pyelonephritis, and necrotizing fasciitis, so if pain or discomfort occurs in the genital or perineal area, consult medical personnel immediately. Additionally, this medication requires caution due to the risk of hypoglycemia when driving or operating machinery. Women who are pregnant or planning to become pregnant are advised not to use this medication, and nursing mothers should discontinue breastfeeding while taking this medication. The safety and efficacy of this medication in children under 18 years of age have not been established. No specific toxicity symptoms have been reported in case of overdose; however, if an overdose is suspected, appropriate treatment should be sought immediately at a medical institution. This medication should be stored out of reach of children, and care should be taken as transferring it to another container may be detrimental to quality.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling (angioedema)
  • ketoacidosis
  • urinary sepsis
  • pyelonephritis
  • necrotizing fasciitis
  • acute kidney injury
  • angioedema
  • necrotizing fasciitis
  • ketoacidosis
Show 15 more
  • urinary sepsis
  • pyelonephritis
  • acute kidney injury
  • angioedema
  • necrotizing fasciitis
  • severe allergic reaction
  • ketoacidosis
  • urinary sepsis and pyelonephritis
  • necrotizing fasciitis
  • angioedema
  • acute cholecystitis
  • autoimmune hepatitis
  • cholelithiasis
  • liver damage
  • acute kidney injury

Mild side effects

  • Hypoglycemia
  • vulvovaginitis
  • vulvar infections
  • balanitis and other genital infections
  • pruritus
  • rash
  • increased urination
  • decreased fluid volume
  • increased serum creatinine
  • decreased glomerular filtration rate
Show 20 more
  • thirst
  • diarrhea
  • nausea
  • gastric ulcer
  • colitis
  • vomiting
  • headache
  • fatigue
  • peripheral edema
  • facial edema
  • fever
  • vascular stent stenosis
  • vascular stent thrombosis
  • constipation
  • dyspepsia
  • abdominal pain
  • dry mouth
  • nasopharyngitis
  • allergic rhinitis
  • cough

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 air or moisture from entering. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow, biconvex, round 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

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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.