Medication info

Empagliflozin 25 mg (Empagliflozin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›25mg / 1 tablet
Manufacturer / importer
명문제약(주)
Appearance
Pale yellow, double convex, oval film-coated tablet
Packaging
10 tablets/box [10 tablets/PTPX1], 30 tablets/box [10 tablets/PTPX3], 30 tablets/bottle
Approval status
Active

MFDS item code 202102093 · Approved 2021.03.05

Summary

Main use
Effect of blood sugar control in 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 monotherapy and in combination therapy with other hypoglycemic agents including insulin. If the 10 mg dose is well-tolerated and additional blood sugar control is needed, the dose can be increased to 25 mg once daily. This medication can be administered regardless of meals. The tablet should be swallowed whole. If a dose is missed, take it as soon as you remember.

Ingredients

Manufacturer
명문제약(주)

Efficacy & effects

Effect of blood sugar control in type 2 diabetes and prevention of cardiovascular events

  • Type 2 diabetes
  • difficulty with blood sugar control
  • cardiovascular disease
  • occurrence of cardiovascular events
View approved original text

This medication is used as an adjunct to diet and exercise to assist with blood sugar control in adult patients with type 2 diabetes mellitus. It can be administered as monotherapy, and when blood sugar control is difficult, it is treated in combination with metformin, pioglitazone, sulfonylureas, insulin, or DPP-4 inhibitors. Especially when used in patients with cardiovascular disease, it should be referenced with professional guidelines. This medication helps manage diabetes effectively through optimal blood sugar regulation.

How to take

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and in combination therapy with other hypoglycemic agents including insulin. If the 10 mg dose is well-tolerated and additional blood sugar control is needed, the dose can be increased to 25 mg once daily. This medication can be administered regardless of meals. The tablet should be swallowed whole. If a dose is missed, take it as soon as you remember.

Precautions

This medication should not be administered to certain patients. For example, it should not be used in patients with an allergy to any of its ingredients, type 1 diabetes patients, patients with severe renal impairment, and patients with genetic metabolic disorders such as lactose intolerance. Patients with weak kidneys should use this medication cautiously. Particularly, if kidney function falls below a certain level, dose adjustment may be necessary, or the medication may need to be discontinued. Furthermore, it is not recommended for patients with end-stage renal disease or those undergoing dialysis as its effectiveness cannot be expected. In patients with heart failure, especially those with severe symptoms, the use of this medication is not recommended, and careful administration is necessary in mild cases as well. The risk of hypoglycemia may increase when this medication is used together with insulin or insulin secretagogues, hence, it is necessary to adjust the doses of these medications accordingly. During treatment, hypoglycemia, infections, especially genital infections and urinary tract infections may occur, so symptoms should be monitored closely. Additionally, since this medication can cause fluid loss, patients with symptoms of dehydration or low blood pressure should be monitored more closely. Patients taking this medication should have regular kidney function checks and are recommended to temporarily suspend its use in cases of acute illness or fasting due to surgery. Women who are pregnant or nursing are advised not to use this medication and should discontinue it immediately if pregnancy is confirmed. Safety in children and adolescents has not been established, so it is not used in those under 18 years of age. Although no specific toxic reactions have been reported with overdose, appropriate treatment should be sought based on the clinical status. This medication should be kept out of reach of children and should not be transferred to other containers. This medication may slightly affect the ability to drive or operate machinery, so caution is necessary, especially if there is a risk of hypoglycemia. Finally, it is important to closely monitor for unusual reactions or effects through regular consultations and examinations with healthcare professionals during the treatment.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, ketoacidosis, urinary tract sepsis, pyelonephritis, angioedema, perineal necrosis, sudden and severe headache, confusion, vision disturbances, paralysis, liver dysfunction (yellowing of skin or eyes), severe swelling or urinary abnormalities (significantly reduced urination, generalized severe swelling, high blood pressure), respiratory problems (difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough + fever)

Mild side effects

  • Hypoglycemia
  • genital mycotic infection
  • vulvovaginitis
  • balanitis and other genital infections
  • increased urination
  • rash
  • itching
  • increased blood creatinine levels
  • reduced glomerular filtration rate
  • thirst
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  • decreased fluid volume
  • increased serum lipids
  • interstitial nephritis
  • urination difficulties
  • general and site-specific abnormalities
  • increased serum aminotransferases
  • diarrhea
  • nausea
  • gastric ulcers
  • colitis
  • vomiting
  • ischemic colitis
  • bowel bleeding
  • soft tissue inflammation
  • appendiceal abscess

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to prolong its effectiveness.

Appearance and packaging

Appearance

Pale yellow, double convex, oval film-coated tablet

Package unit

10 tablets/box [10 tablets/PTPX1], 30 tablets/box [10 tablets/PTPX3], 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.