Medication info
Empagliflozin and Sitagliptin Tablet 25/100 mg

Empagliflozin and Sitagliptin Tablet 25/100 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›25mg / 1 tabletSitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
Beige colored round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202501434 · Approved 2025.06.12

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
The recommended starting dose of this medication is 10 mg of empagliflozin and 100 mg of sitagliptin once daily. If there is tolerance and additional blood sugar control is required, the dose may be increased to 25 mg of empagliflozin and 100 mg of sitagliptin once daily. It should be administered at the existing dosage, irrespective of meals. The tablet should be swallowed whole, and if a dose is missed, take it as soon as remembered.

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used in combination with empagliflozin and sitagliptin to assist adult patients with type 2 diabetes in controlling their blood sugar, alongside dietary and exercise regimens. It helps manage blood sugar levels more effectively.

How to take

Adult dose

The recommended starting dose of this medication is 10 mg of empagliflozin and 100 mg of sitagliptin once daily. If there is tolerance and additional blood sugar control is required, the dose may be increased to 25 mg of empagliflozin and 100 mg of sitagliptin once daily. It should be administered at the existing dosage, irrespective of meals. The tablet should be swallowed whole, and if a dose is missed, take it as soon as remembered.

Precautions

This medication may cause allergic reactions, therefore patients with hypersensitivity should not use it. During the administration of this medication, serious pancreatic symptoms called acute pancreatitis may occur, and if symptoms such as abdominal pain or vomiting arise, immediate consultation with a physician is necessary. Patients with type 1 diabetes or those with diabetic ketoacidosis should not use this medication. Patients with decreased kidney function may experience reduced effectiveness of this medication and an increased risk of side effects, so regular kidney function tests should be conducted, and dose adjustments may be necessary as required. As this medication has a blood sugar-lowering effect, caution is needed when used with other hypoglycemic agents like insulin or sulfonylureas, as the risk of hypoglycemia may increase. Symptoms of dehydration or low blood pressure due to reduced fluid volume may occur, so particularly elderly patients or those with low blood pressure should be closely monitored. There may be an increased risk of urinary tract infections or genital fungal infections, and immediate treatment should be sought if infection symptoms appear. It is important to regularly monitor health status through blood tests and physical examinations while taking this medication. Pregnant or breastfeeding women are advised to avoid the use of this medication and should consult a specialist if necessary. The safety and effectiveness of this medication have not been established in children; therefore, it should not be used in this population. In cases of overdose, immediate medical attention should be sought for appropriate treatment, as it is often not removed by dialysis, requiring caution. Caution is required when driving or operating machinery due to the risk of hypoglycemia, especially when using other hypoglycemic agents in combination. If symptoms such as skin rash, severe joint pain, or blistering skin conditions occur while taking this medication, immediate consultation with a physician is necessary.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis, Stevens-Johnson syndrome, exfoliative skin disease, hemorrhagic or necrotizing pancreatitis, acute pancreatitis, severe allergic reactions, severe dermatological reactions, difficulty breathing, asthma attacks, respiratory problems, liver abnormalities (jaundice), severe neurological symptoms (severe headache, seizures, confusion of consciousness, visual disturbances, paralysis), significant decrease in urine output, generalized severe edema, edema associated with increased blood pressure,

Mild side effects

  • Indigestion
  • abdominal pain
  • hyperglycemia
  • genital pruritus
  • vulvar pruritus
  • vaginal infection
  • weight loss
  • thirst
  • rash
  • gastrointestinal disorders
Show 22 more
  • headache
  • dizziness
  • constipation
  • diarrhea
  • nausea
  • vomiting
  • gastritis
  • upper respiratory infection
  • nasopharyngitis
  • peripheral edema
  • anxiety
  • insomnia
  • musculoskeletal pain
  • myalgia
  • limb pain
  • lower back pain
  • increased serum creatinine
  • decreased glomerular filtration rate
  • increased serum lipids
  • abnormal blood sugar levels
  • blurred vision
  • allergy

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to maintain storage temperature between 1 to 30 degrees Celsius at room temperature to preserve the effectiveness of the medication.

Appearance and packaging

Appearance

Beige colored 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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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.