Medication info
Empagliflozin and Sitagliptin Tablets 10/100 mg

Empagliflozin and Sitagliptin Tablets 10/100 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›10mg / 1 tabletSitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
Orange round film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202501433 · 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 1 time per day, consisting of 10 mg of empagliflozin and 100 mg of sitagliptin. If well tolerated and additional blood glucose control is needed, the dose may be increased to 25 mg of empagliflozin and 100 mg of sitagliptin 1 time per day. This medication can be taken regardless of meals. Tablets should be swallowed whole. 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 conjunction with meal and exercise therapy to assist adult patients with type 2 diabetes mellitus in controlling blood sugar levels by combining empagliflozin and sitagliptin. It effectively acts on individuals requiring blood sugar management to help improve blood sugar levels. This can lead to positive outcomes in managing diabetes for patients.

How to take

Adult dose

The recommended starting dose of this medication is 1 time per day, consisting of 10 mg of empagliflozin and 100 mg of sitagliptin. If well tolerated and additional blood glucose control is needed, the dose may be increased to 25 mg of empagliflozin and 100 mg of sitagliptin 1 time per day. This medication can be taken regardless of meals. Tablets should be swallowed whole. If a dose is missed, take it as soon as remembered.

Precautions

This medication may rarely cause serious allergic reactions, so if symptoms such as rash, difficulty breathing, or swelling of the face or neck occur, treatment should be stopped immediately and a doctor consulted. Additionally, there is a risk of pancreatitis, which means inflammation of the pancreas, so if symptoms such as abdominal pain, nausea, or vomiting occur, healthcare professionals should be informed right away. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis. Patients with decreased kidney function may experience reduced efficacy or an increased risk of side effects, so regular kidney function tests should be conducted before and during treatment, and it is advisable not to use this medication in cases of severe kidney impairment. During treatment with this medication, there may be a risk of hypoglycemia if combined with other medications that have strong blood sugar-lowering effects, so careful monitoring of blood sugar levels is necessary, and adjustments in the dosage of other medications may be needed. Elderly patients or those prone to reduced fluid volume should be cautious of side effects such as dehydration or hypotension and may also need to temporarily stop taking this medication in cases of fluid loss, especially due to diarrhea or vomiting. This medication may increase the risk of urinary tract infections and genital fungal infections, so prompt treatment should be sought if infection symptoms appear. Care should be taken while driving or operating machinery, particularly in cases of concomitant use with insulin or sulfonylureas to avoid hypoglycemia. Pregnant or breastfeeding women should avoid taking this medication, and if pregnancy is confirmed, immediate consultation with a physician to discontinue use is recommended. This medication is not recommended for children under 18, as its safety and efficacy have not been established. In cases of overdose, there are no specific antidotes, so it is important to receive appropriate treatment based on symptoms. Finally, this medication should be kept out of reach of children, and it is safer not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • anaphylaxis
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • hemorrhagic or necrotizing pancreatitis
  • acute pancreatitis
  • perineal necrosis
  • urosepsis
  • pyelonephritis
Show 14 more
  • acute renal failure
  • elevated liver enzymes
  • liver abnormalities (jaundice)
  • thrombocytopenia
  • rhabdomyolysis
  • worsening renal function
  • heart failure
  • severe hypoglycemia
  • serious arthralgia
  • papular urticaria
  • severe allergic reactions
  • ketoacidosis
  • fever
  • cardiac arrest.

Mild side effects

  • Dyspepsia
  • abdominal pain
  • hyperglycemia
  • inadequately controlled diabetes
  • genital itching
  • vulvar itching
  • vaginal infections
  • weight loss
  • thirst
  • rash
Show 26 more
  • pruritus
  • increased urination
  • hypoglycemia
  • itching
  • diarrhea
  • nausea
  • headache
  • dizziness
  • fatigue
  • peripheral edema
  • swelling
  • chest pain
  • weight gain
  • palpitations
  • anxiety
  • insomnia
  • pain
  • vertigo
  • anemia
  • erectile dysfunction
  • constipation
  • gastritis
  • gastrointestinal disturbances
  • cough
  • difficulty breathing
  • blood pressure changes.

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 advisable to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. This way, the effectiveness of the medication can be safely maintained.

Appearance and packaging

Appearance

Orange round film-coated tablets

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.