Medication info

Dapagliflozin and Sitagliptin Tablet 10/100 mg

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletSitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
대원바이오텍주식회사
Appearance
Beige oval film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP X 3)]
Approval status
Approval withdrawn

MFDS item code 202300472 · Approved 2023.02.07

This product's status changed to Approval withdrawn on 2026.01.08. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication can be administered as one tablet once daily to patients taking 100 mg of sitagliptin and 10 mg of dapagliflozin, regardless of meals. The tablet should be swallowed whole.

Ingredients

Manufacturer
대원바이오텍주식회사

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication works by combining sitagliptin and dapagliflozin to more effectively aid in blood sugar control for patients with type 2 diabetes who are also following a diet and exercise regimen. In other words, this medication is used as an adjunct to improve blood sugar levels and help with diabetes management.

Dosage and Administration

Adult dosage

This medication can be administered as one tablet once daily to patients taking 100 mg of sitagliptin and 10 mg of dapagliflozin, regardless of meals. The tablet should be swallowed whole.

Precautions

This medication should not be used in patients who are allergic to certain ingredients or have previously experienced serious allergic reactions such as anaphylaxis or angioedema. There may be a risk of acute pancreatitis symptoms during treatment with this medication, so if symptoms such as abdominal pain or vomiting arise after taking it, immediate consultation with a doctor is necessary. Patients with type 1 diabetes, diabetic ketoacidosis, or those undergoing dialysis should not take this medication. Caution should be exercised in patients with reduced kidney function or low fluid volume, and blood pressure, kidney function, and fluid status should be closely monitored before and during administration. While this medication assists in blood sugar control, it may be less effective in patients with severely impaired kidney function; caution is required. There is an increased risk of genital and urinary tract infections during treatment, so rapid treatment should be sought if infection symptoms appear. There is a risk of hypoglycemia, so attention should be paid to hypoglycemic symptoms if taken with diabetes medications such as insulin or sulfonylureas, and dose adjustments may be necessary. Elderly patients or those with liver impairment may be more affected by this medication, so consultation with a doctor prior to administration and regular checks of kidney function are recommended. It is advisable for pregnant or breastfeeding women to avoid taking this medication, and if pregnancy is confirmed, it should be discontinued. Caution is needed while driving or operating machinery, especially if hypoglycemic symptoms occur. There is no specific antidote in case of overdose, so receiving appropriate treatment based on symptoms is crucial. Finally, the safety and efficacy of this medication have not been established in children, so it should not be administered to those under 18 years of age.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, anaphylaxis, angioedema, exfoliative skin disease, Stevens-Johnson syndrome, acute pancreatitis, fatal/non-fatal hemorrhagic or necrotizing pancreatitis, severe allergic reactions, severe skin adverse reactions, respiratory issues, liver abnormalities (jaundice), severe neurological symptoms, severe edema or voiding abnormalities, acute renal failure, acute kidney injury, urinary tract

Mild side effects

  • Hypoglycemia
  • dry mouth
  • constipation
  • dizziness
  • back pain
  • polyuria
  • nocturia
  • vulvar itching
  • genital itching
  • increased hematocrit
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  • increased serum creatinine
  • dyslipidemia
  • weight loss
  • dyspepsia
  • nausea
  • diarrhea
  • vomiting
  • upper respiratory infection
  • nasopharyngitis
  • headache
  • peripheral edema
  • myalgia
  • limb pain
  • back pain
  • thrombocytopenia
  • insomnia
  • tinnitus
  • itching
  • hives
  • cold sweat
  • abdominal pain
  • dizziness
  • elevated triglycerides

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 and moisture. Additionally, it is best stored at room temperature between 1 to 30 degrees Celsius, avoiding excessively hot or cold locations.

Appearance and packaging

Appearance

Beige oval film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP X 3)]

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.