Medication info
Dapagliflozin and Sitagliptin Tablets 10/100 mg

Dapagliflozin and Sitagliptin Tablets 10/100 mg

Prescription medicationTablet
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›113.4mg / 1 tabletDapagliflozin citric acid›14.7mg / 1 tablet
Manufacturer / importer
일성아이에스(주)
Appearance
Yellow oval film-coated tablet
Packaging
30 tablets/box - 30 tablets/box[(10 tablets/PTP x 3)], 28 tablets/box - 28 tablets/box[(7 tablets/PTP x 4)]
Approval status
Active

MFDS item code 202200489 · Approved 2022.01.28 · Insurance code 655404360

Summary

Main use
Improvement in blood sugar control for type 2 diabetes
Who uses it
Adults
Adult dosage
This medication can be administered to patients receiving sitagliptin 100 mg and dapagliflozin 10 mg once daily, independent of meals, with one tablet taken at a time. The tablet should be swallowed whole.

Ingredients

Manufacturer
일성아이에스(주)

Efficacy & effects

Improvement in blood sugar control for type 2 diabetes

View approved original text

This medication is developed to assist patients with type 2 diabetes in controlling their blood sugar when used alongside diet and exercise. The combination of sitagliptin and dapagliflozin improves blood sugar regulation, allowing for more effective treatment. This medication stabilizes patients’ blood sugar levels and supports blood sugar management in daily life. When used consistently, it can significantly aid in managing diabetes. Therefore, this medication is used for blood sugar control in type 2 diabetes.

Dosage and Administration

Adult dosage

This medication can be administered to patients receiving sitagliptin 100 mg and dapagliflozin 10 mg once daily, independent of meals, with one tablet taken at a time. The tablet should be swallowed whole.

Precautions

This medication may cause allergic reactions; therefore, if symptoms such as skin rashes or difficulty breathing occur after administration, stop taking the medication immediately and consult a doctor. This medication carries a risk of severe pancreatitis, so if symptoms of abdominal pain, nausea, or vomiting appear during treatment, seek medical attention immediately. This medication should not be used in patients with allergies to certain components, type 1 diabetes patients, those with lactose intolerance, and patients undergoing dialysis. Patients with reduced fluid volume or impaired renal function should consult a physician before taking this medication, and should periodically check for symptoms of hypotension or changes in renal function during treatment. This medication may increase the risk of genital and urinary tract infections; therefore, if symptoms of infection occur, immediate treatment should be sought, and patients with a history of infections should use caution. Hypoglycemic symptoms may occur while taking this medication, especially when used in combination with insulin or sulfonylurea, so blood sugar levels should be checked frequently and symptoms closely monitored. Women who are pregnant or planning to become pregnant should avoid using this medication, and nursing women should also refrain from taking it. Elderly patients may experience decreased renal function, so regular renal function testing is recommended before and during treatment with this medication. There is no specific antidote for overdose of this medication; thus, appropriate treatment should be provided according to symptoms, following a doctor's instructions. Precautions should be taken when driving or operating machinery due to the risk of hypoglycemia, especially when combined with other hypoglycemic agents.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), anaphylaxis, angioedema, severe skin reactions, Stevens-Johnson syndrome, acute pancreatitis, fatal/non-fatal hemorrhagic or necrotizing pancreatitis, acute renal failure, worsening renal function, urospesis, pyelonephritis, severe edema, hypertension, headache, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, shortness of breath or difficulty breathing, asthmatic episodes, cough with fever

Mild side effects

  • Hypoglycemia
  • dry mouth
  • constipation
  • dizziness
  • back pain
  • polyuria
  • nocturia
  • itching in the external genitalia
  • itching in the genital area
  • increased hematocrit
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  • decreased creatinine clearance
  • elevated serum creatinine
  • dyslipidemia
  • weight loss
  • vulvovaginitis
  • balanitis
  • fungal infections
  • urinary tract infections
  • paresthesia
  • headache
  • diarrhea
  • vomiting
  • dyspepsia
  • nausea
  • fever
  • foreign body sensation
  • facial edema
  • facial pain
  • warmth
  • flu-like symptoms
  • menstrual issues

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

Storage

This medication can be sensitive to air or humidity, so it should be stored in a tightly sealed container. It is best to keep it at room temperature between 1°C and 30°C. This helps maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets/box - 30 tablets/box[(10 tablets/PTP x 3)], 28 tablets/box - 28 tablets/box[(7 tablets/PTP x 4)]

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.