Medication info
Dapazine SDUO Tablet 10/100 mg (Dapagliflozin, Sitagliptin)

Dapazine SDUO Tablet 10/100 mg (Dapagliflozin, Sitagliptin)

Prescription medicationTablet
Ingredient · strength
Dapagliflozin Bis L-proline›15.63mg / 1 tabletSitagliptin Phosphate Hydrate›128.48mg / 1 tablet
Manufacturer / importer
경동제약(주)
Appearance
White oblong film-coated tablets
Packaging
28 tablets/box [(7 tablets/PTP) X 4]
Approval status
Active

MFDS item code 202301844 · Approved 2023.06.15 · Insurance code 648104910

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
Administer one tablet containing 100 mg of sitagliptin and 10 mg of dapagliflozin once daily, regardless of meals. The tablet should be swallowed whole.

Ingredients

Manufacturer
경동제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication helps control blood sugar levels in patients with type 2 diabetes by using sitagliptin and dapagliflozin together. It aids in effectively managing blood glucose levels in conjunction with dietary and exercise regimens. This contributes to the prevention of diabetes complications and maintaining a healthy lifestyle.

Dosage and Administration

Adult dosage

Administer one tablet containing 100 mg of sitagliptin and 10 mg of dapagliflozin once daily, regardless of meals. The tablet should be swallowed whole.

Precautions

This drug may cause severe allergic reactions due to the sitagliptin component, so it should be discontinued immediately if symptoms such as skin rash, angioedema, or difficulty breathing occur within three months of administration. Additionally, acute pancreatitis may occur, so if symptoms like abdominal pain, nausea, or vomiting arise, prompt consultation with a healthcare provider is advised. This drug should not be used in patients with allergies to the active ingredient or excipients, patients with type 1 diabetes, patients with a genetic lactose intolerance, and patients undergoing dialysis. It should be administered cautiously in patients with reduced fluid volume or kidney function impairment, especially elderly patients or those on diuretics, as they may have a higher risk of lowering blood pressure and kidney damage. The blood sugar control effect may vary based on kidney function, and it is not recommended for patients with severe kidney impairment. This medication may increase the risk of genital infections and urinary tract infections, so patients should receive immediate treatment if symptoms of infection appear, and those with a history of infections should be more vigilant. There is a risk of hypoglycemia; therefore, dose adjustment may be necessary when used in combination with insulin or sulfonylureas. Furthermore, weight loss may occur, and it is crucial to regularly assess kidney function in elderly patients. Use during pregnancy is not recommended, and administration should be avoided while breastfeeding. In case of overdose, there is no specific antidote, so symptomatic treatment is necessary, and emergency medical attention should be sought in severe cases. While taking this medication, caution is required for symptoms of hypoglycemia when driving or operating machinery. Finally, this medication should be kept out of the reach of children, and proper storage conditions should be maintained to preserve product quality.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweats, pallor, severe allergic reactions, severe rash with fever, blisters, skin desquamation, pain in the oral/eye mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory distress with cough and fever, respiratory issues, jaundice (yellowing of the skin or eyes), severe lethargy, liver dysfunction (jaundice), sudden

Mild side effects

  • Vulvovaginal candidiasis
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infections
  • hypoglycemia
  • decreased fluid volume
  • thirst
  • constipation
  • dry mouth
  • back pain
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  • dysuria
  • polyuria
  • nocturia
  • increased hematocrit
  • dyslipidemia
  • weight loss
  • dizziness
  • pruritus
  • headache
  • itching
  • cold sweats
  • edema
  • fever
  • foreign body sensation
  • facial edema
  • facial pain
  • warmth
  • flu-like symptoms
  • anxiety disorder
  • nocturnal enuresis
  • decreased appetite
  • increased appetite
  • dyspepsia
  • nausea

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture, and it is best kept at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

White oblong film-coated tablets

Package unit

28 tablets/box [(7 tablets/PTP) X 4]

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.