Medication info
Dapaciglo Tablet 10/100 mg (Dapagliflozin Propanediol Hydrate, Sitagliptin Phosphate Hydrate)

Dapaciglo Tablet 10/100 mg (Dapagliflozin Propanediol Hydrate, Sitagliptin Phosphate Hydrate)

Prescription medicationTablet
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletSitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
한국유니온제약(주)
Appearance
Beige oval film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP x3)]
Approval status
Active

MFDS item code 202300176 · Approved 2023.01.09 · Insurance code 665508510

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 sitagliptin 100 mg and dapagliflozin 10 mg, regardless of meals. The tablet must be swallowed whole.

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is suitable as an adjunct to diet and exercise for helping patients with type 2 diabetes control their blood sugar. The combination of sitagliptin and dapagliflozin effectively regulates blood sugar, assisting in diabetes management. Therefore, it is a medication that improves blood sugar levels and contributes to diabetes treatment.

Dosage and Administration

Adult dosage

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

Precautions

This medication contains the ingredients sitagliptin and dapagliflozin and is used for blood sugar control in diabetes patients. First, the sitagliptin component can cause allergic reactions, so if symptoms such as skin rash, angioedema, or anaphylaxis appear, use should be stopped immediately. Additionally, symptoms of acute pancreatitis may occur, so careful monitoring for abdominal pain, vomiting, fever, and other symptoms during taking this medication is required. Second, this medication should not be administered to patients with type 1 diabetes, diabetic ketoacidosis, or those undergoing dialysis. Third, the dapagliflozin component may lead to reduced body fluid levels and renal function impairment, thus caution is required in patients with impaired kidney function, elderly patients, and those on diuretics. Regular assessments of fluid status and renal function before and during administration are necessary. Fourth, there may be an increased risk of genital and urinary tract infections while taking this medication, so if symptoms of infection occur, medical consultation should be sought immediately. Fifth, symptoms of hypoglycemia may occur, so especially when taken with insulin or sulfonylureas, blood sugar levels should be frequently checked, and appropriate measures should be taken to prevent hypoglycemia. Sixth, this medication can cause severe metabolic abnormalities such as ketoacidosis. If symptoms such as nausea, vomiting, abdominal pain, or difficulty breathing occur, medical personnel should be notified immediately. Seventh, it is advisable that women who are pregnant or breastfeeding avoid using this medication, especially during breastfeeding, as it may be transmitted through breast milk. Eighth, elderly individuals may experience reduced kidney function, thus dosage adjustments and regular renal function assessments are necessary. Finally, while this medication does not affect driving or machine operation, caution is necessary due to the risk of hypoglycemia. Consult with a physician or pharmacist thoroughly before and during the use of this medication, and seek immediate professional help if abnormal symptoms appear.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), anaphylaxis, angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/eye mucosa, severe dermatological reactions, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe headache, lightning headache, seizures

Mild side effects

  • Hypoglycemia
  • dizziness
  • dry mouth
  • constipation
  • back pain
  • polyuria
  • nocturia
  • genital itching
  • urinary itching
  • increased hematocrit
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  • elevated serum creatinine
  • increased serum urea
  • weight loss
  • urinary tract infections
  • headache
  • indigestion
  • nausea
  • diarrhea
  • vomiting
  • abdominal pain
  • upper respiratory infections
  • nasopharyngitis
  • chest pain
  • fatigue
  • pain
  • edema
  • itching
  • hives
  • cold sweat
  • dizziness
  • increased serum triglycerides

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and it is safely stored at room temperature between 1 to 30 degrees Celsius. Therefore, avoid extremely hot or cold places, and it is best to keep it in a cool place that is not exposed to direct sunlight.

Appearance and packaging

Appearance

Beige oval film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP x3)]

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.