Medication info
Dapagliflozin 10/100mg Tablets

Dapagliflozin 10/100mg Tablets

Prescription medicationTablet
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletSitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
지엘파마(주)
Appearance
Beige oval film-coated tablets
Packaging
30 tablets/PTP [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202204513 · Approved 2022.12.16 · Insurance code 624200070

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication can be administered as 1 tablet once a day, regardless of meals, for patients receiving 100 mg of Sitagliptin and 10 mg of Dapagliflozin. The tablet should be swallowed whole.

Ingredients

Manufacturer
지엘파마(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 is used in conjunction with diet and exercise to effectively improve blood sugar.

Dosage and Administration

Adult dosage

This medication can be administered as 1 tablet once a day, regardless of meals, for patients receiving 100 mg of Sitagliptin and 10 mg of Dapagliflozin. The tablet should be swallowed whole.

Precautions

This medication contains Sitagliptin and Dapagliflozin. Firstly, the Sitagliptin component can rarely cause serious allergic reactions, so if you experience symptoms such as skin rash, difficulty breathing, or swelling of the face or neck, you should stop using it immediately and consult a doctor. Additionally, pancreatitis, which is inflammation of the pancreas, may occur, so if you experience symptoms such as abdominal pain, vomiting, or loss of appetite, you should immediately inform your healthcare provider. This medication is not prescribed for patients with type 1 diabetes or those on hemodialysis. Dapagliflozin can cause a decrease in fluid volume and renal function, so patients with low blood pressure or poor kidney function must assess their fluid status and renal function before use, and during treatment, symptoms of hypotension and kidney function should be monitored continuously. Furthermore, this medication may increase the risk of genital infections and urinary tract infections, so appropriate treatment should be sought if symptoms of infection appear. Diabetic ketoacidosis, a serious metabolic disturbance, can rarely occur, so if you have symptoms such as nausea, vomiting, abdominal pain, or difficulty breathing, you should visit a hospital immediately. Elderly patients or those with liver dysfunction should be cautious with this medication, and if renal function is impaired, dose adjustments may be necessary. Pregnant or breastfeeding women should avoid the use of this medication, and if pregnancy is confirmed, use should be discontinued immediately. Finally, this medication may increase the risk of hypoglycemia when used with other blood-glucose-lowering agents like insulin or sulfonylureas, so dosage adjustments of these medications may be necessary. Lastly, during the use of this medication, adequate hydration should be maintained to prevent dehydration, and caution should be exercised for symptoms of hypoglycemia while driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, anaphylaxis, angioedema, Stevens-Johnson syndrome, exfoliative skin diseases, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory distress accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe reactions.

Mild side effects

  • Dry mouth
  • constipation
  • vomiting
  • headache
  • dizziness
  • weakness
  • hunger
  • itching
  • vaginal discharge
  • hives
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  • cold sweat
  • chest pain
  • fatigue
  • pain
  • swelling
  • foreign body sensation
  • facial pain
  • facial swelling
  • warmth
  • weakness
  • hunger
  • abnormal sensations
  • taste disturbances
  • drowsiness
  • tension headache
  • carpal tunnel syndrome
  • unconsciousness
  • nerve compression
  • neuralgia
  • peripheral neuropathy
  • sleep disturbances
  • fainting
  • tremors
  • dyspepsia
  • diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • discomfort in the abdomen

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 light, and it is safe to store at room temperature between 1°C and 30°C. Storing it this way will help maintain the medication's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Beige oval film-coated tablets

Package unit

30 tablets/PTP [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.