Medication info
Dapagliflozin Propanediol Hydrate / Sitagliptin Phosphate Hydrate / Metformin Hydrochloride Extended-release Tablet 10/100/1000 mg

Dapagliflozin Propanediol Hydrate / Sitagliptin Phosphate Hydrate / Metformin Hydrochloride Extended-release Tablet 10/100/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletSitagliptin Phosphate Hydrate›128.5mg / 1 tabletMetformin Hydrochloride with Colloidal Anhydrous Silica›1010mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
Extended-release film-coated tablet, oval shape, double convex, with a deep yellow color
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202301622 · Approved 2023.05.22 · Insurance code 671807690

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
To reduce gastrointestinal adverse reactions caused by metformin hydrochloride, this medication is taken once daily with the evening meal. Patients taking this 10/100/1000 mg extended-release tablet should take one tablet once daily. Patients taking the 5/50/500 mg, 5/50/750 mg, and 5/50/1000 mg extended-release tablets should take two tablets once daily. Metformin hydrochloride

Ingredients

Manufacturer
대원제약(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 when used in combination with dapagliflozin, sitagliptin, and metformin. It assists in effectively managing blood sugar levels along with dietary and exercise therapies, suitable for patients who find it difficult to control blood sugar levels. Taking this medication contributes to stabilizing blood sugar levels, having a positive impact on diabetes management.

How to take

Adult dose

To reduce gastrointestinal adverse reactions caused by metformin hydrochloride, this medication is taken once daily with the evening meal. Patients taking this 10/100/1000 mg extended-release tablet should take one tablet once daily. Patients taking the 5/50/500 mg, 5/50/750 mg, and 5/50/1000 mg extended-release tablets should take two tablets once daily. Metformin hydrochloride

Precautions

This medication is a combination product containing sitagliptin, dapagliflozin, and metformin, each of which has specific precautions. First, sitagliptin can rarely cause serious allergic reactions, including anaphylaxis, angioedema, and severe skin disorders. If such symptoms occur, stop taking the medication immediately and seek medical attention. Additionally, sitagliptin can lead to acute pancreatitis, so if abdominal pain or vomiting, which are signs of pancreatitis, appears during treatment, discontinue use and visit a hospital immediately. Next, dapagliflozin may cause decreased body fluids and low blood pressure, so patients with impaired kidney function, elderly patients, or those taking diuretics should regularly monitor their blood pressure and kidney function before and during use. This medication may increase the risk of urinary tract infections and genital infections, so appropriate treatment should be obtained if any infection symptoms appear. Patients with a history of infections should exercise additional caution. Moreover, dapagliflozin can lead to diabetic ketoacidosis, even when blood sugar levels are not significantly elevated, so if symptoms such as vomiting, abdominal pain, or difficulty breathing occur, consult healthcare professionals immediately. Patients with severely impaired kidney function, acute or chronic metabolic acidosis, serious infections, or congestive heart failure should not take this medication. Metformin can rarely cause severe lactic acidosis, which can be life-threatening; therefore, patients with reduced kidney function or those at risk due to cardiopulmonary disease or sepsis should avoid taking it. Gastrointestinal side effects (nausea, vomiting, diarrhea, etc.) are common with metformin, and vitamin B12 deficiency can occur, so regular blood testing is recommended. During the course of this medication, irregular meals, excessive exercise, the use of other hypoglycemic agents, and excessive alcohol intake can increase the risk of hypoglycemia, so caution is advised. Patients scheduled to undergo a radiographic iodine contrast procedure should discontinue the use of this medication for a specified period before and after the test and avoid re-administration until kidney function has recovered. Pregnant patients, patients with impaired liver function, and patients with severe infections or cardiovascular collapse should use this medication with caution. Finally, if skin rashes, severe joint pain, blistering skin disorders, pain or swelling around the perineum occur during the use of this medication, consult a physician immediately and discontinue use if necessary.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rashes with high fever, blisters, skin shedding, mucosal pain in the mouth/eyes, severe skin abnormalities, shortness of breath or difficulty breathing, asthma attack, coughing with fever and respiratory abnormalities, jaundice (yellowing of skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and very severe

Mild side effects

  • Itching
  • urticaria
  • cold sweat
  • hypoglycemia
  • dizziness
  • thirst
  • constipation
  • vomiting
  • headache
  • weight loss
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  • dysuria
  • polyuria
  • nocturia
  • vulvar itching
  • genital itching
  • dyslipidemia
  • increased hematocrit
  • elevated serum creatinine
  • urinary tract infection
  • upper respiratory tract infection
  • nasopharyngitis
  • weakness
  • pain
  • swelling
  • foreign body sensation
  • facial swelling
  • facial pain
  • warmth
  • flu-like symptoms
  • chest pain
  • fatigue
  • vaginal discharge
  • menstrual irregularities
  • bleeding

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

Storage

This medication must be stored in a tightly closed container to prevent exposure to air and moisture. The appropriate storage temperature is room temperature between 1 to 30 degrees Celsius, and it should be kept away from extremely hot or cold places.

Appearance and packaging

Appearance

Extended-release film-coated tablet, oval shape, double convex, with a deep yellow color

Package unit

30 tablets/bottle

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.