Medication info
Dapagliflozin Propanediol Hydrate / Sitagliptin Phosphate Hydrate / Metformin Hydrochloride Colloidal Silicon Dioxide Extended-Release Tablets 5/50/750 mg

Dapagliflozin Propanediol Hydrate / Sitagliptin Phosphate Hydrate / Metformin Hydrochloride Colloidal Silicon Dioxide Extended-Release Tablets 5/50/750 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›6.15mg / 1 tabletSitagliptin Phosphate Hydrate›64.25mg / 1 tabletMetformin Hydrochloride with Colloidal Anhydrous Silica›757.5mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
Bright yellow, oval-shaped, bi-convex extended-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202302018 · Approved 2023.06.30 · Insurance code 671807740

Summary

Main use
Improvement in blood sugar control for Type 2 diabetes
Who takes it
Adults
Adult dose
This medication should be taken once daily at dinner time with food to minimize gastrointestinal side effects caused by metformin hydrochloride. For the 10/100/1000 mg extended-release tablet, take 1 tablet once daily. For the 5/50/500 mg, 5/50/750 mg, and 5/50/1000 mg extended-release tablets, take 2 tablets once daily. To maintain the extended-release characteristics, do not split, crush, or chew the tablets.

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

Improvement in blood sugar control for Type 2 diabetes

View approved original text

This medication is used to help control blood sugar levels in patients with Type 2 diabetes. It works in combination with dapagliflozin, sitagliptin, and metformin to support dietary practices and exercise regimens. Through this, it helps manage blood sugar levels effectively. Patients can expect positive effects on blood sugar control if they take the medication consistently.

How to take

Adult dose

This medication should be taken once daily at dinner time with food to minimize gastrointestinal side effects caused by metformin hydrochloride. For the 10/100/1000 mg extended-release tablet, take 1 tablet once daily. For the 5/50/500 mg, 5/50/750 mg, and 5/50/1000 mg extended-release tablets, take 2 tablets once daily. To maintain the extended-release characteristics, do not split, crush, or chew the tablets.

Precautions

This medication contains three active ingredients: sitagliptin, dapagliflozin, and metformin. Firstly, sitagliptin may rarely cause serious allergic reactions, so if any symptoms like rash, difficulty breathing, or swelling of the face or lips occur within three months of taking it, you should stop taking the medication immediately and consult a doctor. Additionally, acute pancreatitis, a serious side effect characterized by inflammation of the pancreas, has been reported, and you should seek medical attention immediately if you experience abdominal pain or vomiting. Next, dapagliflozin increases the excretion of sugar through urine, and patients with low blood pressure or dehydration are at risk of hypotension and deterioration of renal function, so caution is required. Also, genital infections and urinary tract infections may occur frequently, so it is important to maintain cleanliness and notify healthcare professionals immediately if fever or pain occurs. Rarely, necrotizing fasciitis may develop, characterized by pain, swelling, and redness in the perineum, necessitating prompt medical treatment. Metabolic disturbances such as ketoacidosis may occur, so if you experience symptoms such as nausea, vomiting, abdominal pain, or shortness of breath, you should seek medical attention immediately. Metformin may accumulate in patients with impaired renal function, posing a risk for lactic acidosis, a serious metabolic disorder, so regular renal function tests are necessary. Gastrointestinal disturbances can occur frequently, and excessive alcohol consumption should be avoided, as it can be hazardous. Additionally, vitamin B12 deficiency may occur; hence, blood tests during long-term use are necessary. This medication should not be administered to patients with moderate to severe renal impairment, acute heart failure, acute myocardial infarction, severe infections, dehydration, or hepatic dysfunction. Patients scheduled for surgery should discontinue the medication 48 hours before the procedure and can only resume once renal function is confirmed to be normal. During treatment, patients should be attentive to signs of hypoglycemia, and the risk of hypoglycemia may increase when combined with other blood glucose-lowering agents. If volume depletion is suspected, consult a doctor immediately and consider temporarily halting the medication if necessary. If any unusual symptoms or discomfort occur while taking this medication, it is essential to notify healthcare professionals immediately for appropriate evaluation.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe hypersensitivity reactions, anaphylaxis, angioedema, Stevens-Johnson syndrome, exfoliative skin disease, fatal or non-fatal hemorrhagic pancreatitis, necrotizing pancreatitis, acute pancreatitis, lactic acidosis, severe allergic reactions, severe rash with fever, blistering, skin peeling, mucosal pain in mouth/eyes, severe skin abnormal reactions, or difficulty breathing

Mild side effects

  • Hypoglycemia
  • dizziness
  • constipation
  • thirst
  • back pain
  • pain during urination
  • frequent urination
  • nocturia
  • vulvar itching
  • genital itching
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  • headache
  • indigestion
  • nausea
  • diarrhea
  • vomiting
  • urticaria
  • cold sweat
  • pruritus
  • weakness
  • chest pain
  • fatigue
  • pain
  • swelling
  • foreign body sensation
  • facial swelling
  • facial pain
  • warmth
  • irregular menstruation
  • vaginal discharge
  • hair loss
  • dermatitis
  • dry skin
  • allergic dermatitis
  • contact dermatitis
  • excessive sweating eczema
  • coin-shaped eczema

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture exposure. Additionally, it should be kept away from direct sunlight and stored at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Bright yellow, oval-shaped, bi-convex extended-release film-coated tablet

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.